Disease or Syndrome – Page 7

FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

3 weeks ago talkbio0Tagged Accelerated, Alfa, amendment, Approved, Biologics License Application, Clinical pharmacology discipline, Deferred, Denali, Mucopolysaccharidosis II, review extension, tividenofusp, United States Food and Drug Administration

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval

Novo Nordisk Ends Cell Therapy Research Amid Major Restructuring

3 weeks ago talkbio0Tagged cancellations, Cell Therapy, cost-cutting, Diabetes, Novo Nordisk, Obesity, Partnership, R&D strategy, restructuring

Novo Nordisk; cell therapy; restructuring; job cuts; diabetes; cost-cutting; R&D strategy; biotech; obesity; partnership cancellations

Satellos Advances Duchenne Pill Trial in Children; Idorsia Raises $81 Million

3 weeks ago talkbio0Tagged Child, Fund Raising, Idorsia, Indonesian language, Muscular Dystrophy, Duchenne, oral small-molecule therapy, Phase 2 clinical trial, SAT-3247, Satellos, Submission, United States Food and Drug Administration

Satellos; Duchenne muscular dystrophy; SAT-3247; Phase 2 clinical trial; children; FDA IND submission; oral small-molecule therapy; Idorsia; fundraising; biotech

AviadoBio Secures Option to Develop Rare Eye Disease Gene Therapy UGX-202 in $413 Million Deal with China’s UgeneX

4 weeks ago talkbio0Tagged AviadoBio, China, gene therapy, Optogenetics, Retinitis Pigmentosa, UgeneX, UGX-202

AviadoBio; UgeneX; UGX-202; optogenetics; gene therapy; retinitis pigmentosa; China; $413 million deal

Bristol Myers Squibb Enters In Vivo CAR-T Field with $1.5B Acquisition of Orbital Therapeutics

4 weeks ago talkbio0Tagged Acquisition, Autoimmune Diseases, Automobiles, Cell Therapy, immune system reprogramming, in vivo, Myers Squibb, NUSAP1 gene, Obstetric Delivery, Orbital Therapeutics, OTX-201, RNA medicines, RNA, Circular, T-cell therapy

Bristol Myers Squibb; Orbital Therapeutics; in vivo CAR T-cell therapy; autoimmune diseases; RNA medicines; OTX-201; cell therapy; acquisition; LNP delivery; circular RNA; immune system reprogramming

AviadoBio Secures Option to UgeneX’s UGX-202 Gene Therapy for Retinal Disease

4 weeks ago talkbio0Tagged AviadoBio, Clinical Development, Dependovirus, gene therapy, Optogenetics, Retinal Diseases, Retinitis Pigmentosa, UGX-202

AviadoBio; UgeneX Therapeutics; UGX-202; retinitis pigmentosa; gene therapy; optogenetics; adeno-associated virus (AAV); exclusive option; retinal disease; clinical development

Odyssey Therapeutics Appoints Pharmaceutical Leader Nia Tatsis, Ph.D., to Its Board of Directors

4 weeks ago talkbio0Tagged assurance, Autoimmune Diseases, Biological Factors, board of directors, Nia Tatsis, Odyssey Therapeutics, Quality, Regulatory Affairs, RIPK2 scaffolding inhibitor

Odyssey Therapeutics; Nia Tatsis; Board of Directors; Vertex Pharmaceuticals; RIPK2 scaffolding inhibitor; autoimmune diseases; biopharmaceuticals; regulatory affairs; quality assurance

Evommune Files for IPO to Fund Phase 2 Trials of Autoimmune Drug Candidates

4 weeks ago talkbio0Tagged autoimmune drugs, Chronic inflammatory disorder, EVO301, EVO756, Evommune, Funding, IPO, New York Stock Exchange, Phase 2 Trials, Series C financing

Evommune; IPO; Phase 2 trials; autoimmune drugs; EVO756; EVO301; chronic inflammatory diseases; biotech funding; New York Stock Exchange; Series C financing