FDAnews Drug Daily Bulletin

Johnson & Johnson (J&J) has agreed to pay $181 million and enter into a consent decree with 36 states and the District of Columbia to settle allegations that its Janssen subsidiary marketed prescription antipsychotic Risperdal off-label in violation of consumer protection laws, J&J says.

Mylan is launching a generic version of sleep disorder drug Provigil after receiving FDA approval of the follow-on treatment and resolving its tumultuous first-filer fight with Teva.

Known for its relatively relaxed regulations on companion diagnostics (CDx), the European Medicines Agency (EMA) is not expected to provide guidance on the products until it has more experience in this area, an expert says.

Bayer HealthCare Pharmaceuticals’ experimental cancer drug regorafenib — viewed as the “son of Nexavar” from Bayer and Onyx Pharmaceuticals — was submitted Aug. 30 for approval to the Food and Drug Administration, the companies said.

Amgen’s therapeutic vaccine, TVEC, shows promise in controlling regional melanoma, experts told BioPharm Insight.

Ariad Pharmaceuticals said the European Union’s drug regulator has granted its request for accelerated assessment of its new cancer medicine, which may lead to a faster approval.

In yet another instance of India Inc. occupying a larger seat in the global league tables, three out of the top 10 fastest-growing generic companies globally are now from India.

The maker of a drug to prevent premature births, whose pricing policy has been harshly criticized nationwide, is showing a willingness to bargain.

What was Bill Gerhart’s recipe for success at San Diego’s Elevation Pharmaceuticals?