Protocols

Roche names new Foundation Med chief; Akorn shares dip on FDA warning letter; Zai Lab advances pivotal PARP study

→ Six months after Roche paid $2.4 billion to buy complete control of Foundation Medicine the pharma giant is following up by putting its oncology product strategy chief in charge of the operation. Cindy Perettie will take Troy Cox’s position at the helm of Foundation.

→ In April, dialysis provider Fresenius walked away from $4 billion takeover of specialty generic drugmaker Akorn, citing its investigation that found Akorn had materially breached the FDA’s data integrity requirements. On Wednesday, Akorn’s woes multiplied when the FDA slapped a warning letter on the company’s Decatur, Illinois manufacturing facility on Jan. 4, following an inspection in April and May last year. The regulator cited significant violations in manufacturing practices, and suggested the products in the plant were adulterated. Akorn said it will respond to the FDA within the next 15 days, and expects to continue production in the meantime. The company’s shares $AKRX were down about 6.6%.

→ Shanghai-based Zai Lab has finished enrolling patients in its pivotal China trial for Zejula. Tesaro $TSRO, which is in process of being acquired by GSK $GSK, out-licensed the PARP drug to Zai Lab.


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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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