News

Study of Prolia (Amgen/GSK) plus teriparatide shows significant benefits in Osteoporosis

A randomised, controlled trial of postmenopausal women with Osteoporosis shows that teriparatide and Prolia (denosumab), from Amgen/GSK, increased bone mineral densification (BMD) better than previously reported with any available treatment. Ninety four postmenopausal women were assigned in a 1:1:1 ratio to receive 20 ug teriparatide daily, 60 mg denosumab every 6 months, or both. BMD was measured at 0, 3, ...

FDA approves Ilaris (Novartis) for treatment of Systemic Juvenile Idiopathic Arthritis

Novartis announced that the FDA has on 10 May 2013 approved Ilaris (canakinumab) for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older. Ilaris is the first interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection.

SJIA ...

PALACE 4 study confirms success of apremilast (Celgene) in treatment of Psoriaric Arthritis

Celgene International Sàrl,has announced that statistical significance was achieved for the primary endpoint of ACR 20 at week 16 for patients receiving apremilast 20 mg and 30 mg BID monotherapy in PALACE 4 study. PALACE 4 is the fourth randomized, placebo-controlled study evaluating the Company’s novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with Psoriatic Arthritis. This is ...

Synera (Nuvo Research) significantly improves Pain in Shoulder Impingement Syndrome

New data on Synera (lidocaine and tetracaine) topical patch, from Nuvo Research, showed that Synera provided clinically significant improvement of Pain and function in Shoulder Impingement Syndrome (SIS). The data was a pooled analysis of two open label pilot studies of Synera. 70% of patients experienced a clinically meaningful reduction (more than a 30% reduction) in average pain scores. In ...

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. ...

Study shows Ostinol (ZyCal Bioceuticals) improves pain and stiffness in Osteoarthritis

Results of the first double-blind, placebo-controlled study evaluating the benefits of Ostinol (cyplexinol), from ZyCal Bioceuticals, in alleviating symptoms of Osteoarthritis shows that this nutritional supplement decreases pain and stiffness, and offers an increase in quality of life as compared to placebo. Cyplexinol is a biologically active protein complex consisting of bone morphogenetic proteins which stimulate bone and cartilage growth ...

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 ...

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 ...

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 ...

Phase II study of Xiaflex (Auxilium Pharma) shows benefits for patients with Adhesive Capsulitis

Auxilium Pharmaceuticals has announced positive data for Xiaflex (clostridial collagenase injection), from Auxilium Pharma, for the treatment of adults with Adhesive Capsulitis (AC), or Frozen Shoulder Syndrome. The Phase IIa study was an open-label, controlled dose-ranging study designed to assess the safety and efficacy of Xiaflex for the treatment of Stage 2 unilateral idiopathic AC in comparison to an exercise-only ...

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 restricts use of Pletal(Otsuka)and Ekistol(Lacer) to treat Intermittant Claudication

The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) has recommended that the use of cilostazol-containing medicines in the treatment of Intermittent Claudication – a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk – should be restricted with a range of new measures aimed at targeting a ...

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 ...

Enobosarm (GTx) is published in The Lancet Oncology

The Lancet Oncology, has published online ahead of its April print edition the results from the randomized, double-blind, placebo-controlled Phase II clinical trial of Enobosarm from GTx to assess its effects on Muscle Wasting and physical function in patients with cancer.

Enobosarm (GTx-024) is a selective androgen receptor modulator (SARM), a new class of non-steroidal, tissue-specific anabolic agents that ...

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 ...

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 ...

FDA approves the iASSIST Knee (Zimmer) for Knee Replacement surgery

The FDA has given 510(k) clearance to the iASSIST Knee, from Zimmer, which is a personalized guidance system for Knee Replacement procedures. The technology comprises small electronic disposable pod components that are used at the site of knee replacement surgery, providing instantaneous, accurate alignment validation through a simple electronic display.

The disposable pods are manipulated within the surgical field with ...

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 ...

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.

...

Phase II success for AT 2220 in Pompe Disease

Amicus Therapeutics has announced positive preliminary results from all 4 dose cohorts in a Phase II study (Study 010) to evaluate the safety and pharmacokinetic (PK) effects of the pharmacological chaperone AT 2220 (duvoglustat HCl) co-administered with enzyme replacement therapy (ERT) for Pompe disease (Myozyme and Lumizyme). Myozyme and Lumizyme (alglucosidase alfa, or recombinant human GAA enzyme, rhGAA) are ...

