The U.S. Veterans Health Administration (VA) is being applauded for doing what Medicare has refused to do – provide coverage for Leqembi (lecanemab) in the early stages of Alzheimer’s disease. Under the March 13 VA decision, the Eisai Co. Ltd. drug, which was partnered with Biogen Inc. and granted accelerated approval in January, will be listed as a nonformulary therapy that must be prescribed by a VA-board certified neurologist, geriatric psychiatrist or geriatrician who specializes in treating dementia.
China’s NMPA approved Shanghai Shengdi Pharmaceutical Co. Ltd.’s adebrelimab (SHR-1316) for first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy. The approval in mainland China makes adebrelimab the third domestic PD-L1 monoclonal antibody to make it to the domestic market. Shanghai Shengdi is a subsidiary of Jiangsu Hengrui Medicine Co. Ltd.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Mersana.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: PADM Medical.
The U.K. arm of Silicon Valley Bank (SVB) is to be acquired by HSBC UK Bank plc for a symbolic £1, after senior ministers and the Bank of England worked all weekend on a rescue package. The acquisition is to complete immediately, averting what the U.K. government had acknowledged would be a crisis for the biotech and tech sector.
As the aftershocks of two U.S. bank failures rattled global markets, the Biden administration rushed to calm the nerves of the world and to prevent an even bigger tremor. “The banking system is safe,” President Joe Biden said March 13, as he assured companies and individuals who had accounts with Silicon Valley Bank or Signature Bank that they would have access to all their deposits now that the federal government has taken over the failed banks – including deposits exceeding the $250,000 protected by the FDIC.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Genentech, Intercept, Molecular Templates, Pfizer, Seagen.
Acadia Pharmaceuticals Inc. will make available by the end of this month Daybue (trofinetide), a synthetic analogue of the amino‐terminal tripeptide of IGF-1 for Rett syndrome (RS), which was greenlighted by the U.S. FDA March 10 and remains in the works for fragile X syndrome as well as undisclosed other indications.
Securities litigation is a fact of life in the U.S., but the volume of these cases is down somewhat from the four years between 2017 and 2020, during which an average of roughly 380 such cases were filed each year. The life science industries typically account for approximately one in four of these cases, which were down to less than 200 last year, but attorneys with Dechert LLP told BioWorld that the falling numbers do not suggest that this is a time to take anything for granted where securities litigation is concerned.
Pricing won’t be known until later for Pfizer Inc.’s Zavzpret (zavegepant), which became the first and only calcitonin gene-related peptide receptor antagonist nasal spray approved by the U.S. FDA for acute treatment of migraine with or without aura in adults. The product is slated to launch this summer. Meanwhile, Wall Street has questions about New York-based Pfizer’s performance in the migraine space.
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