Recent Developments in Immune Profiling for Early Immuno-Oncology Trials
immune profiling; immuno-oncology; clinical trials; AI in immunotherapy; multi-omic strategies; tumor microenvironment; spatial proteomics; biomarker discovery; personalized medicine
FDA Grants Dupixent (Dupilumab) Eighth Approval: Now Cleared for Bullous Pemphigoid
Dupixent; Dupilumab; Sanofi; Regeneron; bullous pemphigoid; FDA approval; type 2 inflammation; autoimmune disease; priority review; orphan drug
Over One-Third of Biotechs Face Cash Crunch, EY 2025 Report Finds
biotech; EY report; cash runway; life sciences; capital constraints; biopharma; 2025; macroeconomic uncertainty
BioNTech Halts Cell Therapy Manufacturing at Maryland Site, Lays Off Dozens
BioNTech; cell therapy; Maryland; layoffs; CAR-T; BNT211; Gaithersburg; manufacturing facility; cancer therapy; clinical trial
Regeneron Leads $66M Series B for Actio Biosciences’ Rare Disease Therapeutics
Regeneron; Actio Biosciences; rare diseases; Series B financing; KCNT1 inhibitor; TRPV4 inhibitor; ABS-1230; ABS-0871; Charcot-Marie-Tooth disease; epilepsy; orphan drug; clinical trials
FDA Approves Gilead’s Twice-Yearly HIV Prevention Shot
FDA approval; Gilead Sciences; Lenacapavir; Yeztugo; HIV prevention; twice-yearly injection; PrEP; public health
Trump Administration Considers Limits on Direct-to-Consumer Drug Advertising
Trump administration; DTC drug advertising; pharmaceutical regulation; drug pricing; executive order; health policy; pharma marketing
Scholar Rock’s SMA drug helps Zepbound patients retain muscle in phase 2 trial
Scholar Rock; apitegromab; SMA drug; Zepbound; tirzepatide; muscle preservation; obesity; weight loss; phase 2 trial; lean mass; myostatin inhibitor
Bavarian Nordic Sells FDA Priority Review Voucher for $160M Amid Rising Industry Prices and Program Scrutiny
Bavarian Nordic; Priority Review Voucher; FDA; voucher sale; $160 million; chikungunya vaccine; VIMKUNYA; NIH; antitrust review; biotech finance
Genentech’s Kristin Bittenbender Named BIO Board Chair Amid Industry Challenges
BIO; Genentech; Kristin Bittenbender; board chair; biotech industry; FDA; existential threats; leadership change; biotechnology policy