Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Alzamend, Asieris, Inflarx, Menarini, Northwest, Nrx, Oncomatryx, Outlook, Zealand.
In response to the Biden administration announcing on Aug. 29 the first 10 medications up for price negotiations with the Centers for Medicare & Medicaid Services as part of the Inflation Reduction Act of 2022, U.S. Senate and House Republicans are firing back, calling the imposed “price-controls set by Washington bureaucrats” part of a scheme that “will lead to higher prices for new drugs coming to market, stifle the development of new cures and destroy jobs,” ultimately driving up costs for seniors.
After hitting the safety and efficacy endpoints in a pivotal study of wet age-related macular degeneration (AMD), Outlook Therapeutics Inc.’s CEO said he had not expected to receive a complete response letter (CRL) from the U.S. FDA. The BLA for ONS-5010 (bevacizumab-vikg) now is on hold, the company said, because the agency said chemistry, manufacturing, and controls management problems were getting in the way, along with “open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.”
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Bloomsbury Genetic Therapies, BMS, Eagle, Faron, Genentech, Halozyme, Hutchmed, Janssen, Laurent, Merck, Tscan, Valneva, Xortx.
Biontech SE and Pfizer Inc. filed a petition with the U.S. Patent Trial and Appeal Board for an inter partes review against Moderna Inc., the latest move in an ongoing patent battle over the mRNA technology used to develop COVID-19 vaccines.
The U.S. FDA has awarded Bristol Myers Squibb Co. (BMS) with its third approval for treating anemia with Reblozyl (luspatercept-aamt). Specifically, the approval is for treating anemia without previous erythropoiesis stimulating agent use in adults with very low- to intermediate-risk myelodysplastic syndromes who may require regular red blood cell transfusions.
The list of 10 part D Medicare drugs listed by the Centers for Medicare & Medicaid Services (CMS) as eligible for negotiation raised some eyebrows on Wall Street, but proved mostly in accord with what the industry expected. Under the Inflation Reduction Act, Medicare can for the first time bargain with drug companies. The back-and-forth begins this year, carrying into next year, and the agreed-upon prices will take effect in 2026.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Harbour, Tourmaline.
The U.S. FTC has recalibrated its challenge to Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc while one of the biggest trade groups has voiced its concerns about the government’s role in the deal. An amicus brief from the Biotechnology Innovation Organization (BIO), along with the Illinois Manufacturers Association, the Chicagoland Chamber of Commerce and the Illinois Biotechnology Innovation Organization, calls the FTC expansion into such deals overreach that chills pro-competitive biopharma mergers.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Ausper, Ausperbio, Everest, Janssen, Pfizer, Sandoz.
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