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Janssen has filed suit in a New Jersey federal court, hoping to delay a recently approved Remicade biosimilar from entering the market — while the biosimilar’s developer, Samsung Bioepis, bets on an upcoming Supreme Court decision going its way. Read More
Scott Gottlieb was sworn in as the 23rd FDA commissioner May 11, with plans to face the nationwide opioid crisis, which he has called the agency’s number one challenge, and outlined his vision for a more risk-based, patient-centric organization. Read More
The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure Monday, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers. Read More
House and Senate panels proceeded with advancing the FDA user fee reauthorization package last month, even while Trump and HHS called for negotiations on the amounts paid by industry to be reopened — and nearly doubled. Read More
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