FDAnews Drug Daily Bulletin

The FDA has approved Roche subsidiary Genentech’s Perjeta as part of a first-line treatment combination for patients with HER2-positive metastatic breast cancer.

Drugmakers breaking into emerging markets could see supply chain benefits and quicker product launches if these markets automatically registered U.S. Food and Drug Administration (FDA)-approved products before testing for quality issues, according to a new study.

Drug shortages, poor product quality, poor corrective actions and other “manufacturing breakdowns” have conspired to create a crisis state that demands not only strong regulatory enforcement, but also active collaboration among drugmakers, FDA officials say.

Stiefel signs worldwide acquisition and license agreement for Toctino. Stiefel, a GlaxoSmithKline company, announced that it has entered into a worldwide agreement to acquire Toctino (alitretinoin) from Basilea Pharmaceutica.

British researchers report that thiazolidinediones, diabetes medications that are used to help control blood sugar levels, may cause eye problems in those who take them.

Shares of Ampio Pharmaceuticals advanced Monday after the company reported positive data from a trial of its eye drug Optina.

A coalition of AIDS advocates, spearheaded by AIDS Healthcare Foundation, have sent a letter today to the CEO of HIV/AIDS drug maker Gilead Sciences — John C. Martin — urging the company not to “decimate ADAP [AIDS Drug Assistance Programs]” by pricing its latest HIV/AIDS drug combination — known as the “Quad” — higher than Gilead’s Atripla, the most prescribed HIV/AIDS medication.

Jazz Pharmaceuticals announced the closing of its acquisition of EUSA Pharma, a privately-held, specialty pharmaceutical company with a commercial presence in the U.S. and EU and a global distribution network.

Wockhardt Ltd. (WPL) Chairman Habil Khorakiwala says U.S. sales growth and a record profit margin may lure more investors to his company, the world’s top performing major generic drugmaker this year.