News

RELY-ABLE trial shows long-term safety profile of Pradaxa (Boehringer) in patients with Atrial Fibrillation

Results from the RELY-ABLE trial, a long-term extension of the pivotal RE-LY study of Pradaxa (dabigatran etexilate), from Boehringer, in patients with non-valvular Atrial Fibrillation (NVAF), reinforces the drug's profile with encouraging long-term safety results. Patients enrolled in RELY-ABLE continued Pradaxa therapy dosing, bringing the mean duration of treatment to 4.3 years. A total of 5,851 patients participated in the ...

TRANSFORMS study of Gilenya (Novartis) shows sustained improvements in patients with Multiple Sclerosis

Two new analyses from the pivotal Phase III TRANSFORMS study of Gilenya (fingolimod), from Novartis, show early and sustained improvements in disease activity in patients with relapsing remitting Multiple Sclerosis. After switching from interferon to fingolimod, the proportion of patients who were disease activity free increased by almost 50% (from 44.3% to 66.0%) between the end of years one and ...

Phase III study of Avastin (Genentech/Roche) in Brain Cancer patients fails to reach primary endpoints

A Phase III trial of Avastin (bevacizumab), from Genentech/Roche, shows the drug failed to reach its primary endpoints - increase overall survival (OS) or statistically significant progression-free survival (PFS) - for glioblastoma patients in the frontline setting. The randomized, double-blind, placebo-controlled study registered 978 and enrolled 637 patients, respectively, all of whom were newly diagnosed with glioblastoma. Participants underwent surgery, ...

Study shows Multiple Sclerosis patients taking Gilenya (Novartis) show high levels of satisfaction with the drug

People with relapsing Multiple Sclerosis (MS) reported greater treatment satisfaction after starting the oral treatment Gilenya (fingolimod), from Novartis, vs. switching to, or staying on, injectable interferon beta or glatiramer acetate, according to new study data. The US Phase IV randomized, multi-center, open-label study, called EPOC evaluated treatment satisfaction among more than 1,000 patients. At six months, adjusted mean treatment ...

Guide DBS System (Boston Scientific) receives CE Mark

Boston Scientific Corporation has received CE Mark approval for use of the Guide DBS System, the world's first deep brain stimulation (DBS) visualization system for the treatment of Parkinsons Disease.

Guide DBS provides clinicians with 3D visualization information that simulates stimulation output, which may reduce programming time and enable more precise targeting of therapy. With Guide DBS, physicians are able ...

Merck Inc discontinues preladenant for Parkinsons disease

An initial review of data at Merck Inc.,from three separate Phase III trials for treatment of Parkinsons disease did not provide evidence of efficacy for preladenant compared with placebo.Based on these results, Merck is taking steps to discontinue the extension phases of these studies and no longer plans to pursue regulatory filings for preladenant. The decision to discontinue these ...

Bexarotene unlikely to have effect on Alzheimers plaque

Researchers, who included Dr. Rudolph Tanzi of Massachusetts General Hospital in Boston and Dr. David Holtzman of Washington University School of Medicine, wanted to see if the stunning results, reported last year in Science journal related to the effect of bexarotene on Alzheimers plaque, could be replicated in their own labs, a standard part of the scientific process.

The ...

Phase III study of USL 255 (Upsher Smith Labs) shows success for Epilepsy treatment

A global Phase III clinical trial for USL 255 (extended-release topiramate), from Upsher Smith Labs, or the management of Epilepsy in adults, has been successfully completed. In the randomized, multicenter, double-blind, placebo-controlled PREVAIL study, USL 255 demonstrated a positive treatment effect as adjunctive therapy in patients with refractory partial-onset seizures (POS) compared with placebo. USL 255 had a statistically significant ...

Biogen files Plegridy at FDA for treatment of relapsing Multiple Sclerosis

Biogen Idec has announced it has submitted a Biologics License Application (BLA) to the FDA for approval of Plegridy (peginterferon beta-1a), the company’s pegylated subcutaneous injectable candidate for relapsing forms of Multiple Sclerosis.

This regulatory submission was based on the results from the first year of the two-year global Phase III ADVANCE study. The data demonstrated that Plegridy met ...

SAR 302503 (Sanofi) successs in JAKARTA study of Myelofibrosis

Sanofi has announced that the pivotal study, JAKARTA, examining the selective JAK2 inhibitor SAR 302503 for Myelofibrosis versus placebo in 289 patients, met its primary endpoint in both dose groups. The primary endpoint assessed the proportion of patients achieving >35% reduction of spleen volume. Consistent with data reported in previous trials, the most common adverse events were anemia, diarrhea, ...

FDA approves Nymalize (Arbor Pharmaceuticals) for Sub Arachnoid Haemorrhage

The FDA has approved the New Drug Application (NDA) for Nymalize (nimodipine) oral solution, from Arbor Pharmaceuticals, for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with Sub Arachnoid Haemorrhage. It is the only nimodipine oral solution indicated for the improvement of neurological outcome in adult patients with SAH. The company ...

Succesful Phase III studies with Fycompa (Eisai) for Epilepsy published in Epilepsia

Data from three pivotal Phase III clinical studies of Fycompa (perampanel), from Eisai, shows the drug reduced partial Epilepsy seizure frequency and improved responder rates compared to placebo. The pooled analysis of nearly 1,500 patients in Study 304, 306 and 307 showed that median reductions in partial seizure frequency were greater with perampanel 4 mg (-23·3%), 8 mg (-28·8%), and ...

Two analyses show Fycompa (Eisai) effective for Epilepsy

Two new analyses on clinical experience with Fycompa (perampanel), from Eisai, show it is effective and well tolerated in patients with difficult-to-treat partial Epilepsy. The results describe the first real life experiences of perampanel as an adjunctive therapy. In the first study, on 45 patients followed up for at least six months, 47% had a reduction in seizure frequency of ...

PROTECT-AF trial of Watchman LAAC (Boston Scientific) successful for Stroke Prevention

Four-year follow-up data from the PROTECT AF clinical trial demonstrated the Watchman Left Atrial Appendage (LAA) Closure device, from Boston Scientific, was statistically superior to warfarin for preventing cardiovascular death, all-cause Stroke and systemic embolization. The data demonstrated significant reductions in both cardiovascular and all death compared to warfarin.

The observed primary efficacy event rate was 2.3 percent and 3.8 ...

Immunoglobulin (Baxter) fails Phase III study for treatment of Alzheimers disease

Baxter International Inc. has announced that its Phase III clinical study of immunoglobulin (IG) did not meet its co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease. The Gammaglobulin Alzheimer's Partnership (GAP) study was conducted by Baxter in collaboration with the Alzheimer's Disease Cooperative Study (ADCS), a clinical trial consortium ...

Early prediction of Epileptic seizures study from NeuroVista

The Seizure Advisory System from NeuroVista is an implantable device that has successfully and correctly predicted epilepsy seizures in some adults for whom drugs have not worked. A proof of concept study, performed by researchers at the University of Melbourne in Australia, involved 15 patients with an implant of electrodes between the skull and surface of the brain that ...

Phase IIb study with STX 209 (Seaside Therapeutics) reports on efficacy in Autism Spectrum Disorder

Study 209AS208 is a randomized, double-blind, placebo-controlled Phase IIb study which , evaluated the safety, tolerability, and efficacy of STX 209 ( arbaclofen) from Seaside Therapeutics, in 150 subjects (age 5 to 21 years) with Autism Spectrum Disorder (ASD), with a particular focus on the core impairments of social function.

Patients were randomized to receive either arbaclofen or placebo ...

FDA approves Vyvanse (Shire) as maintenance treatment of ADHD for children and adolescents

The FDA has on 1 May 2013, approved the prescription medication Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) from Shire ,as a maintenance treatment in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Vyvanse is currently approved as a maintenance treatment in adults with ADHD. With this new approval, Vyvanse becomes the only stimulant approved for maintenance treatment in children, adolescents, and ...

CHMP recommends approval of Nuedexta (Avanir Pharma) for Pseudo Bulbar Affect

The EMA's CHMP has adopted a positive opinion for Nuedexta (dextromethorphan hydrobromide and quinidine sulphate), from Avanir Pharma, recommending it be approved for the treatment of Pseudo Bulbar Affect (PBA), irrespective of neurologic cause. In addition, the CHMP also recommended approval of two dose strengths; 20/10 mg and 30/10 mg capsules.

The drug has been tested in the Phase III ...

Phase II study of CERE 120 (Ceregene) for Parkinsons fails to reach primary endpoint

Top-line data from a double-blind, randomized, controlled Phase IIb clinical study of CERE 120 (AAV-neurturin), from Ceregene, for Parkinson's disease failed to demonstrate statistically significant efficacy on its primary endpoint. Fifty-one patients with moderately advanced Parkinson's disease which could not be controlled with conventional medication were enrolled. Approximately half received CERE 120 while the other half received sham (placebo) surgery. ...

EU approves Brio/Libra/LibraXP deep brain stimulation systems (St Jude Medical) for Dystonia

The EU has given CE Mark approval of the Brio, Libra and LibraXP deep brain stimulation (DBS) systems, from St Jude Medical, for managing the symptoms of intractable primary and secondary Dystonia, a neurological movement disorder that causes involuntarily spasm. This approval represents the first by a regulatory agency for the use of deep brain stimulation to manage both primary ...

SELECT study of daclizumab High Yield (Biogen) for MS published in The Lancet

Biogen Idec has announced that results from the daclizumab high-yield process (DAC HYP) SELECT clinical trial have been published as an online article in The Lancet. SELECT was a Phase IIb study designed to determine the efficacy and safety of DAC HYP in patients with relapsing-remitting multiple sclerosis.

Published results demonstrate that both 150 mg and 300 mg subcutaneous ...

Phase III success for Cymbalta (Eli Lilly) for Peripheral Neuropathy

Daily Cymbalta( duloxetine) therapy from Eli Lilly, was effective and well-tolerated for the treatment of painful Chemotherapy-induced Peripheral Neuropathy (CIPN), according to a randomized, double-blind, placebo-controlled Phase III trial presented at the 2012 American Society of Clinical Oncology Annual Meeting.

Patients were randomized to receive duloxetine followed by placebo (n=115) or placebo followed by duloxetine (n=116); initial crossover periods for ...

Revance Therapeutics to initiate Phase III trial for RT 001 for treatment of Facial Wrinkles

Revance Therapeutics inc has secured the funding necessary to initiate a Phase III trial for Botulinum Toxin Type A Topical Gel for the treatment of facial wrinkles (crows feet) that is intended to compete with injected therapies such as Botox.

RT 001 is also currently in Phase II trials for the topical treatment of hyperhidrosis (excessive sweating), and chronic migraine ...

IQWiG report on Eliquis (BMS/Pfizer) for Stroke Prevention associated with Atrial Fibrillation

The Institute for Quality and Efficiency in Healthcare (IQWiG)in Germany said that Eliquis (apixaban) from BMS and partner Pfizer Inc.has "significant" additional benefit to prevent Stroke and Systemic Embolism in adults with non-valvular atrial fibrillation (AF) with one or more risk factors -- an indication approved by the European Commission in November.

IQWiG said Eliquis provides "significant" additional ...

Phase II data shows CNV 1014802 (Convergence Pharmaceuticals) provides benefits for patients with Trigeminal Neuralgia

Interim data from the Phase II trial of CNV 1014802, from Convergence Pharmaceuticals, in patients with Trigeminal Neuralgia shows that the drug has a positive pharmacokinetic and safety profile for this pain condition. Eligible patients were entered into a 3-week open-label treatment period with CNV 1014802 at a dose of 150mg three times a day. If a successful response was ...

FDA approves Tecfidera (Biogen IDEC) to treat relapsing Multiple Sclerosis

Biogen Idec has announced that the FDA has on 27 March 2013, approved Tecfidera (dimethyl fumarate), a new first-line oral treatment for people with relapsing forms of Multiple Sclerosis .

The FDA approval of Tecfidera is based on data from a robust clinical development program that included DEFINE and CONFIRM, two global Phase III studies that enrolled more than 2,600 ...

Lundbeck and Otsuka collaborate on Lu AE 58054 as a treatment for Alzheimers disease

Lundbeck A/S and Otsuka Pharmaceutical company have announced a license and development agreement for Lu AE 58054, for the treatment of Alzheimer's disease. Under the terms of the agreement, Lundbeck will grant Otsuka co-development and co-commercialization rights to Lu AE58054 in the U.S., Canada, East Asia including Japan, major European countries and Nordic countries.

The pivotal clinical program with ...

Gilenya (Novartis) decreases brain volume loss in Multiple Sclerosis patients

Gilenya (fingolimod), from Novartis, is the only approved treatment shown to consistently decrease brain volume loss in Multiple Sclerosis patients. Brain volume loss is the best magnetic resonance imaging correlate of long-term disability.

New data presented at the recent 65th Annual Meeting American Academy of Neurology 2013, showed that Gilenya reduced the rate of brain volume loss by ...

CHMP recommends Xarelto (Bayer) for prevention of atherosclerotic events after ACS

The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice-daily in combination with standard antiplatelet therapy for the prevention of atherothrombotic events (myocardial infarction, cardiovascular death or stroke) after an Acute Coronary Syndrome (ACS) in adult patients with elevated cardiac biomarkers. Elevated cardiac biomarkers confirm the ...

Study shows Neupro (UCB) improves GI symptoms in Parkinsons patients

A study shows that when Parkinson's disease (PD) patients are switched from an oral PD medication to Neupro (Rotigotine Transdermal System), from UCB, they reported improvements in pre-existing gastrointestinal symptoms (GI) symptoms. Primary efficacy outcomes included changes in GI symptoms (measured by a visual analogue scale) and the sum score of GI complaints (six items each rated 0-12), in addition ...

