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BioWorld - Friday, December 19, 2025
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
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Illustration of Neisseria gonorrhoeae

Nuzolvence, Blujepa win FDA nods for gonorrhea

Dec. 12, 2025
By Karen Carey
No Comments
Two new therapies are now FDA approved to treat the sexually transmitted infection gonorrhea, with Innoviva Inc.’s Nuzolvence (zoliflodacin) and GSK plc’s Blujepa (gepotidacin) offering additional antibiotic options comparable to standard of care. Both products had fast track, qualified infectious disease product and priority review designations.
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Drug capsule spilling onto brain

Cycle buying Applied Therapeutics to develop CNS drugs

Dec. 12, 2025
By Lee Landenberger
No Comments
Cycle Group Holdings Ltd. is buying Applied Therapeutics Inc. for a small fraction of the company’s value when it went public in 2019. Cycle is paying $0.088, nearly 9 cents, in cash per share plus a contingent value right (CVR).
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Globe showing Asia-Pacific region

Menarini sees Asia Pacific as growth engine for its global future

Dec. 12, 2025
By Tamra Sami
No Comments
Experience gained in the Asia-Pacific region is helping shape the Menarini Group’s global strategy as the Italian pharmaceutical company looks to emerging markets to drive long-term, sustainable growth.
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Doctor holding shield and virtual visualization of bladder organ

CHMP recommends Immunitybio's Anktiva, Cytokinetics' Myqorzo

Dec. 12, 2025
By Nuala Moran
No Comments
The EMA’s Committee for Medicinal Products for Human Use (CHMP) is joining the U.S. FDA and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) in approving Anktiva (nogapendekin alfa inbakicept-pmin) in patients with non-muscle invasive bladder cancer (NMIBC) who have not responded to immune stimulation treatment with Bacillus Calmette-Guérin (BCG) vaccine and would otherwise require surgical removal of the bladder.
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Chalkboard with straight arrow erased, drawing a turning arrow

Arcus shifts effort, bears down on would-be ‘anchor’ in RCC

Dec. 12, 2025
By Randy Osborne
No Comments
Arcus Biosciences Inc. and partner Gilead Sciences Inc. are scrapping phase III work with anti-TIGIT antibody domvanalimab after an independent data monitoring committee said the drug will fail in gastric and esophageal cancers.
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Arcus quits domvanalimab gastric phase III, turns to casdatifan

Dec. 12, 2025
No Comments
A preview of the next edition of BioWorld, Dec. 12, 2025
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Person with chest pain after receiving a COVID-19 vaccine
Inflammatory

Research unpicks molecular mechanism of vaccine-induced cardiac inflammation

Dec. 12, 2025
By Anette Breindl
No Comments
The cardiomyositis that is a rare adverse effect of mRNA-based COVID vaccines is due to immune cell activity as a result of increased levels of the chemokines CXCL10 and interferon-γ (IFN-γ). Blocking CXCL10 and IFN-γ could prevent muscle cell damage in cell culture, and cardiomyositis in animal models. The findings, reported in the Dec. 10, 2025, issue of Science Translational Medicine, suggest a way of mitigating the risk of cardiomyositis.
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COVID-19 vaccine vials on conveyor belt

Petition claims FDA oops! means COVID-19 vaccines misbranded

Dec. 11, 2025
By Mari Serebrov
No Comments
Restricting the recommended use of COVID-19 vaccines in the U.S. wasn’t enough. Now the Children’s Health Defense (CHD) is trying to get the FDA to revoke the BLAs for all versions of the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines.
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Regulatory actions for Dec. 11, 2025

Dec. 11, 2025
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Ajax, Amneal, Beren, Boehringer, Fondazione, GSK, Kane, Sagimet, USAntibiotics.
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Other news to note for Dec. 11, 2025

Dec. 11, 2025
Biopharma happenings, including deals and partnerships, and other news in brief: Indupro, Oxford Biotherapeutics, Polpharma Biologics.
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