Uncategorized
Moderna Wins UK Appeals Court in Covid-19 Patent Case Against Pfizer/BioNTech
Moderna; Pfizer; BioNTech; UK Court of Appeal; COVID-19 vaccine; patent infringement; EP’949 patent; Comirnaty; legal victory
Novo Nordisk’s Leadership Shakeup and Wider Implications; Ex-FDA Official Takes Regulatory Role at GSK
Novo Nordisk; leadership shakeup; new CEO; Maziar Mike Doustdar; share price drop; obesity drug market; competition; GSK; regulatory affairs; Former FDA
FDA Approves LENZ Therapeutics’ VIZZ Eye Drop for Presbyopia
FDA approval; VIZZ; LENZ Therapeutics; presbyopia; aceclidine; eye drop; near vision
Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay
Regeneron; Eylea HD; CRL; FDA; PDUFA; supplemental Biologics License Application; dosing intervals; retinal diseases
Spine BioPharma’s Phase 3 Back Pain Drug Fails to Meet Primary Endpoint, Attributes Miss to High Sham Response
Spine BioPharma; Phase 3 trial; chronic low back pain; degenerative disc disease; SB-01; primary endpoint; sham response; clinical trial results
Merck to Lay Off 6,000 Employees, Reduce Workforce by 8% in $3B Cost-Cutting Move
Merck; layoffs; cost-cutting; restructuring; pharmaceuticals; job cuts; Keytruda; Gardasil; workforce reduction
Alnylam Surpasses $50B Market Cap as Amvuttra Heart Disease Launch Impresses Wall Street
Alnylam Pharmaceuticals; market cap; Amvuttra; heart disease; ATTR-CM; stock surge; Q2 2025 earnings; revenue growth
Frazier Life Sciences Raises $1.3 Billion Amid Biotech Downturn
Frazier Life Sciences; venture capital; biotech; $1.3 billion raise; early-stage investments; biopharmaceutical startups; oversubscribed fund; therapeutics
Trump Administration Unveils Health Data Sharing Scheme Backed by Apple, Amazon, and Others
Trump administration; health data sharing; CMS Interoperability Framework; Apple; Amazon; digital health records; patient data; privacy; tech partnerships
FDA Seeks Greater Alignment Between CBER and CDER: Makary Informs Industry Leaders
FDA; CBER; CDER; regulatory harmonization; Marty Makary; George Tidmarsh; Vinay Prasad; cell and gene therapy; biologics; pharmaceutical industry