Archive for June 2017

Sarepta Taps Allergan Alum as New CEO

<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815×430-sarepta.jpg" NAME"Sarepta Taps Allergan Alum as New CEO" ALT"Sarepta Taps Allergan Alum as New CEO"June 29, 2017By Mark Terry, BioSpace.com Breaking News StaffCambridge, Mass. <A HREF"http://www.biospace.com… Source: BioSpace

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Roche to Slash 75 Jobs in Massachusetts, More Consolidation to Come

<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815×450-roche.jpg" NAME"Roche to Slash 75 Jobs in Massachusetts, More Consolidation to Come" ALT"Roche to Slash 75 Jobs in Massachusetts, More Consolidation to Come"June 29, 2017By Mark Terry, BioSpace.com Breaking News Staff… Source: BioSpace

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SterRx Cited for Sterility Issues

The FDA cited a Plattsburgh, N.Y., outsourcing facility after an inspection in February and March found serious deficiencies in the company’s cleanliness and sterility practices. Source: Drug Industry Daily

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FDA Taking Comments on BsUFA II Review Assessment Project

For the next generation of the FDA’s biosimilar user fee program, the agency is proposing a new model for reviewing 351(k) applications — allowing for additional communication between review teams and sponsors through development meetings across the submission timeline. Source: Drug Industry Daily

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FDA Funding Bill Advances in the House

An appropriations bill that would provide $5.2 billion for the FDA in fiscal 2018 got the nod from a House subcommittee Wednesday, bucking the White House’s spending request and giving the agency a slight spending increase for next year. Source: Drug Industry Daily

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