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A U.S. district court has dismissed patent infringement claims against Hikma Pharmaceuticals, ruling that Takeda Pharmaceuticals USA lacked any “plausible claim to relief” in the case. Read More
The FDA is calling out two dietary supplement makers for a host of issues, including drug-like promotional claims and GMP issues that render their products adulterated. Read More
An Indian court is ordering Pfizer to honor an earlier promise to dump large quantities of its steroid Medrol prior to the drug’s expiration date. Read More
The FDA is proposing a surveillance plan for Merck’s Gardasil 9 to screen for four potential adverse risks associated with human papillomavirus vaccines. Read More
Two GOP senators are sounding off on the FDA over an advisory committee recommendation against Sarepta’s Duchenne muscular dystrophy treatment eteplirsen. Read More
In an effort to lower prescription drug spending, China is slashing prices for three drugs by more than 50 percent, a move that will hit both GlaxoSmithKline and AstraZeneca in the wallet. Read More
France is tightening restrictions on early-phase clinical trials in the wake of one study that left one patient brain-dead and hospitalized five others. Read More