Nucleic Acid, Nucleoside, or Nucleotide – Page 4

NIH and HHS Cancel Major mRNA Vaccine Research Funding, Citing Lack of Public Trust

4 months ago talkbio0Tagged BARDA, COVID19 (disease), grant cancellation, Jay Bhattacharya, mRNA Vaccine, NIH Mouse, public trust, research funding, RFK Jr., Vaccination Hesitancy

NIH; mRNA vaccine; public trust; research funding; BARDA; COVID-19; vaccine hesitancy; RFK Jr.; Jay Bhattacharya; grant cancellation

Novartis antibody ianalumab clinches another Phase 3 win in rare blood disease (ITP)

4 months ago talkbio0Tagged Autoimmune, Autoimmune thrombocytopenia, B-cell depletion, ianalumab, Infrequent, Inosine Triphosphate, Novartis, Phase 3, platelet levels, Psychological inhibition, regulatory submissions, Sjögren 's disease, TNFRSF13C protein, human, treatment failure, VAY736

Novartis; ianalumab; VAY736; primary immune thrombocytopenia; ITP; rare disease; Phase 3; time to treatment failure; safe platelet levels; eltrombopag; autoimmune; B-cell depletion; BAFF-R inhibition; Sjögren’s disease; regulatory submissions

Bayer-allied NextRNA Therapeutics winds down operations after missing a milestone in their collaboration

4 months ago talkbio0Tagged Bayer, Dana-Farber, Funding, Long Intergenic Non-Protein Coding RNA, Massachusetts biotech, missed milestone, Neoplasms, NextRNA, Series, shutdowns

NextRNA Therapeutics; Bayer; lncRNA; long non-coding RNA; oncology; biotech wind-down; missed milestone; Massachusetts biotech; seed and Series A funding; Dana-Farber; Carl Novina; 2025 biotech shutdowns

FDA restricts bluebird bio’s Skysona to CALD patients without suitable stem cell donors after higher blood cancer risk emerges

4 months ago talkbio0Tagged boxed, CALD, Cautionary Warning, Cerebral Adrenoleukodystrophy, Donor person, Elivaldogene autotemcel, gene therapy, Hematologic Neoplasms, HLA Match, label update, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, Safety, Skysona, United States Food and Drug Administration

FDA; bluebird bio; Skysona; elivaldogene autotemcel; eli-cel; cerebral adrenoleukodystrophy; CALD; hematologic malignancies; myelodysplastic syndrome (MDS); acute myeloid leukemia (AML); boxed warning; label update; postmarketing safety; HLA-matched donor; gene therapy safety

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

4 months 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

4 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

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

4 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

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

4 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

Biogen Pledges $2 Billion Manufacturing Investment in North Carolina

5 months ago talkbio0Tagged Antisense Oligonucleotides, Artificial Intelligence, Automation, Biogen, Biotechnology, expansion, gene therapy, Investments, Manufacturing, North Carolina, Research Triangle Park

Biogen; manufacturing investment; North Carolina; Research Triangle Park; biotechnology; antisense oligonucleotides; gene therapy; automation; AI; expansion

FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

5 months ago talkbio0Tagged Accelerated, Approved, Columvi, Complete, Diffuse Large B-Cell Lymphoma, gemcitabine, genentech, oxaliplatin, Rejection, Response Letter, Roche (company), second, second-line treatment, STARGLO, Third line treatment, United States Food and Drug Administration

FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy