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Home » Topics » Regulatory

Regulatory
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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.
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Regulatory actions for Sept. 28, 2023

Sep. 28, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4Web Medical, Siemens Medical Solutions, Sun Nuclear.
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Regulatory actions for Sept. 28, 2023

Sep. 28, 2023
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.
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Samsung Biologics Bio Campus II

Samsung, Celltrion set record targets as S. Korea banks on Bio Economy 2.0

Sep. 28, 2023
By Marian (YoonJee) Chu
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.
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Lee Chang-yang, minister, MOTIE

South Korea rolls out ‘Bio Economy 2.0’ to top global biologics, biosimilar market

Sep. 27, 2023
By Marian (YoonJee) Chu
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.
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