Wading into the “muddied waters” of rounding the numbers used in a range claimed in two drug patents, the U.S. Court of Appeals for the Federal Circuit refused to set a “bright line rule.” Instead, it tossed a lower court win for Actelion Pharmaceuticals Ltd. against Mylan Pharmaceuticals Inc. and sent the case back to that court with instructions to consider the extrinsic evidence and its impact on the claim construction.
The NDA for the formerly named Nyxol is now an open and shut case for Ocuphire Pharma Inc. and Viatris Inc. The U.S. FDA has approved Ryzumvi (phentolamine ophthalmic solution) for treating pharmacologically induced mydriasis, better known as dilating the pupil. Ryzumvi, a small-molecule eye drop, reduces the pupil’s diameter after it is dilated with adrenergic agonists such as phenylephrine or parasympatholytic agents such as tropicamide. The treatment reduces pupil size by acting on the iris dilator muscle.
Sanofi SA’s antitrust challenge of Mylan Inc.’s “exclusionary conduct” in the epinephrine auto-injector market met the end of the road April 17 when the U.S. Supreme Court denied cert.
Viatris Inc.’s chief information officer, Ramkumar Rayapureddy, is facing an SEC insider trading complaint, along with criminal charges brought by the fraud division of the U.S. Department of Justice. Another man, Brian Wong, was charged with illegal trading ahead of Merck & Co. Inc.’s acquisition of Pandion Therapeutics Inc.
Shares of Oyster Point Pharma Inc. (NASDAQ:OYST) soared to $11.57, or 38.6% on word of the buyout by Viatris Inc., which is also taking over privately held, development-stage Famy Life Sciences Ltd. to create an ophthalmology franchise that Viatris estimates could mean at least $1 billion in sales by 2028 as well as at least $500 million more in adjusted EBITDA.
Shares of Oyster Point Pharma Inc. (NASDAQ:OYST) soared to $11.57, or 38.6% on word of the buyout by Viatris Inc., which is also taking over privately held, development-stage Famy Life Sciences Ltd. to create an ophthalmology franchise that Viatris estimates could mean at least $1 billion in sales by 2028 as well as at least $500 million more in adjusted EBITDA.
Long considered a make-or-break market for novel drugs and biologics and a success story for generics, the U.S. has been more challenging for biosimilars than many experts initially expected. U.S. biosimilar “uptake has been good, but not great,” Steven Lucio, senior principal for pharmacy solutions at Vizient Inc., told BioWorld. That could change next year when at least seven biosimilars referencing Abbvie Inc.’s immunosuppressive drug, Humira (adalimumab), are expected to launch in the U.S.
The U.S. FTC isn’t waiting to complete its investigation into potentially anticompetitive practices of pharmacy benefit managers to crack down on some of those schemes.
News that the U.S. FTC is finally going to reexamine the role of pharmaceutical benefit managers (PBMs) and their impact on prescription drug prices and availability is playing to applause from several sectors that have been complaining for years about PBM practices.
2023 may be a pivotal year for biosimilars in the U.S. with a number of approved Humira (adalimumab) biosimilars set for staggered launches under agreements with Abbvie Inc. How successful those launches are, including the launch of Boehringer Ingelheim GmbH’s interchangeable, Cyltezo, and potential other interchangeables, will be determined in large part by three pharmacy benefit managers that together control the prescription drug formularies for nearly 80% of Americans covered by Medicare and private insurance.
