Having a CEO with family ties to the U.S. Senate isn't enough to insulate Mylan NV from demands for a Senate investigation into the pricing of its Epipen Auto-injector, especially when parents across the country and a former presidential candidate with a big microphone take to social media for a public shaming of the drug company and, by extension, the entire biopharma industry. Read More

The disclosure that Sanofi SA was required by the FDA to submit additional information on the pen delivery device for Iglarlixi as part of the agency's review of the new drug application (NDA) challenges once more the use of an FDA priority review voucher (PRV) for strictly commercial purposes. Read More

In September 2015, when Galapagos NV lost its partnership with Abbvie Inc. for Janus kinase (JAK) 1 inhibitor filgotinib in rheumatoid arthritis (RA) – but kept intact their agreement for cystic fibrosis (CF) – the search for a new tie-up began right away, even as the spurning entity moved ahead with its own late-stage, oral JAK1 candidate in RA, ABT-494. Read More

Chasing improved safety and decreased brain damage for stroke sufferers, Nuvox Pharma LLC is preparing for a fourth quarter start to a phase Ib study of NVX-208 (dodecafluoropentane emulsion), one of multiple oxygen therapeutics the company is advancing. Read More

TOKYO – Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has issued a risk warning for filgrastim and a number of its biosimilars after reports that it can lead to anaphylaxis. Read More

DUBLIN – The International Society for Cellular Therapies (ISCT) has added its voice to those opposing the Regrow Act, a bipartisan bill introduced in the Senate in March, which aims to speed development of regenerative medicine and restore what its sponsors regard as America's lost prominence in the field. Read More

Sophiris Bio Inc., of San Diego, said it priced an underwritten public offering of 6.5 million of its common shares and related warrants to purchase 4.87 million of its common shares with an exercise price of $4 per share, offered at a combined price of $4 per share and related warrant. Read More

Asana Biosciences LLC, of Lawrenceville, N.J., relocated its offices from Bridgewater, N.J., to the Princeton Pike Corporate Center in Lawrenceville to gain more office space. Read More

Interleukin Genetics Inc., of Waltham, Mass., disclosed the publication of "Influence of Obesity on Periodontitis Progression is Conditional on IL-1 Inflammatory Genetic Variation" in the Journal of Periodontology. Read More