CHMP recommends Aubagio (Sanofi/Genzyme) for Multiple Sclerosis

Sanofi and its subsidiary Genzyme have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of once-daily, oral Aubagio (teriflunomide) for the treatment of adult patients with relapsing-remitting Multiple Sclerosis (MS). The CHMP did not recommend that Aubagio receive a new active substance ...

New analysis shows Gilenya (Novartis) offers significant benefits in Multiple Sclerosis over four years of treatment

Analysis of three Phase III trials shows Gilenya (fingolimod), from Novartis, offers significant benefits in patients with Multiple Sclerosis after four years of treatment. A new analysis of over 3,600 patients from three large Phase studies (TRANSFORMS, FREEDOMS, and FREEDOMS II) shows that Gilenya offers a significant reduction in the rate of brain volume loss vs. a comparator – by ...

Early start/Late start laquinimod (Teva) in ALLERGO extension trial for MS

Teva Pharmaceutical Industries Ltd. and Active Biotech have announced top-line results from the open-label extension of the Phase III ALLEGRO study that assessed the progression of disability and safety of oral laquinimod in early versus delayed-start relapsing-remitting multiple sclerosis (RRMS) patients. The study compared the effectiveness of laquinimod in patients who received 36 months (early-start) versus those who received 24 ...

EU approves Carotid Embolic Protection Stent (InspireMD) for Stroke prevention

InspireMD's Carotid Embolic Protection Stent has received CE mark approval in the EU. It is based on MicroNet mesh technology, designed to provide procedural and post-procedural distal embolic protection in carotid artery stenting procedures to reduce the risk of Stroke. The MicroNet is designed to hold plaque and thrombus in place against the wall of the blocked artery, preventing debris ...

EU approves expanded approval for Qutenza (Astellas) for Neuropathic Pain

The European Commission has approved expanded options for pre-treatment prior to use of Qutenza (8% capsaicin patch), from Astellas. Before application the patient may now take an oral analgesic, or the treatment area may be pre-treated with a topical anaesthetic. The 8% capsaicin patch is the first and only licensed high concentration (8%) capsaicin cutaneous patch for the treatment of ...

PREVAIL trial of Watchman LAAC (Boston Scientific) shows some benefits for AF patients

New results on the PREVAIL trial, which randomized 407 patients with nonvalvular Atrial Fibrillation to either LAA closure with the Watchman device, from Boston Scientific or warfarin, indicates the study has met 2 of its 3 primary end points. Data shows that the device was implanted more successfully in the trial (95.1%) than in 2 prior Watchman studies: PROTECT AF ...

Xarelto enters Phase III trial for Heart Failure and CAD

Bayer HealthCare and Janssen Research & Development, LLC announced the initiation of COMMANDER-HF, a pivotal Phase III clinical trial that will evaluate Xarelto (rivaroxaban) 2.5 mg twice daily in patients with Chronic Heart Failure (HF) and significant coronary artery disease (CAD). Rivaroxaban is the first novel oral anticoagulant to be evaluated in this patient group who remain at high-risk for ...

German Federal Joint Committee decides additional benefit of Fycompa (Eisai) unproven as a treatment for Epilepsy

The German Federal Joint Committee (G-BA), the decision-making body of the self-governing medical system in Germany, has announced that it considers the additional benefit of Fycompa (perampanel) unproven when compared to two other treatments. Perampanel is indicated as an adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.

This ...

Reanalysis of a trial of LipiGesic M (PuraMed Bioscience) suggests treatment is effective for Migraine

A reanalysis of clinical trial results of homeopathic formulation, LipiGesic M (feverfew and ginger), from PuraMed Bioscience, confirms that the Migraine medication can provide effective relief. The original double-blind, placebo-controlled clinical trial for LipiGesic M, completed in 2010 and published in the July 2011 issue of Headache: The Journal of Head and Face Pain, concluded that 64 percent of patients ...

Phase III success for Vimpat (UCB) as monotherapy for treatment of partial onset seizures

Positive results are announced of a Phase III study designed to evaluate the efficacy and safety of conversion to Vimpat (lacosamide)from UCB as monotherapy in adult patients with partial-onset seizures with or without secondary generalization compared with a historical control.

The study met its primary endpoint demonstrating that the exit rate for patients on lacosamide (400 mg/day) was ...

Two trials demonstrate benefits of Pradaxa/Rendix (Boehringer) for patients with VTE

New findings from two double-blind, randomized trials, RE-MEDYSM and RE-SONATE, show that Pradaxa/Rendix (dabigatran etexilate), from Boehringer, reduces the risk of recurrent Venous ThromboEmbolism (VTE). RE-MEDY demonstrated that treatment with dabigatran 150 mg twice daily was non-inferior to warfarin (p=0.01) in preventing recurrent VTE, including VTE-related death. RE-SONATE demonstrated dabigatran was superior to placebo for the prevention of first recurrent ...

Lyrica (Pfizer) as effective as Keppra (UCB) for Epilepsy treatment

Top-line results are reported by Pfizer for a Phase III study that showed Lyrica (pregabalin) Capsules CV were as effective as Keppra (levetiracetam) from UCB, as an adjunctive therapy in adult Epilepsy patients experiencing refractory partial onset seizures. The top-line results indicate that the study met its primary endpoint by demonstrating that a comparable proportion of patients on Lyrica achieved ...

Success for Solitaire FR (Covidien) in STAR revasculization study

Covidien reports results from the two year Solitaire FR Thrombectomy for Acute Revasculization study(STAR study). The prospective, multi-center, single arm clinical study started with an enrollment of 202 patients at 14 centers across Europe, Australia and Canada in May 2010. In the study, patients diagnosed with Acute Ischaemic Stroke (AIS) (as confirmed by radiographic assessment) were treated with the ...

FDA approves Ravicti (Hyperion Therapeutics ) for Urea Cycle Disorders

On 31 January the FDA approved Ravicti (glycerol phenylbutyrate) from Hyperion Therapeutics, for the chronic management of some Urea Cycle Disorders in patients ages 2 years and older.

Urea Cycle Disorders, or UCDs, are a collection of inherited metabolic disorders in which affected patients suffer from high levels of systemic ammonia, a potent neurotoxin. Ammonia is produced via ...

Phase II study of Monarch eTNS (NeuroSigma) shows benefits for Epilepsy

New results from a Phase II clinical study for the use of Monarch external Trigeminal Nerve Stimulation (eTNS), from NeuroSigma, for the treatment of drug-resistant Epilepsy demonstrated that among patients receiving eTNS there were significant reductions in seizure frequency over the course of the 18-week study. Patients receiving eTNS also demonstrated significant improvements in mood, making eTNS unique among ...

Sanofi/Genzyme files Lemtrada at FDA for treatment of Multiple Sclerosis

Sanofi and its subsidiary Genzyme announced that the FDA has accepted for review the company’s supplemental Biologics License Application file seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing Multiple Sclerosis.

Genzyme expects FDA action on the application in the second half of 2013. Genzyme has already submitted its marketing authorization application for Lemtrada to the European Medicines Agency ...

Peginterferon beta-1a (Biogen) success in ADVANCE study for MS

Biogen Idec released the primary efficacy analysis and safety data from its Phase III pivotal clinical trial, ADVANCE. Results support peginterferon beta-1a as a potential treatment dosed every two weeks or every four weeks for relapsing-remitting Multiple Sclerosis (RRMS). Peginterferon beta-1a is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its ...

NICE recommends Eliquis (Pfizer/BMS) for Stroke Prevention

NICE (The National Institute of Health and Clinical Excellence) has recommended the oral anticoagulant Eliquis (apixaban) from BMS and Pfizer, as an option for Prevention of Sroke and Systemic Embolism in people with non-valvular Atrial Fibrillation with one or more risk factors.

The NICE appraisal committee considered that Eliquis was cost effective and more clinically effective for reducing stroke and ...

FDA issues Complete Response Letter regarding Rytary (Impax Pharma) for Parkinsons disease

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. has announced that the FDA has issued a Complete Response Letter regarding the New Drug Application (NDA) for Rytary (IPX066), an extended-release capsule formulation of carbidopa-levodopa, a potential treatment for the symptomatic treatment of Parkinson's disease currently under review in the United States.

The Complete Response Letter indicates that the FDA ...

European Commission approves Bexsero vaccine (Novartis) for Meningococcal Disease

Novartis has announced that the European Commission has approved Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) for use in individuals from 2 months of age and older. Novartis is committed to making Bexsero available as soon as possible.

MenB disease is a bacterial infection and is the leading cause of meningitis across Europe, particularly in infants. Although ...

FDA approves Zecuity (NuPathe) Migraine patch

NuPathe Inc.has announced that the FDA has approved Zecuity (sumatriptan iontophoretic transdermal system) for the acute treatment of Migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin. Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN). Zecuity is the first ...

EMA rejects Raxone/Catena (Santhera) as a treatment for Leber's Hereditary Optic Neuropathy

Santhera Pharmaceuticals has announced that it has received a negative opinion on its Marketing Authorization Application (MAA) for Raxone (idebenone) as a potential therapy for Leber's Hereditary Optic Neuropathy (LHON). The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has notified Santhera that a narrow majority of CHMP members deemed Raxone not approvable at this time. Santhera ...

European Commission approves Amyvid (li Lilly) for Alzheimers disease investigations

Eli Lilly and Company and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, announced that Amyvid (Florbetapir F 18 Injection) has received marketing authorization from the European Commission as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's ...

Biogen/Elan file Tysabri at FDA and EMA for first line treatment of Multiple Sclerosis

Biogen Idec and Elan Corporation have announced that they have submitted applications to the FDA and European Medicines Agency requesting updates to the Tysabri (natalizumab) labels for treatment of Multiple Sclerosis. The applications request an expanded indication that would include first-line use for people living with certain relapsing forms of Multiple Sclerosis who have tested negative for antibodies to the ...

The Lancet reports successful Phase III study of Bexsero vaccine (Novartis)against MenB

The Lancet published findings online from a pivotal Phase III clinical trial of Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) from Novartis, involving 3,630 infants from two months of age. The study showed that Bexsero demonstrated a protective immune response and has an acceptable safety profile when administered as a three-dose primary series concomitantly with routine vaccines. The investigators ...

Votubia/Afinitor success in treatment of Renal Angiomyolipoma reported in The Lancet

Data published in The Lancet showed that patients on Afinitor (everolimus) tablets from Novartis, with non-cancerous kidney tumors known as Renal Angiomyolipomas associated with Tuberous Sclerosis Complex (TSC) experienced a significant reduction in tumor size and the absence of tumor progression. Additionally, a recent issue of The Lancet featured results from a separate everolimus trial demonstrating a reduction in ...

FDA approves Rebif Rebidose(EMD Serono) for treatment of Multiple Sclerosis

The FDA has approved Rebif Rebidose, a single-use auto-injector prefilled with EMD Serono and Pfizer's interferon beta-1a, for the treatment of relapsing forms of Multiple Sclerosis (MS). Interferon beta-1a is an established and effective disease-modifying treatment for MS, but some people can struggle with injections, and the resulting drops in compliance mean the treatment is less effective.

...

FDA approves Kineret(SOBI) for NOMID

Sobi- Swedish Orphan has announced that the FDA has approved Kineret (anakinra) for the treatment of children and adults with Neonatal-Onset Multisystem Inflammatory Disease (NOMID).

Kineret is the first and only FDA-approved therapy for NOMID, the most severe form of cryopyrin associated periodic syndromes (CAPS). This is the first approval allowing the use of Kineret in children. Kineret was ...

Dexpramipexole (Biogen Idec) fails Phase III EMPOWER trial in ALS

Biogen Idec has reported top-line results of EMPOWER, a Phase III trial investigating dexpramipexole in people with Amyotrophic Lateral Sclerosis (ALS). The trial did not meet its primary endpoint, a joint rank analysis of function and survival, and no efficacy was seen in the individual components of function or survival. The trial also failed to show efficacy in its key ...

FDA approves Eliquis (BMS/Pfizer) to reduce the risk of Stroke and Systemic Embolism

The FDA on 28 December 2012 approved the anti-clotting drug Eliquis (apixaban) from BMS/Pfizer, an oral tablet used to reduce the risk of Stroke and dangerous blood clots (Systemic Embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by ...

Davunetide (Allon Therapeutics) fails trial for Supranuclear Palsy

Allon Therapeutics Inc. has announced that its pivotal clinical trial evaluating its lead product candidate davunetide as a treatment for progressive supranuclear palsy (PSP) failed to demonstrate efficacy in this population. The study had co-primary outcome measures: the Progressive Supranuclear Palsy Rating Scale (PSPRS), and the Schwab and England Activities of Daily Living (SEADL). Data analysis failed to detect an ...

Positive European regulatory procedure for Elvanse (Shire) for ADHD

Shire plc announced a positive outcome from the European Decentralised Procedure (DCP) for Elvanse (to be known as Tyvense in Ireland). Elvanse is indicated as part of a comprehensive treatment programme for Attention Deficit/Hyperactivity Disorder (ADHD) in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate. The MHRA of the UK, ...

New trial planned for solanezumab (Eli Lilly) for mild Alzheimers Disease treatment

Eli Lilly and Company has provided an update on the next steps planned for solanezumab, its Phase III monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer's disease. Following discussions with regulators in the U.S., Europe and Canada, Lilly plans to conduct an additional Phase III study of solanezumab in patients with mild Alzheimer's disease. Additional ...

Positive data from Phase III study of Eliquis (BMS/Pfizer) for VTE prevention

Results of the Phase III AMPLIFY-EXT trial evaluating Eliquis (apixaban), from BMS/Pfizer, vs placebo for preventing VTE, shows it demonstrated superiority in reducing recurrent VTE and death from any cause (11.6% in the placebo group, compared with 3.8% and 4.2% in the Eliquis groups. Eliquis also was superior to placebo for the predefined secondary efficacy outcome of recurrent VTE and ...

