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A class action lawsuit claims that Beijing-based Sinovac Biotech misled shareholders and bribed regulators at the China Food and Drug Administration to expedite its drug and clinical trial applications. Read More
The Association for Accessible Medicines filed a lawsuit against the attorney general of Maryland, hoping to block the state’s recently passed law ostensibly banning generic drug price gouging. Read More
The PTO’s Patent Trial and Appeal Board once again ruled that a patent for AbbVie’s Humira was invalid and unpatentable, responding to additional challenges by Boehringer Ingelheim. Read More
Unable to resolve persistent manufacturing problems, New Jersey-based drugmaker Pacira Pharmaceuticals is ending production of its DepoCyt chemotherapy drug and closing the California plant where it is made. Read More
The FDA plans to expand its capabilities in high performance computing to help build disease models and simulate clinical trials — as well as establish a new framework for regenerative medicine this fall — as part of an agency “innovation initiative” announced Friday by Commissioner Scott Gottlieb. Read More
Drugs labeled as sterile were exposed to unsanitary conditions and may have been contaminated with filth and may be harmful if given to patients. Read More
The decision comes after a review by a data monitoring committee that found more deaths were observed in the Keytruda arms of two Phase III studies. Read More
A federal judge has barred an Alabama compounder from manufacturing, holding or distributing drugs until the facility complies with FDA regulations. Read More