News

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 ...

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. ...

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 ...

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 ...

Phase III study shows Cialis (Eli Lilly) plus finasteride provides benefits for Benign Prostatic Hyperplasia

A new Phase III study showed Cialis (tadalafil), from Eli Lilly and Co, co-administered with finasteride significantly improved scores on the International Prostate Symptom Score (IPSS), compared to placebo/finasteride, in men with lower urinary tract symptoms of Benign Prostatic Hyperplasia (LUTS/BPH) and enlarged prostates. On a pre-specified secondary measure, Cialis/finasteride also improved erectile function scores versus placebo/finasteride in those men ...

IQWiG rejects Eylea for treatment of "wet" Age Related Macular Degeneration

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) reported in a preliminary benefit assessment that Eylea (aflibercept) from BayerHealthCare has "no additional benefit" over Lucentis(ranibizumab), the comparator requested by Germany's Federal Joint Committee (G-BA) to treat wet age-related macular degeneration (AMD). The institute said the data Bayer submitted comparing Eylea and Lucentis were "not suitable" because Lucentis was ...

EU approves Ilaris (Novartis) to treat Gouty Arthritis

Novartis has announced that the European Commission has approved llaris (canakinumab, ACZ885) in the treatment of patients with acute Gouty Arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options. Ilaris is the first biologic approved in the EU for symptomatic pain relief in a gouty arthritis indication, and is administered ...

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 ...

CHMP recommends Ilaris (Novartis) for treatment of Acute Gouty Arthritis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the use of llaris (canakinumab, ACZ885) from Novartis, in the treatment of patients with acute Gouty Arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options.

Ilaris is the only available ...

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 ...

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 ...

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. ...

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 ...

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 ...

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 ...

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 ...

CHMP recommends approval of Cialis (Eli Lilly) for Benign Prostatic Hyperplasia

The CHMP in the EU has recommended approval of Cialis (tadalafil), from Eli Lilly and Co, for once daily use for the treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH). The opinion is now referred for final action to the European Commission, which has the authority to approve medicines for the EU. The Commission usually decides on ...

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 ...

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 ...

Cocoa flavanols (Mars Symbioscience) may improve cognition according to Italian study

A study conducted by researchers from the University of L'Aquila in Italy and Mars Symbioscience provides evidence that the regular consumption of dietary cocoa flavanols may improve cognitive function in elderly subjects with early memory decline. Previous research has suggested that the benefits of cocoa flavanols could extend to the brain. However, these studies were either only short-term or did ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

EC 906 filed by Astellas foe EU approval for LUTS associated with BPH

Astellas Pharma Europe has filed EC 905 its fixed dose combination of Flomaxtra XL (tamsulosin) and Vesicare(solifenacin)in the Netherlands under the EU Mutual Recognition Scheme for lower urinary tract symptoms associated with Benign Prostatic Hyperplasia....

NX 1207 (Recordati/Nymox) starts Phase III trial for BPH

Recordati and Nymox Pharmaceutical Corporation announced the start of activities aimed to the preparation of a European Phase III clinical trial for NX-1207, following the successful completion of a Scientific Advice meeting with the European Medicines Agency. NX-1207, is a Phase III investigational drug from Nymox and is currently in clinical development in the United States for the treatment of ...

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 approves Single-Site Instrumentation for Da Vinci Si Surgical System (Intuitive Surgical)

The FDA has given marketing approval for the Single-Site Instrumentation for the Da Vinci Si Surgical System, from Intuitive Surgical, for laparoscopic Cholecystectomy procedures, the surgical removal of the gall bladder. The da Vinci Surgical System is a surgical platform designed to enable complex surgery using a minimally invasive approach. It is commonly used for prostatectomies, and increasingly for cardiac ...

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 ...

Cialis Phase III study in Benign Prostatic Hyperplasia is reported in Jo.Sexual Medicine

A pivotal Phase III study of Cialis (tadalafil) tablets 5 mg from Eli Lilly and Company for once daily use met its co-primary endpoints, significantly improving measures of both erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both conditions. The study is available online in The Journal of Sexual Medicine . It is ...

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 ...

Cialis is FDA approved for Benign Prostatic Hyperplasia

The FDA has approved Cialis (tadalafil) tablets, the PDE 5 inhibitor marketed for erectile dysfunction ,from Eli Lilly Company, for once daily use for the treatment of men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH). The FDA also approved Cialis for once daily use for a separate indication for the treatment of ...

Surfaxin is re-filed at FDA for Respiratory Distress Syndrome

The FDA has accepted the re-application for the humanised surfactant Surfaxin (lucinactant) from Discovery Laboratories as a preventive therapy for respiratory distress syndrome (RDS) in premature infants as complete and has classified it as a Class 2 submission, setting 6 March 2012 as the Prescription Drug User Fee Act action date. Respiratory Distress Syndrome is a condition in which premature ...

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 ...