BioSpace News Archive

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I Remember Aduhelm. The Return of Roche in Alzheimer’s Is a Turning Point

After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.

December 2, 2025

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2 min read

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Annalee Armstrong

Illustration of a syringe and medicine bottle with some broken glass

Manufacturing

Biotechs Secure Alternative Fill/Finish Capacity Amid Scrutiny of Novo Site

Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.

December 2, 2025

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6 min read

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Nick Paul Taylor

Axial view of the brain showing a glioblastoma in the left frontal lobe with central necrosis, peripheral infiltration, and early midline shift.

Brain cancer

Imvax Heads to FDA With 6-Month Survival Gain in Glioblastoma, Despite Endpoint Miss

While Imvax’s autologous immunotherapy IGV-001 missed the primary endpoint of progression-free survival in a Phase IIb trial, the company will request a meeting with the FDA to discuss next steps for “synergistic” treatment.

December 2, 2025

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2 min read

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Dan Samorodnitsky

A brain hovers over a hand against a yellow-striped background

Alzheimer’s disease

Roche Is Back in Alzheimer’s as Latest Antibody Clears Amyloid Plaques

Trontinemab lowered amyloid levels below the threshold of positivity in 92% of treated patients.

December 2, 2025

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2 min read

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Tristan Manalac

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Regulatory

Experts Decry Prasad Memo’s Lack of Transparency as Vaccine Stocks Dip

With no evidence to support the claim that 10 children died due to COVID-19 vaccines, experts unpack the impact of CBER chief Vinay Prasad’s leaked vaccine memo.

December 2, 2025

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4 min read

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Dan Samorodnitsky

FDA

Pazdur To Retire Weeks After Taking On Coveted FDA Role

Newly appointed Center for Drug Evaluation and Research director Richard Pazdur has filed retirement papers with the agency—three weeks after accepting the role—amid clashes with Commissioner Marty Makary over certain FDA programs.

December 2, 2025

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3 min read

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Heather McKenzie

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Artificial intelligence

FDA Rolls Out Agentic Models in Bid to ‘Modernize’ Regulatory Workflows

Agentic AI can help FDA staff manage meetings, conduct pre-market reviews and validate reports, among other tasks, though the agency emphasized that using this technology is optional for its employees.

December 2, 2025

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1 min read

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Tristan Manalac

2006 James Gathany Captured by James Gathany, Centers for Disease Control's biomedical photographer, this 2006 image depicted the exterior of the new "Tom Harkin Global Communications Center", otherwise known as Building 19, located on the organization's Roybal Campus in Atlanta, Georgia. The facility houses the CDC's Information Center/Library, auditoria and meeting halls, which are used to accommodate in-house staff meetings, and national/international conferences hosted by the CDC, and the National Center for Health Marketing's, Division of Creative Services, which includes a full service television broadcast facility. The exhibit area currently features the "Global Symphony", the first of several permanently installed exhibitions, and changing exhibitions that focus on a variety of public health topics. The exhibits in the Center are self-guided, and require no advance reservations. Additional curriculum-based exhibits and programming will be added in the future. Tom Harkin Global Communications Center Exhibit Area Centers for Disease Control and Prevention - 1600 Clifton Road, N.E., Atlanta, Georgia 30333 - Hours: Monday Friday, 9 am 5 pm, except for federal holidays Admission is free - Government-issue photo ID is required for entry. Please note that CDC is a working federal facility and as such does not provide public tours of its campus and laboratories. - For more information please call 404-639-0830.

Vaccines

ACIP To Discuss Hep B, Childhood Vaccine Schedule Under New Chair Who Linked COVID Shots to Cancer

This week’s meeting of the Advisory Committee on Immunization Practices will be led by Kirk Milhoan, a physician and pastor who recently claimed that COVID-19 vaccines contained a contamination that causes cancer.

December 2, 2025

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2 min read

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Tristan Manalac

Press Releases

Jazz Pharmaceuticals to Present Pivotal Phase 3 Results of Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma at the 2026 ASCO Gastrointestinal Cancers Symposium

Late-breaking HERIZON-GEA-01 presentation highlights the expanding clinical profile of Ziihera across HER2-driven gastrointestinal cancers Jazz to host investor webcast on Friday, January 9, 2026, to review data

December 2, 2025

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15 min read

Press Releases

PharmaTher Closes Sale of Ketamine ANDA, Sharpening Focus on Long-Acting Injectable Ketamine Franchise

December 2, 2025

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1 min read