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The FDA Tuesday ordered drugmakers in the $1.6 billion testosterone-replacement therapy market to update their labels with warnings of the potential for increased heart attack risks when used for aging-related low testosterone. Read More
The FDA has warned a Kansas compounder for multiple GMP violations, including poor sterile drug manufacturing practices and using ingredients that aren’t FDA-approved. Read More
Chinese leaders want drugmakers to stop using third-party distributors and sell directly to hospitals in an effort to curb corruption in the supply chain. Read More
European regulators have granted Celgene’s nanotechnology-based therapy Abraxane its third cancer indication as a first-line treatment alongside carboplatin for non-small cell lung cancer patients who don’t qualify for surgery or radiation therapy. Read More
A federal appeals court issued an injunction halting sales of Actavis’ generic version of AstraZeneca’s inhaled asthma drug Pulmicort Respules, just four days after the generics maker launched its version. Read More
The FDA has laid out a regulatory research agenda for the year that includes identifying better methods for assessing generics, improving drug safety and biosimilars development, and finding ways to assess advanced, new drugs as areas where the agency would like to sponsor research. Read More
The FDA is pushing ahead with efforts to spur development of hard-to-copy generics, this time sponsoring research into bioequivalence testing for long-acting periodontal drugs and developing methods for assessing generic, long-acting injectables. Read More