Drug Industry Daily

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The FTC is challenging a GlaxoSmithKline (GSK)-Teva patent settlement deal, filing an amicus brief that argues authorized generic agreements fall under the category of pay-for-delay deals and are anticompetitive.

Akorn and Bausch + Lomb (B+L) have received warning letters from the FDA for marketing unapproved ophthalmic drugs containing pilocarpine hydrochloride at various strengths.

Drugmakers evaluating multiple sclerosis (MS) treatments for the EU should use relapse rate as the primary efficacy parameter in clinical trials for relapsing-remitting MS or secondary progressive MS with superimposed relapses, according to a draft EMA guideline.

Sanofi Pasteur MSD, a Merck-Sanofi vaccine venture, is recalling 16 batches of its typhoid vaccine Typhim Vi after recent investigations found some syringes may have sub-potent antigen levels, the Medicines and Healthcare products Regulatory Agency (MHRA) says.