Drug Industry Daily

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Drugmakers could bring breast cancer treatments to market a decade earlier with new FDA guidance on trial designs for evaluating pathologic complete response (pCR) to support accelerated approval of drugs to treat high-risk, early-stage breast cancer.

Several drugmakers in China are being ordered to power down production lines and hand over their licenses for producing capsule-based drugs after a crackdown on chromium contamination by the country’s regulatory agency.

The FDA has handed Johnson & Johnson (J&J) a complete response letter on its sNDA for a once-daily formulation of HIV drug Prezista.

The European Medicines Agency (EMA) is recommending approval of Vertex Pharmaceuticals’ cystic fibrosis (CF) treatment Kalydeco as the first drug to address the underlying cause of the life-threating genetic disorder.

A flood of Lipitor generics is expected to hit the market today, but Teva, the world’s largest generic-drug maker, has decided a better strategy is not to sell what was once the world’s best-selling drug — at least not yet.