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Pfizer’s novel breast cancer drug Ibrance shows reasonable evidence of clinical benefit to warrant marketing it ahead of a Phase III study, the FDA said in granting accelerated approval Tuesday. Read More
Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain bioequivalence testing batches for drugs protected by REMS product safety protocols. Read More
The FDA warned an Indian manufacturer to immediately stop ignoring poor test results, the second Indian facility in a week to get a warning letter for data integrity violations. Read More
The FDA is creating a simple, one-step process for physicians to gain access to experimental drugs for patients facing terminal, untreatable conditions. Read More
The FDA slapped Canadian generics maker Apotex with a warning letter for serious lapses in current good manufacturing practices at its Bangalore, India, finished product plant. Read More
The number of new drug shortages in 2014 remained at 44 for the second year in a row, with the FDA making full use of new tools to prevent shortages that reached a critical mass three years ago at 251. Read More
Nearly half of all serious adverse event reports submitted to the FDA by drugmakers don’t include basic information such as the patient’s age and gender and the event date, a new analysis of adverse event reports shows. Read More
Teva is asking a federal court to bar any generic versions of Copaxone from entering the market until the last of the blockbuster MS drug’s patents expires in September. Read More
Japanese regulators have notified Novartis Pharma K.K., the Japanese arm of the Swiss drug giant, that they are planning to temporarily suspend the firm from doing business in the country. Read More