National support for the biosimilar sector and the domestic industry’s efforts to increase production and sales may not be enough for South Korean biosimilar firms to box out competition in the ever-changing regulatory court of the U.S. “Competition in U.S. negotiations and rebates are fierce,” Choi Sung-ho, chairman of the Korean Society for Bioeconomy, said. “Even if you get listed, it is crucial to be placed in an advantageous class to lower out-of-pocket costs.
The Advanced Research Projects Agency for Health (ARPA-H) reported the opening of a series of regional offices that focus on both administrative and research assignments, a development that may bolster cures and treatments for tough-to-treat conditions. However, the U.S. House and Senate have different ideas about how much money the agency will receive in 2024, casting a cloud of uncertainty over how many projects the agency will be able to finance in the twelve months that will start on Oct. 1, 2023.
It has been a long time coming, but Fabre-Kramer Pharmaceuticals Inc. finally received U.S. FDA approval for its major depressive disorder candidate, Exxua (gepirone hydrochloride extended-release tablets). The approval comes three months after the June 23 PDUFA date (as a result of amendments filed by the company in April and May), but 24 years after the original NDA was filed in 1999.
Brainstorm Cell Therapeutics Inc. said it’s exploring all its options in the wake of a Sept. 27 U.S. FDA advisory committee vote, in which the committee overwhelmingly disagreed with the company that the data it presented supported the effectiveness of Nurown (debamestrocel) for the treatment of mild to moderate amyotrophic lateral sclerosis.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4SC, ABM, Ideaya, Ocuphire, Remegen, Shionogi, Ultragenyx, Viatris.
As South Korea increases its stakes on the “bioeconomy” as its next growth engine and as its “second semiconductor industry,” leading domestic biologic and biosimilar drug producers such as Samsung Biologics Co. Ltd. and Celltrion Inc. are setting record production targets to become forerunners in the global playing field.
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.
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