Less than a year after submitting their NDA and several weeks before the June 28 PFUFA date, Bausch + Lomb Corp. and partner Novaliq GmbH have been awarded U.S. FDA approval for Miebo, their perfluorohexyloctane eye drop formulation designed to treat the signs and symptoms of dry eye disease associated with meibomian gland dysfunction.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alligator, Antengene, Galera, Immupharma, Pepgen, Vifor, Westvac.
The roadmap and conservative substitution methods Amgen Inc. laid out to “enable” its genus claims for antibodies that inhibit PCSK9 to lower LDL cholesterol are “little more than two research assignments,” the U.S. Supreme Court said in a unanimous opinion handed down May 18 in Amgen Inc. v. Sanofi SA that gave the win to Sanofi. The roadmap “merely describes step-by-step Amgen’s own trial-and-error method for finding functional antibodies — calling on scientists to create a wide range of candidate antibodies and then screen each to see which happen to bind to PCSK9 in the right place and block it from binding to LDL receptors,” the court said in the decision written by Justice Neil Gorsuch.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ardelyx, Avidity, Elevar, Flavocure, Hist, Indapta, Intercept, Lumen, Pharmala, Shaman, Takeda, Ultragenyx.
The U.S. FDA’s release of its briefing document for the upcoming advisory committee meeting on obeticholic acid 25 mg as a fatty liver disease treatment sent Intercept Pharmaceuticals Inc. on a downwards spiral May 17. Soon after the document was released, Intercept stock (NASDAQ:ICPT) dropped as low as $11.41 – down almost 30% from its May 16 close of $16.21. As the day wore on, it regained some of that lost value in heated trading that was more than eight times the company’s average daily volume of 782,285. The rebound helped Intercept close the day at $13.83, down about 15%.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aravive, Astellas, Bayer, Bioartic, Bionxt, Biophytis, Cabaletta, Cormedix, Eisai, Kamada, Kimera, Orchard, Phio, Sarepta, Virios, YS.
The U.S. FTC’s unprecedented antitrust challenge to Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc, could be a disruptor to biotech investment if the agency is victorious, some analysts are warning. “With essentially zero commercial overlap [between the two companies], this deal would seem to be a slam dunk under long-established antitrust considerations,” said Christopher Raymond, a senior research analyst with Piper Sandler Research.
Lianbio Co. Ltd. gained its first Asian approval in Macau for Camzyos (mavacamten/Myokardia Inc.) for treating adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The company in-licensed mavacamten rights from Myokardia, now a wholly owned subsidiary of Bristol Myers Squibb Co., in August 2020 for developing and commercializing mavacamten in mainland China, Hong Kong, Macau, Taiwan, Thailand and Singapore. Mavacamten was granted breakthrough therapy designation in China in February 2022 for patients with oHCM.
Nearly a year and a half after Francis Collins stepped down as director of the U.S. NIH, President Joe Biden announced May 15 his intent to nominate Monica Bertagnolli as the next NIH director.
To the chagrin of some and the joy of others, the U.S. Supreme Court denied cert to Teva Pharmaceuticals USA Inc. v. Glaxosmithkline May 15, leaving standing a split Federal Circuit decision that could threaten the use of FDA-approved label carve-outs, or so-called skinny labels, for generics and biosimilars.
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