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Regulatory
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US-South Korean flags

Korean biosimilars locked in ‘fierce’ battle to box out competition in US

Sep. 29, 2023
By Marian (YoonJee) Chu
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.
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Amicus’ Pompe disease treatment gets FDA approval and looks for blockbuster status

Sep. 29, 2023
By Lee Landenberger
After a nearly year-long delay pegged to COVID-19 travel restrictions, the U.S. FDA has approved Amicus Therapeutics Inc.’s Pompe disease drug, introducing competition for Sanofi SA’s standard-of-care treatment and anticipating blockbuster sales. The combination of Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) 65-mg capsules was approved for adults with late-onset Pompe disease, who weigh at least 40 kg and who are not improving on their current enzyme replacement therapy.
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US-South Korean flags

Korean biosimilars locked in ‘fierce’ battle to box out competition in US

Sep. 29, 2023
By Marian (YoonJee) Chu
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.
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U.S. Capitol building

US ARPA-H program prepared to go live as Congress mulls FY 2024 appropriations

Sep. 29, 2023
By Mark McCarty
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.
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Regulatory actions for Sept. 29, 2023

Sep. 29, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Seastar Medical.
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Health professional, EHR/medical icons

US NIH preparing to dive into real-world data pool for basic research

Sep. 29, 2023
By Mark McCarty
The U.S. FDA may be the most prominent agency in the federal government when it comes to the use of real-world data (RWD), but the National Institutes of Health is keen to immerse itself in this trove of information. The agency has made a request for public comment on how NIH centers can best leverage RWD for biomedical and behavioral research, although some ethical and practical considerations may have to be overcome.
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Regulatory actions for Sept. 29, 2023

Sep. 29, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Akeso, Alpha Cognition, Antibe, Baudax, Biomea, Bolt, Brainstorm, Calliditas, Everest, Fabre-Kramer, Karuna, Merck & Co., Oncopeptides, Stada, Takeda.
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Illustration of blood vessel that isn't clotting due to hemophilia
Hematologic

FDA awards orphan drug designation to Baudax’s TI-168 for hemophilia A with inhibitors

Sep. 29, 2023
Baudax Bio Inc.’s lead clinical candidate, TI-168, has been awarded U.S. orphan drug designation by the FDA for the treatment of hemophilia A with inhibitors. TI-168 is a next-generation, factor VIII (FVIII)-specific regulatory T-cell (Treg) therapy designed to address hemophilia A in patients with FVIII inhibitors.
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Fabre-Kramer’s NME Exxua approved in US for MDD

Sep. 28, 2023
By Karen Carey
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.
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Stem-cells2.png

Adcom leaves Brainstorm looking at options

Sep. 28, 2023
By Mari Serebrov
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.
Read More
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