December 13, 2024

FDA Halts Pediatric RSV Vaccine Trials Due to Safety Concerns

6 months ago talkbio0Tagged concerns, pediatric trials, Respiratory syncytial virus, Risk, Safety, United States Food and Drug Administration, Vaccines, VAERD

RSV vaccines, pediatric trials, safety concerns, FDA hold, VAERD risk

Gilead Sciences Appoints Dietmar Berger as Chief Medical Officer to Spearhead R&D Revamp

6 months ago talkbio0Tagged Biotechnology, Chief Medical Officer, Dietmar Berger, Drug Industry, Gilead Sciences, R&D, reSET (device)

Gilead Sciences, Dietmar Berger, Chief Medical Officer, R&D Reset, Biotechnology, Pharmaceutical Industry

FDA Warns of Serious Liver Injury Risk with Ocaliva (Obeticholic Acid) in Patients with Primary Biliary Cholangitis

6 months ago talkbio0Tagged Biliary Cholangitis, Cautionary Warning, Injury of liver, Liver diseases, medication safety, obeticholic acid, Ocaliva, United States Food and Drug Administration

Ocaliva, obeticholic acid, liver injury, FDA warning, primary biliary cholangitis, liver disease, medication safety

Gilead CEO Daniel O’Day Welcomes Former Colleague Dietmar Berger as New Chief Medical Officer

6 months ago talkbio0Tagged Chief Medical Officer, Daniel, Dietmar Berger, Gilead Sciences, Neoplasms, O'Day, sanofi

Daniel O’Day, Gilead Sciences, Dietmar Berger, Sanofi, Chief Medical Officer, Oncology

Avalere Health Appoints Amar Urhekar as New CEO to Drive Strategic Growth

6 months ago talkbio0Tagged Amar Urhekar, Appointments, CEO, Health, healthcare strategic partner, Leadership

Amar Urhekar, Avalere Health, CEO appointment, healthcare strategic partner, leadership transition

Editas Medicine Undergoes Major Restructuring, Laying Off 65% of Staff Including CMO Amid Failed Search for RENI-CEL Partner

6 months ago talkbio0Tagged Anemia, Sickle Cell, Chronic multifocal osteomyelitis, Editas Medicine, Gene Modification, RENI-CEL, restructuring, Thalassemia

Editas Medicine, layoffs, gene editing, biotech, RENI-CEL, sickle cell disease, thalassaemia, CMO, workforce reduction, restructuring.

ICER Report Highlights Unjustified Price Hikes on Five Brand-Name Drugs, Costing U.S. $815 Million in 2023

6 months ago talkbio0Tagged Biktarvy, Cabometyx, CREM gene, Darzalex, drug price, Entresto, Increased, Johnson & Johnson, Novartis, pharmaceutical companies, Prices

ICER, unsupported price increases, drug price hikes, pharmaceutical companies, Gilead Sciences, Johnson & Johnson, Novartis, Biktarvy, Darzalex, Entresto, Cabometyx, Xeljanz.

iTeos Therapeutics Deprioritizes Inupadenant Despite Encouraging Phase 2 Data in NSCLC

6 months ago talkbio0Tagged Adenosine A2A Receptor Antagonist, deprioritization, Inupadenant, iTeos, Non-Small Cell Lung Carcinoma, Phase 2 trial

iTeos Therapeutics, Inupadenant, Adenosine A2A Receptor Antagonist, NSCLC, Phase 2 Trial, Deprioritization

Biotech Industry Prepares for Trump 2.0: Regulatory Changes and M&A Activity Expected

6 months ago talkbio0Tagged biotech industry, Changing, Drug Industry, Health Policy, M&A activity, regulatory environment, Transplant Registry Unified Management Program, United States Food and Drug Administration

Biotech industry, Trump 2.0, FDA changes, M&A activity, regulatory environment, pharmaceutical industry, healthcare policy

Editas Medicine Undergoes Major Restructuring, Cutting 65% of Staff and Halting Sickle Cell Therapy Development

6 months ago talkbio0Tagged Cell Therapy, Clustered Regularly Interspaced Short Palindromic Repeats, Editas Medicine, Gene Modification, Industry, restructuring, sickle

Editas Medicine, layoffs, restructuring, sickle cell therapy, CRISPR gene editing, biotech industry