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Maryland’s governor allowed a ban on generic drug price gouging to become law without his signature, in part due to reservations over its constitutionality. Read More
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
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
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
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 sponsored by FDAnews in Washington D.C. Thursday on combination products. Read More
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. Read More
A pharmacy chain operator that brought antitrust class action lawsuits against more than a dozen generics manufacturers earlier this week has added three more — Actavis Holdco, Lannett and Epic Pharma — claiming they colluded to raise the prices of the gallbladder stone treatment ursodiol. Read More