Trial of Reminyl XL/Razadyne (Janssen Pharmaceuticals) shows positive results in patients with Alzheimer's Disease

A new study shows a significantly lower mortality rate in patients with mild to moderately severe Alzheimer's disease who were treated with Reminyl XL/Razadyne (galantamine), from Janssen Pharmaceuticals, versus those on placebo. Patients treated with galantamine also had significantly lesser decline in cognitive impairment after two years.

The trial enrolled 2,051 people and was conducted at 127 sites in 13 ...

EU awards CE mark to Revivent Myocardial Anchoring System (BioVentrix) for Heart Failure patients

BioVentrix has received the CE mark for its Revivent Myocardial Anchoring System, a surgical device that offers Heart Failure patients an alternative therapy to surgical ventricular restoration. The Revivent system is comprised of a series of titanium anchor pairs, each consisting of an internal anchor and an external anchor, which are introduced by transmural catheters. Once the desired number of ...

MK 8931 enters Phase II/III trial for Alzheimers Disease

Merck Inc., announced it has started a Phase II/III clinical trial designed to evaluate the safety and efficacy of MK-8931 versus placebo in patients with mild-to-moderate Alzheimer's Disease. MK-8931 is Merck's novel investigational oral beta-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor, and is the first with this mechanism to advance to this stage of clinical research. The global, multi-center study, ...

Study shows PET scans with Amyvid (Cardinal Health) provides significant value in treating patients with cognitive impairment

Results of a new study to assess the value of Amyvid (florbetapir F18) PET, from Cardinal Health, in detecting brain amyloid deposits associated with Alzheimer disease in patients with cognitive impairment, and in helping with clinical decision-making, shows the technique can play a significant role. The study included 229 patients previously evaluated for cognitive decline or impairment of uncertain etiology. ...

GSK returns US rights of Horizant to Xenoport

GlaxoSmithKline (GSK) plc announced that it has reached an agreement with XenoPort, Inc., to terminate their collaboration concerning Horizant (gabapentin enacarbil) Extended-Release Tablets, a treatment for Restless legs, for which GSK had commercialisation rights and certain development rights in the United States. Under the termination and transition agreement, GSK is returning Horizant rights to XenoPort and providing certain assistance during ...

Study of Pradaxa (Boehringer) for Atrial Fibrillation shows positive safety profile and efficacy

New data from the RELY-ABLE study have provided additional support to the safety profile and efficacy of Pradaxa (dabigatran etexilate), from Boehringer, for stroke prevention in patients with nonvalvular Atrial Fibrillation (AF) over a period in excess of 2 years. The international multi-centre RELY-ABLE study followed 5,851 patients on dabigatran etexilate for a further 28 months after completion of the ...

FDA approves Fycompa (Eisai) as a treatment for Epilepsy

Eisai Inc. has received approval on 22 October 2012 from the FDA for the AMPA receptor antagonist Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with Epilepsy age 12 years and older.

The approval decision was based primarily on clinical data from three pivotal Phase III, global, randomized, double-blind, ...

CHMP recommends Amyvid (Eli Lilly) for Alzheimers investigations

The Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Amyvid (florbetapir 18F) from Eli Lilly, as a diagnostic agent in patients who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline. Amyvid is a radiopharmaceutical agent used in positron emission tomography (PET) imaging in the brains of adults. It can ...

CHMP rejects Acrescent (Lundbeck)/Balaxur (Merz) as a treatment for Alzheimers Disease

On 18 October 2012, the CHMP adopted a negative opinion, recommending the refusal of the marketing authorisation for the combination medicinal product memantine hydrochloride and donepezil hydrochloride, known as Acrescent from Lundbeck and Balaxur from Merz, intended for the treatment of moderate to moderately severe Alzheimer’s disease in patients who are already taking memantine and donepezil.

The Committee was ...

Allergan to co market Levadex in USA

Upon FDA approval, Allergan will commit its existing U.S. sales force currently pushing BOTOX for Chronic Migraine to headache specialists with MAP Pharmaceuticals' field sales force targeting neurologists and pain specialists doubling the sales opportunity. Levadex for Acute Migraine patients and Botox for Chronic Migraine patients....

Levadex is filed at the FDA for Migraine

MAP Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for Levadex orally inhaled migraine drug for the potential acute treatment of migraine in adults.The submission is based on the FREEDOM-301 study see Headache. 2011 Apr;51(4):507-17. doi: 10.1111/j.1526-4610.2011.01869.x. MAP0004, orally inhaled DHE: a randomized, controlled study in the acute treatment of migraine. Aurora SK, Silberstein SD, Kori SH, ...

Complete Response Letter from FDA for Levadex (MAP Pharma) for Migraine

The FDA has issued a Complete Response Letter to MAP Pharma to its new drug application for Levadex (dihydroergotamine meyslate) inhalation aerosol for the acute treatment of Migraine. The FDA has raised issues on chemistry, manufacturing and controls but has not required a new trial Allergan will co-market Levadex in the USA....

MAP Pharma re-submits Levadex to the FDA for treatment of Migraine

MAP Pharmaceuticals, has announced that it has re-submitted its New Drug Application (NDA) to the FDA for Levadex, orally inhaled migraine drug ,for the potential acute treatment of Migraine in adults. MAP Pharmaceuticals has entered into a collaboration agreement with Allergan to co-promote Levadex to neurologists and pain specialists in the U.S. and Canada. MAP Pharmaceuticals retains all rights to ...

Positive results in MOVE2 study of Sativex (Almirall) for patients with Multiple Sclerosis spasticity

Results of the MOVE2 study showed that one month's treatment with Sativex (delta-9-tetrahydrocannabinol and cannabidiol), from Almirall, reduces moderate to severe Multiple Sclerosis spasticity (MSS) by 20% or more in 4 out of 10 patients previously unresponsive to conventional therapies. After three months, the improvement observed was 30% or more. Overall, 55% of the initial patients were eligible for continuing ...

New global study to assess 3 drugs to prevent early-onset Alzheimer's Disease

A new clinical study will examine 3 drugs to determine whether they can prevent early-onset Alzheimer’s disease. The drugs chosen for the study which will take place at Washington University in St. Louis, are R1450 (gantenerumab), from Roche and LY 2062430 (solanezumab), from Eli Lilly and Co. R1450 is currently in a Phase III trial known as SCarlet RoAD, started ...

Positive results in three studies of Gilenya (Novartis) for patients with Multiple Sclerosis

Three new studies of Gilenya (fingolimod), from Novartis, reinforce the generally early and sustained efficacy benefit and long-term safety profile that the drug demonstrates in patients with Multiple Sclerosis. A new post hoc analysis of two Phase III studies (FREEDOMS and FREEDOMS II) showed that patients receiving the drug saw significant benefits on brain volume loss and relapse-related outcomes compared ...

Nypta (Zeltia/Noscira) fails Alzheimers Disease study

Zeltia/ Noscira announces that the primary cognitive endpoint and two of the secondary endpoints were not met in the 26-week ARGO Phase IIb trial involving Nypta (tideglusib). This study evaluated the efficacy of tideglusib versus placebo plus standard of care for the treatment of mild-to-moderate Alzheimers Disease. No decision regarding future development has yet been taken as Zeltia says pending ...

Positive results from study of Genesis Neurostimulator (St Jude Medical) in patients with Migraine

Results from a large-scale study of peripheral nerve stimulation (PNS) of the occipital nerves using the Genesis neurostimulation system, from St Jude Medical, in patients suffering from chronic Migraine show a significant reduction in pain, headache days and migraine-related disability. Conducted at 15 medical centers in the US, the study followed 157 participants who, on average, suffered from headache approximately ...

Sub Analysis of Eliquis (BMS/Pfizer)in ARISTOTLE trial show consistent reductions in Stroke and bleeding risk

The reductions in stroke or systemic embolism, major bleeding and mortality demonstrated with Eliquis (apixaban) from BMS/Pfizer ,compared to warfarin in the ARISTOTLE trial were consistent across a wide range of stroke and bleeding risk scores in patients with nonvalvular atrial fibrillation. These results of a subanalysis from the ARISTOTLE trial were published today in The Lancet.The subanalysis demonstrated ...

Botox (Allergan) approved by MHRA in UK for Urinary Incontinence

The Medicines and Healthcare products Regulatory Agency (MHRA)in the UK has given Botox (botulinum toxin type A) approval for managing Urinary Incontinence caused by neurogenic detrusor overactivity(NDO) due to subcervical spinal cord injury (SCI; traumatic or non-traumatic) or multiple sclerosis (MS), but only if treatment with anticholinergics does not work. Recently published NICE Guidelines recommend the use of botulinum toxin ...

FDA approves Quillivant XR (Next Wave) for ADHD

The FDA has approved Quillivant XR (methylphenidate hydrochloride) from Next Wave Pharma for extended-release oral suspension for treatment of Attention Deficit Hyperactivity Disorder (ADHD). Quillivant XR is the first once-daily, extended-release liquid methylphenidate available for patients with ADHD.The drug will be launched early in 2013....

Vercise DBS system receives CE Mark for Parkinsons Disease

Boston Scientific Corporation has received CE Mark approval for use of its Vercise Deep Brain Stimulation (DBS) System for the treatment of Parkinson's disease. The Vercise DBS System is the first and only commercially available DBS system to incorporate multiple independent current control, which is designed to selectively stimulate targeted areas in the brain. This system is an innovative technology ...

Eon Mini neurostimulator (St Jude Medical ) receives CE Mark for Migraine

St. Jude Medical has gained approval for its Eon neurostimulators, including its Eon Mini, which the company claims as the world's smallest rechargeable device in the space. the device is as big as a man's watch and weighs about 1 ounce, powered by a battery that can recharge for about 10 years. The peripheral nerve stimulation device delivers mild electrical ...

CHMP recommends Eliquis (BMS/Pfizer) for Prevention of Stroke and Systemic Embolism in NVAF patients

BMS and Pfizer have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Eliquis (apixaban) be granted approval for the Prevention of Stroke and Systemic Embolism in adult patients with nonvalvular atrial fibrillation (NVAF) and one or more risk factors for stroke The positive ...

Lundbeck files vortioxetine at EMA for Major Depressive Episodes

Lundbeck A/S has announced the submission to the European Medicines Agency (EMA) of a marketing authorisation application (MAA) for the approval of the investigational multimodal antidepressant vortioxetine (Lu AA21004), and the dossier has been accepted for review. Vortioxetine belongs to a new generation of antidepressants that has been developed for the treatment of patients with major depressive episodes (MDE).The data ...

Positive results from study of STX 209 (Seaside Therapeutics) for patients with Fragile X Syndrome

A new study shows STX 209 (arbaclofen), from Seaside Therapeutics, is effective for addressing the social withdrawal and challenging behaviors characteristic of Fragile X Syndrome, making it the first such discovery and potentially the first for autism spectrum disorder. The Phase II clinical trial initially recruited 63 subjects at 12 sites across the US and participants ranged in age from ...

Results of DEFINE and CONFIRM trials of BG 12(Biogen IDEC) in Multiple Sclerosis published in NEJM

Biogen Idec announced that detailed results from its two pivotal clinical trials evaluating oral BG-12 (dimethyl fumarate) for the treatment of Multiple Sclerosis (MS) were published in the Sept. 20, 2012 issue of The New England Journal of Medicine (NEJM). Data from the Phase III DEFINE and CONFIRM studies show that dimethyl fumarate (240 mg), administered twice daily (BID) or ...

TC 5619 (Targacept) fails Phase II trial in ADHDi

Targacept Inc., has announced top-line results from a Phase II trial of TC-5619 as a treatment for inattentive-predominant attention deficit/hyperactivity disorder (ADHDi). In the trial, TC-5619 did not meet the primary outcome measure, change from baseline on the inattention subscale of the Conners' Adult ADHD Rating Scale-Investigator-Rated (CAARS-INV), after four weeks of treatment versus placebo. Across the study measures, patients ...

FDA reviews sNDA of Vyvanse (Shire) as maintenenace treatment for young patients with ADHD

The FDA has accepted the filing for review of a supplemental New Drug Application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) Capsules, from Shire, as a maintenance treatment in children and adolescents ages 6 to 17 years with Attention-Deficit/Hyperactivity Disorder (ADHD). This application is based on results of a Phase IIIb, randomized withdrawal, multicenter, extension study to evaluate the long-term maintenance of ...

18F Flutemetamol (GE HealthCare) Beta Amyloid studies positive

GE Healthcare announced pooled results from Phase III brain autopsy and biopsy studies on the investigational PET amyloid imaging agent, [18F]flutemetamol, which showed a strong concordance between [18F]flutemetamol images and Alzheimer's disease-associated beta amyloid brain pathology.For patients from four separate biopsy studies [18F]flutemetamol detected beta amyloid with a median sensitivity ranging from 75-100 percent and specificity ranging from 99-100 percent. ...

EPI 743 (Edison Pharmaceuticals) granted orphan status for Leigh Syndrome in EU

Edison Pharmaceuticals announced today that the Committee for Orphan Medicinal Products at the European Medicines Agency, has granted orphan designation to EPI 743 for the treatment of Leigh syndrome. Leigh Syndrome is a very rare and severe disease caused by mutations in mitochondrial respiratory enzymes, leading mainly to neurological deficits and a poor survival for these patients. In June 2012 ...

FDA approval for Aubagio(Sanofi/Genzyme) as a treatment for relapsing Multiple Sclerosis

Sanofi and its subsidiary Genzyme announced that the FDA has approved Aubagio (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of Multiple Sclerosis (MS). Aubagio has shown significant efficacy across key measures of MS disease activity,including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by ...

