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.
With the U.S. Centers for Medicare & Medicaid Services soon expected to publish the list of 10 drugs selected for the first round of the Inflation Reduction Act’s (IRA) price negotiations, Astrazeneca plc is the latest to file a challenge. It’s the first non-U.S.-headquartered company to do so and, unlike the other challenges, Astrazeneca’s complaint focuses on the impact to the Orphan Drug Act (ODA). In a statement, the Cambridge, U.K.-based firm said the “drug price negotiation provisions of the IRA run headlong into the goals” of the ODA.
Biosimilars continue to pose cheaper alternatives to their established, blockbuster counterparts. The U.S. FDA has approved Tyruko (natalizumab-sztn) from Sandoz Inc., the generics business of Novartis AG. It is the first approved biosimilar to Biogen Inc.’s blockbuster Tysabri (natalizumab), an injectable monoclonal antibody for treating adults with relapsing forms of multiple sclerosis (MS).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Alentis, Astrazeneca, Bioxytran, Collegium, Comanche, Gilead, Merck, Novaliq, Taysha Gene Therapies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Dizal, Immix, Nexcella, Pfizer.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akava, Amgen, Fulcrum, Geron, Janssen, Nascent, Pfizer, Vigeneron, Vincerx.
Boehringer Ingelheim GmbH is the latest company to dive into the legal fray surrounding the federal government’s plan to change drug costs. The drug price negotiation program established by the Inflation Reduction Act is “unlawful,” according to the company’s brief, because it violates the due process clause and the just-compensation portion of the U.S. constitution’s Fifth Amendment.
Shares of Fulcrum Therapeutics Inc. shot up 38.5% on Aug. 22 following news that the U.S. FDA had lifted the clinical hold on the company’s phase Ib sickle cell disease candidate, FTX-6058.
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