Men taking MDV3100 lived for a median of 18.4 months, compared with 13.6 months for men taking placebo (p < 0.0001; HR=0.631); MDV3100 also met all secondary endpoints, including radiographic progression-free survival (8.3...
Both pivotal Phase III studies are fully recruited, and all patients have been treated, reached the primary endpoint and are in long-term follow-up. The study met all primary, secondary and tertiary efficacy endpoints....
In the Phase I trial, newly diagnosed patients are enrolled to one of two regimens evaluating ADCETRIS administered either sequentially with CHOP or concurrently with CH-P, which removes vincristine from the regimen: The...
Keppra was previously approved in the US as adjunctive therapy for partial onset seizures in adults and children four years of age and older with epilepsy. The approval was based on data from...
Results from the trial, expected in 2014, could potentially impact atrial fibrillation treatment guidelines by providing further clinical evidence regarding the benefits of the Arctic Front system in treating a largely underserved patient...
GS-7340 is a novel prodrug of tenofovir, the active agent in Viread, or tenofovir disoproxil fumarate. In previous studies, GS-7340 has demonstrated the ability to provide greater antiviral efficacy at a dose that...
An independent watchdog group has asked the Food and Drug Administration to disregard a safety panel's recommendation to keep the popular birth control drugs Yaz and Yasmin on the market, citing evidence that...
The head of the Food and Drug Administration's medical device unit stopped in San Diego last week for a series of one-on-one meetings with some of the area's largest device makers, including ResMed...
Stony Brook University has entered into a multiyear research partnership with the global pharmaceutical company Sanofi to develop a potential treatment for tuberculosis and other bacterial infections. The university didn't disclose the terms...
PRINCETON, N.J. & WILMINGTON, Del. -- Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the...
MedPro EVP Garyen Denning to Speak at Drug Delivery Partnerships Conference LEXINGTON, Ky. -- MedPro Safety Products, Inc. (OTCBB: MPSP), a leading developer of transformational technologies that enable safer medication delivery and blood...
DUBLIN -- Research and Markets (http://www.researchandmarkets.com/research/42dee7/product_profiles) has announced the addition of the "Product Profiles: Asthma/COPD - Novel Combinations Edge Closer to Market" report to their offering. Despite a number of well-established therapies, the...
XenoPort to Receive $10 Million Milestone Payment TOKYO & SANTA CLARA, Calif. -- Astellas Pharma Inc. (Tokyo:4503) and XenoPort, Inc. (NASDAQ:XNPT) announced today that Regnite([R] ) (gabapentin enacarbil) has received marketing approval in...
SHEFFIELD, England -- Simcyp Limited, the leader in modelling and simulation of drug-drug interactions in virtual human populations, today announces it has extended its animal models to include a virtual mouse. Laboratory mice...
Tokyo, Jan 18, 2012 - (JCN Newswire) - Eisai Co. Ltd announced today that it received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) on January 18, 2012 to market Lunesta...
ROCKVILLE, Md. -- Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing oncology and CNS therapeutics, today announced that it has secured Hungarian Regulatory Authority and Ethics Committee...
BRIDGEWATER, N.J. -- NovaDel Pharma Inc. (OTCBB: NVDL), a specialty pharmaceutical company that develops oral spray formulations of marketed pharmaceutical products, today announced that, as previously disclosed, it is continuing to explore various...
DUBLIN -- Research and Markets (http://www.researchandmarkets.com/research/454d3a/product_profiles) has announced the addition of the "Product Profiles: Marketed Antibacterials - Increasing genericization and fragmentation shape a crowded market" report to their offering. In the last two...
EWING, N.J. -- Antares Pharma, Inc. (NYSE Amex: AIS) today announced that it has licensed exclusively its Oxybutynin Gel 3% to Daewoong Pharmaceuticals Co. Ltd.,for marketing in South Korea. Antares will receive undisclosed...
LOS ANGELES -- ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular" or the "Company") (OTCBB: IMUC.OB), an emerging biotechnology company focused on developing novel-immune-based therapies, today announced that its President and CEO, Manish Singh Ph.D., will present...