FDA Considers Noninvasive Endpoint for MASH Trials, Boosts Biotech Shares
FDA; noninvasive endpoint; liver disease; MASH; clinical trials; biomarker; biotech stocks; Madrigal Pharmaceuticals; Viking Therapeutics; Inventiva; Altimmune
Personalizing Metabolic Care with Digital Twins: Recent Developments
digital twins; metabolic health; AI healthcare; personalized medicine; biomarkers; diabetes management; obesity reversal; real-time guidance; GLP-1; Twin Health
Vinay Prasad Explains FDA’s Revocation of Pfizer’s Covid Vaccine EUA for Children
FDA; Pfizer; COVID-19 vaccine; emergency use authorization (EUA); children; Vinay Prasad; vaccine policy; risk-benefit analysis
Genentech’s $700M North Carolina Plant and Telix’s FDA CRL Update
Genentech; Roche; North Carolina; manufacturing facility; $700 million; Holly Springs; metabolic medicines; obesity treatments; biomanufacturing; Telix; FDA; Complete Response Letter (CRL); imaging agent
Exelixis to Lay Off 130 Employees, Shut Down Pennsylvania Site in Post-Pandemic Downsizing
Exelixis; layoffs; Pennsylvania site closure; post-pandemic downsizing; biotech reorganization; Alameda headquarters; zanzalintinib; cabozantinib; King of Prussia
Fosun Licenses Immunology Asset FXS6837 to Sitala in $670M Deal
Fosun Pharma; Sitala; FXS6837; immunology; license agreement; autoimmune diseases; biotech; pharmaceuticals; $670 million
Indivior Initiates Cost-Cutting Plan with Job Cuts and Real-Estate Review
Indivior; job cuts; real-estate; cost-cutting; restructuring; sales guidance; profit guidance; Opvee divestiture; competition; generic drugs
Wugen Nabs $115M for Pivotal Study of Allogeneic CAR-T
Wugen; CAR-T; allogeneic; off-the-shelf therapy; fratricide-resistant; funding; pivotal trial; T-cell malignancies
Exelixis Closes Pennsylvania Site, Cuts 130 Jobs in Major Restructuring
Exelixis; layoffs; Pennsylvania; King of Prussia; biotech; job cuts; site closure; restructuring; Alameda Headquarters; cancer drugs
Sanofi Contributes to Report Emphasizing Importance of Sustainably Paid Community Health Workers
Sanofi; community health workers; sustainability; health equity; National Association of Community Health Workers; policy advocacy; digital infrastructure; CHW Access Act