Two AIDS patient advocacy groups urged New York Attorney General Eric Schneiderman — a frequent foe of anticompetitive behavior by drugmakers — to investigate potential pay-for-delay deals by Gilead. Source:…
A District of Columbia federal court ruled Mylan Pharmaceuticals and two chemical companies must pay $67 million to Blue Cross Blue Shield of Massachusetts and three other insurers in a…
The FDA outlined its procedures for conducting filing reviews of ANDA applications, detailing the standards agency staff will use to judge whether a submission is sufficiently complete before beginning a…
Arizona joined the growing number of states filing lawsuits alleging marketing fraud by opioid manufacturers, as Attorney General Mark Brnovich filed suit against Insys Therapeutics and three doctors for allegedly…
The FDA took its first step in requiring sponsors to submit REMS documents electronically, publishing a draft guidance that outlines the specifications. Source: Drug Industry Daily
Baxter International will divest the rights to two drugs held by Claris Lifesciences to offset the anticompetitive effects of its acquisition of Claris, under terms of a final FTC order.…
The European Medicines Agency has begun to adopt a new addendum to the ICH’s 1998 clinical trial statistics guideline, as well as a revision to the 23-year-old ICH guideline on…
A mutual fund, citing $80 billion in losses on its investment in drugmaker Valeant, filed a lawsuit alleging securities violations, mail and wire fraud, and violations of the Racketeer Influenced…
A Georgia compounding pharmacy ran afoul of the FDA after losing the exemption from agency rules that is extended to compounders that limit their production to filling prescriptions for individual…
The European Medicines Agency updated its advice on navigating its centralized pre-authorization procedures to include a section on combination packs of medications. Source: Drug Industry Daily