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news.Avigen completes Phase IIb spasticity trial
This Phase IIb spasticity trial is evaluating the safety, tolerability and efficacy of AV650 in multiple sclerosis (MS) patients at doses up to 900mg/day for one month followed
This Phase IIb spasticity trial is evaluating the safety, tolerability and efficacy of AV650 in multiple sclerosis (MS) patients at doses up to 900mg/day for one month followed
According to the company, the FDA has not requested any new clinical studies surrounding the efficacy or safety of Actemra as a prerequisite for approval. The FDA has
Under the agreement, the companies will co-develop Maxy-4 candidates for rheumatoid arthritis and other autoimmune diseases and Astellas will exclusively develop Maxy-4 candidates for transplant rejection. In addition,
The 510(k) clearance was based on the results of a multi-center, international clinical trial that established equivalency of titanium:sapphire laser trabeculoplasty (TLT) to argon laser trabeculoplasty (ALT) in
According to the company, MultiBead assays do not require specialized instrumentation and work on commercially available dual-laser flow cytometers, making access to instrumentation convenient and economical. Proprietary data
Dr Ohrstrom was previously part of the senior management team that took ZymoGenetics public, and played a key role in bringing recombinant human thrombin to the US market.
Based on the original Prescription Drug User Fee Act (PDUFA) date for Zolpimist, the FDA will reply on or before December 19, 2008. NovaDel submitted its Zolpimist application
Mr Harwood is a healthcare industry advisor for Avista Capital Partners, a private equity firm. Prior to working with Avista, Mr Harwood was president and CEO of privately-held
The dismissal of the lawsuit ends the 30-month Hatch-Waxman stay period, which was originally set to expire in September 2010. Upon receiving final regulatory approval, Perrigo expects to
Favorable efficacy data from preclinical studies in the ferret model have influenced the company’s decision. Ferrets are the standard species for testing the efficacy of candidate influenza vaccines