FDAnews Drug Daily Bulletin

Rep. Edward Markey (D-Mass.) continues to push the FDA for answers about how it will respond to a compounding pharmacy linked to 14 deaths.

The European Medicines Agency (EMA) will soon allow biosimilars sponsors to reference biologics made outside the European Economic Area (EEA) in some preclinical and clinical studies required for approval.

Endo Pharmaceuticals is petitioning the FDA to require generics referencing its crush-resistant pain drug, Opana ER CRF, demonstrate they are similarly crush-resistant.

Obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit despite their risks may get speedier U.S. approvals under plans being discussed to better balance innovation and safety.

Genzyme announced that key data from the TOWER trial were presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis.

Pfizer has reported positive top-line results from a Phase III open-label long-term safety study of ALO-02, oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules, in patients with moderate-to-severe chronic, non-cancer pain.

Indonesia’s government has taken steps to override patents on a range of HIV drugs, highlighting a growing trend by Asian states to allow local production of cheap generic drugs that cut into sales of global pharmaceutical companies.

When there was a shortage of a drug used to prevent IV-related infections in children, the frequency of those infections increased almost tenfold at one Michigan hospital, a new study shows.

Paladin Labs entered into a licensing agreement with QRxPharma Limited, an Australian-based specialty pharmaceutical company, whereby Paladin received the exclusive rights to market and sell Moxduo (morphine and oxycodone) in Canada.