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The FDA published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs. Read More
Relying on a U.S. Supreme Court precedent involving Actavis, the Third Circuit Court of Appeals ruled June 26 that patent settlements in pay-for-delay cases can face antitrust scrutiny even if they do not include cash. Read More
Early notice of production shutdowns by manufacturers of life-supporting and life-sustaining drugs and biologics have allowed the FDA to avert more than 550 potential drug shortages in the last three years, the agency says in a final rule mandating early notice. Read More
Brazil’s antitrust watchdog has fined Eli Lilly and its local affiliate $11.7 million for filing contradictory and misleading lawsuits in Brazilian courts to maintain exclusive rights to its cancer drug Gemzar. Read More
Oncology drugmaker Delcath Systems has received orphan drug designation for melphalan to treat intrahepatic cholangiocarcinoma, or ICC, a cancer of the bile duct that arises within the liver. Read More
Insects found in IV solutions have forced Baxter International to voluntarily recall two lots of product, the firm’s seventh recall of an intravenous solution since December 2013. Read More
Venture capitalists invested roughly $2.3 billion in biotechnology companies in the second quarter of 2015, up 32 percent from the prior quarter — the largest quarterly investment in the sector since PwC began issuing its quarterly MoneyTree Report two decades ago. Read More
In its latest study of direct-to-consumer ads, the FDA wants to know if the inclusion of efficacy information in drug advertisements affects how patients perceive the drug. Read More
Bristol-Myers Squibb cut short a Phase 3 study of Opdivo for the treatment of renal cell carcinoma after the immunotherapy drug met its primary endpoint versus everolimus, the current standard treatment. Read More
Beleaguered Indian generics maker Wockhardt is conducting its third U.S. recall since the end of April — this time pulling 162,142 cartons of drugs used to treat high blood pressure and ulcers. Read More