Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB, Ardelyx, Astrazeneca, Hoth, Innocare, Kala, Minerva, Pfizer, Polarean, Transcode.
Despite pipeline setbacks in 2022, TG Therapeutics Inc. ended the year on a positive note, with U.S. FDA approval of its glycoengineered CD20 monoclonal antibody, ublituximab, in relapsing multiple sclerosis (MS). Branded Briumvi, the drug is set to go up against approved anti-CD20 antibodies Kesimpta (ofatumumab, Novartis AG) and Ocrevus (ocrelizumab, Roche Holding AG).
Although the war is still raging in Ukraine, Russia is marching forward with asserting its regulatory framework on health care in the parts of Ukraine it’s claiming as the spoils of the war it started 11 months ago.
Facing a 26.5% rebate on 2023 sales of branded prescription drugs in the U.K., the Association of the British Pharmaceutical Industry (ABPI) is seeking talks with the government early in the new year to develop a new biopharma settlement for the future that will reflect the potential of the life sciences sector to drive improvements in the health and economy of the U.K.
The Australian government delivered an early Christmas present to the biopharma industry in the form of a new National Medicines Policy giving voice to major industry goals – among them a clear vision to “achieve the world’s best health, social and economic outcomes for all Australians through a highly supportive medicines policy environment.”
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genentech, Intercept, Ipsen, Janux, Kaken, Leo, Mediwound, Mindrank AI, Neuren, Neurocrine, Nova Mentis, Regeneron, Revive, Springworks, Valneva, Zielbio.
Congress has wrapped up the budget for fiscal year 2023 with yet another significant boost to funds for the National Institutes of Health, but the omnibus legislation also authorizes the U.S. FDA to designate academic research centers as centers of excellence for continuous drug manufacturing. A conspicuous omission from the omnibus was the Verifying Accurate, Leading-edge IVCT Development (VALID) Act for FDA regulation of lab-developed tests (LDTs), an omission that drew both praise and criticism from stakeholders.
Two weeks ahead of its Jan. 6, 2023, PDUFA date, the U.S. FDA has approved the bispecific Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. It’s the first bispecific antibody approved for treating any type of non-Hodgkin lymphoma (NHL). FL is the most common slow-growing form of NHL.
Topping biopharma regulatory news in 2022 was the signing of the Inflation Reduction Act (IRA), as its provisions requiring Medicare to directly negotiate certain prescription drug prices will open the door for the first time to a degree of government price controls in the U.S., affecting the bottom line of drug companies around the world.
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