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The U.S. Supreme Court ruled that patent infringement lawsuits may only be filed where defendant companies are incorporated, and not simply in any location where their products are sold — a decision with serious implications for drugmakers. Read More
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 of intestinal inflammation after treatment. Read More
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. Read More
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 conference on drug-device combination products last week. Read More
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 U.S. Supreme Court ruled biosimilar manufacturers do not have to wait for FDA approval before beginning a six-month delay on commercial marketing. Read More
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. Read More