Archive for December 2017
2 Small-Cap Biotechs Bestie Celgene is Cutting Back On
Celgene has been unloading some of its shares in two of its investments, CRISPR Therapeutics and Atara Biotherapeutics. Source: BioSpace
Read More5 Biotechs Awaiting FDA Decisions in January 2018
From 1997 through 2013, there was an average of 27 novel drugs approved in the U.S. per year. Source: BioSpace
Read MorePharma Bro Shkreli's Ex-Lawyer Convicted of Helping Him Defraud Pharma Firm
Evan Greebel was found guilty by a federal jury in Brooklyn of charges he conspired to commit wire fraud and securities fraud. Source: BioSpace
Read MorePTAB Says Sovereign Immunity Traded Away By Filing Infringement Suits in Court
The PTO’s Patent Trial and Appeal Board dismissed a patent owner’s claims of sovereign immunity from the proceedings — in a move that might have implications for Allergan’s Restasis patent case involving a Native American tribe that is currently pending before the board. Source: Drug Industry Daily
Read MoreFDA Flags Impax Laboratories for Equipment Problem
The FDA cited Impax Laboratories after an inspection revealed a significant discrepancy in the operational qualification of its packaging line’s tablet counter/elevator. Source: Drug Industry Daily
Read MoreCanadian Drugmaker Warned for Sterility, Verification, Procedural Issues
The FDA issued a warning letter to Deserving Health International after an inspection of the drug manufacturer’s facility in Richmond, British Columbia in July revealed sterility problems, failure to verify the identity of drug components and other significant violations. Source: Drug Industry Daily
Read MoreQuality System Deficiencies Dominate MHRA’s GDP Deficiency Report
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency. Source: Drug Industry Daily
Read MoreFDA Issues New Class Warning, Requirements for Gadolinium Contrast Agents
The FDA is mandating a new class warning and labeling changes for all gadolinium-based contrast agents — as well as requiring manufacturers to conduct additional human and animal safety studies. Source: Drug Industry Daily
Read MoreNovartis' Tasigna Wins FDA Nod for First and Only CML Therapy With Treatment-Free Remission Data …
Novartis announced today that the FDA approved the inclusion of Treatment-free Remission data in the Tasigna U.S. product label. Source: BioSpace
Read MoreShire Plans to Hire in 2018 for its Georgia Manufacturing Site
Shire filed its first submission to the FDA for its new plasma manufacturing site in Covington, Georgia. Source: BioSpace
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