Functional Concept
Gilead Partners with Xilio Therapeutics for Novel Tumor-Activated IL-12 Program
interleukin-12, Xilio, XTX301, development aspects
Praxis’ Mid-Stage Triumph Propels Advancement of Novel Epilepsy Drug
Praxis Precision Medicines, PRAX-628, Functionally Selective Small Molecule, Hyperexcitable State of Sodium Channels, Adult Focal Onset Epilepsy Treatment, Phase IIa Proof of Concept Study Success, Second Half of 2024 Efficacy Study Planned
Medicare Partially Covers Weight Loss Drugs Amidst High Price Concerns and Future Negotiation Prospects
Medicare, Obesity drugs, Wegovy, Semaglutide, Price negotiation, Affordability, Accessibility, Premium increases, Utilization management
EU Approves Novo Nordisk’s Groundbreaking Once-Weekly Basal Insulin Icodec for Adults with Diabetes
Novo Nordisk, Once-Weekly Insulin Shot, Awiqli, Insulin Icodec, European Medicines Agency (EMA), CHMP Positive Opinion, Type 1 & Type 2 Diabetes Treatment
FDA Greenlights Idorsia’s Aprocitentan (Tryvio) for Resistant Hypertension Patients
FDA approval, Idorsia, Aprocitentan, Tryvio, Resistant hypertension, Endothelin receptor antagonist, Systolic blood pressure, Uncontrolled hypertension, Combination therapy, Clinical trials, PRECISION study, Recommended dosage: 12.5 mg, Availability: Second half of 2024, Edema and fluid retention side effects
Lonza Acquires Roche’s Massive Biologics Production Facility in Vacaville, California for $1.2 Billion
Lonza, Roche, Genentech, Biologics Manufacturing Site, Vacaville/ California, $1.2 Billion Deal, Large-Scale Commercial Mammalian Products, Expansion Plans ($561 Million), Capacity Utilization, Contract Development and Manufacturing Organizations (CDMOs), Global Biologics Market Growth
Crinetics’ Paltusotine Demonstrates Success in Second Phase III Trial for Oral Acromegaly Treatment, Prepares for FDA Filing
Crinetics Pharmaceuticals, Paltusotine, Acromegaly, Phase III trials, FDA submission, Oral treatment, Symptom reduction
Boehringer Ingelheim and Sosei Sign Potential $732 Million Collaboration for Schizophrenia Treatment
Boehringer Ingelheim, Sosei, Schizophrenia Treatment, Partnership, $732 Million Deal, GPR52 Targeting Portfolio
FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review
Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.
Amylyx’s ALS Treatment Relyvrio Disappoints in Phase III PHOENIX Study, Company Considering Market Withdrawal
Amylyx, Relyvrio, ALS, Failure, Phase III PHOENIX Study, Market Withdrawal, Clinical Trial, Placebo, No Statistical Significance