Gene or Genome – Page 6

Bayer Expands Oncology Pipeline with $1.3B Kumquat Deal

4 months 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

4 months 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

5 months 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

5 months 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

5 months 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)

5 months ago talkbio0Tagged Artificial Intelligence, 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

Avalyn Pharma Raises $100M to Advance Inhaled Lung Disease Drugs

5 months ago talkbio0Tagged AP01, AP02, aspects of adverse effects, Avalyn, Clinical Trials, drug safety, Holdings, inhaled lung disease, nintedanib, Pharma, pirfenidone, Pulmonary Fibrosis, Series D, SNCG gene, Suvretta Capital Management

Avalyn Pharma; $100 million Series D; inhaled lung disease medications; pulmonary fibrosis; AP01; AP02; pirfenidone; nintedanib; clinical trials; drug safety; side effects; Suvretta Capital Management; SR One; Novo Holdings

Sarepta Reports Third Patient Death in Gene Therapy Studies for Limb-Girdle Muscular Dystrophy

5 months ago talkbio0Tagged AAVS1 gene, ELEVIDYS, gene therapy, Liver Failure, Acute, Muscular Dystrophies, Limb-Girdle, Patient Death, Safety, Study on Hold, United States Food and Drug Administration, vector

Sarepta Therapeutics; limb-girdle muscular dystrophy; SRP-9004; gene therapy; patient death; acute liver failure; FDA clinical hold; AAV vector; Elevidys; safety concerns

Kowa Secures Expanded Rights to Nicox’s Glaucoma Drug NCX 470 in Major Global Deal

5 months ago talkbio0Tagged Clinical Trials, Denali, Glaucoma, Kowa, licensing agreement, milestone payments, naproxen-n-butyl nitrate, Ophthalmology specialty, royalties, TLX2 gene

Kowa; Nicox; NCX 470; glaucoma; exclusive rights; licensing agreement; Denali clinical trial; ophthalmology; royalties; milestone payments

RFK Jr. Removes Top HHS Aides in Major Leadership Shakeup

5 months ago talkbio0Tagged Buckham, chief of, Hannah Anderson, Health, Heather Flick Melanson, Leadership, Policy, reshuffle, RFK Jr., Shakeup, Social Welfare, Staff, TMEM79 gene, Trump loyalists

RFK Jr.; Health and Human Services; leadership reshuffle; chief of staff; Matt Buckham; Heather Flick Melanson; Hannah Anderson; Trump loyalists; policy shakeup