Nervous System News and Research

Latest Nervous System News and Research

FDA schedules Advisory Committee meeting to review Orexigen's Contrave NDA

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration (FDA) has tentatively scheduled a Division of Metabolic and Endocrine Drug Products Advisory Committee meeting on December 7, 2010 to review the Company's New Drug Application (NDA) for Contrave® (naltrexone sustained release (SR)/bupropion SR) for the treatment of obesity.

24 Jun 2010

AstraZeneca, Targacept commence enrollment in TC-5214 Phase 3 clinical development for MDD

AstraZeneca and Targacept, Inc., today announced the enrollment of the first patient in the Phase 3 clinical development program for TC-5214, a nicotinic channel blocker.

23 Jun 2010

$Phase 1 clinical trial of XMT-1107 initiated in patients with refractory advanced solid tumors$

Phase 1 clinical trial of XMT-1107 initiated in patients with refractory advanced solid tumors

Mersana Therapeutics, a platform-based cancer therapeutics company, today announced that it has initiated a Phase 1 clinical trial to study the safety and pharmacokinetics of XMT-1107 in patients with refractory advanced solid tumors. XMT-1107 is a novel anti-angiogenic fumagillin analog that employs Mersana's Fleximer platform. Mersana's XMT-1001, a conjugate of Fleximer and camptothecin, is currently completing a Phase 1 study.

23 Jun 2010

MJFF supports Ceregene's CERE-120 Phase 2 study for PD with $2.5M award

The Michael J. Fox Foundation for Parkinson's Research (MJFF) will provide $2.5 million to support Ceregene Inc.'s new Phase 2 study of CERE-120. This novel gene therapy product delivers the gene for neurturin, a potent neurotrophic (growth) factor that has shown potential to improve the status of degenerating neurons in both preclinical and clinical studies. CERE-120 has the potential to improve motor function as well as slow Parkinson's disease (PD) progression.

23 Jun 2010

No increased risk of childhood cancer if born near mobile phone stations: Study

There have been concerns regarding increased risk for cancer in children born to mothers who lived near mobile phone stations during their pregnancy after a report of a cluster of childhood cancer cases near such stations. A newly published study in the British Medical Journal refutes such beliefs and has found no link to early childhood cancers and living near mobile phone masts.

22 Jun 2010

Neurologix announces positive results from Phase 2 trial of NLX-P101 for advanced PD

Neurologix, Inc., today announced positive results in a Phase 2 trial of its investigational gene therapy for advanced Parkinson's disease, NLX-P101. Study participants who received NLX-P101 experienced statistically significant and clinically meaningful improvements in off-medication motor scores compared to control subjects who received sham surgery.

22 Jun 2010

SYMPLICITY HTN-1 study: RDN treatment significantly reduces blood pressure

Long-term data presented today from Ardian's SYMPLICITY HTN-1 study demonstrate that the significant reductions in blood pressure achieved using Renal Denervation treatment are sustained through 24 months. The data were presented at the late breaking trials session of the European Society of Hypertension Annual Scientific meeting in Oslo, Norway.

22 Jun 2010

Phase IIb EMBLEM study results of epratuzumab in patients with SLE presented at EULAR 2010

Immunomedics Inc. today announced that clinical trial results from the Phase IIb EMBLEM study of epratuzumab, a monoclonal antibody targeting CD22, in patients with moderate-severe systemic lupus erythematosus were presented at the 2010 annual Congress of the European League Against Rheumatism in Rome, Italy.

21 Jun 2010

Valeant, Biovail announce definitive merger agreement

Valeant today announced that both companies' Boards of Directors have unanimously approved a definitive merger agreement under which the companies would combine to generate enhanced value for stockholders. The combined company will be called Valeant Pharmaceuticals International, Inc.

21 Jun 2010

Neupro improves wellbeing impaired by pain related to Restless Legs Syndrome

The first data to show that Neupro® (rotigotine transdermal system) significantly improved wellbeing and daily activities that are often impaired by pain related to Restless Legs Syndrome (RLS) were presented this week at the 14th International Congress of Parkinson's Disease and Movement Disorders in Buenos Aires, Argentina.

18 Jun 2010

Additional results from BLISS-52 Phase 3 trial of BENLYSTA for SLE to be presented at EULAR 2010

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced the presentation of additional results from BLISS-52, one of two pivotal Phase 3 trials of BENLYSTA (belimumab) in seropositive patients with systemic lupus erythematosus. The additional data will be presented in Rome at the 2010 Congress of the European League against Rheumatism on Saturday, June 19.

18 Jun 2010

Trial eases concerns over effects of gamma secretase inhibitors for Alzheimer's disease treatment

The first trial of a new model for testing Alzheimer's treatments has reassured researchers that a promising class of drugs does not exacerbate the disease if treatment is interrupted.

