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
- INOVIO's Pan-COVID-19 Vaccine Candidate (INO-4802) Induces Broad Immunity Against Major Viral Variants in Preclinical Studies
- Moderna Announces New Supply Agreement with Australia for 25 Million Doses of its COVID-19 Vaccine
May 13, 2021
- New Tezepelumab Data Continue To Strengthen Profile For A Broad Population Of Severe Asthma Patients
- Second-Generation COVID-19 Vaccine Candidate, CV2CoV, Demonstrates High Immunogenicity Against Virus Variants in Preclinical Study
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
- Sanofi and GSK COVID-19 Vaccine Candidate Demonstrates Strong Immune Responses Across all Adult Age Groups in Phase 2 Trial
- Incyte Announces Positive Results from Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream in Patients with Vitiligo
- AffyImmune Therapeutics' AIC100 Granted Fast Track Designation for Treating Thyroid Cancer
May 18, 2021
- Medicago and GSK Announce Positive Interim Phase 2 Results for Adjuvanted COVID-19 Vaccine Candidate
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
- MEI Pharma and Kyowa Kirin Announce New Clinical Data on Zandelisib at American Society of Clinical Oncology Annual Meeting 2021
- Veru Enrolls First Patient in Phase 3 Clinical Trial of Sabizabulin (VERU-111) in High Risk Hospitalized COVID-19 Patients
- Updated Amivantamab and Lazertinib Combination Data Demonstrate Durable Responses and Clinical Activity for Osimertinib-Relapsed Patients with EGFR-Mutated Non-Small Cell Lung Cancer
- Valneva to Participate in the World’s First COVID-19 Vaccine Booster Trial in the UK
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
- Positive Results from Investigator-Initiated Phase II Clinical Study of Remetinostat in Patients with Squamous Cell Carcinoma Published
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
- PharmaTher Files for FDA Orphan Drug Designation for Ketamine to Treat Lou Gehrig’s Disease
- Eyenovia Announces Positive Topline Results from VISION-1 Phase 3 Clinical Study of MicroLine for the Treatment of Presbyopia
- 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
- GlycoMimetics Announces Investigator-Sponsored Phase 2 Clinical Trial Evaluating Uproleselan for Prevention of Gastro-Intestinal Toxicity in Autologous Hematopoietic Cell Transplantation
- 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
May 27, 2021
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