ORG
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
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
AbbVie Raises 2025 Guidance and Eyes Strategic Deals in Neuroscience, Obesity, and Oncology
AbbVie; 2025 guidance; earnings; neuroscience; obesity; PD-1/VEGF; strategic deals; pharmaceuticals
Lilly’s Mounjaro Matches Cardiovascular Benefit of Trulicity in Landmark Trial, Paving Way for Expanded Approval
Mounjaro; tirzepatide; Eli Lilly; cardiovascular outcomes; type 2 diabetes; SURPASS-CVOT; Trulicity; dulaglutide; major adverse cardiovascular events (MACE-3); non-inferiority; A1C reduction; weight loss; mortality; FDA expansion
ImmuneOnco and Instil Bio’s PD-L1xVEGF Bispecific Antibody Shows Promising Results in Phase 2 Lung Cancer Trial
ImmuneOnco; Instil Bio; IMM2510/AXN-2510; PD-L1xVEGF bispecific antibody; NSCLC; Phase 2 clinical trial; response rate; safety profile; chemotherapy combination; lung cancer
Viridian Licenses Promising Eye Disease Candidates to Kissei for Japanese Market
Viridian Therapeutics; Kissei Pharmaceutical; veligrotug; VRDN-003; thyroid eye disease; Japan partnership; anti-IGF-1R antibodies; clinical trials; biopharma deal