FDAnews Drug Daily Bulletin

International cooperation between regulators is “taking off” — a trend that could limit the amount of duplicate inspections drugmakers face, a top CDER official says.

A dishonest and insubordinate study coordinator has compromised a clinical trial, endangered subjects and led the site’s clinical investigator to discontinue conducting clinical research, according to an FDA warning letter.

The FDA should be able to handle the additional requirements of the new iteration of the Prescription Drug User Fee Act (PDUFA V) with little worry of a repeat of the infamously slowed drug reviews from five years ago, agency officials say.

Activist investor Carl Icahn, who is seeking representation on the board of Forest Laboratories, said he is suing the U.S. drugmaker to get more information about its succession planning.

The Third Circuit on Thursday revived a proposed class action from two Humana units seeking reimbursement from GlaxoSmithKline for costs borne by the insurers for treatment of Medicare patients harmed by the diabetes drug Avandia.

Roche announced it was closing a decades-old campus in Nutley, N.J., but it plans to open a 240-employee clinical research center on the East Coast.

Synta Pharmaceuticals announced encouraging results from a planned interim analysis of the GALAXY trial, a randomized Phase IIb/III study designed to evaluate the efficacy and safety of the company’s lead Hsp90 inhibitor, ganetespib, in combination with standard-of-care docetaxel vs. docetaxel alone as second-line treatment for advanced non-small cell lung cancer.

Millennium, the Takeda Oncology Company along with Takeda Pharmaceutical has begun a Phase III trial of MLN9708 in patients with relapsed and/or refractory multiple myeloma.

Actelion Pharmaceuticals announced that the FDA approved their supplemental new drug application (sNDA) for second generation VELETRI, for the treatment of pulmonary arterial hypertension to improve exercise capacity.