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The Department of Justice is looking into Allergan’s pricing of certain generic drugs as part of a larger federal probe into rising generic prices. Read More
Amarin Pharmaceuticals has a constitutional right to promote its cholesterol-lowering drug Vascepa for an off-label use as long as the communication is truthful and not misleading, a New York federal judge ruled Friday — dealing a blow to FDA efforts to prevent off-label drug promotion. Read More
AstraZeneca is planning to test at least one A2A receptor-blocking compound across a range of cancers, including in combination with the company’s existing immunotherapy portfolio, under a new collaboration with Heptares Therapeutics. Read More
The Indian government has canceled talks with the EU’s chief trade negotiator to protest the European Commission’s ban of scores of generic drugs tested by Hyderabad-based GVK Biosciences. Read More
A bipartisan group of 33 House lawmakers is challenging the Centers for Medicare & Medicaid Services’ plan to lump all biosimilars of the same reference product into a single payment code, arguing that each product deserves a unique code. Read More
A new study looking at large-scale clinical trials funded by NIH shows the number reporting positive results dropped precipitously in the years since they were required to preregister on the clinicaltrials.gov website. Read More
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