Gene or Genome – Talk Bio

J&J’s Akeega Advances PARP Inhibition in Prostate Cancer, but FDA Pathway in Broader Patient Subsets Remains Unclear

4 days ago talkbio0Tagged Akeega, Amplitude, Approved, BRCA, HRR gene, Inhibitor, J&J, Malignant neoplasm of prostate, mCSPC, Metastatic castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer, Mutation, PARP1 gene, United States Food and Drug Administration

Akeega; J&J; prostate cancer; PARP inhibitor; FDA approval; BRCA mutations; HRR gene alterations; AMPLITUDE study; metastatic castration-sensitive prostate cancer (mCSPC); metastatic castration-resistant prostate cancer (mCRPC)

AstraZeneca Details Its Oral SERD ‘Switching’ Regimen Amid Feasibility Questions

1 week ago talkbio0Tagged AstraZeneca, camizestrant, CDK4/6 inhibitor, Disease Progression, ESR1 gene, Malignant neoplasm of breast, Mutation, Oral SERD, SERENA-6 trial, treatment resistance

AstraZeneca; oral SERD; camizestrant; breast cancer; ESR1 mutation; SERENA-6 trial; CDK4/6 inhibitor; disease progression; ASCO 2025; treatment resistance

iTeos to Shut Down Operations After TIGIT Therapy Setback

1 week ago talkbio0Tagged asset, belrestotug, Clinical trial failure, ENT1, EOS-215, EOS-984, Exit, Failure (biologic function), immuno-oncology, iTeos, Obesity, Programs - Publication Format, Sales - occupational activity, SmithKline Beecham, TIGIT gene

iTeos Therapeutics; TIGIT failure; GSK exit; clinical trial failure; belrestotug; asset sale; immuno-oncology; EOS-984; EOS-215; ENT1 obesity program

Recent Developments in NLP and Generative AI for Life Sciences and Precision Medicine (2025)

2 weeks ago talkbio0Tagged Biological Science Disciplines, Drug Discovery, Generative AI, Health care facility, language models, multimodal AI, NINL gene, Pharmacovigilance, Precision Medicine, quality management

NLP; Generative AI; life sciences; precision medicine; healthcare; large language models; multimodal AI; quality management; drug discovery; pharmacovigilance

FDA Advisory Committee Unanimously Votes Against Expanding Pfizer’s Prostate Cancer Drug Combo

2 weeks ago talkbio0Tagged Advisory Committees, enzalutamide, expansion, Inhibitor, Labels (device), Malignant neoplasm of prostate, mCRPC, PARP1 gene, Pfizer, talazoparib, Talzenna, unanimous vote, United States Food and Drug Administration

FDA; advisory committee; Pfizer; Talzenna; talazoparib; enzalutamide; prostate cancer; mCRPC; PARP inhibitor; label expansion; unanimous vote

Tourmaline Bio’s Heart Drug Pacibekitug Shows Promise Against Cardiovascular Inflammation, Targets Competition with Novo, CSL

3 weeks ago talkbio0Tagged Cardiovascular system, heart drug, Inflammation, interleukin-6, Markers (device), Nordisk, pacibekitug, Phase 2 trial, SMPX gene, tourmaline, United States Food and Drug Administration

Tourmaline Bio; heart drug; pacibekitug; cardiovascular inflammation; inflammation markers; Novo Nordisk; CSL; Phase 2 trial; FDA; IL-6

Regeneron to Acquire 23andMe Out of Bankruptcy for $256 Million

3 weeks ago talkbio0Tagged Acquisition, Bankruptcy, data privacy, Genetic testing for cancer risk, Genome, personal genome service, Purchased Services, Clinical and Biomedical, Research, Regeneron, total health

Regeneron; 23andMe; acquisition; bankruptcy; genetic testing; genome; personal genome service; total health; research services; data privacy

BioMarin Acquires Inozyme Pharma for $270M, Gaining Phase 3 Rare Disease Therapy

3 weeks ago talkbio0Tagged Acquisition, BioMarin, Deficiency, ENPP1 gene, Enzyme Replacement Therapy, Infrequent, Inozyme, INZ-701, Pharma, Phase 3 clinical trial

BioMarin; Inozyme Pharma; acquisition; rare disease; INZ-701; ENPP1 Deficiency; enzyme replacement therapy; Phase 3 clinical trial

Neurogene Details New Safety Measures After Young Patient’s Death in Rett Syndrome AAV Gene Therapy Trial

3 weeks ago talkbio0Tagged AAVS1 gene, ASGCT, Clinical Trials, Dosage, gene therapy, Individual Adjustment, Lymphohistiocytosis, Hemophagocytic, Measures, MECP2 gene, Neurogene, NGN-401, Rett Syndrome, Safety, United States Food and Drug Administration

Neurogene; AAV gene therapy; Rett syndrome; NGN-401; ASGCT; safety measures; HLH; clinical trial; MECP2 gene; FDA; dose adjustment

Incyte’s Zynyz Secures FDA Approval for Anal Cancer After Previous Rejection

3 weeks ago talkbio0Tagged Approved, Clinical Trials, Combination Drug Therapy, first-line therapy, Immunotherapy, Incyte, Inhibitor, Malignant neoplasm of anus, PDCD1 gene, POD1UM-303, Retifanlimab, United States Food and Drug Administration, Zynyz

Incyte; Zynyz; retifanlimab; FDA approval; anal cancer; PD-1 inhibitor; first-line therapy; immunotherapy; clinical trial; POD1UM-303; combination chemotherapy