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Partner Sanofi wants to produce the insulin to be used in MannKind's Afrezza

MannKind signed a deal on July 31, 2014, to buy €120.1 million ($155.7 million) worth of recombinant human insulin from Amphastar France Pharmaceuticals to fill its inhalers.

More FDA issues arise for Hospira in India

About three months before Hospira closed on its acquisition of an API plant from India's Orchid Chemicals & Pharmaceuticals, FDA inspectors made a visit to the facility in Waluj. They had concerns with what they found.

Baxter issues recall, this time because antibacterial gets mixed in wrong carton

Baxter International is again recalling a sodium chloride product, but this time, instead of particulate contamination, it is because another product was mistakenly mixed in the shipment.

FDA procedural delay on Rytary gives Impax breathing room

The FDA has put off reconsideration of Impax Laboratories' Parkinson drug Rytary. The delay will give the California company some additional time to work on the latest in a series of FDA concerns over its manufacturing that have kept the drug sidelined.

Gilead hands Sovaldi manufacturing tech to 7 generics makers

Gilead Sciences is presenting a huge gift to Mylan and half a dozen Indian generics makers. It is transferring the manufacturing technology for its biggest product and its blessing to go make cheap copies in 91 markets.

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FierceBiotechIT

AstraZeneca is following the well-trodden path of offshoring part of its IT to India. But unlike some of its peers--and in a reversal of its own strategy--the Big Pharma is adding in-house capacity and lessening its reliance on IT service providers.

FierceBiotechIT

With clinical trial sponsors spending a sizable chunk of their huge Phase III trial budgets on source data verification in return for questionable benefits, risk-based monitoring is an obvious target for TransCelerate BioPharma's R&D efficiency agenda. The Big Pharma consortium has further clarified its thinking on the topic in two research papers.