North America

SHERIDAN, WYOMING - December 3, 2025 - AGC Biologics is expanding its Cell Line Development Center of Excellence through a new partnership with ATUM, integrating the Leap-In Transposase® expression platform to help biopharma developers move monoclonal antibodies and complex next-generation biologics into the clinic faster and more cost-effectively.

New options for faster, more flexible cell line development

As pressure grows to launch high-value biologics at lower cost, drug sponsors are looking for cell line development (CLD) solutions that combine speed, robustness and scalability. AGC Biologics' collaboration with ATUM adds a modern transposase-based expression platform to its CLD toolkit, creating a menu of fit-for-purpose options for standard monoclonals, multi-specific antibodies and other complex molecules.

SHERIDAN, WYOMING - December 3, 2025 - AGC Biologics has signed a new manufacturing agreement with AAVantgarde Bio to produce dual-vector AAV gene therapies for Stargardt disease and retinitis pigmentosa, positioning its BravoAAV™ platform at the center of next-generation treatments for inherited retinal disorders with no approved therapies.

Dual-vector AAV platform targets previously "untreatable" retinal genes

Under the deal, AGC Biologics will provide GMP manufacturing for AAVantgarde's two clinical-stage candidates: AAVB-039 for Stargardt disease, the most common inherited form of macular degeneration in children and young adults, and AAVB-081 for retinitis pigmentosa caused by Usher syndrome type 1B. Both programs are in Phase 1/2 trials, with AAVB-039 being tested in the U.S., UK and Europe, and AAVB-081 representing the first-ever dual AAV gene therapy in an ocular indication.

SHERIDAN, WYOMING - December 3, 2025 - AGC Biologics is partnering with public benefit company Rarity PBC to bring a potentially life-saving gene therapy for Adenosine Deaminase Severe Combined Immunodeficiency (ADA-SCID) through commercial manufacturing and toward FDA approval, underscoring how CDMO collaborations are becoming central to translating academic breakthroughs into scalable rare disease treatments.

From transformational trials to a U.S. commercial pathway

Under the new agreement, AGC Biologics will provide end-to-end development and GMP manufacturing for Rarity's ex vivo autologous gene therapy RDP-101. If approved, RDP-101 would become the first gene therapy commercially available in the United States to reverse ADA-SCID, a rare inherited immunodeficiency that leaves infants dangerously exposed to severe, recurrent infections.

SHERIDAN, WYOMING - December 2, 2025 - Roche has secured FDA 510(k) clearance with a CLIA waiver and CE IVDR certification for its first point-of-care test to diagnose Bordetella infections, providing primary care and emergency clinicians with PCR-accurate results in just 15 minutes to help control whooping cough and related diseases.

Fast, PCR-accurate diagnosis at the point of care

Running on the cobas® liat system, Roche's new assay delivers lab-quality PCR results in GP offices and emergency rooms within a standard consultation. The 15-minute turnaround allows physicians to move from suspicion to definitive diagnosis immediately, supporting timely antibiotic prescribing that can prevent severe complications and reduce onward transmission.

SHERIDAN, WYOMING - December 2, 2025 - Royal Philips is expanding commercial availability of its LumiGuide 3D Device Guidance solution across Europe and the United States, positioning its real-time, AI-enabled, light-based navigation technology as a new benchmark for radiation-free image-guided therapy in complex endovascular procedures.

Real-time 3D navigation without continuous X-ray

SHERIDAN, WYOMING - December 2, 2025 - Roche is re-entering the frontline of Alzheimer's disease drug development, after new Phase I/II data showed its next-generation antibody trontinemab cleared amyloid plaques below the threshold of positivity in the vast majority of treated patients while keeping key safety signals under tight control.

Early Brainshuttle data show deep amyloid clearance

In the ongoing Brainshuttle AD Phase I/II study, 92% of patients treated with trontinemab achieved amyloid levels below 24 centiloids, the PET scan threshold commonly used to define amyloid positivity. The data, presented at the 2025 Clinical Trials on Alzheimer's Disease (CTAD) meeting, mark one of the strongest plaque-clearing signals yet seen in a mid-stage program.

SHERIDAN, WYOMING - December 2, 2025 - A leaked memo from FDA vaccine chief Vinay Prasad alleging that COVID-19 vaccines caused the deaths of 10 children has triggered a sharp backlash from scientific experts and investors, underscoring deep tensions inside U.S. vaccine regulation and adding fresh volatility for mRNA players Moderna and BioNTech.

An internal memo with external market consequences

In a six-page document titled "Deaths in children due to COVID-19 vaccines and CBER's path forward," Center for Biologics Evaluation and Research head Vinay Prasad claimed that an internal investigation had identified 10 child deaths "linked" to COVID-19 vaccination, based on reports in the Vaccine Adverse Events Reporting System (VAERS). The memo, published by The Washington Post, did not provide specific data, case details or manufacturer names.

SHERIDAN, WYOMING - December 2, 2025 - Imvax is moving its autologous glioblastoma immunotherapy IGV-001 toward the FDA, despite a missed primary endpoint in Phase IIb, betting that a six-month overall survival benefit and a novel "synergistic" treatment concept will resonate in a setting where outcomes have barely budged in two decades.

Phase IIb data highlight survival benefit despite PFS miss

In a mid-stage trial of 99 patients with newly diagnosed glioblastoma, Imvax evaluated IGV-001, a biologic-device combination, against placebo. While the study did not achieve its primary endpoint of improving progression-free survival, the company reported a median overall survival of 20.3 months in the treatment arm-around six months longer than in the control group.

SHERIDAN, WYOMING - December 2, 2025 - After years of volatility in Alzheimer's R&D, Roche's re-emergence with positive early data for trontinemab is reshaping expectations for the next competitive cycle in disease-modifying therapies, signaling that big pharma is not done pushing for better outcomes in this high-risk, high-need market.

From Aduhelm's fallout to a more mature Alzheimer's market

The modern Alzheimer's era was defined-some would say scarred-by the 2021 approval of Biogen and Eisai's Aduhelm, a controversial and costly monoclonal antibody that ultimately failed to deliver convincing clinical benefit and was later withdrawn. The backlash damaged Biogen's reputation and, for a time, cast doubt on the entire amyloid-directed approach, raising questions about regulatory standards and payer willingness to back expensive, marginally effective therapies.

SHERIDAN, WYOMING - December 2, 2025 - A series of FDA findings at Novo Nordisk's Bloomington, Indiana, fill/finish facility is forcing biotechs to rethink their commercial manufacturing strategies, with Regeneron and Scholar Rock now accelerating alternative capacity plans to break regulatory logjams linked to the ex-Catalent site.

FDA scrutiny at Novo's Bloomington site triggers CRLs

The Bloomington plant, one of three former Catalent sites Novo acquired for $11 billion to support surging GLP-1 demand, has become a bottleneck rather than a release valve for some of its biopharma customers. As a CDMO hub, the facility provided fill/finish services for a range of partners, but repeated quality issues have resulted in an Official Action Indicated (OAI) classification and multiple complete response letters (CRLs) from the FDA.