Functional Concept
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
Brukinsa by BeiGene Secures FDA Approval for Follicular Lymphoma Amid Imbruvica Setbacks
Brukinsa (zanubrutinib), BeiGene, FDA approval, follicular lymphoma, accelerated approval, obinutuzumab (Gazyva) combination therapy, ROSEWOOD trial, overall response rate (ORR), disease progression or unacceptable toxicity, competition with CAR-T cell therapies/ bispecific antibodies
FDA Greenlights Opdivo Combination Therapy for First-Line Bladder Cancer Treatment
Overall Survival, Combined, cisplatin, Opdivo
Boehringer Ingelheim Caps Out-of-Pocket Costs for Asthma and COPD Inhalers in the U.S.
Boehringer Ingelheim, Out-of-pocket costs, Asthma, COPD, Inhalers, $35 cap, June 1/ 2024, Uninsured and under-insured patients, List price reduction