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.
U.S. Sen. Bernie Sanders (I-Vt.) sent letters to Sanofi SA and Novo Nordisk A/S executives on March 1, urging them to follow Eli Lilly and Co.’s example in cutting prices for their insulin products, offering more affordable access for Americans with diabetes. Industry leaders, however, have long argued that the problem goes far beyond list price, as pharmacy benefit managers and health plans have simply not passed their rebates onto consumers.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Alvotech, Astrazeneca, Checkpoint, Genenta, Intellia, Santhera, Serda, Valneva.
The U.S. development path for rare disease treatments is strewn with numerous challenges, not least of which are the regulatory hurdles. For companies developing promising candidates to treat ultra-rare diseases and the patients who are running out of time, the regulatory obstacles in the U.S. may seem almost insurmountable. And new concerns about drug development in general could make those barriers even higher.
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