In July 2023, South Korea’s Ministry of Trade, Industry and Energy ramped up efforts to kickstart the so-called “Bio Economy 2.0,” the newfound initiative that banks on the biopharmaceutical industry to potentially revitalize the country’s slowing economic and social growth. Highlighting four major areas – biopharmaceuticals, biomaterials, bioenergy and digital technologies – as the four “wheels” to carry the biopharma industry, the new plan underscored the government’s unwavering support for the sector while highlighting its vision to become the “number one bioeconomy” worldwide.
Brainstorm Cell Therapeutics Inc.’s Nurown got a thumbs down from the U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee Sept. 27, as the committee voted 1-17, with one abstention, that the data presented demonstrated substantial evidence of effectiveness for treatment of mild to moderate amyotrophic lateral sclerosis.
The NDA for the formerly named Nyxol is now an open and shut case for Ocuphire Pharma Inc. and Viatris Inc. The U.S. FDA has approved Ryzumvi (phentolamine ophthalmic solution) for treating pharmacologically induced mydriasis, better known as dilating the pupil. Ryzumvi, a small-molecule eye drop, reduces the pupil’s diameter after it is dilated with adrenergic agonists such as phenylephrine or parasympatholytic agents such as tropicamide. The treatment reduces pupil size by acting on the iris dilator muscle.
The U.S. FDA recently convened an advisory hearing to discuss whether three in vitro diagnostics should be reclassified from class III to class II, including tests for the pathogens responsible for Hepatitis B and tuberculosis. The panel agreed that all three of the test types should be reshuffled to the lower-risk class II category, suggesting that test developers now have an opportunity to jump into a market with lower-cost tests that won’t need expensive and drawn-out clinical studies to obtain the FDA’s seal of approval.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Affamed, Akebia, Altrubio, Biostem, Cel-Sci, Chrysalis, Defender, Ideaya, Mythic, Phathom, Sandoz, Sanofi, Veru.
Safety concerns overrode benefit when the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously, 19-0, Sept. 21 that the potential risks of Intarcia Therapeutics’ ITCA-650 outweighed the compliance and A1C-lowering benefits the twice-yearly implantable exenatide-device combination product could provide for adults with type 2 diabetes.
As biosimilar development expands beyond monoclonal antibodies to more complex biologics, the flexibility built into regulatory paths across the world will become more essential. Rather than making wholesale changes to those pathways, regulators need to follow the science in exercising the flexibility they already have, Leah Christl, executive director of global biosimilars regulatory affairs and R&D policy at Amgen Inc., told BioWorld. In doing so, “we do need to look forward to what might be coming down the pipeline,” in addition to looking backwards at what types of biosimilars have already been approved, she said.
Thanks to a raft of new approvals by Japan’s Ministry of Health, Labor and Welfare (MHLW), patients in Japan will soon have access to Biogen Inc./Eisai Co. Ltd.’s Leqembi (lecanemab), an amyloid-beta binder, for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acelrx, Alvotech, Appili, Ardelyx, Biogen, Biora, Cara, Coherus, Daewoong, Eisai, Genmab, Nymox, Pfizer, Sanofi, Shuttle, Takeda, Theratechnologies, Tris.