The Biden administration released a blueprint for the U.S. federal government’s fiscal 2024 budget year on March 9, which includes additional funding for pandemic preparedness. However, the White House has signaled its intent to drill down on drug prices with an increase in the scope of the number of drugs subject to Medicare price negotiations along with a 67% increase in the Advanced Research Projects Agency–Health (ARPA-H) to $2.5 billion, a boost that is sure to draw cheers from companies in the life sciences.
Noting that the FDA had rejected its previous proposal last year to voluntarily withdraw Makena from the U.S. market, Covis Pharma BV is again offering to voluntarily withdraw the drug, which is the only drug approved to reduce the risk of preterm birth. Along with its offer, the company asked the agency “to allow for an orderly wind-down that would best serve the interests of the patients,” according to a March 6 letter from Covis’ attorney to FDA Commissioner Robert Califf and Namandjé Bumpus, the agency’s chief scientist.
After placing a temporary hold on the merger between F-star Therapeutics Ltd. and Sino Biopharmaceutical Ltd.’s Invox Pharma Ltd., citing “unresolved national security risks,” the Committee on Foreign Investment in the United States (CFIUS) has finally cleared the merger to proceed.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Genethon, Ionis, Novan, Regeneron, Sanofi, Shorla, Siga, Takeda.
The Biden administration offered a sneak peek March 7 at its fiscal 2024 budget by outlining ways it proposes extending the life of the U.S. Medicare Hospital Insurance Trust Fund by at least 25 years.
The U.S. Court of Appeals for the Federal Circuit once again delved into genus claims as it affirmed Gilead Sciences Inc.’s win in its inter partes review (IPR) challenge of several claims in a patent held by the University of Minnesota.
Chiesi Farmaceutici SpA has agreed to pay Affibody AB up to $214 million in a collaboration and licensing agreement to develop an inhaled treatment for respiratory diseases, with a further $423 million also in the cards if the deal is extended to two more programs. The fees consist of up front and milestone payments, based on certain development, regulatory and commercial achievements, with additional mid-single to low double-digit royalties on sales.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioarctic, Cantex, Coherus, Eli Lilly, Ikena, Merck, Milestone.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aptorum, BMS, Merck, Ractigen, Valeo.
Shares of Veru Inc. hit a 52-week low March 3 after the U.S. FDA declined to grant an emergency use authorization (EUA) for sabizabulin for use in hospitalized adults with moderate to severe COVID-19 who are at high risk for acute respiratory distress syndrome. The decision comes as little surprise, given the negative advisory panel vote in November, but the agency’s wording might suggest potential use for the microtubule disruptor in the future.
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