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In a result that could have far-reaching implications for brand-name drug manufacturers, the California Supreme Court unanimously ruled Novartis can be held liable for injuries caused by generics of its products. Read More
United Therapeutics agreed to pay $210 million to resolve Justice Department claims that the drugmaker collaborated with charity Caring Voice Coalition (CVC) to boost sales of United’s pulmonary arterial hypertension drug by illegally covering Medicare patients’ out-of-pocket costs. Read More
The FDA is requesting all NDA and ANDA holders to submit a one-time, written status report to the agency after reviewing the information published in the Orange Book. Read More
The FDA finalized its May 2015 guidance on how makers of immediate-release, solid, oral products can request waivers for subsequent in vivo bioavailability and bioequivalence studies. Read More
Sens. Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) asked FDA Commissioner Scott Gottlieb in a Dec. 18 letter to clarify the agency’s policies on importing prescription drugs from Canada. Read More
The trial results showed the combinations did not significantly increase the risk of asthma-related hospitalizations, intubations or asthma-related deaths. Read More