Finding – Talk Bio

Structure Therapeutics’ oral obesity drug shows competitive early data vs Novo and Lilly; Ascletis reports early obesity results

2 days ago talkbio0Tagged ASC41, Ascletis, eli lilly, Glucagon-Like Peptide 1, GSBR-1290, Obesity, Oral cavity, Ozempic, Phase 2 trial, safety profile, Structure Therapeutics, Wegovy, Weight Loss, Weight-Loss Agents, Zepbound

Structure Therapeutics; GSBR-1290; oral GLP-1; obesity pill; weight-loss drug; Novo Nordisk; Eli Lilly; Wegovy; Ozempic; Zepbound; Ascletis; ASC41; ASC42; phase 1 trial; phase 2 trial; weight reduction; safety profile

FDA Refuses to Release Detailed Data on Claimed COVID Vaccine-Linked Child Deaths in Near Term

7 days ago talkbio0Tagged COVID19 (disease), Data Release, Death of child, Myocarditis, United States Food and Drug Administration, vaccine oversight, Vaccine Safety, Vaccines

FDA; COVID-19 vaccine; child deaths; myocarditis; vaccine safety; Vinay Prasad; data release; vaccine oversight

Top Drug Regulator Richard Pazdur to Retire from FDA Amid Industry Concerns

1 week ago talkbio0Tagged Center for Drug Evaluation, Drug Regulations, Leadership, Personnel Turnover, research, Retirement, Richard Pazdur, United States Food and Drug Administration

Richard Pazdur; FDA; retirement; Center for Drug Evaluation and Research; drug regulation; Marty Makary; leadership turnover

Lilly Slightly Lowers Self-Pay Prices for Single-Dose Vials of Zepbound

1 week ago talkbio0Tagged Direct-to-Consumer, eli lilly, Glucagon-Like Peptide 1, LillyDirect, Obesity Drug, price cut, Self-pay, single-dose vials, Zepbound

Eli Lilly; Zepbound; price cut; self-pay; single-dose vials; direct-to-consumer; LillyDirect; obesity drug; GLP-1

FDA’s Vinay Prasad Links 10 Child Deaths to COVID-19 Vaccines, Calls for Stricter Review Guidelines

1 week ago talkbio0Tagged Biological Factors, COVID19 (disease), Death of child, Evaluation, Myocarditis, United States Food and Drug Administration, vaccine guidelines, vaccine regulation, Vaccine Safety, Vaccines, VAERS, Vinay Prasad

FDA; Vinay Prasad; COVID-19 vaccines; child deaths; myocarditis; vaccine safety; vaccine regulation; biologics evaluation; VAERS; stricter vaccine guidelines

Generate:Biomedicines Launches Global Phase 3 Trials for AI-Engineered Anti-TSLP Antibody GB-0895 in Severe Asthma

1 week ago talkbio0Tagged AI-engineered antibody, Asthma, Biomedicines, Clinical Trials, GB-0895, Generate, Phase 3, Programmable Biology, Severe (severity modifier), SOLAIRIA-1, SOLAIRIA-2, thymic stromal lymphopoietin, TSLP gene

Generate:Biomedicines; GB-0895; Phase 3 clinical trials; TSLP; thymic stromal lymphopoietin; severe asthma; AI-engineered antibody; programmable biology; SOLAIRIA-1; SOLAIRIA-2

Cereno Scientific Secures SEK 100m in Directed Share Issue and SEK 350m Loan Financing, Targeting Milestones by Q4 2027

1 week ago talkbio0Tagged Cardiovascular Diseases, Cereno Scientific, Clinical Development, Directed share, Histone deacetylase inhibitor, Infrequent, Loan, loan financing, milestones, portfolio, Problem, Pulmonary arterial hypertension

Cereno Scientific; SEK 100 million; Directed share issue; SEK 350 million; Loan financing; Q4 2027 milestones; HDAC inhibitor portfolio; Pulmonary arterial hypertension; Clinical development; Rare cardiovascular diseases

Marengo’s invikafusp alfa shows promising monotherapy activity in PD-1 resistant gastrointestinal cancers

1 week ago talkbio0Tagged Alfa, Colorectal Carcinoma, fast-track designation, High tumor mutational burden, High-Frequency Microsatellite Instability, Immunotherapy, invikafusp, Malignant neoplasm of gastrointestinal tract, Marengo Therapeutics, PDCD1 gene, resistant tumors, United States Food and Drug Administration

Invikafusp alfa; Marengo Therapeutics; PD-1 resistant tumors; Gastrointestinal cancers; Colorectal cancer; TMB-H; MSI-H; Immunotherapy; ESMO 2025; FDA Fast Track designation

Otsuka’s Anti-APRIL Antibody (Voyxact/Sibeprenlimab) Receives FDA Approval for IgA Nephropathy (IgAN)

2 weeks ago talkbio0Tagged anti-APRIL antibody, Approved, IGA Glomerulonephritis, Monoclonal Antibodies, Otsuka, Proteinuria, Sibeprenlimab, United States Food and Drug Administration, Voyxact

Otsuka; anti-APRIL antibody; Voyxact; sibeprenlimab; FDA approval; IgA nephropathy; IgAN; proteinuria; monoclonal antibody

Novo Nordisk’s Amycretin Significantly Reduces Weight and Blood Sugar in Phase 2 Type 2 Diabetes Trial

2 weeks ago talkbio0Tagged Administration, Oral, Agonist, amycretin, Amylin Receptor Agonists, Diabetes Mellitus, Non-Insulin-Dependent, Glucagon-Like Peptide 1, Glycosylated hemoglobin A, Novo Nordisk, Phase 2 clinical trial, subcutaneous administration, Weight Loss

Novo Nordisk; Amycretin; Type 2 diabetes; Weight loss; HbA1c reduction; GLP-1 agonist; Amylin receptor agonist; Phase 2 clinical trial; Subcutaneous administration; Oral administration