Archive for June 2017

Compounder Warned for Long List of GMP Violations

A Texas-based compounder specializing in hormone therapies for men and women was warned by the FDA for extensive cGMP violations as well as producing drugs for which there was no valid prescription. Source: Drug Industry Daily

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FDA Orphan Products Office to Focus on Clearing Backlog

To meet its goals of clearing a backlog of about 200 orphan designation requests before Sept. 21 — and committing to 90-day reviews thereafter — the FDA has formed a “SWAT team” of reviewers dedicated to the task, starting with the oldest applications first. Source: Drug Industry Daily

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TiGenix Begins Recruiting for New U.S. HQ in Massachusetts

<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815×450-scientist5.jpg" NAME"TiGenix Begins Recruiting for New U.S. HQ in Massachusetts" ALT"TiGenix Begins Recruiting for New U.S. HQ in Massachusetts"June 29, 2017By Mark Terry, BioSpace.com Breaking News Staff<A HREF… Source: BioSpace

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Omeros Pursuing Legal Action Against Short Seller for Report That Caused Stock to Tank This Week

<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815×450-stocks2.jpg" NAME"Omeros Pursuing Legal Action Against Short Seller for Report That Caused Stock to Tank This Week" ALT"Omeros Pursuing Legal Action Against Short Seller for Report That Caused Stock to Tank This Week"June 29, 2017By <A HREF"http://www.biospace.com/news_subject_all_results.aspx?CatagoryId… Source: BioSpace

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