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 rejects Ampligen (Hemispherx) as a treatment for Chronic Fatigue Syndrome

The FDA Arthritis Advisory Committee rejected the re-application by Hemispherx for Ampligen (rinatatolimod) as a treatment for Chronic Fatigue Syndrome. The Committee voted 8 votes to 5 votes to reject the drug. The FDA was unimpressed with the clinical trial evidence as to efficacy, but accepted that the drug was safe. There are currently no approved treatments for Chronic Fatigue ...

Early study shows Dantrium (JHP Pharmaceuticals) has promise for treating Duchenne Muscular Dystrophy

Scientists at UCLA have found Dantrium (sodium dantrolene), from JHP Pharmaceuticals, provides a powerful boost to drug therapy for Duchenne Muscular Dystrophy. The hope is that when used in combination, the drug will provide a one-two punch that will overcome the genetic mutations that cause Duchenne Muscular Dystrophy, and restore a missing protein needed for proper muscle function, and ...

FDA approves NavioPFS orthopedic surgical system (Blue Belt Technologies) for Knee Replacement

Blue Belt Technologies has received 510(k) clearance from the FDA to market its NavioPFS orthopedic surgical system. The clearance is for Unicondylar Knee Replacement, commonly known as partial Knee Replacement. The NavioPFS system incorporates technology to provide precision information to surgeons via smart instrumentation with robotic control. It delivers intra-operative navigation and 3D visualization during the surgery based on a ...

PTC Therapeutics submits PTC 124 to the EMA for treatment of patients with Duchenne Muscular Dystrophy

A Marketing Authorization Application to the EMA seeking conditional approval for PTC 124 (ataluren), from PTC Therapeutics, for the treatment of patients with nonsense mutation Duchenne Muscular Dystrophy (nmDMD) has been accepted. Validation of the MAA confirms that the submission is complete and begins the EMA's Committee for Human Medicinal Products' (CHMP) review process.

The submission is based on a ...

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 ...

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 ...

Eteplirsen (Sarepta Therapeutics)success in extension trial for Duchenne Muscular Dystrophy

Sarepta Therapeutics has announced that treatment with its lead exon-skipping compound, eteplirsen, met the primary efficacy endpoint, increase in novel dystrophin, and achieved a significant clinical benefit on the primary clinical outcome, the 6-minute walk test (6MWT) over the placebo/delayed treatment cohort in a Phase IIb extension trial in Duchenne Muscular Dystrophy (DMD patients.

Eteplirsen administered once weekly at either ...

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 ...

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 ...

FDA approves Lospa Knee System (Corentec America) for Knee Replacement Surgery

The FDA has given clearance to market the Lospa Knee System, from Corentec America in the United States. The innovative Knee Joint Replacement System is available and offers an anatomically featured shape for both a cruciate retaining (CR) and a posterior stabilized (PS) knee within a single system. This ensures successful patient outcomes with natural knee range of motion and ...

Legion HK Hinge Knee implant launched by Smith & Nephew in US and Canada

Smith & Nephew the global medical technology business, announced the launch of its Legion HK Hinge Knee implant to surgeons in the US and Canada. As the first hinged knee to be designed using normal knee kinematics, the implant provides a new option for those patients facing difficult primary or revision knee surgery....

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 ...

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 ...

NICE recommends Xgeva for as a treatment for people with bone metastases from most solid cancer tumours including Breast Cancer

The National Institute for Health and Clinical Excellence (NICE) has published final draft guidance recommending Xgeva(denosumab) from Amgen/GSK as a treatment for people with bone metastases from most solid cancer tumours.It provisionally recommends denosumab for the prevention of skeletal-related events in: •people with bone metastases from breast cancer and •people with bone metastases from solid tumours (other than breast or ...

Positive data from Phase III study of Xgeva (Amgen) in Breast Cancer patients

Treatment with Xgeva (denosumab), from Amgen, resulted in a greater reduction in skeletal-related events in patients with Breast Cancer that spread to the bones compared with zoledronic acid, while also maintaining health-related quality of life, according to the results of a Phase III study published in Clinical Cancer Research. The study randomly assigned 2,046 patients to receive subcutaneous denosumab and ...

EMA approves Votrient (Glaxo Smith Kline) for patients with Soft Tissue Sarcoma

The European Commission has granted marketing authorisation for the use of Votrient (pazopanib), from Glaxo Smith Kline, for treatment of patients with advanced Soft Tissue Sarcoma (aSTS) who have received prior chemotherapy or have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes. According to results of the ...

Hemispherx files response to FDA for Ampligen treatment of Chronic Fatigue Syndrome

Hemispherx Biopharma filed its complete response to the FDA’s November 25, 2009 Complete Response Letter in support of the New Drug Application for Ampligen for Chronic Fatigue Syndrome (“CFS”). As previously reported, at a recent meeting with the Agency, Hemispherx reached agreement on the filing. The FDA has indicated that the new submission will be reviewed on a 6 month ...

