Disease or Syndrome – Page 27

FDA tightens Skysona label, restricting use to CALD patients without alternative options due to increased blood cancer risk

3 months ago talkbio0Tagged boxed, CALD, Cautionary Warning, Cerebral Adrenoleukodystrophy, Elivaldogene autotemcel, gene therapy, Hematologic Neoplasms, HLA‑matched donor, labeling changes, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, Safety, Skysona, United States Food and Drug Administration

FDA; bluebird bio; Skysona; elivaldogene autotemcel; labeling changes; boxed warning; hematologic malignancy; myelodysplastic syndrome; acute myeloid leukemia; cerebral adrenoleukodystrophy; CALD; HLA‑matched donor; gene therapy safety; post‑marketing reports

Two Courts Reject Challenges to Inflation Reduction Act, Marking Major Win for Government

3 months ago talkbio0Tagged administrative law, AstraZeneca, constitutional challenge, Drug Negotiation Program, federal courts, Inflation, Ira (eukaryote), Medicare, Myasthenic Syndromes, Congenital, Third Circuit Court

Inflation Reduction Act; IRA; Medicare Drug Negotiation Program; AstraZeneca; federal courts; constitutional challenge; administrative law; Third Circuit Court; CMS; Medicare

Novo Nordisk Maintains Edge in Obesity Pill Race as Lilly’s Pill Shows Modest Results

3 months ago talkbio0Tagged competition, Contraceptives, Oral, eli lilly, Glucagon-Like Peptide 1, Market, Nordisk, Obesity, oral semaglutide, orforglipron, Wegovy, Weight-Loss Agents, Zepbound

Novo Nordisk; Eli Lilly; obesity pill; oral semaglutide; orforglipron; weight loss drugs; Wegovy; Zepbound; GLP-1; market competition

Lilly’s Q2 2025 Beat-and-Raise Overshadowed by Orforglipron Data

3 months ago talkbio0Tagged earnings, Eli, Eli Lilly, Expectations, franchise, Glucagon-Like Peptide 1, Obesity, Oral cavity, orforglipron, Q2 2025, regulatory submission, Weight Loss

Eli Lilly; Q2 2025 earnings; orforglipron; oral GLP-1; weight loss; obesity franchise; regulatory submission; analyst expectations

Sarepta Pursues Efficiency Measures Amid $1 Billion Debt Due in 2027

3 months ago talkbio0Tagged 2025, debt, decline, Efficiency, ELEVIDYS, Financial cost, financial results, Financial savings, Measures, Muscular Dystrophy, Duchenne, restructuring, United States Food and Drug Administration

Sarepta Therapeutics; debt 2027; efficiency measures; ELEVIDYS; cost savings; restructuring; financial results 2025; FDA; Duchenne muscular dystrophy; stock decline

Execution, Execution, Execution: Novo’s New CEO Doubles Down on Obesity, Diabetes and Trims Pipeline

3 months ago talkbio0Tagged Diabetes, Glucagon-Like Peptide 1, Incretins, Leadership Change, Market, Maziar Mike Doustdar, Nordisk, Obesity, Ozempic, pipeline, Wegovy

Novo Nordisk; Maziar Mike Doustdar; obesity; diabetes; pipeline cuts; GLP-1 drugs; Wegovy; Ozempic; incretin market; leadership change

XtalPi and DoveTree Announce Landmark $6 Billion AI-Powered Drug Discovery Collaboration

3 months ago talkbio0Tagged Artificial Intelligence, Collaboration, Dosage Forms, DoveTree Medicines, Drug Discovery, Gregory Verdine, Immunology, Metabolic Diseases, milestone payments, Neoplasms, Neurology speciality, Robotics, royalties, upfront payment, XtalPi

XtalPi; DoveTree Medicines; AI drug discovery; robotics; pharmaceutical R&D; Gregory Verdine; oncology; immunology; neurology; metabolic diseases; collaboration; upfront payment; milestone payments; royalties

HHS Ends BARDA Funding for Future mRNA Vaccine Development, Citing Efficacy Concerns

3 months ago talkbio0Tagged BARDA, CHARGE Syndrome, COVID19 (disease), Effectiveness, Influenza, mRNA Vaccines, project cancellation, public health policy, Robert F. Kennedy, Vaccines

mRNA vaccines; BARDA; Robert F. Kennedy Jr.; vaccine efficacy; HHS; COVID-19; flu; project cancellation; public health policy

Novo Nordisk’s Pipeline Cull Prompts Hopes of Strategic Shift

3 months ago talkbio0Tagged competition, GLP-1/GIP co-agonist, Leadership Change, Market, Nordisk, Obesity, pipeline cull, R&D pipeline, semaglutide, strategic shift, Wegovy

Novo Nordisk; pipeline cull; GLP-1/GIP co-agonist; obesity drugs; leadership change; strategic shift; semaglutide; Wegovy; R&D pipeline; market competition

HHS Cancels $500 Million in BARDA-Funded mRNA Vaccine Contracts Amid Strategic Shift

3 months ago talkbio0Tagged BARDA, CHARGE Syndrome, contract cancellation, COVID19 (disease), development aspects, federal funding, Moderna, mRNA Vaccine, Pfizer, Robert F. Kennedy Jr., Seqirus, Vaccines

HHS; BARDA; mRNA vaccine; vaccine development; contract cancellation; Robert F. Kennedy Jr.; COVID-19; federal funding; Moderna; Pfizer; Seqirus