New Phase III trial tests LMTX (TauRX Therapeutics) in patients with Pick's Disease

A new global Phase III clinical trial will test LMTX, from TauRx Therapeutics, in patients with a type of Frontotemporal Dementia (FTD) also known as Pick's Disease. The study focuses on a type of FTD known as behavioural-variant, or bvFTD, which can cause early changes in personality and loss of empathy. A large percentage of these patients have a specific ...

EU approve Monarch eTNS system (NeuroSigma) for treatment of Epilepsy

The EU have given CE Certification to the Monarch external Trigeminal Nerve Stimulation (eTNS) system, from NeuroSigma, for the adjunctive treatment of Epilepsy and major depressive disorder, for adults and children 9 years and older. Monarch is composed of an external pulse generator and disposable electric patches placed on the forehead that are replaced daily. The patches can be worn ...

FDA approves new dosage of Exelon (Novartis) for patients with Alzheimers

The FDA has approved a higher dose of Exelon (rivastigmine transdermal system), from Novartis, for the treatment of people with mild to moderate Alzheimer's disease. The new dosage strength provides physicians with a new treatment option for patients who are experiencing a decline in overall function and cognition. Approval of the patch was based on the 48-week OPTIMA study, a ...

FDA approves Afinitor Disperz(Novartis) for SEGA Tumours

The FDA has on 29 August 2012 approved Afinitor Disperz (everolimus tablets for oral suspension; Novartis), a new pediatric dosage form of Afinitor (everolimus) indicated for treatment of Tuberous Sclerosis Complex (TSC) in patients aged >1 year who are diagnosed with Subependymal Giant Cell Astrocytoma (SEGA) that cannot be treated with surgery. Afinitor Disperz is the first approved pediatric-specific dosage ...

Aspirin-clopidogrel no better than aspirin alone for patients with Lacunar Stroke

Aspirin combined with the antiplatelet drug clopidogrel is no better than aspirin alone for stroke prevention in people with a history of lacunar strokes, and the combination carries a greater risk of gastrointestinal bleeding, according to results of a trial funded by the National Institutes of Health. Lacunar strokes occur due to chronic high blood pressure and typically produce small ...

EMA 401 has Phase II success for Post Herpetic Neuralgia

There have been positive headline results from the Phase II clinical trial of EMA 401 from Spinifex Pharmaceuticals, in Postherpetic Neuralgia (PHN), a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals. The clinical trial met its primary endpoint, reduction in mean daily pain score versus placebo ...

Positive results in trial of Solitaire (Covidien) for blood flow restoration

The Solitaire Flow Restoration Device for opening blocked arteries, from Covidien, performs better than a conventional device, according to new results from the SWIFT trial which have been published in The Lancet.

In the double-blind, randomised trial of 113 patients, the researchers compared the performance of the Solitaire device to the Merci retriever. Patient outcomes were significantly improved in the ...

EU Commission approves Jakavi (Novartis) for Myelofibrosis

Novartis received approval from the European Commission for Jakavi (INC424, ruxolitinib), a JAK 1 and JAK 2 inhibitor for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as Chronic Idiopathic Myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. The European Commission's decision was based on positive findings from the COMFORT (COntrolled MyeloFibrosis Study ...

Genzyme receives Refusal to File Letter from FDA relating to Lemtrada application for Multiple Sclerosis

Genzyme has received a Refuse to File letter from the FDA in response to the supplemental Biologics License Application (sBLA) for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing Multiple Sclerosis. After collaborative consultations with the FDA, the agency requested that the company modify the presentation of the data sets to enable the agency to better navigate the ...

Mixed results from Phase III studies of LY 2062430 (Eli Lilly) in Alzheimer's Disease patients

Results show that the primary endpoints were not met in either of the two Phase III placebo-controlled EXPEDITION trials of LY 2062430 (solanezumab), from Eli Lilly and Co, in patients with mild-to-moderate Alzheimer's Disease. However, a pre-specified secondary analysis of pooled data across both trials shows statistically significant slowing of cognitive decline in the overall study population.

In addition, secondary ...

Positive results in two Phase III studies of Fycompa (Eisai) for Epilepsy

Results from the final pivotal Phase III study and long term Phase III extension study of Epilepsy drug Fycompa (perampanel), from Eisai, have been published online in Epilepsia. Findings from Study 305, one of three pivotal global studies, and the extension study for perampanel add further weight to the growing body of clinical evidence supporting the efficacy and safety of ...

FDA approve Trevo Pro Retriever (Stryker) for clot removal

The Trevo Pro Retriever, from Stryker, has been granted 510(k) market clearance by the FDA for clot removal. Approval is based on clinical results from the TREVO 2 clinical trial presented at the 2012 European Stroke Conference in May. This technology demonstrated the highest rate of revascularization in a randomized embolectomy stroke device trial, and achieved significantly better post-procedure revascularization ...

Positive results from Phase III study of Avastin (Genentech/Roche) in Brain Cancer patients

The Phase III AVAglio study of Avastin (bevacizumab), from Genentech/Roche, plus radiation and temozolomide chemotherapy in people with newly diagnosed Glioblastoma met its co-primary endpoint of a significant improvement in progression-free survival (PFS). In the study, Avastin in combination with radiation and temozolomide chemotherapy significantly extended the time people with this aggressive form of primary Brain Cancer lived without their ...

NKTR 102 (Nektar) update on cancer trials

Nektar Therapeutics announced the start of a Phase II study of NKTR 102 (etirinotecan pegol) in patients with bevacizumab (Avastin)-resistant high-grade Glioma being conducted at Stanford Cancer Institute. The primary endpoint of the Phase II study is the six-week progression free survival (PFS) rate. Secondary endpoints include survival from time of first etirinotecan pegol infusion, overall survival from date ...

Phase III development of bapineuzumab (Janssen Alzheimer Immunotherapy) in Alzheimer's disease discontinued

Janssen Alzheimer Immunotherapy has announced that its Phase III clinical development of bapineuzumab intravenous (IV) in mild-to-moderate Alzheimer's disease is being discontinued. This is based on the co-primary clinical endpoints not being met in the Janssen AI-led Studies 301 and 302. Four placebo-controlled Phase III studies comprised the bapineuzumab clinical development program. Janssen AI led the two completed 18-month, Phase ...

NuPathe re-files transdermal Migraine patch at FDA

FDA has accepted for review the resubmitted new drug application for the transdermal sumatriptan migraine patch NP101 fom NuPathe. The FDA has set 17 January as the new Prescription Drug User Fee Act action date.This will be the first transdermal patch for Migraine ever reviewed by the agency....

Phase II proof of concept trial for APG 101 (Apogenix) is confirmed for Glioblastoma Multiforme

Apogenix announced the figures that confirm that the primary objective of its Phase II proof-of-concept trial investigating its lead product, APG101, as a second line treatment of Glioblastoma Multiforme (GBM), had been met, The company expects to unveil overall survival data from the study in the fourth quarter of 2012.In March 2012 the company reported that the primary objective of ...

EU approves Fycompa (Eisai) for treatment of Epilepsy

The European Commission has granted marketing authorisation approval for the use of Fycompa (perampanel) from Eisai as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in people with Epilepsy aged 12 years and older.The FDA issued a refusal to file letter for perampanel in July 2011, following a preliminary review of the acceptability of the original ...

Early results for E 2609 (Eisai) in Alzheimers Disease

Eisai has disclosed the first clinical data (Phase 1) for its new early stage candidate for Alzheimer's disease, the beta-site amyloid precursor protein-cleaving enzyme (BACE1) inhibitor E 2609. Results from healthy adult volunteers presented to the 2012 Alzheimer's Association International Conference in Vancouver, Canada, showed that E 2609 reduced plasma levels of amyloid-beta by up to 92% relative to baseline ...

Ecopipam (Psyadon Pharmaceuticals) success in Phase II study for Tourette Syndrome

Psyadon Pharmaceuticals, Inc. announced that its Phase II study of ecopipam in patients with Tourette Syndrome was stopped early when a planned interim analysis revealed a statistically significant reduction in the severity of the patients' tic symptoms. This decision was supported by both the independent Drug Safety and Monitoring Committee overseeing the study and by the external Research Committee established ...

Phase III study of bapineuzumab (Janssen Alzheimer Immunotherapy) for Alzheimers Disease fails to meet endpoint

In a Phase III trial of intravenous bapineuzumab, from Janssen Alzheimer Immunotherapy, in patients with mild-to-moderate Alzheimer’s disease who carry the ApoE4 genotype (Study 302), the co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met. Study 302 is the first of four placebo-controlled Phase III studies to complete in the development of bapineuzumab IV. ...

EVP 6124 (EnVivo Pharma)success in Phase IIb Alzheimers Disease trial

EnVivo Pharmaceuticals, announced positive results from its Phase IIb clinical trial of EVP-6124, a novel alpha-7 agonist, in patients with Alzheimer's Disease during an oral presentation at the Alzheimer's Association International Conference 2012 being held in Vancouver, British Columbia. The six-month, double-blind Phase IIb clinical trial evaluated EVP-6124 against placebo in patients with mild to moderate Alzheimer's Disease. The EVP-6124 ...

Early results from Phase II study of Gammagard Liquid 10%(Baxter) for Alzheimers Disease

Baxter International presented three-year data on 16 patients in the Phase II study of Gammagard, which originally enrolled 24 participants. Overall, all 11 study participants who received Gammagard for the full three years showed improvements in thinking abilities, behavior and daily functioning.Of these, the four patients who received the most effective dose (0.4g/kg) for the full 36 months fared the ...

Laquinomod (Active Biotech/Teva) is filed at EMA for Multiple Sclerosis

Active Biotech/Teva has announced that the European Medicines Agency (EMA) has completed the validation process for the marketing authorization application of laquinimod for the treatment of relapsing-remitting Multiple Sclerosis.The submission is supported by a pooled analysis of data from the two global Phase III clinical trials in RRMS involving more than 2,400 patients treated for two years, the ALLEGRO and ...

Stem cells improve memory for Alzheimers Disease

Preclinical data showed that human neural stem cells from Stem Cells Inc.restored and improved memory in animal models of Alzheimer's Disease without affecting amyloid beta or delta tau, two key proteins targeted by therapeutics in pharmaceutical development. The study results were presented at the Alzheimer’s Association International Conference in Vancouver, Canada and represent the first time human neural stem cells ...

Neupro (UCB/Schwarz) re inrroduced in US for RLS and Parkinsons Disease

Neupro(rotigotine transdermal patch) from UCB/Schwarz is now available again in the US after getting release from the FDA in April to treat the signs and symptoms of early and advanced stage idiopathic Parkinsons Disease and moderate-to-severe primary Restless Legs Syndrome. Neupro is a once-daily patch that provides continuous delivery of the dopamine agonist rotigotine for 24 hours. The treatment was ...

Eisai applies to EMA to extend use of Zonegran to children for treatment of partial seizures

The EMA has accepted the submission of an application to extend the use of Epilepsy drug Zonegran (zonisamide), from Eisai, in the treatment of partial seizures (with or without secondary generalisation) to include children aged six years and above. A decision on this new licence extension application is expected in September 2012.

This submission was based on data from ...

Benefit assessment finds slight advantage of Gilenya (Novartis) for adults with Multiple Sclerosis

The German Institute for Quality and Efficiency in Health Care (IQWiG) has carried out an early benefit assessment to see if Gilenya (fingolimod), from Novartis, offers added benefit compared with present standard therapy in patients with highly-active relapsing-remitting Multiple Sclerosis (RRMS). The assessment reports that adult patients with this form of the disease taking Gilenya experience fewer flu-like symptoms than ...

FDA approves Gammagard Liquid 10% (Baxter) for Multifocal Motor Neuropathy

The FDA has approved Gammagard Liquid 10% [Immune Globulin Infusion (Human)] as a treatment for Mmultifocal Motor Neuropathy (MMN). This is the first immunoglobulin treatment approved for MMN patients in the United States. It was approved for use with MMN patients in Europe in 2011. MMN is associated with a progressive, asymmetric limb weakness mostly affecting the upper limbs, which ...

FDA issues Complete Response Letter for Eliquis (BMS/Pfizer) in Stroke Prevention

The FDA has issued a Complete Response Letter regarding the New Drug Application for Eliquis (apixaban) from BMS/Pfizer for the Prevention of Stroke and Systemic Embolism in patients with nonvalvular atrial fibrillation. The FDA requests additional information on data management and verification from the ARISTOTLE trial. BMS and Pfizer will work closely with the FDA on the appropriate next steps ...

FDA refuses to recommend semuloparin (Sanofi) for prevention of VTE

The FDA's Oncologic Drugs Advisory Committee voted 14 to 1 not to recommend approval of semuloparin, from Sanofi, for the prevention of Venous Thromboembolism (VTE) in patients receiving chemotherapy for metastatic Lung or Pancreatic Cancer. The committee also rejected its use in patients with advanced solid tumours with a VTE risk score greater than or equal to three. The submission ...

FDA issues Complete Response Letter for tafamidis (Pfizer) for TTR-FAP

The FDA has issued a Complete Response Letter for the transthyretin familial amyloid polyneuropathy drug, tafamidis from Pfizer. The FDA has requested the completion of a second efficacy study to establish substantial evidence of effectiveness prior to an approval. Tafamidis was approved in the EU as an orphan drug with the name Vyndaqel....

Sub-analysis of RE-LY trial shows Pradaxa (Boehringer) similar to warfarin in Atrial Fibrillation patients undergoing surgery

A new retrospective sub-analysis of the RE-LY trial for Pradaxa (dabigatran etexilate), from Boehringer, vs warfarin suggested similar rates of peri-procedural bleeding and thromboembolic complications, such as a Stroke or systemic embolism, in non-valvular Atrial Fibrillation (NVAF) patients undergoing a surgical or invasive procedure. A total of 4,591 out of 18,113 patients in the trial had anti-coagulant therapy interrupted at ...

