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BioWorld - Wednesday, February 4, 2026
Breaking News: BioWorld 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sector
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Pazdur ‘optimal fit’ to lead FDA’s CDER

Nov. 12, 2025
By Mari Serebrov
No Comments
In reaching within to name 26-year FDA veteran Richard Pazdur as the next CDER director, FDA Commissioner Marty Makary likely chose the best possible person to helm the drug evaluation center at a time marked by uncertainty, morale issues and upheaval, according to several agency watchers.
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Regulatory actions for Nov. 12, 2025

Nov. 12, 2025
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: March, Purdue.
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Other news to note for Nov. 12, 2025

Nov. 12, 2025
Biopharma happenings, including deals and partnerships, and other news in brief: Bayer, Eli Lilly, Insilico, Kezar, Neuphoria, Oncotelic, Sapu, Vividion.
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In the clinic for Nov. 12, 2025

Nov. 12, 2025
Clinical updates, including data readouts and publications: ACTG, Altimmune, Alzinova, Belenos, Calliditas, Celecor, Engene, Esperion, Idorsia, Intellia, LIB, Lytix, Neurocrine, Novo Nordisk, Precision, Prothena, Shilpa Medicare.
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Financings for Nov. 12, 2025

Nov. 12, 2025
Biopharmas raising money in public or private financings, including: Decoy, Inovio, Precision, Salarius, Vor.
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Appointments and advancements for Nov. 12, 2025

Nov. 12, 2025
New hires and promotions in the biopharma industry, including: Abcellera, Evox, Medincell, Odyssey, Pharmaessentia, Prokarium, Santa Ana, Trimtech.
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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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