FDA Introduces Standardized Framework for Gene Therapy Safety
New FDA guidance on evaluating the safety of gene therapies will establish a more predictable development process as these measures are implemented They provide a standardized, layered framework for uncovering off-target effects and other safety issues https://t.co/D7lsBeZybT
Infants Too Young for MMR Face Highest Measles Risk
Associated Press: “Too young for the MMR shot, babies become ‘sitting ducks’ in measles outbreaks” “Babies too young to be vaccinated are among the most vulnerable in a measles outbreak. The disease can wreak havoc on their fragile bodies” https://t.co/Ph5WD35jGu
Mono Infection Triples Risk of Developing Multiple Sclerosis
New study has strengthened link between infectious mono and Multiple Sclerosis. By analyzing 2 decades of health records, researchers found people who contracted mono as teenagers or adults were 3x more likely to develop MS later vs those who didn’t https://t.co/6DLZMEWyU6
FDA Guidance Sparks Innovation Path for Inherited Disorders
My article in today's issue of the Journal of the American Medical Association Health Forum, on FDA's new rare disease guidance, and how the agency can build on these policy steps to promote innovation for inherited disorders, authored with Maarika...
FDA Draft Guidance Streamlines Low‑Cost Biosimilar Approval
New FDA draft guidance outlines important streamlining of path to getting low-cost biosimilars to the market - could reduce cost of pharmacokinetic studies and allow ex-U.S. comparitor products to be used for proving biosimilarity to U.S.-licensed drugs https://t.co/ErjNOga0qo
Trump's Drug Pricing Deals Promise Lower Consumer Costs
My @CNBC segment on how President Trump's drug pricing deals will achieve many of the initial aims set out by tariff proposals, with respect to reshoring drug manufacturing, and how the biggest consumer impact in terms of lower drug costs...
New Drug Development Reforms Aim to Match China
These proposed reforms to pre-clinical drug development and to smoothing the transition to first-in-human studies could be the most consequential steps toward leveling the playing field with China. https://t.co/oVY6N3xo9Y
FDA Guidance Clears Path for Wearable Wellness Claims
An inventive new guidance from @US_FDA, opens opportunities for wellness claims for wearable devices like blood pressure. Enables innovation that empowers consumers and providers, and creates avenues for technology-enabled, high-access primary care. https://t.co/sxmD1DNkNW
Advancing Rare Disease Therapies: Policy and Regulatory Outlook
I’m coming up on @SquawkCNBC where I’ll be discussing recent advances in the treatment of rare diseases and the policy and regulatory path for bringing them to patients. https://t.co/9xsIvvY5Tm
