How This New Jersey Biotech is Taking on Amgen
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x400-amgen.jpg" NAME"How This New Jersey Biotech is Taking on Amgen" ALT"How This New Jersey Biotech is Taking on Amgen"March 24, 2017By Mark Terry, BioSpace.com Breaking News StaffPCSK9 inhibitors are…
FDA Posts Draft Guidance For Drugs to Prevent Kidney Delayed Graft Function
Because no drugs exist for delayed graft function prevention, the FDA yesterday issued guidance to help foster discussion between drugmakers and the agency on developing drugs to treat the problem.…
MHRA Lists Most Common Errors in Clinical Trial Applications
More than half of unapproved applications for clinical trials require more information, the MHRA said in new guidance to industry. Source: Drug Industry Daily
BIO, Two Drugmakers Side With Amgen in Biosimilar Case
An industry group and two drugmakers have filed U.S. Supreme Court briefs backing Amgen’s request that a Federal Circuit ruling be partially affirmed to mandate that biosimilar makers share information…
Lawmakers Take Investigation into Emflaza’s Price to New Owner, PTC Therapeutics
Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) have not halted their investigation into the pricing of Emflaza, pursuing its sale from Marathon to PTC Therapeutics. Source: Drug Industry…
Bay Area's Ultragenyx Tanks as Seizure Drug Flunks Phase II Test
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-scientist5.jpg" NAME"Bay Area's Ultragenyx Tanks as Seizure Drug Flunks Phase II Test" ALT"Bay Area's Ultragenyx Tanks as Seizure Drug Flunks Phase II Test"March 23, 2017By Alex Keown, BioSpace.com Breaking…
Turns Out Editas Medicine's R&D Deal With Allergan Could be Worth $1 Billion
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-deal.jpg" NAME"Turns Out Editas Medicine's R&D Deal With Allergan Could be Worth $1 Billion" ALT"Turns Out Editas Medicine's R&D Deal With Allergan Could be Worth $1 Billion"March 23, 2017By…
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