ORG – Page 18 – Talk Bio

GSK set to receive over $500M from mRNA patent settlement tied to BioNTech–CureVac–Pfizer deal

1 month ago talkbio0Tagged BioNTech, BioNTech acquisition, COVID19 (disease), CureVac, global framework, Influenza virus vaccine, Licensing, Litigation, Pfizer, RNA, Messenger, royalties, settlement, SmithKline Beecham, U.S., upfront payment, Vaccines, Vaccines, Combined

GSK; CureVac; BioNTech; Pfizer; mRNA patents; settlement; royalties; COVID-19 vaccine; influenza vaccine; combination vaccines; licensing; upfront payment; US litigation; global framework; BioNTech acquisition of CureVac

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

1 month 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

1 month 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

AbbVie and Genmab Move to Expand Use of T Cell Engager Epkinly Following Strong Phase III Results

1 month ago talkbio0Tagged AbbVie, Antibodies, Bispecific, Approved, Epcoritamab, EPKINLY, expansion, Genmab, Labels (device), lenalidomide, Lymphoma, Follicular, Phase 3 Clinical Trials, rituximab, T-Cell engager, United States Food and Drug Administration

Epkinly; epcoritamab; AbbVie; Genmab; follicular lymphoma; T cell engager; bispecific antibody; Phase III trial; FDA approval; label expansion; Rituximab; Lenalidomide

Assembly Bio Reports Phase 1b Success in Herpes; Gilead Increases Stake with 2.3M Shares

1 month ago talkbio0Tagged ABI-5366, Assembly (construction), Bio, Collaboration, genital lesion reduction, Gilead Sciences, herpesvirus 2, human, safety profile, Simplexvirus, stock purchase, viral shedding

Assembly Bio; Phase 1b trial; ABI-5366; herpes simplex virus (HSV-2); viral shedding reduction; genital lesion reduction; safety profile; Gilead Sciences; collaboration; stock purchase

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

1 month 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

Agentic AI is Here: Real-World Applications in Life Sciences & Healthcare (2025 Update)

1 month ago talkbio0Tagged agentic AI, Automation, Biological Science Disciplines, commercialization, Data Analysis, Health care facility, Pharma, Pharmacovigilance, Precision Medicine, R&D

Agentic AI; life sciences; healthcare; R&D; pharma; personalized medicine; pharmacovigilance; commercialization; automation; data analysis

FDA Launches PreCheck Program to Accelerate Domestic Drug Manufacturing

1 month ago talkbio0Tagged alpha 1-antitrypsin, Construction worker, domestic drug manufacturing, Facility (object), National Security, Pharmaceutical Supply Chain, PreCheck, regulatory streamlining, Trump administration, United States Food and Drug Administration

FDA PreCheck; domestic drug manufacturing; pharmaceutical supply chain; API; regulatory streamlining; facility construction; national security; Trump administration