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BioWorld - Tuesday, February 24, 2026
Home » Topics » Regulatory

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Infection

BARDA offers $100M in prize money for antiviral development

Feb. 4, 2026
No Comments
Looking to fill a treatment gap, the U.S. Biomedical Advanced Research and Development Authority (BARDA) is launching the first stage of a $100 million prize competition to support development of broad-spectrum, small-molecule antiviral therapies targeting viruses in the Togaviridae and Flaviviridae families.
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BARDA offers $100M in prize money for antiviral development

Feb. 4, 2026
No Comments
Looking to fill a treatment gap, the U.S. Biomedical Advanced Research and Development Authority (BARDA) is launching the first stage of a $100 million prize competition to support development of broad-spectrum, small-molecule antiviral therapies targeting viruses in the Togaviridae and Flaviviridae families.
Read More
Gavel and block with Chinese flag

China amends drug rules to enforce lifecycle accountability

Feb. 4, 2026
By Tamra Sami
No Comments
China’s State Council updated its Drug Administration Law, and the changes mark a substantive evolution in the country’s drug regulatory framework.
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Rare pediatric PRV extended to 2029

Feb. 4, 2026
By Jennifer Boggs
No Comments
Reauthorization of the rare pediatric disease priority review voucher (PRV) was included in the spending package signed into law Feb. 3 by U.S. President Donald Trump, removing at least one aspect of uncertainty facing rare disease companies, many of which have relied on the PRV’s transferrable option as a lucrative source of funding.
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Amgen headquarters

Amgen thumbs-down on FDA’s ask, Tavneos sales continue

Feb. 4, 2026
By Randy Osborne
No Comments
Amgen Inc.’s head of R&D James Bradner said his firm was “surprised” by the request from the U.S. FDA Jan. 16 to take Tavneos (avacopan) off the market – and the company said no. “We're in discussions with FDA, and we'll answer questions as we talk with them,” he added.
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FTC consent order beefs up PBM reforms in spending bill

Feb. 4, 2026
By Mari Serebrov
No Comments
In a one-two-punch to pharmacy benefit managers (PBMs), the U.S. FTC announced Feb. 4 what it’s calling a “landmark settlement” with the Cigna Group’s Express Scripts Inc. and its affiliates that will require fundamental changes to the company’s business practices.
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FDA updates cybersecurity guidance for medical devices

Feb. 4, 2026
No Comments
The U.S. FDA released the latest version of its premarket cybersecurity guidance regarding medical devices, replacing the 2025 edition and offering recommendations on implementing measures for preventing digital attacks or authorized access.
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3D illustration showing cross section of a human bone
Cancer

Prelude’s JAK2 V617F inhibitor PRT-12396 gains IND clearance

Feb. 4, 2026
No Comments
Prelude Therapeutics Inc. has received IND clearance from the FDA for PRT-12396, a mutant-selective JAK2 V617F inhibitor being developed for the treatment of patients with certain myeloproliferative neoplasms.
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Kim Dong-gun (DG), CEO, Elevar

Elevar gets new CEO, files NDAs for lirafugratinib, rivoceranib

Feb. 3, 2026
By Marian (YoonJee) Chu
No Comments
Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.
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China NMPA approves Sciwind’s GLP-1 injection for diabetes

Feb. 3, 2026
By Marian (YoonJee) Chu
No Comments
Sciwind Biosciences Co. Ltd. said Jan. 30 it won Chinese approval for self-developed glucagon-like peptide-1 (GLP-1) receptor agonist, ecnoglutide (Xianyida), to treat adults with type 2 diabetes.
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