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During a one-year period, the UK’s Medicines & Healthcare products Regulatory Agency conducted 47 inspections of pharma companies, during which they found 27 critical findings, 169 major and 155 minor findings. Read More
Legal experts say the FDA’s off-label regulation of pharmaceuticals may be on shaky ground after it agreed to settle with Pacira Pharmaceuticals this week in a case involving the pain drug Exparel. Read More
The House Energy & Commerce Committee is calling on the GAO to evaluate whether the FDA’s regulatory pathway for generic versions of complex drugs is sufficient. Read More
Valeant Reduces Prices at Walgreens, Has Similar Plans for Other Pharmacies
Sanofi, Boehringer in Asset Swap Negotiations
Kitov Eyes 2016 Submission for Arthritis-Hypertension Combo
Amgen Reacquires Product Rights on 3 Drugs From GSK
Merck Snags Approval for Bridion Read More
In what may be a first, the FDA has settled an industry suit accusing the agency of overstepping its regulatory authority over pharmaceutical promotion. Read More
India’s Natco Pharma and partner Alvogen announced Monday that they have settled a patent infringement suit filed by Gilead Sciences, Roche and Genentech over a proposed generic version of Tamiflu. Read More
With the clock about to strike midnight on 2015, CDER Director Janet Woodcock laid out a set of priorities the center will focus on in 2016, with negotiating new PDUFA and GDUFA agreements topping that list. Read More
Despite a vast, “herculean feat” to obtain clinical trial data, the effect of Merck’s lipid-lowering Vytorin on cardiovascular health was just too small — with worrying holes in data that could hinder any proof of clinical meaningfulness, FDA advisors said. Read More
Following congressional outcry, an NIH task force issued findings that show underlying problems with its now-shuttered drug compounding facilities were “widespread and longstanding,” but did not cause any direct harm to patients. Read More