FDAnews Drug Daily Bulletin

U.S. lawmakers want the FDA to explain who regulates the 28,000 compounding pharmacies operating in the country and how the agency can better control them.

Clinical trials of drugs to treat complicated intra-abdominal infections (cIAI) should have a primary endpoint of complete resolution of symptoms at 28 days following randomization and the absence of clinical failure, according to an FDA draft guidance.

Mylan is suing the FDA over its refusal to grant 180-day exclusivity for the company’s four generic versions of Novartis’ high blood pressure drug Diovan.

Amarin Corp. (AMRN), maker of the blood-fat drug Vascepa (icosapent ethyl), fell the most in two weeks after the company said U.S. regulators hadn’t determined whether to grant the medicine five-year marketing exclusivity.

A New Jersey federal judge ordered Merck & Co. to hand over purportedly privileged documents produced for government investigations concerning Vioxx (rofecoxib) — a partial discovery win for multidistrict litigation plaintiffs accusing the company of inflating its stock through misrepresentations about the recalled arthritis medication.

Treatment with ranibizumab can preserve and even improve the perceived driving ability of patients with age-related macular degeneration (AMD), show the results of two randomized trials.

Three Tennessee cities, including Chattanooga, made the top 11 of the nation’s 100 fall allergy capitals.

Pfizer’s investigational extended-release painkiller met safety goals in a 12-month study that included patients with moderate-to-severe, chronic non-cancer pain.

A new clinical trials website launched today will make it easier for consumers to enrol in clinical trials and help grow the numbers of clinical trials conducted in Australia, Medicines Australia chief executive Dr Brendan Shaw said today.