Now that the U.S. FDA has nearly 15 years of experience with developing and implementing a biosimilar pathway, it’s time for that regulatory path to catch up with the science, according to experts that have been involved in biosimilar development even before Congress passed the Biologics Price Competition and Innovation Act that created the framework for the U.S. biosimilar market.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, Aspargo, Astrazeneca, CSL, Inmune, Italfarmaco, Krystal, Nykode, Uniqure, Viatris, Wave, X4.
The queue of lawsuits challenging the constitutionality of the U.S. Inflation Reduction Act’s (IRA) prescription drug price negotiations continues to grow. Novartis AG is the latest drug company, but probably not the last, to join the line. It filed its challenge in federal court in New Jersey Sept. 1, a few days after the Centers for Medicare & Medicaid Services included the company’s heart failure drug, Entresto (sacubitril and valsartan), on its list of the 10 drugs subject to the first round of IRA negotiations.
The U.S. FTC’s antitrust challenge to Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc has been resolved. Amgen agreed to do what it said it would do all along: not bundle pharmacy benefit manager rebates on high volume blockbuster drugs Tepezza and Krystexxa.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alcresta, Astrazeneca, Biontech, Daiichi Sankyo, Mallinckrodt, Pfizer.
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.
RSS
