Given the advances being made in cancer treatments, it’s time to move beyond the maximum tolerated dose (MTD) to dose-optimization trials for targeted therapies, the U.S. FDA said in a new draft guidance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Astrazeneca, Harbour, Novo Nordisk, Revive.
Following Therapeutic Goods Administration approval of its first-generation donor-derived microbiome-based therapy, Biomictra, for recurrent Clostridioides difficile infection, Australia’s Biomebank is scaling up to meet increasing global demand for fecal microbiota products and is developing a more scalable second-generation synthetic product.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biontech, Genentech, Pfizer.
Although the U.S. Inflation Reduction Act charges the Centers for Medicare & Medicaid Services with negotiating prices of the Part B and D drugs with the highest Medicare spend, the first two rounds of negotiations will focus solely on Part D drugs, which are dispensed through pharmacies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Avillion, Eisai, Intellia, SFA, Takeda, Union.
Sen. Bernie Sanders (I-Vt.), the incoming chair of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, penned a blistering letter that takes Moderna Inc. CEO Stéphane Bancel to task over the company’s plans to more than quadruple the U.S. list price of its COVID-19 vaccine once the government’s supply is depleted.
China's National Healthcare Security Administration will not be adding Pfizer Inc.'s COVID-19 treatment Paxlovid to its list of medicines covered by basic medical insurance schemes in the country, due to its high prices.
Proposed mergers with Chinese companies will likely be subject to increased scrutiny from the Committee on Foreign Investment in the United States (CFIUS) as evidenced by the temporary hold placed on the merger between F-star Therapeutics Ltd. and Sino Biopharmaceutical Ltd.’s Invox Pharma Ltd. that was announced in June 2022.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Can-Fite, Dizal, Minerva, Qualigen, Renexxion, Treadwell.
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