Clinical Trial News Archive - June 2021
June 1, 2021
- Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
- Biogen and Bio-Thera Announce Positive Results From Phase 3 Study of BAT1806, a Proposed Biosimilar Referencing Actemra (tocilizumab)
- Moderna Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S. FDA for the Moderna COVID-19 Vaccine
- Pfizer Initiates Study Exploring Coadministration of Its 20-valent Pneumococcal Conjugate Vaccine Candidate Along With a Third Dose of the Pfizer-BioNTech COVID-19 Vaccine in Older Adults
June 2, 2021
June 3, 2021
- Karyopharm Announces Xpovio (selinexor) Is Now Available in Additional Strength Tablets
- FDA Grants Priority Review for New Drug Application for Oleogel-S10 for the Treatment of Epidermolysis Bullosa
June 4, 2021
- Novartis Investigational Checkpoint Inhibitor Tislelizumab Met Primary Endpoint of Overall Survival in Pivotal Phase III Trial of Esophageal Cancer After Systemic Therapy
- FDA Authorizes Lower 1,200 mg Intravenous and Subcutaneous Dose of REGEN-COV™ (casirivimab and imdevimab) Antibody Cocktail to Treat Patients with COVID-19
June 9, 2021
June 10, 2021
- Johnson & Johnson Statement on FDA Approval of Shelf Life Extension for Company’s COVID-19 Vaccine
- Moderna Files for Emergency Use Authorization for its COVID-19 Vaccine in Adolescents in the United States
June 11, 2021
- Novavax Announces Positive Data from Three Complementary Studies of COVID-19 Beta (B.1.351) Variant Strain Vaccine
- Novartis Investigational Oral Therapy Iptacopan (LNP023) Shows Benefit as Monotherapy in Treatment-Naïve Patients with Rare and Life-Threatening Blood Disorder Paroxysmal Nocturnal Hemoglobinuria
June 14, 2021
- U.S. Clinical Trial Results Show Novavax Vaccine is Safe and Prevents COVID-19
- Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial
- Novavax Announces Positive Results from First Study of Influenza Vaccine and COVID-19 Vaccine Candidate Administered Simultaneously
June 15, 2021
- Sage Therapeutics and Biogen Announce Positive Pivotal Phase 3 Results for Zuranolone, an Investigational Two-Week, Once-Daily Therapeutic Being Evaluated for Major Depressive Disorder
- Update on AZD7442 STORM CHASER Trial in Post-Exposure Prevention of Symptomatic COVID-19
- COVID-19 Vaccine AstraZeneca Effective Against Delta (‘Indian’) Variant
June 16, 2021
June 21, 2021
- Tarsus Pharmaceuticals, Inc. Announces Positive Results of Saturn-1 Pivotal Trial Evaluating TP-03 for the Treatment of Demodex Blepharitis
- GSK and Vir Biotechnology Announce Continuing Progress of the COMET Clinical Development Programme for Sotrovimab
- CytoDyn Inc. Announces Positive Preliminary Results of Unblinded Data from Long-Haulers Trial Showing Greater Improvement in Leronlimab Group over Placebo in 18 of 24 Symptoms
June 23, 2021
- Biogen and Eisai Update for the Alzheimer’s Disease Community
- Eisai and Biogen Inc. Announce U.S. FDA Grants Breakthrough Therapy Designation for Lecanemab (BAN2401), an Anti-Amyloid Beta Protofibril Antibody for the Treatment of Alzheimer's Disease
June 24, 2021
- Genentech’s Actemra Receives FDA Emergency Use Authorization for the Treatment of COVID-19 In Hospitalized Adults and Children
- Lilly's Donanemab receives U.S. FDA's Breakthrough Therapy Designation for Treatment of Alzheimer's disease
- Treatment With Hepcludex (bulevirtide) Was Shown to Achieve Significant Response in Chronic Hepatitis Delta Virus After 24 Weeks
June 25, 2021
- Orphalan Announces Positive Top Line Data with Trientine Tetrahydrochloride for Maintenance Patients with Wilson’s Disease
- Lilly's SURPASS-2 Results Published in The New England Journal of Medicine Show Tirzepatide Achieved Superior A1C and Body Weight Reductions Compared to Injectable Semaglutide in Adults with Type 2 diabetes
June 26, 2021
June 28, 2021
- Nirsevimab MEDLEY Phase II/III Trial Demonstrated Favourable Safety and Tolerability Profile in Infants at High Risk of RSV
- Vaxzevria Induced Immunity for at Least One Year Following a Single Dose and Strong Immune Responses Following Either a Late Second Dose or a Third Dose
June 30, 2021
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