Clinical Trial News Archive - May 2021
May 3, 2021
- Novavax Initiates Pediatric Expansion for Phase 3 Clinical Trial of COVID-19 Vaccine
- Bristol Myers Squibb Presents New Clinical and Real-World Data on Mavacamten and Obstructive Hypertrophic Cardiomyopathy at Upcoming American College of Cardiology’s 70th Annual Scientific Session
- MAPS’ Phase 3 Trial of MDMA-Assisted Therapy for PTSD Achieves Highly Statistically Significant Results for Patients with Severe, Chronic PTSD
May 4, 2021
May 5, 2021
- New England Journal of Medicine Publishes Phase 2b Clinical Trial Results Demonstrating Efficacy of Novavax COVID-19 Vaccine Against the B.1.351 Variant
- Moderna Announces Positive Initial Booster Data Against SARS-CoV-2 Variants of Concern
May 6, 2021
May 7, 2021
- Imfinzi and Tremelimumab with Chemotherapy Demonstrated Overall Survival Benefit in POSEIDON Trial for 1st-Line Stage IV Non-Small Cell Lung Cancer
- Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine
May 8, 2021
May 10, 2021
May 12, 2021
May 13, 2021
- New Tezepelumab Data Continue To Strengthen Profile For A Broad Population Of Severe Asthma Patients
May 15, 2021
May 17, 2021
- Phase 3 Data Presented at ATS 2021 Show REGEN-COV™ (casirivimab with imdevimab) Reduced Risk of Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patients
- Incyte Announces Positive Results from Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream in Patients with Vitiligo
May 19, 2021
- Reata Announces that The FDA Has Asked The Company to Request a Pre-NDA Meeting for Omaveloxolone for the Treatment of Friedreich’s Ataxia
- Updated Amivantamab and Lazertinib Combination Data Demonstrate Durable Responses and Clinical Activity for Osimertinib-Relapsed Patients with EGFR-Mutated Non-Small Cell Lung Cancer
May 20, 2021
- Lilly's Tirzepatide Achieves All Primary and Key Secondary Study Outcomes Against Insulin Glargine in Adults with Type 2 Diabetes and Increased Cardiovascular Risk in SURPASS-4 Trial
- Merck Announces Positive Topline Results from PNEU-DIRECTION (V114-027) and PNEU-PLAN (V114-024) Phase 3 Pediatric Studies for V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine
May 21, 2021
- AstraZeneca COVID-19 Vaccine Vaxzevria Authorised for Emergency Use in Japan
- U.S. Food & Drug Administration Grants Priority Review of Maribavir for the Treatment of Post-Transplant Recipients With Cytomegalovirus Infection in Those Resistant and/or Refractory to Prior Anti-CMV Treatment
- Ferring and Rebiotix Present Landmark Phase 3 Data Demonstrating Superior Efficacy of Investigational RBX2660 Versus Placebo to Reduce Recurrence of C. difficile Infection
May 22, 2021
May 24, 2021
- Janssen’s Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients with Heavily Pretreated Multiple Myeloma
- Akeso's Penpulimab Monoclonal Antibody Submitted BLA in the United States
- Janssen Presents Updated Data on First-in-Class Talquetamab at ASCO Suggesting Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma
- Boehringer Ingelheim’s BI 425809 for Cognitive Impairment Associated with Schizophrenia Receives FDA Breakthrough Therapy Designation
May 25, 2021
- Acer Therapeutics Plans NDA Submission for ACER-001 in Q3 2021 Following Pre-NDA Meeting with FDA
- Travere Therapeutics Provides Regulatory Update on Sparsentan Development Program for Focal Segmental Glomerulosclerosis
- Travere Therapeutics Provides Regulatory Update on Sparsentan Development Program for Focal Segmental Glomerulosclerosis
- Moderna Announces TeenCOVE Study of its COVID-19 Vaccine in Adolescents Meets Primary Endpoint and Plans to Submit Data to Regulators in Early June
May 26, 2021
- GSK and Vir Biotechnology Announce Sotrovimab (VIR-7831) Receives Emergency Use Authorization from the US FDA for Treatment of Mild-to-Moderate COVID-19 in High-Risk Adults and Pediatric Patients
- Emergent BioSolutions Announces Positive Two-Year Persistence Data From Phase 2 Study Evaluating CHIKV VLP, the Company’s Chikungunya Virus Virus-Like Particle Vaccine Candidate
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