ORG – Page 35 – Talk Bio

TIGIT Turmoil: How Pharma Burned Billions on Failed Immuno-Oncology Projects

3 months ago talkbio0Tagged Arcus Biosciences, Clinical Trials, Gilead, immuno-oncology, iTeos, Merck, Myers, Novartis, Pharma, Roche (company), SmithKline Beecham, squibb, TIGIT gene, Tiragolumab

TIGIT; immuno-oncology; failed clinical trials; pharma investment loss; Gilead; GSK; Bristol Myers Squibb; Novartis; Merck; Roche; iTeos; Arcus Biosciences; tiragolumab; belrestotug

Biogen Ushers Spinraza Follow-Up (Salanersen) Into Pivotal SMA Studies

3 months ago talkbio0Tagged Antistreptolysin O, Biogen, Clinical Trials, motor milestones, Nerve Degeneration, Novartis, Pediatric brand name, Phase III, salanersen, Spinal Muscular Atrophy, Spinraza, Zolgensma

Biogen; SMA; Spinraza; salanersen; Phase III; clinical trials; neurodegeneration; motor milestones; pediatric; Novartis Zolgensma; ASO therapy

Kymera Snags Gilead as New Partner; Sanofi Opts for Next-Gen IRAK4 Degrader

3 months ago talkbio0Tagged biotech collaborations, CDK2 protein, human, Degrader, Gilead Sciences, IRAK4 gene, Kymera, Malignant neoplasm of breast, Molecular Glue Degrader, oncology partnership, sanofi, Solid Neoplasm

Kymera Therapeutics; Gilead Sciences; Sanofi; molecular glue degrader; CDK2; solid tumors; breast cancer; oncology partnership; IRAK4 degrader; biotech collaborations

Kymera Faces Sanofi Setback but Secures $750M Gilead Oncology Deal

3 months ago talkbio0Tagged CDK2 protein, human, Gilead, Kymera, Molecular Glue Degrader, Neoplasms, protein degrader, sanofi

Kymera; Sanofi; Gilead; molecular glue degrader; CDK2; oncology; deal; protein degrader

FDA Investigates Patient Deaths Linked to Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

3 months ago talkbio0Tagged ELEVIDYS, Evaluation, gene therapy, Liver, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient deaths, regulatory, Toxicity aspects, Unable to walk (finding), United States Food and Drug Administration

FDA; Sarepta; Elevidys; Duchenne muscular dystrophy; gene therapy; patient deaths; acute liver failure; liver toxicity; regulatory investigation; non-ambulatory patients

Nektar Declares Phase IIb Eczema Win for Rezpeg, but Analysts Remain Skeptical

3 months ago talkbio0Tagged analysts, Clinical Trials, Dermatitis, Atopic, Dupixent, EASI, Eczema, Lilly partnership, Nektar Therapeutics, Phase II B Trial, Rezpeg, Rezpegaldesleukin, Score, Skepticism

Nektar Therapeutics; Rezpegaldesleukin; Rezpeg; Phase IIb trial; eczema; atopic dermatitis; clinical trial; EASI score; Dupixent; analyst skepticism; Lilly partnership

Leap Therapeutics Slashes 75% of Workforce, Ends Clinical Trial, Considers Strategic Options

3 months ago talkbio0Tagged Biotech Layoffs, Clinical Trials, FL-501, Flatulence, LEAP, Sirexatamab, strategic alternatives

Leap Therapeutics; workforce reduction; biotech layoffs; clinical trial; strategic alternatives; sirexatamab; FL-501; R&D wind down

Nuvalent Reports Positive Pivotal Data for ROS1-Targeted Lung Cancer Drug; Rolling FDA Submission Planned

3 months ago talkbio0Tagged ARROS-1 trial, Frequency of Responses, Metastatic malignant neoplasm to brain, Neoplasms, Non-Small Cell Lung Carcinoma, Nuvalent, Protein-tyrosine kinase inhibitor, ROS1-positive Lung Cancer, Submission, United States Food and Drug Administration, zidesamtinib

Nuvalent; ROS1-positive lung cancer; zidesamtinib; FDA submission; ARROS-1 trial; NSCLC; tyrosine kinase inhibitor; objective response rate; brain metastases; oncology

BrightGene’s Dual GLP-1/GIP Agonist BGM0504 Shows Promise in Phase 2 Diabetes and Obesity Trials at ADA25

3 months ago talkbio0Tagged ADA25, BGM0504, BrightGene, Diabetes Mellitus, Non-Insulin-Dependent, GLP-1/GIP agonist, Glycosylated hemoglobin A, Obesity, semaglutide, Weight maintenance regimen

BrightGene; BGM0504; GLP-1/GIP agonist; ADA25; Type 2 diabetes; Obesity; Phase 2 clinical trial; weight management; HbA1c reduction; semaglutide; tirzepatide

FDA Acting CDER Head Jacqueline Corrigan-Curay to Retire Amid Leadership Turnover

3 months ago talkbio0Tagged agency departures, CDER, Drug Regulations, Jacqueline Corrigan-Curay, Leadership, Personnel Turnover, Retirement, United States Food and Drug Administration

FDA; Jacqueline Corrigan-Curay; CDER; retirement; leadership turnover; drug regulation; agency departures