ORG – Page 37 – Talk Bio

Gilead Wins Groundbreaking FDA Approval for Twice-Yearly HIV Prevention Shot

3 months ago talkbio0Tagged Approved, Gilead, Guidelines, HIV Prevention, Lenacapavir, Long-acting injectable, PREP gene, twice-yearly injection, United States Food and Drug Administration, World Health Organization, Yeztugo

Gilead; FDA approval; lenacapavir; Yeztugo; HIV prevention; twice-yearly injection; PrEP; long-acting injectable; WHO guidelines

Inside the FDA’s Listening Tour: Officials Agree US Lags Behind China on Drug Development

3 months ago talkbio0Tagged Biotechnology, China, Clinical Trials, Drug Development, Drug Industry, innovation, Regulation, United States Food and Drug Administration

FDA; China; drug development; biotechnology; regulation; clinical trials; pharmaceutical industry; biotech innovation

FDA’s Top Cell and Gene Therapy Leaders Exit Amid CBER Upheaval

3 months ago talkbio0Tagged Anatol, biopharma regulation, CBER, Cell Therapy, Changing, gene therapy, Leadership, Nicole Verdun, Peter Marks, Rachael, United States Food and Drug Administration

FDA; cell therapy; gene therapy; CBER; Nicole Verdun; Rachael Anatol; Peter Marks; leadership changes; biopharma regulation

Zealand Pharma’s Dual GLP-1/GLP-2 Agonist Dapiglutide Shows Promising 11.6% Weight Loss at 28 Weeks

3 months ago talkbio0Tagged Clinical Trials, Dapiglutide, Glucagon-Like Peptide 1, Glucagon-Like Peptide 2, Obesity, Safety, Weight Loss, Zealand Pharma

Zealand Pharma; dapiglutide; GLP-1; GLP-2; weight loss; obesity; phase 1b trial; clinical trial; dual agonist; safety

FDA Grants Dupixent (Dupilumab) Eighth Approval: Now Cleared for Bullous Pemphigoid

3 months ago talkbio0Tagged Approved, Autoimmune Diseases, Bullous pemphigoid, Drugs, Orphan, dupilumab, Dupixent, Priority Review, Regeneron, sanofi, type 2 inflammation, United States Food and Drug Administration

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

3 months ago talkbio0Tagged Biological Science Disciplines, Biopharma, capital constraints, cash runway, EY, macroeconomic

biotech; EY report; cash runway; life sciences; capital constraints; biopharma; 2025; macroeconomic uncertainty

FDA Approves Gilead’s Twice-Yearly HIV Prevention Shot

3 months ago talkbio0Tagged Approved, Gilead Sciences, HIV Prevention, Lenacapavir, PREP gene, public health medicine (field), twice-yearly injection, United States Food and Drug Administration, Yeztugo

FDA approval; Gilead Sciences; Lenacapavir; Yeztugo; HIV prevention; twice-yearly injection; PrEP; public health

Regeneron Leads $66M Series B for Actio Biosciences’ Rare Disease Therapeutics

3 months ago talkbio0Tagged ABS-0871, ABS-1230, Actio, Biosciences, Charcot-Marie-Tooth Disease, Clinical Trials, Drugs, Orphan, Epilepsy, Infrequent, Inhibitor, KCNT1 gene, Regeneron, Series B financing, TRPV4 protein, human

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

BioNTech Halts Cell Therapy Manufacturing at Maryland Site, Lays Off Dozens

3 months ago talkbio0Tagged BioNTech, BNT211, Cancer Therapeutic Procedure, CAR-T, Cell Therapy, Clinical Trials, Gaithersburg, layoffs, Manufacturing Facilities, Maryland (geographic location)

BioNTech; cell therapy; Maryland; layoffs; CAR-T; BNT211; Gaithersburg; manufacturing facility; cancer therapy; clinical trial

Bavarian Nordic Sells FDA Priority Review Voucher for $160M Amid Rising Industry Prices and Program Scrutiny

3 months ago talkbio0Tagged Bavarian Nordic, biotech finance, chikungunya vaccine, NIH Mouse, Priority Review, Sales - occupational activity, United States Food and Drug Administration, Vimkunya

Bavarian Nordic; Priority Review Voucher; FDA; voucher sale; $160 million; chikungunya vaccine; VIMKUNYA; NIH; antitrust review; biotech finance