Regeneron – Talk Bio

Regeneron Heads to FDA Seeking Approval for Game-Changing Hearing Loss Gene Therapy

2 weeks ago talkbio0Tagged Approved, CHORD trial, DB-OTO, Deafness, gene therapy, OTOF gene, Regeneron, United States Food and Drug Administration

Regeneron; hearing loss; gene therapy; DB-OTO; FDA approval; OTOF gene; CHORD trial

Regeneron Prepares U.S. Submission for Garetosmab After Breakthrough Phase III Result in Ultra-Rare FOP

1 month ago talkbio0Tagged bone lesion prevention, Drugs, Orphan, fibrodysplasia, Fibrodysplasia Ossificans Progressiva, Garetosmab, Infrequent, OPTIMA trial, ossificans, Phase III, progressiva, Regeneron, Submission, United States Food and Drug Administration

Regeneron; garetosmab; FOP; fibrodysplasia ossificans progressiva; Phase III; OPTIMA trial; bone lesion prevention; rare disease; FDA submission; orphan drug

Regeneron and Sandoz Settle Eylea Biosimilar Patent Dispute

2 months ago talkbio0Tagged Approved, Biosimilars, Enzeevu, Eylea, launch, Ophthalmology specialty, Patent Settlement, Regeneron, sandoz, United States, United States Food and Drug Administration

Regeneron; Sandoz; Eylea; Enzeevu; biosimilar; aflibercept; patent settlement; FDA approval; U.S. launch; ophthalmology

Regeneron Reports Phase 3 Success for Cemdisiran in Rare Disease Generalized Myasthenia Gravis

2 months ago talkbio0Tagged Alnylam, cemdisiran, Infrequent, Myasthenia Gravis, Generalized, Regeneron, regulatory submission, RNA drug, RNA, Small Interfering, United States

Regeneron; Phase 3 trial; cemdisiran; generalized myasthenia gravis; rare disease; RNA drug; siRNA; Alnylam Pharmaceuticals; U.S. regulatory submission

FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

2 months ago talkbio0Tagged Biosimilars, Deferred, Edema, Eylea HD, macular, manufacturing issues, Nordisk facility, Pre-filled Syringe, Regeneron, regulatory approval, Retinal Vein Occlusion, United States Food and Drug Administration

FDA delay; Regeneron; Eylea HD; manufacturing issues; Novo Nordisk facility; biosimilars; pre-filled syringe; macular oedema; retinal vein occlusion; regulatory approval

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

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

4 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

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

4 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

23andMe to Restart Auction After Former CEO Anne Wojcicki Outbids Regeneron

5 months ago talkbio0Tagged Anne Wojcicki, asset, auction, Bankruptcy, Regeneron, Sales - occupational activity, Science of genetics, TTAM

23andMe; auction; Anne Wojcicki; Regeneron; TTAM Research Institute; bankruptcy; asset sale; genetics

Regeneron Licenses Hansoh’s GLP-1/GIP Obesity Drug to Compete with Zepbound

5 months ago talkbio0Tagged Biopharma, eli lilly, GLP-1/GIP receptor agonist, Hansoh Pharmaceuticals, HS-20094, Licensing Deal, Obesity, Regeneron, Zepbound

Regeneron; Hansoh Pharmaceuticals; HS-20094; GLP-1/GIP receptor agonist; obesity drug; Zepbound; Eli Lilly; obesity treatment; licensing deal; biopharma