FDAnews Drug Daily Bulletin

A former Genentech employee is suing the drugmaker, alleging the Roche unit engaged in illegal and unethical conduct during a cancer drug development program, despite warnings by the then-employee to do otherwise.

The international Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the European Medicines Agency (EMA) are harmonizing their good manufacturing process (GMP) guides for drugs to ease the flow of shared inspection data.

Generic preemption issues may again wind up before the Supreme Court as generic maker Mutual Pharmaceutical is calling on it to reverse an appeals court decision that upheld a $21 million jury award to a patient injured by Mutual’s sulindac.

Three children died and one suffered life-threatening hyperventilation after taking codeine that was broken down in their bodies very quickly, likely causing a morphine overdose, U.S. health officials warned on Wednesday.

While its long-awaited novel drug to treat Parkinson’s disease inches closer to the finish line, Impax Laboratories has found other ways to keep its growth engine humming.

Regulus Therapeutics has staked out a strategy as a developer of drugs that alter microRNA, but today it has struck a new deal with Biogen Idec to look at microRNA in a different way.

An experimental drug that would eliminate the need for onerous and sometimes risky eye surgery in elderly patients showed promising results in two studies to be published Thursday in the New England Journal of Medicine.

Pfizer’s experimental rheumatoid arthritis pill tofacitinib eased symptoms of patients with ulcerative colitis, an inflammatory bowel disease that affects 750,000 Americans, a company-sponsored study showed.

Like vultures, generic manufacturers are circling over Medicis Pharmaceutical Corp.’s new skin cancer drug.