Positive results from analyses of levodopa-carbidopa intestinal gel (Abbott) in patients with Parkinson's Disease

Studies evaluating levodopa-carbidopa intestinal gel (LCIG), from Abbott, in patients with advanced Parkinson's Disease show positive effects in a long-term safety and tolerability trial, as well as secondary endpoint analyses from a Phase III pivotal trial. Data suggests that at week 54, mean daily "off" time (periods of poor mobility) had decreased an average of 4.5 hours, and "on" time ...

Semuloparin (Sanofi) may need more data for FDA approval for prophylaxis of VTE

Semuloparin, a low molecular weight heparin from Sanofi ,is filed at the FDA for the prophylaxis of venous thromboembolism in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors. FDA regulators have commented that the application does not have enough data to support its approval for that use. The ...

FDA approves vaccine Menhibrix (GSK)for bacterial diseases

The FDA on 14 June 2012 approved Menhibrix, from Glaxo Smith Kline, a combined meningococcal disease (serogroups C and Y) and Haemophilus influenzae type b (Hib) conjugated vaccine for infants and children ages 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Yand Haemophilus influenzae type b. Diseases caused by the bacteria ...

Positive results from GALA Phase III trial of Copaxone (Teva) for Multiple Sclerosis patients

Top-line results from the GALA Phase III trial assessing the efficacy, safety and tolerability of Copaxone (glatiramer acetate injection), from Teva, administered subcutaneously three times a week in Multiple Sclerosis patients showed that Copaxone significantly reduced disease activity, while maintaining a favorable safety and tolerability profile. The one-year study of more than 1,400 patients showed that Copaxone (40 mg/1 ml) ...

Lemtrada (Sanofi/Genzyme) filed at FDA and EMA for relapsing Multiple Sclerosis

Sanofi and Genzyme have announced that they have submitted a supplemental Biologics License Application (sBLA) to the FDA and a marketing authorization application to the European Medicines Agency seeking approval of Lemtrada (alemtuzumab) for treatment of relapsing Multiple Sclerosis (MS). Genzyme is developing Lemtrada in MS in collaboration with Bayer HealthCare. Genzyme’s clinical development program for Lemtrada included two Phase ...

Mallinckrodt to co market Sumavel Dose Pro for Migraine in US

Zogenix Inc. have appointed Mallinckrodt to co market Sumavel Dose Pro in the US. The 95-person Zogenix sales force in the US targeting neurologists, headache specialists and other physicians will be joined by a team of Mallinckrodt sales representatives who market pain drugs to primary care doctors....

Prescribing update to Pradaxa (Boehringer) for Stroke Prevention (AF) patients

Prescribing information for Pradaxa (dabigatran etexilate) capsules, from Boehringer, has been updated to affirm that "Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin." The update to the Clinical Studies section is based on the results of the pivotal RE-LY trial conducted in 18,000 patients with non-valvular atrial fibrillation (NVAF). In the RE-LY trial, ...

FDA reject Taltorvic (Merck Inc) for Sarcomas

The FDA has issued a complete response letter to an application for Sarcoma drug Taltorvic (ridaforolimus), from Merck Inc., saying it cannot approve the application in its present form, and "that additional clinical trial(s) would need to be conducted to further assess safety and efficacy". The rejection follows a vote in March in which the agency's Oncologic Drugs Advisory Committee ...

Aubagio (Genzyme/Sanofi)reports results of TOWER trial in Multiple Sclerosis

Top-line results are reported by Genzyme/Sanofi from the TOWER trial that assessed the efficacy and safety of once-daily, oral Aubagio (teriflunomide) in patients with relapsing forms of Multiple Sclerosis (MS). In the study, patients receiving teriflunomide 14 mg had a statistically significant reduction in annualized relapse rate and risk of sustained accumulation of disability. Analysis of the full TOWER data ...

LuAE 58054 success in Phase II study for Alzheimers Disease

Data was announced by Lundbeck from a 278-patient Phase II proof of concept study that showed that LuAE 58054 has met its primary cognition-based endpoint.In the study, adding a fixed dose of Lu AE 58054 to 10mg/day of the acetylcholinesterase inhibitor donepezil resulted in a significantly greater improvement in cognition as measured by the ADAS-Cog scale over a 24-week treatment ...

CHMP extends use of Zonegran (Eisai) as monotherapy for Epilepsy

May 2012-The CHMP has issued a positive opinion for extending the use of once-daily Zonegran (zonisamide), from Eisai, as monotherapy for the treatment of partial seizures (with or without secondary generalisation) in adults with newly diagnosed Epilepsy. For patients with newly diagnosed epilepsy, monotherapy is the preferred option for managing their condition as this reduces the potential for adverse drug ...

CHMP recommends approval of Fycompa (Eisai) for Epilepsy

The CHMP has issued a positive opinion for the use of Fycompa (perampanel), from Eisai, as an adjunctive treatment of focal seizures, with or without secondarily generalised seizures, in patients with Epilepsy aged 12 years and older. Fycompa is a new option for the management of partial onset Epilepsy as it is the first AED to exhibit clinical efficacy against ...

FDA Advisory Committee votes on tafamidis (Pfizer) for TTR-FAP

The FDA Peripheral and Central Nervous System Drugs Advisory Committee voted on the clinical data package for tafamidis meglumine submitted by Pfizer. Tafamidis is a novel, investigational, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) in adult patients with symptomatic polyneuropathy to delay neurologic impairment. The Advisory Committee did not find substantial evidence of efficacy on a ...

Phase III trials shows Vyvanse (Shire) effective in children and adolescents with ADHD

Results from a Phase III extension study of Vyvanse (lisdexamfetamine dimesylate), from Shire, show that after 6 months of treatment, a significantly lower proportion of subjects with ADHD experience treatment failure compared to those on placebo. This study was designed to evaluate the long-term efficacy and safety of Vyvanse for the treatment of ADHD in children and adolescents aged 6 ...

NovoTTF-100A (NovoCure) shows positive Phase III results for Brain Cancer

A Phase III randomised controlled trial comparing TTFields therapy versus chemotherapy in patients with recurrent Glioblastoma shows that the NovoTTF-100A, from NovoCure, is comparable to chemotherapy in extending overall survival, with minimal side effects and far better quality of life. Patients with a median age of 54 years were randomised to NovoTTF alone or active chemotherapy control. At a median ...

FDA discusses Phase III studies of Arimenda (Adamas Pharmaceuticals) for Alzheimers treatment

Adamas Pharmaceuticals has held an end-of-Phase II meeting with the FDA to discuss the proposed safety and efficacy studies to be conducted for the registration of Arimenda (memantine HCl extended release and donepezil HCl) capsules, for treatment of Alzheimers Disease. At the meeting, the FDA agreed to Adamas' Phase III clinical safety studies and confirmed that, if successful, those studies ...

NICE to recommend Botox (Allergan) for Migraine

NICE,the health technology appraisal institute for England and Wales, will now recommend Botox (botulinum toxin type A) injections from Allergan, as a preventative treatment for Chronic Migraine, in its final draft guidance. NICE was undecided about the drug and one area of concern was that the data supporting Botox were confounded by a large placebo effect. Allergan have provided more ...

BG-12 (Biogen) is filed at FDA and EMA for Multiple Sclerosis

FDA and EU regulatory authorities have accepted for review applications for BG-12 (dimethyl fumarate) from Biogen IDEC, an oral drug for Multiple Sclerosis. The FDA has 10 months to take action on the application, unless it requests additional time to complete the review.The European Medicines Agency has validated its marketing authorisation application for review of BG-12 in the European Union. ...

Lipoprotein 2086 vaccine (Pfizer) shows promise in protecting against Meningococcal infection

New results show that Lipoprotein 2086, a new vaccine for serogroup B Neisseria meningitidis, from Pfizer, is safe and immunogenic in adolescents, the majority of whom generated bactericidal antibodies that were active against strains that represent 90% of invasive Meningococcus serogroup B strains circulating in the USA and Europe. This Phase II trial enrolled 539 healthy adolescents from 25 sites ...

Success For Watchman LAAC device ( Boston Scientific) in Stroke Prevention

Results were announced by Boston Scientic from the ASA Plavix (ASAP) Study, which studied the Watchman Left Atrial Appendage Closure (LAAC) device. The data showed a reduction in the risk of ischemic stroke by 75 percent in patients with atrial fibrillation who have a contraindication to oral anticoagulants such as warfarin.The prospective multi-center ASAP Study evaluated 150 patients with contraindications ...

Alzheimer's drug Ebixa/Namenda XR (Lundbeck) fails to reduce significant agitation

Ebixa/Namenda XR (memantine), from Lundbeck, does not ease clinically significant agitation in patients with Alzheimers Disease. A new study finds that while the drug does improve cognitive functioning and neuropsychiatric symptoms such as delusion, mood and anxiety, it is no more effective in reducing significant agitation than a placebo. It looked at 153 nursing home residents and hospital inpatients with ...

Janssen files Xarelto at FDA for Venous Thromboembolism and ACS

Janssen Research & Development, a Johnson & Johnson subsidiary, has filed at the FDA for approval of Xarelto (rivaroxaban) as a treatment for Deep Vein Thrombosis and Pulmonary Embolism, and as a preventative treatment for recurring Venous Thromboembolism. Deep Vein Thrombosis is a blood clot in large veins, usually in the legs. Those blood clots sometimes dislodge and travel to ...

Study shows Stroke risk high when Xarelto (Bayer HealthCare) stopped

Patients with irregular heartbeats who are taken off anti-clotting medication Xarelto (rivaroxaban), from Bayer HealthCare, face a high risk of Stroke within a month. Researchers analyzed data from the Phase III ROCKET AF trial following concerns about possible increased rates of Stroke and blood clots after discontinuing Xarelto. They found strokes and blood clots occurred at similar rates with either ...

NICE rejects Benlysta (GSK) for SLE in final guidance

The health technology appraisal body in England and Wales, NICE, has in its final guidance rejected Benlysta ((belimumab ) from GSK/Human Genoma Sciences for Systemic Lupus Erythematosus (SLE) treatment. The decision was criticised by GSK, which said the UK's failure to adopt innovative medicines is a continuing systemic problem....

Review shows Botox (Allergan) offers modest benefit for chronic Migraine and daily headaches

A review of previous studies of Botox (onabotulinumtoxin A), from Allergan, finds a small to modest benefit for patients with chronic Migraine headaches and chronic daily headaches, although Botox injections were not associated with greater benefit than placebo for preventing episodic Migraine or chronic tension-type headaches. Pooled analyses of the data suggested that Botox was associated with fewer headaches per ...

Additional data from CARE-MS II trial of Lemtrada (Genzyme) in Multiple Sclerosis treatment

Genzyme report additional data from the Phase lll CARE-MS ll trial. Accumulation of disability was significantly slowed in patients with Multiple Sclerosis (MS) who were treated with Lemtrade (alemtuzumab) versus Rebif (high dose subcutaneous interferon beta-1a), as measured by the Expanded Disability Status Scale (EDSS), a standard assessment of physical disability progression. In addition, significant improvement in disability scores was ...

Pivotal Study of E 2087 (Eisai) shows positive results in treating Epilepsy

A pivotal Phase III study of E 2087 (perampanel), from Eisai, developed as an adjunctive therapy for partial seizures in adult patients with Epilepsy, provides evidence that 4 and 8 mg/day doses of the drug are effective and well-tolerated in reducing uncontrolled partial-onset seizures when compared with placebo. Efficacy in seizure reduction was seen despite treatment with up to three ...

CHMP recomends heart monitoring for Gilenya (Novartis) patients

The CHMP has reviewed Gilenya (fingolimod) from Novartis,following the unexplained sudden death in a patient within 24 hours of taking the drug . The CHMP recommends that Gilenya should not be prescribed for patients with a history of cardiovascular and cerebrovascular disease or who take heart-rate lowering medication. When treatment is considered necessary in these patients, their heart activity should ...

Levodopa-carbidopa gel (Abbott) Phase III results

The results were announced from a Phase III trial evaluating the levodopa-carbidopa intestinal gel (LCIG) from Abbott Labs for advanced Parkinsons Disease. The study showed that patients treated with LCIG for 12 weeks reported clinically meaningful and statistically significant improvements in "off" time compared to levodopa-carbidopa immediate release (IR) tablets, without increasing troublesome dyskinesia. "Off" time refers to the periods ...

ONO 4641 success In Phase II trial for Multiple Sclerosis

An investigational oral drug called ONO-4641 which is in joint development by Ono Pharma and Merck Serono, reduced the number of lesions in people with Multiple Sclerosis (MS), according to the results of a Phase II clinical trial, DreaMS study,to be presented as Emerging Science (formerly known as Late-Breaking Science) at the American Academy of Neurology's 64th Annual Meeting in ...

IQWiG finds limited effect of Vyndaqel (Pfizer)in TTR-FAP

The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed Vyndaqel (tafamidis)from Pfizer at the request of the Federal Joint Committee. Only one of the two relevant studies (Fx-005) provided reliable data - and only for patients with a particular genetic defect (Val30Met). The second study (Fx1A-201) in adults with different genetic defects was not controlled, i.e. ...

Newron Pharma licenses US and EU rights to safinamide for Parkinsons Disease to Zambon SPA

Newron Pharma has agreed with Zambon SPA to licence safinamide, an add-on therapy to dopamine agonists and levodopa in patients with Parkinson's Disease, in the EU and USA and has granted an option exercisable by 17 April 2012 to permit Zambon SPA to acquire ROW rights to the drug except the territories of Japan and Asia where the drug is ...

Neupro (UCB) FDA approved for advanced Parkinsons and RLS

advanced Parkinsons and RLS Neupro(rotigotine transdermal system) from UCB/Schwarz is FDA approved as a therapy to treat the signs and symptoms of advanced stage idiopathic Parkinson's Disease and as a treatment for moderate-to-severe primary Restless Legs Syndrome. Neupro was previously approved in the USA as a therapy to treat the signs and symptoms of early stage idiopathic Parkinson's disease....

