Archive for May 2017
Drugmaker Warned Over Long-Term Quality Problems
The FDA sent a warning to a drug manufacturing facility in Irvine, Calif., for failure to resolve quality issues dating back to 2013. Source: Drug Industry Daily
Read MoreFDA Approves First Strattera Generic for ADHD, Plus Five Other First-Time Generics
The FDA approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit hyperactivity disorder in pediatric and adult patients, including multiple strengths manufactured by Apotex, Teva, Aurobindo Pharma and Glenmark Pharmaceuticals. Source: Drug Industry Daily
Read MoreEMA Unveils Action Plan to Support Small- and Medium-Sized Companies
The European Medicines Agency announced a three-year, 16-point action plan to boost small- and medium-sized pharmaceutical companies. Source: Drug Industry Daily
Read MoreHHS Estimates Mylan Overcharged $1.27 Billion for the EpiPen Over a Decade
The HHS inspector general’s office is estimating that taxpayers overpaid for the EpiPen by as much as $1.27 billion between 2006 and 2016. Source: Drug Industry Daily
Read MoreEMA Answers Drugmakers’ Brexit Questions on Transfers and Relocations
The European Medicines Agency says marketing authorization holders must be based in the European Economic Area post-Brexit — and UK-based companies will likely need to transfer marketing authorizations to new addressees. Source: Drug Industry Daily
Read MoreCRISPR, Editas Medicine and Intellia Fall as Scientific Paper Warns of Unintended Mutations Linked to Gene-Editing
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815×450-scientist5.jpg" NAME"CRISPR, Editas Medicine and Intellia Fall as Scientific Paper Warns of Unintended Mutations Linked to Gene-Editing" ALT"CRISPR, Editas Medicine and Intellia Fall as Scientific Paper Warns of Unintended Mutations Linked to Gene-Editing"May 31, 2017By <A HREF"http://www.biospace.com/news… Source: BioSpace
Read MoreForward Pharma Appeals The Initial Decision In The U.S. Patent Interference To The Federal Circuit
Life Sciences Jobs … Source: BioSpace
Read MoreVancouver???s Zymeworks to Hire an Additional 45 Employees by the End of 2017
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815×430-zymeworks.jpg" NAME"Vancouvers Zymeworks to Hire an Additional 45 Employees by the End of 2017" ALT"Vancouvers Zymeworks to Hire an Additional 45 Employees by the End of 2017"May 31, 2017By Renee Morad, BioSpace.com Breaking… Source: BioSpace
Read MoreCompugen Ltd. Provides Update On COM701 And Upcoming Presentations
Life Sciences Jobs … Source: BioSpace
Read MoreA Look at Gilead's Possible New Drug Strategy
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815×400-gilead.jpg" NAME"A Look at Gilead's Possible New Drug Strategy" ALT"A Look at Gilead's Possible New Drug Strategy"May 31, 2017By Mark Terry, BioSpace.com Breaking News Staff<A HREF"http://www.biospace.com/company… Source: BioSpace
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