Clinical Trials
Sanofi’s Strategic Acquisition of Principia Bears Fruit with Rilzabrutinib’s Phase III Success
Sanofi, Principia, acquisition, Rilzabrutinib, Phase III, clinical trial, success, strategic investment, pharmaceutical industry, biotechnology, drug development.
Barinthus’ HPV Therapy Demonstrates Safety Yet Falls Short in Efficacy
Barinthus, HPV therapy, safety, efficacy, clinical trials, human papillomavirus, vaccine alternatives
Cerevel Reports Phase 3 Parkinson’s Study Success Amidst AbbVie Acquisition
Cerevel Therapeutics, Phase 3 Parkinson’s disease trial, Tavapadon, AbbVie acquisition, Successful clinical trial results
Detailed PHOENIX Study Reveals Relyvrio’s Failure in ALS Treatment
Relyvrio, PHOENIX study, Amyotrophic Lateral Sclerosis (ALS), Trial failure, Amylyx Pharmaceuticals
FDA Launches CDER Center for Clinical Trial Innovation (C3TI) to Boost Trial Design and Efficiency
FDA, CDER (Center for Drug Evaluation and Research), C3TI (CDER Center for Clinical Trial Innovation), Clinical trial innovation, Efficiency, Drug development, Trial design, Collaboration
Bristol Myers-backed TORL Raises $158M to Advance Antibody-Drug Conjugates (ADCs) in Clinical Trials
Bristol Myers Squibb, TORL, $158M funding, Antibody-Drug Conjugates (ADCs), Clinical Trials
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
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