Teva Pharmaceuticals USA Inc.’s quest to get the U.S. Supreme Court to overturn the Federal Circuit and preserve label carveouts, or so-called skinny labels, continued Oct. 3 with the high court asking the solicitor general to weigh in.
While it continues to deny all kickback allegations raised in a whistleblower suit filed seven years ago, Biogen Inc. agreed Sept. 26 to pay $900 million to resolve claims that it paid doctors in the U.S. to prescribe its multiple sclerosis drugs from 2009 through March 2014.
If the U.S. Supreme Court agrees to hear Teva Pharmaceuticals USA Inc. vs. Glaxosmithkline LLC, it could be one of the biggest biopharma cases on the court’s calendar in the coming year. But that’s still an if. Whether the patent infringement case involving a so-called “skinny label” makes it to the high court’s docket depends on which interpretation of the underlying question the court accepts.
The U.S. Court of Appeals for the Federal Circuit struck a blow Nov. 30 to Biogen Inc.’s blockbuster multiple sclerosis (MS) drug, Tecfidera, affirming a lower court’s determination that a patent claiming a method of treating MS was invalid for lack of written description. In two other precedential cases the next day, the appellate court opened the door for Arbutus Biopharma Corp. to seek royalties on Moderna Inc.’s COVID-19 vaccine.
Biopharma companies that have agreed to pay the U.S. Department of Justice millions of dollars to resolve allegations that they illegally used charities to cover patients’ Medicare copays for brand drugs are finding those settlements may be just the beginning of their legal woes, even when the companies admit no liability in the settlement.
With so much ire in Congress directed toward U.S. prescription drug prices in 2019, it’s not surprising that prices remained relatively stable that year. That’s not to say there weren’t price hikes. In its second report on unsupported price increases, the Institute for Clinical and Economic Review (ICER) identified nine of the 100 top-selling drugs that had list price increases more than double the rate of medical inflation in 2019 and that accounted for the largest increases in U.S. spending on drugs.
With a Nov. 6 FDA adcom meeting on Biogen Inc.'s Alzheimer's candidate, aducanumab, creeping ever closer, the candidate's prospects stole the show in its third-quarter earnings report, even outshining attention to the cloud of generics raining on the company's years-long Tecfidera (dimethyl fumarate) parade. FDA acceptance for aducanumab's BLA lines the candidate up for a priority review and regulatory action by March 7, the company said. Furthermore, global progress remains underway, with an EU marketing application now made and one in Japan on deck.
The U.S. District Court for the Northern District of West Virginia ruled against Biogen Inc., of Cambridge, Mass., and in favor of Mylan NV, of Hertfordshire, U.K., in a patent dispute regarding Biogen’s blockbuster multiple sclerosis drug, Tecfidera (dimethyl fumarate).
At 26 years old, Karen Jury stood before a class of elementary students as her right arm tingled before falling completely numb. That led to a conversation with her doctor. Years of migraine headaches and a recurring sensation of shock waves throughout her body, simply from the turn of her head, resulted in a scheduled spinal tap and an MRI. She received a diagnosis of Arnold-Chiari malformation, a structural defect in the base of the skull and cerebellum.
What the phase III multiple sclerosis (MS) win scored by Biogen Inc. and partner Alkermes plc might mean in the marketplace for diroximel fumarate – tested against their approved MS therapy Tecfidera (dimethyl fumarate) – became fodder for speculation as investors weighed the fine points of side-effect profiles and would-be reimbursement hitches.