FDA Rolls Out Informational Campaign on Biosimilars
The FDA launched an educational campaign to inform healthcare providers about biosimilars and how they are approved and regulated. Source: Drug Industry Daily
Puerto Rico Drug Production Still Lagging Badly, Gottlieb Tells Congress
The FDA continues to work to restore drug manufacturing crippled by hurricane Maria in Puerto Rico, with special response teams set up to tackle the job, but none of the…
Compounder Missed Marks for Sterile Drug Processing, FDA Says
An Alabama compounding pharmacy fell short of several standards for sterile drug processing, the FDA said in a Form 483 inspection report. Source: Drug Industry Daily
Tennessee Judge Denies Endo Request to Move Opioid Lawsuit to Federal Court
A Tennessee judge denied Endo Pharmaceuticals’ request to move a lawsuit against opioid makers from state to federal court. Source: Drug Industry Daily
Judge Turns Down Abbott’s Motion in Depakote Birth Defects Case
An Illinois judge denied a request from Abbott Laboratories to throw out a suit accusing the drugmaker of failing to properly warn of safety risks associated with its drug Depakote.…
EMA’s PRAC Recommends New Safety Warnings and Side Effect Labeling
The European Medicines Agency’s pharmacovigilance panel made recommendations for updated label warnings for a variety of products. Source: Drug Industry Daily
Boehringer Sues Five Generics Companies to Protect its Gilotrif Lung Cancer Therapy
Over the past month, Boehringer Ingelheim has sued five manufacturers seeking to produce generic versions of the company’s Gilotrif lung cancer treatment — most recently naming Sandoz and Sun Pharmaceutical.…
DBV Technologies Crashed as Allergy Drug Flunked Phase III Test
DBV's share price crumbled over the weekend after its Phase III peanut allergy trial failed to show a statistically significant response against placebo. Source: BioSpace
Takeda's Partner Merges With Crestovo to Form Finch Therapeutics Group
Two privately-held biotechs have merged to tackle recurrent C. difficile infections. Source: BioSpace
The 5 Key Drugs That Need to Keep Performing to Keep Johnson & Johnson on Top
If J&J's going to keep rewarding investors, it's going to need these top drugs to continue racking up sales. Source: BioSpace
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