Gilenya (Novartis) toxicity problems issue

The Institute for Safe Medicine Practices says the FDA should substantially restrict the use of Gilenya (fingolimod) from Novartis and enhance patient monitoring. Problems of widespread toxicity that were already evident in clinical testing of Gilenya are now producing strong signals in the postmarket adverse event data....

NBI-98854 (Neurocrine Biosciences) moves into Phase IIb for Tardive Dyskinesia

NeuroCrine Biosciences has announced efficacy and safety results from a Phase II trial of NBI-98854 in 37 tardive dyskinesia patients. For the final analysis, data from one site was removed due to the inconsistent and incorrect application of the efficacy assessment protocol. With this site removed, the results showed a significant reduction in tardive dyskinesia symptoms at end of two ...

NICE recommends Xarelto (Bayer) for Stroke Prevention

NICE (The National Institute for Health and Clinical Excellence) has recommended Xarelto (rivaroxaban) from Bayer Healthcare in a final draft guidance as an option for the Prevention of Stroke and Systemic Embolism in people with atrial fibrillation. NICE revised its original decision not to recommend Xarelto after Bayer supplied requested additional evidence on the clinical and cost effectiveness of the ...

Yervoy (BMS) in Brain Metastases study

Yervoy (ipilimumab) from BMS may help shrink some tumors and may slow progression of secondary tumors in the brain (metastases) in some patients with advanced melanoma. The researchers enrolled 72 patients with brain metastases to participate in the study:Cohort A contained 51 neurologically asymptomatic patients Cohort B contained 21 symptomatic patients receiving corticosteroids for clinical or radiological control of their ...

Complete Response Letter from FDA for Levadex (MAP Pharma) for Migraine

The FDA has issued a Complete Response Letter to MAP Pharma to its new drug application for Levadex (dihydroergotamine meyslate) inhalation aerosol for the acute treatment of Migraine. The FDA has raised issues on chemistry, manufacturing and controls but has not required a new trial Allergan will co-market Levadex in the USA....

Positive results for Xarelto (Bayer/Janssen) in PE and VTE

The results of the Phase III EINSTEIN-PE 4,833-patient study have been presented at the American College of Cardiology meeting in Chicago which show that Xarelto (rivaroxaban) from Bayer/Janssen was as effective and safe as the current dual drug approach of subcutaneous Lovenox (enoxaparin), followed by warfarin, in treating patients with acute symptomatic pulmonary embolism (PE) and preventing them from developing ...

Addex Pharma reports success in Phase IIa trial for Dipraglurant for Parkinsons Disease

Addex Pharma reports positive top line data from a Phase IIa clinical study of dipraglurant in Parkinson's disease patients suffering from debilitating levodopa-induced dyskinesia (LID). The data show that dipraglurant met the primary objective of the study by exhibiting a good safety and tolerability profile. Dipraglurant also demonstrated statistically significant reduction in LID severity with both 50mg and 100mg doses. ...

No proof of added benefit of Trobalt (Glaxo Smith Kline) for Epilepsy

In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether retigabine, from Glaxo Smith Kline, offers an added benefit compared with the present standard therapy for Epilepsy. It found that no such added benefit can be inferred. The Federal Joint Committee (G-BA) had specified lamotrigine as the appropriate comparator therapy if this ...

CHMP recommends Tecfidera(Biogen IDEC) for treatment of Multiple Sclerosis

Biogen Idec has announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) recommending a marketing authorization be granted for Tecfidera (dimethyl fumarate) as a first-line oral treatment for adults with relapsing-remitting Multiple Sclerosis (RRMS). The CHMP, on the basis of quality, safety and efficacy data submitted ...

FDA advisors vote against Taltorvic (Merck/Ariad) for Sarcoma patients

The FDA's ODAC voted 13-1 against the use of Taltorvic (ridaforolimus), from Merck / Ariad, as maintenance therapy for patients with metastatic soft-tissue Sarcoma or Bone Sarcoma whose disease has not progressed after at least four cycles of chemotherapy. This was based on data showing patients on Taltorvic had a median progression-free survival of 17.7 weeks compared with 14.6 weeks ...

CHMP recommends extended approval for Menveo(Novartis)for Meningococcal Disease

The CHMP recommends approval for an extended indication of Menveo (meningococcal vaccine) from Novartis which protects against Neisseria meningitidis groups A, C, W135 and Y,and will shortly be indicated for use in children aged two years and older, as well as adolescents and adults at risk of exposure to the bacteria, to prevent invasive disease. It is currently approved for ...

Alcon acquires non USA rights to Ocriplasmin for Vitreomacular Adhesion

Alcon,a division of Novartis, has announced that it has gained exclusive rights from ThromboGenics, to commercialize ocriplasmin outside the United States for the treatment of Symptomatic Vitreomacular Adhesion (VMA). If approved, it will be the first pharmacological treatment for patients with symptomatic VMA, including macular hole. Symptomatic VMA is a progressive, debilitating eye disease that may lead to visual distortion, ...

NICE recommends Gilenya (Novartis) for Multiple Sclerosis

The National Institute of Clinical Evidence (NICE) initially said it was unclear if Gilenya (fingolimod) from Novartis, was any better than existing treatments. It has changed its mind after Novartis presented data showing the benefits of using Gilenya in a subgroup of adults with highly active disease, whose relapses had increased or stayed the same compared with the previous year ...

Shire withdraws FDA application for Replagal for Fabry Disease

Shire has withdrawn its Biologics License Application (BLA) for Replagal (agalsidase alfa) with the FDA. Shire has been in ongoing dialogue with the FDA since the supply shortage of the only USA approved treatment for Fabry disease. In 2009, and again in 2011, the FDA encouraged Shire to submit an application for the approval of Replagal. Recent interactions with the ...

Zemplar (Abbott) shows positive results in Phase IV Hyperparathyroidism study

A Phase IV clinical trial comparing the efficacy of Zemplar, from Abbott, against cinacalcet plus low-dose vitamin D in treating secondary Hyperparathyroidism (SHPT) in patients on kidney dialysis (hemodialysis) shows that more patients treated with intravenous Zemplar achieved their treatment goal, compared to patients treated with cinacalcet plus low-dose vitamin D. The study, IMPACT-SHPT, was an international, multi-centre investigation of ...

CRTX 080 (Cornerstone) is filed at FDA for Hyponatraemia

FDA has accepted the new drug application for the investigational Hyponatraemia treatment CRTX 080, from Cornerstone Therapeutics CRTX 080 is a highly potent oral non-peptide, which acts on the vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes. Hyponatremia is a metabolic condition that occurs when there is not enough sodium in ...

Banzel/Inovelon(Eisai) is launched in Germany for LGS

Banzel/Inovelon(rufinamide), from Eisai, for treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older has been launched in Germany. The new formulation, an oral suspension for adjunctive (add-on) treatment of seizures, has been developed as a child friendly drinkable liquid to aid administration since many patients who receive it are children. "In addition, administration of suspension ...

FDA approves Gintuit (Organogenesis) for Mucogingival Conditions

The FDA on 9 March 2012 approved Gintuit from Organogenesis Inc., being the first cell-based product made from allogeneic human cells (from a donor unrelated to the patient) and bovine collagen. Gintuit is indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults. With Gintuit, Organogenesis hopes to address the ...

Results of Study 102 for Quad (Gilead) for HIV

Phase III results were announced from the pivotal Study 102 demonstrating that Quad,from Gilead Sciences, a fixed-dose, single-tablet regimen made up of the investigational drugs elvitegravir and cobicistat combined with the two active ingredients in Truvada (emtricitabine and tenofovir), is non-inferior to Atripla (efavirenz/tenofovir/emtricitabine) after 48 weeks of therapy in treatment-naive adults. At the end of the trial, 88% of ...

Renadyl (Kibow Biotech) in study for Kidney Failure patients

Interim data from an expanded clinical trial of Renadyl, a probiotic dietary supplement from Kibow Biotech, confirms positive results for safety and quality of life previously established in a pilot-scale study for Kidney Failure patients. The probiotic microbial strains in the product formulation are "Generally Recognized As Safe" as per US FDA regulations. Renadyl, originally marketed under the name of ...

FDA approves FreeStyle InsuLinx Blood Glucose Monitoring System (Abbott)

The FDA has issued clearance for the FreeStyle InsuLinx Blood Glucose Monitoring System, from Abbott. This machine is designed to translate blood glucose measurements and individual patient data into accurately calculated insulin dosing suggestions. It includes a touch-screen interface, automated logbook and several personalization features designed to improve the diabetes management experience for patients. This device is equipped with built-in ...

Positive interim analysis of blisibimod (Anthera Pharma) clinical trial for SLE

The Phase IIb PEARL-SC clinical study of blisibimod, from Anthera Pharma, for Systemic Lupus Erythematosus (SLE) is recommended for continuation following an interim analysis of all safety and efficacy data. Following the review by the Company's Data Safety Monitoring Board, the study will proceed as planned without modification. PEARL-SC is examining the therapeutic benefit of weekly and monthly subcutaneous injections ...

Shire initiates Phase IV trials to compare Vyvanse ands Concerta

Shire will initiate two Phase IV clinical trials to compare Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta® (methylphenidate HCl) Extended-Release Tablets, (CII).e two Phase 4 clinical trials are randomized, double-blind, multi-center, parallel-group, active-controlled studies. They are designed to explore differences in efficacy between Vyvanse and Concerta in adolescents ages 13 to 17 with ADHD. This clinical trial program will utilize ...

Da Vinci Surgical System a benefit for HPV-related Oral Cancer

A study of robotic surgery conducted with the da Vinci Surgical System, and made through patients' mouths reveals it provides excellent results in removing squamous cell carcinoma at the back of the throat, especially in patients with HPV. The study followed 66 patients with Oropharyngeal Cancer who underwent transoral robotic surgery. Every few months, the patients had imaging studies, scans ...

FDA approves Ultresa and Viokace (Aptalis Pharma) for Exocrine Pancreatic Insufficiency

Aptalis Pharma received FDA approval on 1 March 2012 to market Ultresa (pancrelipase) and Viokace (pancrelipase) to treat Exocrine Pancreatic Insufficiency (EPI), a condition in which the body is unable to properly digest fat, protein and carbohydrates and absorb nutrients.Ultresa is specifically indicated as a treatment for EPI in adults and children due to Cystic Fibrosis or other conditions, while ...

Lorqess is filed at EU by Arena Pharma for weight loss

Arena Pharma has filed at the EU its selective serotonin 2C receptor agonist, Lorqess (lorcaserin)for use in weight loss and maintenance of weight loss in patients who are obese (BMI>30) or who are overweight (BMI>27) and have at least one weight-related comorbid condition. The rights in the USA are held by Eisai and outside the EU the rights are held ...

Positive results for NA-1 (NoNo) in Phase II Trial of Stroke patients

Final results of the ENACT Phase II clinical trial of the drug, NA-1 (TAT-NR2B9c) for reducing Stroke damage, from NoNo Inc, have been presented. The ENACT trial was a 185-patient, randomized, double-blind placebo-controlled study performed to assess the safety and efficacy of NA-1 in reducing small embolic strokes in patients that underwent an endovascular repair of intracranial Aneurysms. Patients enrolled ...

Biogen Idec files BG-12 at FDA for Multiple Sclerosis

Biogen Idec has announced the company has submitted a New Drug Application (NDA) to the FDA for marketing approval of BG-12 (dimethyl fumarate), the oral therapeutic candidate for the treatment of Multiple Sclerosis (MS). The regulatory submission was based on BG-12’s comprehensive development program, in which BG-12 demonstrated significant reductions in MS disease activity coupled with favorable safety and tolerability ...

Avonex Pen (Biogen Idec) is FDA approved for relapsing Multiple Sclerosis

The FDA has approved two separate dosing innovations designed to improve the treatment experience for patients receiving once-a-week Avonex from Biogen Idec for relapsing forms of Multiple Sclerosis (MS). Avonex Pen, the first intramuscular (IM) autoinjector approved for MS, incorporates a smaller needle and easier administration to help patients reduce anxiety about Avonex self-injection. A new dose titration regimen, which ...

Phase II study of SKL 11197 (SK Biopharmaceuticals) for Diabetic Peripheral Neuropathy initiated in US

SK Biopharmaceuticals has initiated a Phase II trial for US patients suffering with Diabetic Peripheral Neuropathy using their investigational drug SKL11197. Unlike many other drugs currently marketed for the treatment of Neuropathic Pain that were originally developed for the treatment of epilepsy or depression, SKL11197 has been developed solely for the treatment of pain. SKL11197 has already been proven safe ...

CHMP recommends Nimenrix vaccine (GSK) for Meningococcal Diseases

The CHMP has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nimenrix, powder and solvent for solution for injection from GSK, intended for active immunisation of individuals from the age of 12 months and above against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135 and Y....

NICE rejects Botox (Allergan) for Migraine prevention

NICE,the National Institute for Health and Clinical Excellence has published draft guidance rejecting the use of Botox (botulinum toxin type A)from Allergan, to prevent headaches in adult patients experiencing chronic Migraines. The Institute's committee of experts has concluded that there is not enough evidence to recommend the drug, and so has asked that its manufacturer Allergan provide additional information in ...

FDA accepts new drug application from Pfizer for tafamidis for TTR-FAP

After a Refusal to File notification from the FDA for tafamidis from Pfizer, the FDA has now accepted the new drug application for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) a rare, progressive fatal neurodegenerative disease, which affects about 8,000 patients worldwide.The drug is approved as Vyndaqel in the EU....

