The Senate Health, Education, Labor and Pensions Committee sought to answer basic questions on what is driving drug prices sky high, in a Tuesday hearing ostensibly dedicated to the pharmaceutical…

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…

Bangalore-based pharmaceutical company Strides Sashun, formerly known as Strides Arcolab, was recently cited by the FDA for quality problems with pills bound for U.S. markets. Source: Drug Industry Daily

The Australian Therapeutic Goods Administration issued an industry guidance proposing to quickly approve certain types of low-risk variations to registered medicines without requiring evaluation, allowing sponsors to implement the changes…

The 21st Century Cures Act represents a “missed opportunity” to clarify the distinction between a drug and a device and improve transparency, according to experts at a June 8 conference…

The PTO’s Patent Trial and Appeal Board invalidated several claims relating to the manufacture of the widely used anesthetic Diprivan (propofol), in a patent held by Fresenius Kabi. Source: Drug…