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BioWorld - Tuesday, December 9, 2025
Breaking News: ASH 2025: Casgevy for kids? Expanding, improving SCD gene therapiesBreaking 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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Qilu gains China rights to Laekna’s AKT inhibitor in ¥2B deal

Nov. 12, 2025
By Marian (YoonJee) Chu
No Comments
Laekna Inc. outlicensed select rights to LAE-002 (afuresertib), an oral pan-AKT kinase inhibitor licensed from Novartis AG in 2018, to Qilu Pharmaceutical Co. Ltd. under a potential ¥2.045 billion (US$287.23 million) deal.
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Colorectal cancer 3D illustration

Low CRC efficacy bar, few prospects; hello, Cytomx

Nov. 12, 2025
By Randy Osborne
No Comments
At the busy annual congress of the American College of Surgeons in Chicago, attendees heard about a study that found rectal bleeding in younger adults – those under 50 years of age – increased their odds of a colorectal cancer (CRC) diagnosis by a shocking 850%. Already, the demographic has turned up sharply higher cases of the disease in recent years. The ACS meeting was held Oct. 4-7.
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Amended stopgap spending bill includes full 2026 funding for FDA

Nov. 12, 2025
By Mari Serebrov
No Comments
The U.S. House is expected to vote late Nov. 12 on an amended continuing resolution (CR) to end the historic 43-day partial government shutdown. Already passed by the Senate, the CR would fully reopen the government and fund it through Jan. 30. President Donald Trump has said he will sign the CR, which ensures federal employees furloughed during the shutdown will receive back pay and will not be terminated.
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Female doctor and patient
FT Global Pharma and Biotech Summit

Could restricting diversity efforts stall women’s health research?

Nov. 12, 2025
By Nuala Moran
No Comments
Recent progress in redressing the historical underfunding and neglect of women’s health could be undermined by the backlash against diversity, equity and inclusion (DEI) initiatives, according to executives participating in the FT Global Pharma and Biotech Summit 2025 in London Nov. 11-12.
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Man falling asleep in car

Alkermes’ alixorexton hits endpoints in narcolepsy phase II

Nov. 12, 2025
By Lee Landenberger
No Comments
Alkermes plc’s placebo-controlled phase II study of alixorexton in treating narcolepsy type 2 (NT2) hit its dual primary endpoints, producing statistically significant and clinically meaningful improvement in wakefulness and excessive daytime sleepiness. Alkermes said alixorexton is the first oral orexin 2 receptor agonist that has shown efficacy in a large phase II clinical trial in those with NT2.
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Alkermes’ positive phase II data in narcolepsy hits endpoints

Nov. 12, 2025
No Comments
A preview of the next edition of BioWorld, Nov. 12, 2025
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Regulatory actions for Nov. 11, 2025

Nov. 11, 2025
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Avenzo, Boehringer, City, Tenaya, UCB, Vera.
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Other news to note for Nov. 11, 2025

Nov. 11, 2025
Biopharma happenings, including deals and partnerships, and other news in brief: AN2, Damora, Eli Lilly, Galecto, Genfit, GSK, Meiragtx, Teva, Transition, Voyager.
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In the clinic for Nov. 11, 2025

Nov. 11, 2025
Clinical updates, including data readouts and publications: Adarx, Amgen, Anaptysbio, Apogee, Astrazeneca, Atai Beckley, Bioinvent, Bluejay, Camurus, Cogent, Inflarx, Ionis, Mannkind, Merck, Mineralys,  Neurogastrx, Novo Nordisk, Organon, Roche, Swedish Orphan Biovitrum, Vor.
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Financings for Nov. 11, 2025

Nov. 11, 2025
Biopharmas raising money in public or private financings, including: Arch Biopartners, Evommune, Onchilles.
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