Nucleic Acid, Nucleoside, or Nucleotide – Page 2

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

1 month 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

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

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

1 month 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

1 month 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

2 months ago talkbio0Tagged Antisense Oligonucleotides, Aortic Valve Insufficiency, 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

2 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

Flagship’s Sail Biomedicines announces second round of layoffs in 2025

2 months ago talkbio0Tagged CAR-T, eRNA, Flagship, Immunology pipeline, in vivo, layoffs, Pioneering, RNA, Sail Biomedicines

Sail Biomedicines; Flagship Pioneering; layoffs; immunology pipeline; endless RNA; eRNA; in vivo CAR-T; biotech workforce reduction

Sarepta Shifts Focus to siRNA Platform, Lays Off 500 After Elevidys Receives Black Box Warning

2 months ago talkbio0Tagged acute liver injury, black box, Cautionary Warning, ELEVIDYS, gene therapy, layoffs, Muscular Dystrophy, Duchenne, pipeline shift, restructuring, RNA, Small Interfering

Sarepta Therapeutics; siRNA platform; Elevidys; Duchenne muscular dystrophy; layoffs; black box warning; pipeline shift; acute liver injury; gene therapy; restructuring

BioNTech Acquires CureVac to Advance mRNA Cancer Therapies and End Patent Disputes

3 months ago talkbio0Tagged Acquisition, BioNTech, biotech merger, COVID19 (disease), CureVac, Immunotherapy for cancer, Legal patent, Merger, RNA, Messenger, Vaccines

BioNTech; CureVac; mRNA; acquisition; COVID-19 vaccine; cancer immunotherapy; merger; patent dispute; biotech merger