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MedImmune and Mirati Therapeutics are collaborating on early-phase clinical trials to evaluate the safety and efficacy of investigational drugs in patients with non-small cell lung cancer. Read More
Sipra Labs landed an FDA warning letter for major cGMP violations, including failure to investigate batch discrepancies and failure to establish and document testing methods. Read More
Baxalta has rejected Shire’s $30 billion hostile takeover bid, saying it significantly undervalues the company, which makes treatments for hemophilia and other blood disorders. Read More
Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients. Read More
The European Commission has cleared the way for Pfizer to acquire Hospira, pending the divestiture of its Remicade biosimilar and certain sterile injectable drugs. Read More
United Therapeutics claims Allergan’s Paragraph IV ANDA for a generic version of its hypertension drug Tyvaso violates three of the drug’s patents. Read More