EyeGate Implodes as Eye Drug Flunks Phase II Test
EGP-437 demonstrated better clinical performance than vehicle control but did not meet its co-primary endpoints. Source: BioSpace
House Republicans Ask Gottlieb for Details on Heparin Imports, Contingency Plans for Shortage
Leaders of the House Energy and Commerce Committee sent a letter to FDA Commissioner Scott Gottlieb Friday asking him to investigate contradictory data on available supplies of heparin, and explain…
Anti-Dengue Vaccine May Be Linked to Three Deaths in the Philippines, Task Force Reports
Philippine health officials investigating the anti-dengue vaccine Dengvaxia announced Friday that the drug may be linked to the deaths of three children. Source: Drug Industry Daily
New York AG Sues Insys Alleging Illegal Off-Label Promotion, Bribery to Boost Fentanyl Drug
New York’s attorney general is suing Insys for deceptive marketing of the spray form of one of its fentanyl products, a move the state says is part of a multi-pronged…
FDA Adds Black Box Warning to Intercept’s Liver Disease Medicine
The FDA issued a black box warning for Ocaliva (obeticholic acid), a liver disease medication that was incorrectly dosed as daily instead of weekly for patients with primary biliary cholangitis…
Study: Generic Substitution Could Have Saved Medicare $2.9 Billion
Medicare could have saved up to $3 billion over a five-year period if they used the same strategy employed by pharmacy benefit managers for privately-insured patients to favor generics, according…
Mysterious Biotech Unicorn Moderna Nabs Another $500M, Is Now Worth $7B
One can only hope that Moderna Therapeutics can live up to the hype, both scientifically and financially. Source: BioSpace
M&A Chatter Swirls Over Amgen's $70B Cashpile
Amgen reported its fourth-quarter financials yesterday, but in anticipation of this year's hot merger-and-acquisition market, a lot of focus has been on the company's considerable available cash. Source: BioSpace
Array BioPharma Slaps $192M Lawsuit on AstraZeneca Over Cancer Drug Royalties
AstraZeneca did not immediately respond to a request for comment. Source: BioSpace
Amgen to Build New $300M Facility After Tax Changes
Amgen is expected to add 220 jobs to the local economy and employ up to 300 full-time employees. Source: BioSpace