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…
3 Biotechs the Super-Rich Regret Buying in 2017 (So Far)
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-stocks.jpg" NAME"3 Life Science Stocks Battling Big Headwinds in 2017" ALT"3 Life Science Stocks Battling Big Headwinds in 2017"March 23, 2017By Mark Terry, BioSpace.com Breaking News StaffaffYesterday, Keith... Source:…
Woodcock, AAM Testify on REMS Programs Delaying Generic Competition
The FDA has received 150 inquiries from generic companies that have had trouble accessing samples, CDER Director Janet Woodcock told lawmakers at a House oversight subcommittee hearing Wednesday. Source: Drug…
Sanofi, Regeneron Sue Amgen to Prevent Patent Dispute over Eczema Drug Dupixent
Sanofi and Regeneron filed a complaint seeking a declaratory judgment that their eczema drug Dupixent, which is pending an FDA approval, does not infringe an Amgen patent on an unsuccessful…
GAO to Investigate the FDA’s Approval Process for Orphan Drugs
The Government and Accountability Office has agreed to grant a Senate request to conduct an investigation into the FDA’s handling of orphan drugs approvals. Source: Drug Industry Daily
Woodcock: FDA Must Hire Specialists to Implement PDUFA VI, 21st Century Cures
The FDA will have to staff up and hire new kinds of scientists to fully implement the provisions of the 21st Century Cures Act and the next generation of user…
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