The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee declared the chemotherapy drug docetaxel safe to use after it concluded that there is no evidence of changes in the known risk…

The FDA rejected Coherus Bioscience’s proposed biosimilar for Amgen’s Neulasta, Coherus announced. Source: Drug Industry Daily

Mylan challenged two patents on Sanofi’s insulin glargine formulation, Lantus, and is requesting an inter partes review by the PTO’s Patent and Trial Appeal Board. Source: Drug Industry Daily

President Donald Trump’s executive order on new regulations will likely lead to increased use of internal communications to make drug policy at the FDA, an expert said at an FDAnews…

In a decision that reshapes the patent dance between biosimilar applicants and reference holders — and could affect the course of billions of dollars in the pharmaceutical industry — the…