ARRAY-797 (Array Biopharma) reports Phase II results in Osteoarthritis

ARRAY-797 from Array Biopharma met its primary endpoint in a randomized, placebo-controlled and active-controlled (oxycodone ER) Phase II clinical trial in 157 Osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs). Patients in all treatment groups continued using NSAIDs throughout the trial.The investigational compound, ARRY-797, is a novel, oral, selective p38 ...

Sarepta Therapeutics success with eteplirsen in Phase IIb trial for Duchenne Muscular Dystrophy

Sarepta Therapeutics (formerly AVI Pharma), the developer of innovative RNA-based therapeutics, announced that treatment with its exon-skipping compound, eteplirsen, achieved a significant clinical benefit on the primary clinical outcome, the 6-minute walk test (6MWT), over a placebo/delayed treatment cohort in a Phase IIb trial in Duchenne Muscular Dystrophy (DMD) patients. Eteplirsen administered once weekly at 50mg/kg over 36 weeks ...

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 ...

Positive data from Phase III SUMMIT trial of MACI (Genzyme/Sanofi) for cartilage repair

New results show that MACI (matrix-induced autologous chondrocyte implant), from Genzyme/Sanofi, met its co-primary endpoint in a two-year, randomized, controlled clinical trial compared to microfracture, a surgical procedure designed to stimulate the growth of new cartilage.

The pivotal safety and efficacy Phase III trial (SUMMIT) enrolled 144 patients across seven countries in Europe with symptomatic articular cartilage defects in ...

Stryker withdraws Rejuvenate Modular and ABG II neck stem Hip Replacements

Patients have encountered Stryker hip replacement problems and developed symptoms similar to those seen in metal-on-metal hip replacement devices. Stryker Orthopaedics will voluntarily remove Rejuvenate and ABG II modular-neck stem hip replacemenrs and terminate global distribution of these products. The decision comes after continued post-market surveillance. Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to ...

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 ...

Horizon Pharma licenses Latin American rights to Duexis to Grunenthal

Horizon Pharma has exclusively licensed Duexis (ibuprofen and famotidine) to Grunenthal for commercialisation in Latin America. Duexis is a single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine. It is indicated in the US for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, in ...

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 ...

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 ...

NICE recomends Xgeva (Amgen) for bone metastases

The latest draft guidance from NICE recommends Xgeva (denosumab)from Amgen: •For adults with bone metastases from breast cancer •For adults with bone metastases from solid tumours other than breast and prostate only if zoledronic acid or disodium pamidronate would otherwise be prescribed for these patients....

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 ...

Votrient (Glaxo Smith Kline) prolongs progression-free survival in advanced Soft Tissue Sarcoma

For patients with metastatic Soft Tissue Sarcoma (STS) whose disease has progressed following standard chemotherapy, treatment with Votrient (pazopanib), from Glaxo Smith Kline, nearly tripled progression-free survival compared with placebo, according to results of the PALETTE trial. This is the first time a randomised Phase III trial in metastatic STS has shown improvement in PFS. Of 369 patients enrolled, they ...

Positive results in Phase III trial of BST-CarGel (Piramal Healthcare) for Tissue Repair

A pivotal Phase III clinical trial of BST-CarGel, from Piramal Healthcare, reveals that when used for Tissue Repair, the treatment results in more repair cartilage of higher quality at 12 months than microfracture, the current orthopaedic standard of care, with a similar safety profile. The trial also met both primary endpoints by reaching statistical significance over microfracture in the degree ...

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. ...

Successful Phase III study for Signifor for Acromegaly

Results of the largest Phase III study of Acromegaly patients, PASPORT-ACROMEGALY, show the novel therapy Signifor ( pasireotide) long-acting release (LAR) from Novartis, was significantly more effective at inducing full biochemical control compared to the current standard medical therapy, Sandostatin LAR (octreotide/IM injection). These data were presented at the 2012 joint 15th International Congress of Endocrinology and 14th European Congress ...

FDA approves Votrient (GSK) to treat Soft Tissue Sarcoma

The FDA on 26 April 2012 approved Votrient (pazopanib)from Glaxo Smith Kline to treat patients with advanced Soft Tissue Sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, and other tissues. A rare cancer with many subtypes, Soft Tissue Sarcoma occurs in about 10,000 cases annually in the United ...

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 ...