Tysabri(Biogen IDEC/Elan) enters Phase III ASCEND trial for Secondary Progressive Multiple Sclerosis

Biogen Idec and Elan Corporation, have announced a global Phase IIIb study, ASCEND, that is being conducted to evaluate the effectiveness of Tysabri as a treatment for secondary-progressive multiple sclerosis (SPMS). According to the National Multiple Sclerosis Society, approximately half of all people initially diagnosed with relapsing-remitting Multiple Sclerosis (RRMS) - the most common form of Multiple Sclerosis (MS) - ...

Rebif (Merck Serono) is EU approved for Early Multiple Sclerosis

The European Commission has approved an extended indication for Rebif (interferon beta-1a) from Merck Serono, allowing its use in patients with early Multiple Sclerosis, in line with an earlier recommendation by the CHMP. It recommended that 44 micrograms of Rebif three times weekly should be given to patients who have experienced a single demyelinating event, an early sign of Multiple ...

Ipsen returns ROW rights to fipamezole to Santhera Pharma

Ipsen returns ROW rights to the adrenergic alpha-2 receptor antagonist fipamezole outside North America and Japan. Biovail ( now Valeant Pharma) returned the North American rights in 2010. Fipamezole is a first-in-class compound development for the treatment of levodopa-induced dyskinesia in Parkinson's disease and has completed Phase II trials. Santhera will seek other partners....

NICE final guidance positive for Eliquis(BMS/Pfizer)in VTE

NICE, the health technology appraisal body for England and Wales, has published final guidance recommending Eliquis (apixaban) from BMS/Pfizer as an option for preventing venous thromboembolism after knee and hip surgery. Eliquis will compete against Pradaxa from Boehringer abd Xarelto from Bayer HealthCare in this indication. No decision was made as to cost benefit comparisons....

Gammagard Liquid10% (Baxter) in second Alzheimers Disease Phase III trial

Baxter International Inc. will initiate a second Phase III trial to evaluate the use of its Gammagard Liquid 10% [Immune Globulin Infusion (Human)] (marketed as Kiovig outside the United States and Canada), for the treatment of mild to moderate Alzheimer's Disease. The company plans to initiate the new trial in the first quarter of 2012, having satisfactorily completed a futility ...

FDA label change for Tysabri (Biogen IDEC) for Multiple Sclerosis and approval of JCV antibody test

The FDA has approved a product label change for Tysabri(natalizumab) from Biogen IDEC/Elan that will help enable individual benefit risk assessment for patients with relapsing remitting Multiple Sclerosis (MS).The new label identifies anti-JCV antibody status as a risk factor for developing an infrequent but serious brain infection known as progressive multifocal leukoencephalopathy(PML). Infection with the JC virus (JCV) is required ...

Gilenya(Novartis) patients with Multiple Sclerosis to be monitored after first dosing

The European Medicines Agency has received reports of unexplained deaths of patients taking Gilenya (fingolimod) the Multiple Sclerosis treatment from Novartis.The EMA has advised doctors to monitor patients new to the drug for six hours after first dosing as has the FDA. Six Gilenya patients have died of unknown causes, three of them suddenly. Another four died from cardiovascular problems ...

Positive results for 4CMenB (Novartis) vaccine against group B Meningococcal Disease

Results of a Phase IIb/III placebo-controlled clinical trial of 4CMenB, from Novartis, in which 1631 adolescents received the vaccine, suggest that is is a safe and efficacious vaccine for protection against group B meningococcal disease. Immunogenicity was assessed as serum bactericidal activity using human complement (hSBA), an established immunological correlate of protection against meningococcal disease, for three of the antigens ...

Stenting with Emboshield Pro (Abbott Vascular) for Carotid Arteryt Disease becoming safer in high-risk patients

Placing a stent in a key artery in the neck is safer than ever in patients ineligible for the standard surgical treatment of carotid artery disease, according to results from the PROTECT trial designed to examine the safety of Emboshield Pro, from Abbott Vascular. Emboshield Pro is an embolic protection device used in combination with stenting to help enlarge the ...

Pradaxa(Boehringer) risk of Myocardial Infarction and Acute Coronary Syndrome

Pradaxa/Rendix (dabigatran etexilate), from Boehringer, is associated with an increased risk of Myocardial Infarction (MI) or Acute Coronary Syndrome (ACS) in a broad spectrum of patients when tested against some other medicines, according to a study published by the Archives of Internal Medicine. The meta-analysis of 7 studies, with 30,514 participants, Ken Uchino and Adrian V. Hernandez of the Cleveland ...

Intuniv (Shire) shows positive response for children with ADHD

A new trial has assessed the efficacy and safety of Intuniv (guanfacine extended release), from Shire, as an adjunct to psychostimulants in children and adolescents diagnosed with ADHD who had a suboptimal response to a psychostimulant alone. Participants continued their stable dose of psychostimulant given in the morning and were randomised to receive Intuniv in the morning, Intuniv in the ...

Rebif Rebidose approved by FDA for self administration to treat Multiple Sclerosis

The FDA has on 3 January 2013. approved Rebif Rebidose (interferon beta-1a), a single-use auto-injector for the self-administration of Rebif, a disease-modifying drug used to treat relapsing forms of Multiple Sclerosis.

Rebif Rebidose was evaluated in a 12-week Phase IIIb multicenter, open-label, single-arm study for the self-administration of Rebif with respect to ease of use, patient satisfaction and ...

Eisai re-submits perampanel to FDA for Epilepsy

Eisai has resubmitted a new drug application for its perampanel, for which it is seeking approval in this key market as an adjunctive therapy for partial onset seizures associated with Epilepsy.The FDA had issued a refusal to file letter for perampanel in July....

Aubagio (Sanofi/Genzyme) results in TENERE trial for Multiple Sclerosis

Sanofi-Aventis and its subsidiary Genzyme reported top-line results from TENERE, a Phase III clinical trial comparing the effectiveness, safety and tolerability of once-daily oral teriflunomide to interferon beta-1a (Rebif), an approved injectable therapy, in people with relapsing forms of multiple sclerosis (RMS). The TENERE trial, which included 324 patients, is the second completed study of five efficacy studies of teriflunomide ...

Pfizer will not proceed with Lyrica for Restless Legs Syndrome

Pfizer will not proceed with regulatory approval for Lyrica (pregabalin), its GABA analogue, for Restless Legs Syndrome despite reporting positive Phase III results for the drug in this patient group....

Lamictal (Glaxo Smith Kline) one of superior drug combination for treating Epilepsy

A combination of two drugs, Lamictal (lamotrigine), from Glaxo Smith Kline, and valproate, is more effective in treating difficult-to control Epilepsy than other anti-epileptic regimens. This large-scale, retrospective study of a population of patients with very difficult-to-control Epilepsy revealed that only the Lamictal/valproate treatment regimen, out of the 32 drug combinations studied, significantly decreased seizure frequency in this group. This ...

Gilenya (Novartis) shows reduction in relapse rates in Phase III Multiple Sclerosis study 2309

Novartis announced new data from the Phase III 2309 study showing patients with relapsing-remitting Multiple Sclerosis (RRMS) treated with Gilenya (fingolimod) had a statistically significant 48% reduction in annualized relapse rates (ARR) at 24 months compared to placebo. Study 2309 is the third Phase III clinical trial to demonstrate a significant reduction of relapse rates with Gilenya treatment in patients ...

Eyebrain Tracker (EyeBrain) used in Parkinson's Therapy trial

The EyeBrain Tracker device, from EyeBrain, is being used in a clinical trial exploring the dyskinesia induced by treating patients suffering from idiopathic Parkinson’s disease with levodopa. The endpoint of the trial is to find biomarkers for the late-onset complications of a treatment regime using levodopa (BIODYS). This compound, which is naturally transformed into dopamine in the brain, is one ...

Olesoxime(Trophos S.A.) fails Phase III trial for ALS

Olesoxime from Trophos S.A. failed to show an increase in survival compared to placebo in patients receiving Rilutek (riluzole) in its Phase III trial for Amyothrophic Lateral Sclerosis (ALS),often known as "Lou Gehrig's Disease". Actelion has withdrawn from its option to acquire the shares of Trophos S.A. and the company has announced that it will concentrate on other indications for ...

Buccolam(Viro Pharma) is launched in UK for prolonged, acute convulsive seizures in paediatric patients

Buccolam (midazolam oromucosal solution) from Viro Pharma for the treatment of prolonged, acute convulsive seizures in paediatric patients from three months to 18 years has been launched in the UK, its first European market. The product was the first ever to be approved through the European Medicines Agency’s new PUMA (paediatric use marketing authorisation) process that came into force in ...

Lipitor (Pfizer) may benefit Alzheimer's patients

Evidence obtained from in vitro studies and some clinical trials has suggested that a reduction in cholesterol levels could be beneficial in patients with Alzheimer's Disease. A new study published in Nature Reviews Neurology on the Alzheimer's Disease Cooperative Study has investigated the therapeutic effects of Lipitor (atorvastatin), from Pfizer, in the treatment of mild to moderate Alzheimer's Disease, and ...

NICE does not recommend Gilenya(Novartis) for Relapsing Remitting Multiple Sclerosis

The second appraisal consultation document from the National Institute of Clinical Evidence (NICE) provisionally does not recommend Gilenya (fingolimod) from Novartis for highly active relapsing-remitting Multiple Sclerosis; a type of the condition characterised by periods when symptoms worsen and then improve. The second draft has been published following a proposed discount from Novartis (called a Patient Access Scheme) to the ...

NICE recommends Eliquis (BMS/Pfizer) for Venous Thromboembolism Prevention

The National Institute for Clinical Excellence (NICE) has published final draft guidance recommending Eliquis (apixaban) from BMS/Pfizer as an option for the prevention of venous thromboembolism (VTE) in adults who have undergone planned total hip replacement or total knee replacement surgery/...

FDA accepts for review Eliquis (BMS/Pfizer) for Stroke Prevention associated with Atrial Fibrillation

The FDA has accepted for review a New Drug Application for Eliquis (apixaban) from BMS/Pfizer,an investigational compound for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The FDA accepted the filing and assigned a priority-review designation. The Prescription Drug User Fee Act goal date for a decision by the FDA is March 28, 2012. An application ...

NovoTTF-100A (NovoCure) therapy achieves encouraging long term survival time for Glioblastoma patients

Results from a Phase III EF-11 study comparing overall survival at two and three years after initiating therapy in patients with recurrent glioblastoma multiforme (GBM) treated with NovoTTF-100A therapy, from NovoCure, versus standard chemotherapy show they remain consistent with one-year survival data. With a median follow-up of 39 months, overall survival in the TTF group compared to the chemotherapy group ...

UCB will not market SYN 118 for Parkinsons Disease

UCB will not exercise its option to acquire rights to SYN 118 from Biotie Therapeutics as the drug did not show an improvement in Parkinsons Disease motor function compared to placebo in its Phase IIa trial....

CHMP continues to monitor safety profile of Pradaxa (Boehringer) for VTE

The EMA has issued a safety update on VTE treatment Pradaxa/Rendix, from Boehringer. It reports that the Agency is aware of recent media interest regarding fatal cases of bleeding in patients treated with the drug, but the CHMP is of the opinion that the recommended changes to the use of Pradaxa adequately manage the risk of bleeding. A worldwide total ...

Vyndaqel(Pfizer) is EU approved for TTR-FAP

Vyndaqel (tafamidis), an orphan medicine from Pfizer to treat transthyretin familial amyloidosis in adult patients with symptomatic polyneuropathy (TTR-FAP), a neurogenerative disease, is EU approved The approval is based on studies that demonstrated the novel specific transthyretin stabiliser showed efficacy in delaying peripheral neurologic impairment, plus 51%-81% less deterioration in neurologic function, plus large and small fibre function compared with ...

Lemtrada(Genzyme/Sanofi) superior to Rebif in CARE-MS II Multiple Sclerosis study

The Phase lll CARE-MS ll trial met both of its co-primary endpoints for Lemtrada(alemtuzumab)from Genzyme/Sanofi in the treatment of Multiple Sclerosis (MS). In this randomized trial involving 840 patients, a 49 percent reduction in relapse rate was observed in patients treated with Lemtrada 12 mg compared to Rebif ( subcutaneous interferon beta-1a) over two years of study(p<0.0001). Importantly, there was ...

Eliquis versus enoxaparin in ADOPT study for VTE acutely ill patients

Phase 111 ADOPT (Apixaban Dosing to Optimize Protection from Thrombosis) trial evaluated Eliquis (apixaban) versus enoxaparin in acutely ill medical patients and showed that Eliquis did not meet the primary efficacy outcome of superiority to enoxaparin for the endpoint of venous thromboembolism (VTE) and VTE-related death at day 30. The apixaban arm had a 13 percent lower rate of events ...

Huntexil (Neurosearch) trial suggests it is well tolerated and may offer benefits for patients with Huntington's Disease

A new study suggests that Huntexil (pridopidine), from Neurosearch, is well tolerated and warrants further study in patients with Huntington's disease (HD). Until now, no drug has been shown to improve the loss of the ability to move muscles voluntarily, and the only drug currently approved for HD, tetrabenazine, treats only chorea (involuntary movements) and is associated with serious side-effects. ...

Ipsen sells Apokyn North America rights to Britannia Pharma

Ipsen has sold to Britannia Pharmaceuticals the development and marketing rights for Apokyn (apomorphine) in North America, where the drug is the only product indicated for the acute, intermittent treatment of hypomobility "off" episodes associated with advanced Parkinson's disease....

Teva will not file laquinimod at the FDA for Multiple Sclerosis in the immediate future

Teva has announced that it will not be prudent to file laquinimod at the FDA for Multiple Sclerosis in the immediate future. Initial results from the Phase III BRAVO study, the second of two late-stage trials on laquinimod, showed that the drug failed to meet its primary endpoint of reducing the annualised relapse rate when compared with placebo....

