LONDON – A $1 billion program to develop vaccines against emerging infectious diseases that, like Zika and Ebola viruses, have the potential to cause serious epidemics, will be launched at the World Economic Forum in Davos, Switzerland. Read More
Countering the congressional clamor for more competition and negotiations to reduce prescription drug prices in the U.S., the biopharma industry is providing some context that shows competition among branded drugs and tough negotiations often translate into bigger rebates, not cheaper prices for patients. Read More
The FDA draft guidance for communications with payers and formulary committees was widely anticipated, but offers little in the way of surprises. The agency has drawn very tight lines about what may be discussed for approved products, disallowing even a communication about the long-term benefits of a drug approved only for acute treatment of the underlying disease. Read More
Takeda Pharmaceutical Co. Ltd. and Ovid Therapeutics Inc. have agreed to jointly develop and commercialize Takeda's TAK-935 in rare pediatric epilepsies, splitting costs and potential profits 50-50. Read More
The FDA has released a draft guidance for communications regarding on-label use of drugs and devices, which seems motivated in part by an interest in lending clarity to the off-label discussion. Read More
Inmed Pharmaceuticals Inc., of Vancouver, British Columbia, said it increased its private placement, closing on approximately 8.3 million units priced at 18 cents apiece for gross proceeds of C$1.5 million (US$1.135 million). Read More
Apricus Biosciences Inc., of San Diego, said Mexico granted its commercialization partner, Ferring Pharmaceuticals SA, of Saint-Prex, Switzerland, approval to market Vitaros (alprostadil cream) to treat erectile dysfunction. Read More
Paratek Pharmaceuticals Inc., of Boston, said it completed enrollment in the pivotal phase III trial testing aminomethylcycline antibiotic omadacycline for the treatment of community-acquired bacterial pneumonia. Read More
