FDA PreCheck Could Help New CDMO Sites – But Key Questions Remain
Summary:
CDMOs see the FDA’s PreCheck program as a way to reduce the first-mover disadvantage at new U.S. manufacturing sites by enabling earlier regulatory validation through mechanisms like Type V Drug Master Files. However, companies including Lonza and Novo Nordisk raise concerns around confidentiality, scope, and practical use of DMFs, while uncertainty remains over whether and how CDMOs will be fully included in the program.
NIH Reinstates Comprehensive Ban on Aborted Fetal Tissue Research
Summary:
The NIH has reimposed a full ban on the use of tissue from elective abortions in federally funded research as of Jan. 22, while continuing to allow fetal tissue from miscarriages and stillbirths. NIH leaders say the policy redirects resources toward newer models like organoids and tissue chips, but scientists warn it could slow advances in disease research and vaccine development where fetal tissue has historically played a critical role.
FDA Introduces Faster Approval Pathway for Multiple Myeloma Drugs
Summary:
The FDA has released new guidance allowing accelerated approvals for certain multiple myeloma therapies based on deep tumor response measures such as minimal residual disease and complete response, rather than traditional objective response rates. The shift could speed development of cell therapies and other treatments, while still requiring later proof of survival benefit to secure full approval.
Investors Fuel a New Gold Rush in Brain Science
Summary:
Driven by advances in biomarkers, brain mapping, AI, and neuromodulation, neuroscience and neurotech are attracting strong investor interest in 2026 despite recent high-profile clinical failures. Venture capitalists and Big Pharma see massive opportunity in CNS therapeutics and devices – especially for neurodegenerative diseases – while acknowledging the scientific and translational risks remain high.
U.S. Formally Exits WHO, Leaving $260M in Unpaid Dues
Summary:
The United States is officially withdrawing from the World Health Organization under President Trump, halting future funding despite owing $260 million in unpaid dues for 2024 and 2025. Global health experts warn the exit could weaken disease surveillance, pandemic preparedness, and vaccine development, while forcing the WHO – its largest funder – to cut programs and staff.
