India's Drug and Cosmetics Act purports to keep clinical trials kosher under something called Schedule Y, but the law – which has not been amended since 2005 – lacks rules for mandatory practice and does not specify what recourse trial participants have when things go wrong. Read More
Weighing in on a drug preemption case that could impact the future liability of makers of biosimilars, the author of the Hatch-Waxman Amendments told the Supreme Court that the law, which opened the floodgates to generics, was intended to speed access to cheaper drugs – not to protect generic drugmakers from patient lawsuits arising from injuries caused by their drugs. Read More
Randomized controlled trials are the gold standard of clinical research, and for good reason. They are "at the top of the evidence hierarchy. . . . They give us the most robust evidence," Caroline Sabin of University College London told the audience at a recent workshop on clinical trial design. Read More
Shares of Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) spiked Friday after the company reported that prescriptions of opioid-induced constipation (OIC) drug Relistor (methylnaltrexone bromide) increased by 90 percent in the fourth quarter of 2012 compared to the same period in 2011, growing by 137 percent for the full year compared to 2011. Read More
ThromboGenics NV is banking a €45 million (US$58.8 million) milestone payment from its partner, Alcon, a unit of Novartis AG, following formal European Union (EU) approval for Jetrea (ocriplasmin) for treating patients with vitreomacular traction (VMT), including those with a macular hole up to 400 microns in diameter. Read More
• Stem Cell Therapeutics Corp., of Toronto, said it closed its prospectus offering of about 12.3 million units priced at C25 cents (US24 cents) each for aggregate gross proceeds of $3.1 million. Read More
• Ark Therapeutics Group plc, of London, said it is no longer in discussions in the context of a formal sale process and is no longer in an offer period for the purposes of the City Code on Takeovers and Mergers. Read More
• Diffusion Pharmaceuticals LLC, of Charlottesville, Va., said it completed enrollment in a Phase II trial of trans sodium crocetinate (TSC), an oxygen diffusion-enhancing compound. Read More
Researchers from Temple University discovered that glycogen synthase kinase-three alpha (GSK-3 alpha) is an overall regulator of aging in many different cell types. Read More
