Body Part, Organ, or Organ Component

CorestemChemon Partners with ATG Lifetech to Expand Organoid and Transcriptomics Capabilities

1 day ago talkbio0Tagged Blood - brain barrier anatomy, CorestemChemon, Drug Discovery, FDA/EMA regulatory pathways, Gene Expression Profiling, heart organoids, Lifetech, liver organoids, lymphocyte immune globulin, anti-thymocyte globulin, Organoids, preclinical CRO, Predictive analytics, Tumorigenicity

CorestemChemon; ATG Lifetech; organoids; transcriptomics; preclinical CRO; drug discovery; predictive analytics; tumorigenicity; FDA/EMA regulatory pathways; liver organoids; heart organoids; blood-brain barrier models

FDA Advisory Committee Votes Against GSK’s Blenrep in Multiple Myeloma

1 week ago talkbio0Tagged Advisory Committees, Clinical Trials, drug safety, Eye, Multiple Myeloma, ODAC, SmithKline Beecham, Toxicity aspects, United States Food and Drug Administration, vote

FDA Advisory Committee; Blenrep; GSK; multiple myeloma; ODAC vote; drug safety; ocular toxicity; clinical trials

FDA Flags Eye Safety Concerns as GSK Seeks Blenrep’s US Return

1 week ago talkbio0Tagged Advisory Committees, Blenrep, Drug Approval, Eye, Eye safety, Multiple Myeloma, relapsed/refractory multiple myeloma, SmithKline Beecham, Toxicity aspects, United States, United States Food and Drug Administration

GSK; Blenrep; FDA; eye safety; ocular toxicity; advisory committee; multiple myeloma; drug approval; United States; relapsed/refractory multiple myeloma

Apple Watch AI Model Enhances Health Predictions Using Behavioral Data

2 weeks ago talkbio0Tagged Aortic Valve Insufficiency, Apple Watch, Behavior, health prediction, Heart, Machine Learning, pregnancy detection, Wearable Behavior Model

Apple Watch; AI model; behavioral data; health prediction; machine learning; Wearable Behavior Model; pregnancy detection; Heart and Movement Study

Deal Roundup: Novartis Options Sironax’s Neuro Platform, Plus Moves from Revolution, Iambic, Sernova, and Eledon

2 weeks ago talkbio0Tagged Blood - brain barrier anatomy, Brain Delivery Module, dealmaking, Eledon, Iambic, Neuroscience discipline, Novartis, Revolution Medicines, Sernova, Sironax

Novartis; Sironax; Brain Delivery Module; neuroscience; blood-brain barrier; biotech; dealmaking; Revolution Medicines; Iambic; Sernova; Eledon

FDA Investigates Patient Deaths Linked to Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

4 weeks ago talkbio0Tagged ELEVIDYS, Evaluation, gene therapy, Liver, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient deaths, regulatory, Toxicity aspects, Unable to walk (finding), United States Food and Drug Administration

FDA; Sarepta; Elevidys; Duchenne muscular dystrophy; gene therapy; patient deaths; acute liver failure; liver toxicity; regulatory investigation; non-ambulatory patients

Senate Drops Orphan Cures Act from Trump’s Tax Bill, Dealing Setback to Biopharma

1 month ago talkbio0Tagged Beak, Big Beautiful Bill, Biopharma, Drugs, Orphan, healthcare legislation, Infrequent, Ira (eukaryote), Mediation, Orphan Cures Act, Prices, reconciliation, Senate, Transplant Registry Unified Management Program

Orphan Cures Act; orphan drugs; Trump tax bill; biopharma; Senate; IRA price negotiations; rare diseases; Big Beautiful Bill; healthcare legislation; reconciliation bill