18 Jun 2010

DURATION-4 study tests superiority of BYDUREON as compared to other type 2 diabetes medications

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of BYDUREON (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications.

18 Jun 2010

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Psychopharmacologic Drugs Advisory Committee meeting on September 16, 2010, for the review of the company's supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence.

18 Jun 2010

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 31, 2011 for the review of the Contrave® (naltrexone sustained release (SR)/bupropion SR) New Drug Application (NDA).

17 Jun 2010

Chelsea presents Northera study data at International Congress on Parkinson's Disease and Movement Disorders

Chelsea Therapeutics International, Ltd. announced that data from its pivotal studies of Northera™ (droxidopa) in symptomatic neurogenic orthostatic hypotension was presented during a poster session and featured in a symposium highlighting the role of norepinephrine (NE) deficiency in Parkinson's disease at the 14th International Congress on Parkinson's Disease and Movement Disorders in Buenos Aires, Argentina.

17 Jun 2010

HGS, GSK announce full presentation of BLISS-76 Phase 3 BENLYSTA trial results for SLE at EULAR 2010

Human Genome Sciences, Inc. and GlaxoSmithKline PLC (GSK) today announced the full presentation of results from BLISS-76, one of two pivotal Phase 3 trials of BENLYSTA® (belimumab) in seropositive patients with systemic lupus erythematosus (SLE). The results will be presented today in Rome at the 2010 Congress of the European League Against Rheumatism (EULAR).

17 Jun 2010

Studies suggest role for IL-10 in prevention and treatment of neurological disease in newborns

This bacterium, Escherichia coli K1, is the most common cause of meningitis in premature infants and the second most common cause of the disease in newborns. "The ineffectiveness of antibiotics in treating newborns with meningitis and the emergence of antibiotic-resistant strains of bacteria require new strategies," explains Nemani V. Prasadarao, PhD, associate professor of infectious disease at Childrens Hospital Los Angeles.

17 Jun 2010

FDA approves clinical testing of SanBio's SB623 for stroke recovery

SanBio Inc. announced today that the United States Food and Drug Administration (FDA) has approved the clinical testing of their SB623 regenerative medicine product in patients suffering from disability caused by cerebral stroke. SB623 is derived from bone marrow stromal cells (MSCs) isolated from healthy adult donors.

17 Jun 2010

Phase IIb EMBLEM study demonstrates clinical efficacy of epratuzumab in patients with SLE

UCB and Immunomedics Inc. announced new lupus drug candidate, epratuzumab, provided a significant reduction in disease activity in patients with moderate to severe active systemic lupus erythematosus (SLE). Data presented at the European League Against Rheumatism (EULAR) meeting in Rome from the phase IIb study, EMBLEM™, showed the clinical efficacy of epratuzumab in patients with SLE.

16 Jun 2010

Nervous System News and Research

Latest Nervous System News and Research

FDA schedules Advisory Committee meeting to review Orexigen's Contrave NDA

AstraZeneca, Targacept commence enrollment in TC-5214 Phase 3 clinical development for MDD

Phase 1 clinical trial of XMT-1107 initiated in patients with refractory advanced solid tumors

MJFF supports Ceregene's CERE-120 Phase 2 study for PD with $2.5M award

No increased risk of childhood cancer if born near mobile phone stations: Study

Neurologix announces positive results from Phase 2 trial of NLX-P101 for advanced PD

SYMPLICITY HTN-1 study: RDN treatment significantly reduces blood pressure

Phase IIb EMBLEM study results of epratuzumab in patients with SLE presented at EULAR 2010

Valeant, Biovail announce definitive merger agreement

Neupro improves wellbeing impaired by pain related to Restless Legs Syndrome

Additional results from BLISS-52 Phase 3 trial of BENLYSTA for SLE to be presented at EULAR 2010

Trial eases concerns over effects of gamma secretase inhibitors for Alzheimer's disease treatment

DURATION-4 study tests superiority of BYDUREON as compared to other type 2 diabetes medications

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Chelsea presents Northera study data at International Congress on Parkinson's Disease and Movement Disorders

HGS, GSK announce full presentation of BLISS-76 Phase 3 BENLYSTA trial results for SLE at EULAR 2010

Studies suggest role for IL-10 in prevention and treatment of neurological disease in newborns

FDA approves clinical testing of SanBio's SB623 for stroke recovery

Phase IIb EMBLEM study demonstrates clinical efficacy of epratuzumab in patients with SLE

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Nervous System News and Research

Latest Nervous System News and Research

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How the Vutara VXL simplifies single-molecule imaging

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