Xarelto(Bayer/Johnson & Johnson) is FDA approved for Stroke prevention in patients with non valvular atrial fibrillation

The FDA has approved Xarelto (rivaroxaban) from Bayer HealthCare/Johnson & Johnson for prevention of stroke in patients with nonvalvular atrial fibrillation, making it the first oral direct factor Xa inhibitor to secure an indication for stroke prevention.The drug had already been approved for prevention of deep vein thrombosis in patients undergoing joint replacement surgery...

FDA finds ADHD drugs have no link to Cardiovascular problems

The US FDA has announced that a large, recently-completed study in children and young adults treated with medication for Attention-Deficit/Hyperactivity Disorder (ADHD) has not shown an association between use of certain ADHD medications and adverse cardiovascular events. These adverse cardiovascular events include stroke, heart attack (myocardial infarction or MI), and sudden cardiac death. The study was conducted with 1,200,438 children ...

NICE recommends Pradaxa for Stroke Prevention in non vavular atrial fibrillation patients

NICE has made a final appraisal determination that recommends the direct thrombin inhibitor Pradaxa (dabigatran etexilate) from Boehringer as an option for preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation with one or more of the following risk factors •previous stroke, transient ischaemic attack or systemic embolism; •left ventricular ejection fraction below 40%; •symptomatic heart failure of ...

Lixiana development in VTE for USA and EU is discontinued

The US and EU development of Lixiana (edoxaban) from Daichi Sankyo is discontinued for the prevention of venous thromboembolic events after orthopaedic surgery although the drug is approved in Japan for that indication. Daiichi Sankyo will concentrate on the indication of stroke prevention in atrial fibrillation, for which results from the ongoing ENGAGE AF-TIMI 48 Phase III trial which compares ...

Nuedexta is filed at EU for Pseudobulbar Affect

Avanir Pharmaceuticals has submitted an EU marketing authorisation application for Nuedexta (dextromethorphan HBr and quinidine sulfate) for the treatment of Pseudobulbar Affect(PBA). PBA is a neurological disorder, secondary to neurological disease or brain injury (e.g. Parkinsons, Alzheimers or Multiple Sclerosis) causing unpredictable episodes of crying, laughing and other emotional displays out of proportion to the underlying emotional state. Nuedexta was ...

Genetics and Plavix/Iscover play role in risk of post-stent thrombosis

A new study published in JAMA shows that it is possible to identify genetic or other factors in patients who have received a coronary stent which give this sub-population a higher potential risk of experiencing a blood clot within the stent. Despite the use of dual antiplatelet therapy - DAPT; aspirin and Plavix/Iscover (clopidogrel), from BMS and Sanofi-Aventis - which ...

CONFIRM trial positive for BG-12 in Multiple Sclerosis

Biogen announced positive top-line results from CONFIRM, the second of two pivotal Phase III clinical trials designed to evaluate the oral compound BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS).Th earlier trial was DEFINE study. Results showed that 240 mg of BG-12, administered either twice a day (BID) or three times a day (TID), demonstrated significant efficacy and ...

Genes predict child's response to Equasym in treatment of ADHD

New research suggests that the genetic characteristics of a child with ADHD may offer a useful indicator in selecting the treatment most suitable for them. The study, published in the Journal of the American Academy of Child and Adolescent Psychiatry, found that out of 89 children aged from 7-11 with ADHD, those with specific variations of the dopamine receptor D4 ...

Implanted SPR Micropulse System shows benefit for patient with Post-Stroke Shoulder Pain

Doctors involved in a multi-centre clinical study for the treatment of Post-Stroke Shoulder Pain have made the first implantation of the Micropulse system, an investigational pain therapy device from SPR Therapeutics. SPR's short-term, temporary therapy significantly reduced his pain after just a few weeks but when SPR's fully implantable device was implanted into the patient, he was pain-free within a ...

Onfi from Lundbeck is FDA approved for Lennox-Gaastaut Syndrome.

The FDA has approved Onfi (clobazam)from Lundbeck (USA) and Sanofi-Aventis (ROW) as adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome (LGS)in patients two years and older. LGS is a rare and severe form of epilepsy that is typically diagnosed in childhood. A Phase III trial in 238 patients with a current or prior diagnosis of LGS showed that high doses ...

Lemtrada success over Rebif in CARE-MS 1 trial for Multiple Sclerosis

New results from the CARE-MS I trial, the first of two randomized, Phase III clinical trials comparing the investigational drug Lemtrada (alemtuzumab) from Genzyme/Sanofi and Bayer HealthCare, to Rebif (high dose subcutaneous interferon beta-1a) in patients with relapsing-remitting multiple sclerosis (MS). New data show that 78 percent of patients treated with alemtuzumab remained relapse-free for two years, providing statistically significant ...

Aubagio from Genzyme/Sanofi is filed at FDA for relapsing Multiple Sclerosis

Genzyme/Sanofi announced that the FDA has accepted for review the new drug application (NDA) for oral teriflunomide (Aubagio) as a potential therapy for people with relapsing forms of multiple sclerosis (MS). Sanofi expects to file an application for regulatory approval with the European Medicines Agency (EMA) in the first quarter of 2012....

Aubagio reduces significant relapses in patients with Multiple Sclerosis

A new Phase III trial shows that once-daily oral Aubagio (teriflunomide), from Sanofi-Aventis, significantly reduces annualised rates of relapses leading to hospitalization in patients with Multiple Sclerosis. The data also confirmed the safety profile and efficacy of Aubagio over a six-year period after the initial randomization. According to this post-hoc analyses of the TEMSO study, Aubagio-treated patients’ annualized rate of ...

BG-12 results from DEFINE study in Multiple Sclerosis will be presented by Biogen at ECTRIMS and ACTRIMS conference

Phase III DEFINE clinical trial of oral BG-12 (dimethyl fumarate) from Biogen-IDEC was performed in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 mg of BG-12, administered either twice a day (BID) or three times a day (TID), significantly reduced the proportion of patients who relapsed by 49 percent and 50 percent, respectively, at two years compared with ...

Merck KGaA returns rights to safinamide the Parkinsons treatment to Newron Pharma

Merck KGaA will return all rights to the Parkinson's disease drug ,safinamide, to its developer, Newron Pharmaceuticals. The treatment's potential commercial value to Merck KGaA is limited and the decision was part of a rationalisation of the Merck KGaA development pipeline. The decision was made as part of an "ongoing review and re-prioritisation of the company's R&D pipeline"....

Vyvanse positive in European Phase III study for ADHD

Vyvanse- lisdexamfetamine (LDX) from Shire is the long acting, prodrug of dexamfetamine for the treatment of ADHD and is currently licensed only in the US, Canada and Brazil. A study, conducted at 48 sites across Europe, showed that LDX demonstrated efficacy on the primary and key secondary measures compared to placebo, and a safety profile consistent with the known effects ...

FDA rejects ADAGIO study results as showing Azilect delays progression of Parkinsons Disease

The FDA Peripheral and Central Nervous System Drugs Advisory Committee decided that the 1,176 patient, randomized, multicentre, double-blind study, known as ADAGIO, failed to provide compelling evidence that the 1mg dose of Azilect(rasagiline mesylate)from Teva met its specified criteria in delaying the progression of Parkinsons Disease. The data were seen as promising but not compelling. Azilect was approved in 2006 ...

Lemtrada and Aubagio trials to report at ECTRIMS/ACTRIMS congress

Genzyme/Sanofi will report more than 20 abstracts at ECTRIMS/ACTRIMS congress. Data will include Phase III results of Lemtrada(alemutuzumab) and Aubagio ( oral teriflunomide) in relapsing remitting Multiple Sclerosis (MS) including CARE-MS 1 study comparing Lemtrada and Rebif (interferon beta 1-a) in relapsing remitting MS and five year extension of TEMSO study of oral Aubagio (Poster 924) and efficacy of Aubagio ...

Gantenerumab reduces amyloid levels in patients with Alzheimer's Disease

According to a report in Archives of Neurology, patients with Alzheimer's Disease who received gantenerumab, from Roche,in a Phase 1 study, exhibited reductions in brain amyloid levels. Ex vivo experiments show that gantenerumab, a human anti-Aß monoclonal antibody, induces phagocytosis of human amyloid and the aim of the study was to determine whether the drug might impact Aß amyloid brain ...

Gantenerumab reduces amyloid levels in patients with Alzheimer's Disease

According to a report in Archives of Neurology, patients with Alzheimer's Disease who received gantenerumab, from Roche,in a Phase 1 study, exhibited reductions in brain amyloid levels. Ex vivo experiments show that gantenerumab, a human anti-Aß monoclonal antibody, induces phagocytosis of human amyloid and the aim of the study was to determine whether the drug might impact Aß amyloid brain ...

Lyrica as monotherapy is positive in Epilepsy

The Lyrica (pregabalin) epilepsy study- A0081047 entitled “A Double-Blind, Randomized, Multicenter Efficacy and Safety Study of Pregabalin (Lyrica) as Monotherapy in Patients with Partial Seizures” Data Monitoring Committee (DMC) has completed their review of the interim analysis. The DMC recommended that the study be stopped based on positive findings for the primary efficacy endpoint. Pfizer has accepted the DMC’s recommendation ...

Merck Inc. files ridaforolimus at FDA for Metastatic Sarcomas

Merck Inc. has filed ridaforolimus at the FDA seeking approval of the drug as a treatment for patients with metastatic soft tissue or bone Sarcomas. There have been no new treatments in the US for sarcomas in 20 years. The application is based on results of the SUCCEED trial....

Tysabri shows benefits in Multiple Sclerosis patients

Patients with Multiple Sclerosis who take anti-inflammatory Tysabri (natalizumab), from Biogen and Elan, for two years showed a reduced risk of experiencing at least one relapse (at 2 years this was reduced by 40%). The study also showed that the number of patients whose disability progressed in the time interval was reduced by 25%. In addition, MRI scans showed evidence ...

TEMSO study for Aubagio in Multiple Sclerosis is published in NEJM

The pivotal Phase III TEMSO study with investigational once-daily oral medication Aubagio (teriflunomide) from Sanofi/Genzyme is published in The New England Journal of Medicine (NEJM). Results showed that teriflunomide at the 14mg dosage significantly reduced the annual relapse rate, reduced disability progressions and improved several magnetic resonance imaging (MRI) measures of disease activity, including new or worsening brain lesions in ...

NICE refuses to recommend Benlysta for SLE

In a draft guidance, NICE, the health technology appraisal institute for England and Wales, has provisionally rejected Benlysta (belimumab) from GlaxoSmithKline (GSK) and Human Genome Sciences (HGS), for the treatment of adult patients with active autoantibody-positive systemic lupus erythematosus, where patients have a high degree of disease activity despite the individual receiving standard therapy. GSK plans to contest the decision....

Astellas cancels its oral Factor Xa inhibitor ,darexaban

Astellas Pharma has decided to cancel its oral Factor Xa inhibitor, darexaban, after considering the competitive market for anticoagulants and the difficulty in finding a partner for the drug....

Eliquis launched in UK for VTE

BMS and Pfizer have launched their oral direct Factor Xa inhibitor, Eliquis (apixaban), in the UK for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or knee replacement surgery....

Zonegran shows potential for partial Epilepsy in paediatric patients

Preliminary results from a new Phase III study of Zonegran (zonisamide) from Eisai, shows that it is more effective than placebo and well tolerated in paediatric patients with partial-onset seizures treated with one or two other anti-epileptic drugs. The data, presented at the 2011 International Epilepsy Congress, showed that significantly more patients responded positively to treatment with Zonegran (50.5%) versus ...

Menactra (Sanofi Pasteur) indication is expanded by FDA

Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group announced that the FDA has granted a license to expand the indication for its meningococcal conjugate vaccine, Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), to include a two-dose schedule for infants and children 9 months through 23 months of age. This is the first U.S. ...

NovoTTF-100A system is FDA approved for Glioblastoma

FDA recently approved the NovoTTF-100A System, a new device from Novocure Inc. to treat adults with glioblastoma multiforme (GBM) that recurs or progresses after receiving chemotherapy and radiation therapy....

Merck Inc. returns rights to betrixaban to Portola Pharma

Merck will return to Portola Pharma all rights for betrixaban, an investigational oral Factor Xa inhibitor anticoagulant being evaluated for the prevention of stroke in patients with atrial fibrillation (SPAF). This decision was made following a review of Merck's investigational portfolio....

FDA advisory committee recommends Novo TTF-100A for Glioblastoma

The FDA Neurological Devices Advisory Panel of the Medical Devices Advisory Committee voted (7 yes; 3 no; 2 abstain) that for patients with supra-tentorial glioblastoma multiforme (GBM) tumors that recur after maximal surgical and radiation treatments, there is reasonable assurance that the benefits of the NovoTTF-100A System (NovoTTF) from Novocure, outweigh its risks when administered as a monotherapy in place ...

Dimebon (Medivation/Pfizer) fails pivotal Phase III CONCERT study in Alzheimers Disease and development terminated.

The CONCERT trial is a Phase III trial that evaluated Dimebon (latrepirdine), from Medivation/Pfizer, which was added to ongoing treatment with donepezil HCL tablets in patients with mild-to-moderate Alzheimer’s Disease. Dimebon did not achieve statistically significant results for either of the two co-primary endpoints, the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog), which measures cognitive ability, or the Alzheimer’s ...

FDA refuses approval for new Copaxone indication

The FDA refused approval for Teva Industries supplemental NDA for a new formulation of its multiple sclerosis drug, Copaxone (glatiramer acetate) - one containing a higher concentration/lower volume (20mg of drug infused in 0.5mL, versus the current formulation of 20mg/1.0mL). Teva's goal has been to offer patients an alternative that may potentially improve tolerability based on the results of the ...