Japan’s Central Social Insurance Medical Council said it would issue similar drug price revisions in 2023 as it did in 2022 for drugs listed on the National Health Insurance, confirming the move to annual price cuts on drugs.
Tucked into the 4,155-page, $1.7 trillion spending bill for fiscal 2023 that U.S. President Joe Biden signed into law Dec. 23 is a small provision that may have outsized impact on future biosimilar and other drug development. Championed by lawmakers on both sides of the political spectrum, the provision modernizes the data that can be used to support drug development, including alternatives to animal studies.
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).
The fifth medical device user fee agreement (MDUFA V) included several new programs, such as a program intended to aid device makers in an efficient to-market process. However, MDUFA V also boosted device user fees for many applications by 55% but turnaround times for these applications will remain essentially flat compared to MDUFA IV.
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 submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Polarean Imaging.
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.
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