September 20, 2024

Navigating Complex Regulatory Landscapes: The Importance of External Support for Biotech Sponsors in IRB, IBC, DMCs, and EACs

7 months ago talkbio0Tagged 6-aminocaproic acid, Biotech sponsors, Clinical Trials, Clinical Trials Data Monitoring Committees, DMCs, Ethics Advisory Committees, Ethics Committees, Research, gene therapy, IBC, Institutional Biosafety Committee, Regulatory Compliance, research, Risk Management

Biotech sponsors, IRB (Institutional Review Board), IBC (Institutional Biosafety Committee), DMCs (Data Monitoring Committees), EACs (Ethics Advisory Committees), Regulatory compliance, Clinical trials, Gene therapy research, Risk management

Gilead Partners with Yuhan for $81M HIV Drug Ingredient Supply Deal

7 months ago talkbio0Tagged Gilead Sciences, HIV drug ingredients, pharmaceutical partnership, Yuhan

Gilead Sciences, Yuhan, HIV drug ingredients, $81M deal, pharmaceutical partnership

Gilead’s Kite Terminates China Cell Therapy Joint Venture with Fosun Pharma

7 months ago talkbio0Tagged CAR-T, Cell Therapy, China, Fosun Pharma, Gilead Sciences, Joint Ventures, Kite Pharma, Yescarta

Gilead Sciences, Kite Pharma, Fosun Pharma, cell therapy, joint venture, China, CAR-T therapy, Yescarta

Edgewise Therapeutics Sees 50% Stock Surge Following Positive Safety Data for Heart Disease Drug EDG-7500

7 months ago talkbio0Tagged Camzyos Rival, Cardiomyopathies, EDG-7500, Edgewise Therapeutics, Heart Disease, Safety, Stock Surge

Edgewise Therapeutics, EDG-7500, Heart Disease, Cardiomyopathy, Stock Surge, Safety Data, Camzyos Rival

Pioneers in Obesity Treatment: Lasker Award Honors Scientists Behind GLP-1 Drugs

7 months ago talkbio0Tagged Glucagon-Like Peptide 1, Habener, Lasker Award, Lotte Bjerre Knudsen, Medical Research activity, Mojsov, Obesity

Lasker Award, GLP-1 drugs, obesity treatment, Joel Habener, Svetlana Mojsov, Lotte Bjerre Knudsen, medical research, pharmaceuticals.

Novo Nordisk’s CB1 Drug Monlunabant Shows Weight Loss Potential, but Raises Efficacy and Safety Concerns

7 months ago talkbio0Tagged concerns, Effectiveness, monlunabant, neuropsychiatric side, Nordisk, Obesity, Receptor, Cannabinoid, CB1, Safety

Novo Nordisk, Monlunabant, CB1 receptor, obesity treatment, weight loss, efficacy, safety concerns, neuropsychiatric side effects

FDA Approves Rybrevant for Third NSCLC Indication This Year

7 months ago talkbio0Tagged Approved, Epidermal Growth Factor Receptor, J&J, Malignant neoplasm of lung, Mutation, Non-Small Cell Lung Carcinoma, Rybrevant, United States Food and Drug Administration

Rybrevant, NSCLC, FDA approval, J&J, EGFR mutations, lung cancer treatment

Vanda Pharmaceuticals Receives FDA Rejection for Gastroparesis Treatment, Criticizes Agency’s Decision

7 months ago talkbio0Tagged conclusory, Gastroparesis, refusal, Rejection (Psychology), Tradipitant, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals, FDA rejection, gastroparesis treatment, tradipitant, conclusory refusal

Organon Expands Dermatology Portfolio with $1.2B Acquisition of Dermavant and VTAMA Cream

7 months ago talkbio0Tagged Acquisition (action), Dairy Cream, Dental Plaque, Dermatitis, Atopic, Dermatology field, Dermavant, Organon, Psoriasis, steroid-free skin cream, Vtama

Organon, Dermavant, VTAMA cream, dermatology, acquisition, steroid-free skin cream, plaque psoriasis, atopic dermatitis

Aligos Therapeutics’ HERALD Study Shows Promising MASH Treatment Results, Yet Fails to Impress Investors

7 months ago talkbio0Tagged ALG-055009, Aligos, Clinical Research, HERALD, investor, Liver, MASH, phase 2a

Aligos Therapeutics, HERALD study, MASH treatment, ALG-055009, liver fat reduction, Phase 2a results, investor reaction.