August 1, 2025 – Talk Bio

Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay

6 days ago talkbio0Tagged Application procedure, dosing, Eylea HD, IL31RA gene, Interval, PDUFA, Regeneron, Retinal Diseases, Supplement, United States Food and Drug Administration

Regeneron; Eylea HD; CRL; FDA; PDUFA; supplemental Biologics License Application; dosing intervals; retinal diseases

FDA Approves LENZ Therapeutics’ VIZZ Eye Drop for Presbyopia

6 days ago talkbio0Tagged aceclidine, Approved, Eye Drops, LENZ, Myopia, presbyopia, United States Food and Drug Administration, VIZZ

FDA approval; VIZZ; LENZ Therapeutics; presbyopia; aceclidine; eye drop; near vision

Novo Nordisk’s Leadership Shakeup and Wider Implications; Ex-FDA Official Takes Regulatory Role at GSK

6 days ago talkbio0Tagged CEO, competition, Drops - Drug Form, drug market, Leadership, Maziar Mike Doustdar, Nordisk, Obesity, Prices, Regulatory Affairs, Shakeup, SmithKline Beecham, United States Food and Drug Administration

Novo Nordisk; leadership shakeup; new CEO; Maziar Mike Doustdar; share price drop; obesity drug market; competition; GSK; regulatory affairs; Former FDA

Moderna Wins UK Appeals Court in Covid-19 Patent Case Against Pfizer/BioNTech

6 days ago talkbio0Tagged appeal, BioNTech, court, COVID19 (disease), EP'949, infringement, Legal patent, legal victory, Moderna, Pfizer, UK, Vaccines

Moderna; Pfizer; BioNTech; UK Court of Appeal; COVID-19 vaccine; patent infringement; EP’949 patent; Comirnaty; legal victory

Trump Gives Pharma CEOs 60-Day Ultimatum for ‘Most Favored Nation’ Drug Pricing

6 days ago talkbio0Tagged Drug Industry, Drug Prescriptions, drug price, executive order, Health Policy, Medicaid, nation policy, Transplant Registry Unified Management Program

Trump; pharmaceutical industry; drug pricing; most favored nation policy; executive order; prescription drugs; healthcare policy; Medicaid; tariffs

Spine BioPharma’s Phase 3 Back Pain Drug Fails to Meet Primary Endpoint, Attributes Miss to High Sham Response

6 days ago talkbio0Tagged Chronic low back pain, Clinical Trials, Intervertebral Disc Degeneration, primary endpoint, Response process, salicylhydroxamic acid, SB-01, Spine BioPharma

Spine BioPharma; Phase 3 trial; chronic low back pain; degenerative disc disease; SB-01; primary endpoint; sham response; clinical trial results

Alnylam Surpasses $50B Market Cap as Amvuttra Heart Disease Launch Impresses Wall Street

6 days ago talkbio0Tagged Alnylam, Amvuttra, ATTR-CM, Caps, earnings, Heart Diseases, Market, revenue growth, Stock Surge

Alnylam Pharmaceuticals; market cap; Amvuttra; heart disease; ATTR-CM; stock surge; Q2 2025 earnings; revenue growth

Merck to Lay Off 6,000 Employees, Reduce Workforce by 8% in $3B Cost-Cutting Move

6 days ago talkbio0Tagged cost-cutting, Gardasil, Keytruda, layoffs, Merck, restructuring

Merck; layoffs; cost-cutting; restructuring; pharmaceuticals; job cuts; Keytruda; Gardasil; workforce reduction

Frazier Life Sciences Raises $1.3 Billion Amid Biotech Downturn

6 days ago talkbio0Tagged biopharmaceutical startups, Early-stage, Frazier Life Sciences, Investments, oversubscribed fund, venture capital

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

6 days ago talkbio0Tagged Administration occupational activities, Amazona, CMS Interoperability Framework, digital health records, Genus Malus, health data, Privacy, tech partnerships, Transplant Registry Unified Management Program

Trump administration; health data sharing; CMS Interoperability Framework; Apple; Amazon; digital health records; patient data; privacy; tech partnerships