Positive results in Phase IIb study of CG100649 (CrystalGenomics) for Osteoarthritis

A Phase IIb study of the CG100649, from CrystalGenomics, shows the candidate drug for Osteoarthritis met its primary and secondary endpoints in an evaluation of the safety, analgesic efficacy and functional benefits of CG100649 (2 mg or 4 mg per day) versus Celebrex (celecoxib) (200 mg per day) over a 4 week treatment period. Anti-arthritic efficacy was evaluated using the ...

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 ...

MHRA recalls MITCH TRH hip replacements

The MHRA has advised surgeons to stop using the MITCH TRH cup/heads, made by Finsbury Orthopaedics, used in combination with Accolade femoral stems made by Stryker Orthopaedics, and to closely monitor patients who already have them. The MITCH TRH hip is a metal-on-metal hip replacement system consisting of components which can be used in different combinations to carry out either ...

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 ...

Eteplirsen (AVI Biopharma) results in Phase IIb study in Duchenne Muscular Dystrophy

Treatment with eteplirsen from AVI Biopharma met the primary efficacy endpoint in a randomized, double-blind, placebo-controlled Phase IIb study in boys with Duchenne muscular dystrophy (DMD). Eteplirsen administered once weekly at 30mg/kg over 24 weeks resulted in a statistically significant (p ? 0.002) increase in novel dystrophin (22.5% dystrophin-positive fibers as a percentage of normal) compared to no increase in ...

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 Xgeva (Amgen/GSK) for SRE prevention of Solid Tumors

NICE, The National Institute for Health and Clinical Excellence, has issued draft guidance recommending the use of human monoclonal antibody Xgeva (denosumab) from Amgen/GSK for for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) for those with bone metastasis from breast cancer, patients with painful bone metastasis from hormone-refractory prostate cancer ...

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. ...

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 recommend approval of Votrient (Glaxo Smith Kline) for Soft Tissue Sarcoma

The FDA's Oncologic Drugs Advisory Committee voted to support use of Votrient (pazopanib), from Glaxo Smith Kline, for patients with advanced Soft Tissue Sarcoma who have received prior chemotherapy. Data from a 369-patient study showed the drug enabled patients to live a median of 4.6 months, about 3.1 months longer than placebo, without disease progression. The trial excluded patients with ...

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 ...

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 ...

Sinergy Cooled RF System (Kimberly-Clark Health Care) shows benefits for patients with Sacroiliac Joint Pain in the Lower Back

Results from a randomized controlled trial on the use of the Sinergy Cooled Radiofrequency System, from Kimberly-Clark Health Care, to treat Sacroiliac Joint (SIJ) Pain in the Lower Back have been published in the March edition of Pain Medicine. At the three-month follow-up, those patients treated with cooled radiofrequency showed significant improvements in pain, disability and quality of life outcomes. ...

Posiive Phase III results for OMS302 (Omeros Corp) in Cataract Surgery

A Phase III clinical trial evaluated OMS302, from Omeros Corporation, in patients undergoing intraocular lens replacement surgery has met its primary endpoint by demonstrating statistically significant maintenance of intraoperative mydriasis (pupil dilation). OMS302 also demonstrated statistical superiority (p<0.00001) over placebo in reduction of pain in the early postoperative period. The trial enrolled 405 patients randomized 1:1 to receive either OMS302 ...

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 ...

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 ...

MHRA issues guidance on all metal hip replacement

The MHRA in the UK has issued guidance on hip implants (large head implants) requiring blood tests to check for metal ions and to require a MRI if patients have raised metal levels due to breakup and consquent debris from all metal hips. The MHRA estimates that around 49 000 patients out of 69 000 all metal hip patients fall ...

Actelion acquires rights to Xiaflex/Xiapex from Auxilium Pharma

Actelion will acquire from Auxilium Pharma exclusive rights to commercialise Xiaflex (collagenase Clostridium histolyticum) as a treatment for two rare progressive collagen deposit conditions, Dupuytren’s contracture and Peyronie’s disease, in Canada, Australia, Brazil and Mexico.Xiaflex has already been approved in the US and the EU to treat Dupuytren’s contracture, a fibroproliferative disease in which abnormal collage deposits result in nodules ...

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....

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 ...

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 ...

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 ...

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 ...

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 ...

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....

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 ...

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....

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 ...

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....

Rituxan/MabThera may alleviate Chronic Fatigue Syndrome

Research suggests that anti-cancer drug Rituxan/Mab Thera (Rituximab), from Roche, may help alleviate Chronic Fatigue Syndrome (CFS). The cause of this syndrome, with symptoms whch include extreme exhaustion, has remained uncertain but this new study, led by Oystein Fluge and Olav Mella of Haukeland University Hospital in Norway, could answer this mystery. The study began when they noticed a patient's ...

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"....

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 ...

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 ...

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 ...