Gene or Genome – Page 2

CSL Announces Vaccine Unit Spin-Off and Major Workforce Cuts

3 weeks ago talkbio0Tagged cost-cutting, demerger, Seqirus, SMPX gene, strategic restructuring, Vaccines

CSL; Seqirus; vaccine spin-off; workforce reduction; demerger; strategic restructuring; biotech; cost-cutting

FDA Extends PDUFA Date for Regenxbio’s Hunter Syndrome Gene Therapy RGX-121

3 weeks ago talkbio0Tagged clemidsogene lanparvovec, Deferred, gene therapy, IDS gene, Infrequent, Mucopolysaccharidosis II, PDUFA, Regenxbio, RGX-121, United States Food and Drug Administration

FDA delay; PDUFA extension; Regenxbio; Hunter syndrome; clemidsogene lanparvovec; RGX-121; gene therapy; Mucopolysaccharidosis II; IDS gene; rare disease

Insmed Secures FDA Approval for First DPP1 Inhibitor in Lung Disease

4 weeks ago talkbio0Tagged Approved, brensocatib, Brinsupri, Bronchiectasis, CTSC gene, Inhibitor, Insmed, Lung diseases, United States Food and Drug Administration

Insmed; FDA approval; DPP1 inhibitor; Brensocatib; Brinsupri; bronchiectasis; lung disease

Insmed’s Brinsupri Receives First-Ever FDA Approval for Progressive Lung Disease

4 weeks ago talkbio0Tagged Approved, brensocatib, Brinsupri, Bronchiectasis, CTSC gene, Inhibitor, Insmed, Lung diseases, neutrophil-mediated disease, non-cystic fibrosis bronchiectasis, Progressive, United States Food and Drug Administration

Brinsupri; Insmed; FDA approval; non-cystic fibrosis bronchiectasis; bronchiectasis; DPP1 inhibitor; brensocatib; progressive lung disease; neutrophil-mediated disease; first-in-class

Bayer Expands Oncology Pipeline with $1.3B Kumquat Deal

4 weeks ago talkbio0Tagged Approved, Bayer, Cancer Therapeutic Procedure, commercialization, G12D inhibitor, K-ras Oncogene, Kumquat Biosciences, milestone payments, Oncology Pipeline, precision oncology, United States Food and Drug Administration

Bayer; Kumquat Biosciences; oncology pipeline; KRAS G12D inhibitor; FDA approval; cancer therapy; precision oncology; commercialization; milestone payments

HHS ousts MAHA implementation lead amid rushed cancellations of $500M in mRNA vaccine contracts

1 month ago talkbio0Tagged BARDA, CHARGE Syndrome, Contract agreement, Gray Delany, MAHA, Moderna, mRNA contracts, Pfizer, Policy, Robert F. Kennedy, Seqirus, Shakeup, SMPX gene, Staff, terminations, Vaccines

HHS; MAHA; Gray Delany; mRNA contracts; BARDA; Robert F. Kennedy Jr.; vaccine policy; contract terminations; Moderna; Pfizer; CSL Seqirus; staff shakeup

Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay

1 month ago talkbio0Tagged Application procedure, dosing, Eylea HD, IL31RA gene, Interval, PDUFA, Regeneron, Retinal Diseases, Supplement, United States Food and Drug Administration

Regeneron; Eylea HD; CRL; FDA; PDUFA; supplemental Biologics License Application; dosing intervals; retinal diseases

Madrigal Pharmaceuticals Inks up to $2B Deal with CSPC for Preclinical Oral GLP-1, Plans Combination with Rezdiffra for MASH

1 month ago talkbio0Tagged Combined Modality Therapy, global license agreement, GZMH gene, Madrigal Pharmaceuticals, MASH, milestone payments, oral small molecule, Pharmaceutical Group, preclinical drug, Product containing glucagon-like peptide 1 receptor agonist (product), Rezdiffra

Madrigal Pharmaceuticals; CSPC Pharmaceutical Group; GLP-1 receptor agonist; SYH2086; Rezdiffra; MASH; oral small molecule; preclinical drug; global license agreement; combination therapy; milestone payments

RFK Jr. Reportedly Weighs Preventive Services Panel Revamp, Raising Risks for HIV PrEP Drugmakers

1 month ago talkbio0Tagged Advisory Committees, drugmakers, health disparity, HIV Prevention, Insurance, PREP gene, preventive services panel, public health policy, revamp, RFK Jr., USPSTF

RFK Jr.; preventive services panel; USPSTF; PrEP; HIV prevention; insurance coverage; public health policy; drugmakers; health disparities; revamp; task force

Rethinking Clinical Trial Data in the Era of Decentralization: Key Trends and Challenges (2025)

1 month ago talkbio0Tagged Aortic Valve Insufficiency, Clinical Trials, Data Integration, Data Quality, DCT gene, decentralized, Diversity, Preventive monitoring, regulatory guidance, Remote, risk-based oversight, trials

decentralized clinical trials; DCT; data quality; patient diversity; remote monitoring; AI in trials; data integration; risk-based oversight; clinical trial data; regulatory guidance