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
- Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma
- Amgen and Kyowa Kirin to Jointly Develop and Commercialize KHK4083, a Phase 3-Ready, Potential First-In-Class Treatment for Atopic Dermatitis
- 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
- Anifrolumab Showed Benefit Across Different Measures of Skin and Joint Disease Activity in Patients with Systemic Lupus Erythematosus
- Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for BI 456906 for NASH
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
- Valneva Completes Phase 3 Trial Recruitment for its Inactivated COVID-19 Vaccine Candidate
June 4, 2021
- Sanofi Partnering with Leading Academic Cooperative Groups to Study Amcenestrant in the Adjuvant Setting for Patients with Estrogen Receptor Positive Breast Cancer
- Novartis Investigational Checkpoint Inhibitor Tislelizumab Met Primary Endpoint of Overall Survival in Pivotal Phase III Trial of Esophageal Cancer After Systemic Therapy
- Phase 2 Fight Trial Continues To Show Improved Overall Survival With Bemarituzumab Plus Chemotherapy In Patients With FGFR2b+ Gastric And Gastroesophageal Cancers
- 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 8, 2021
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
- Acer Therapeutics Plans Clinical Trial for Edsivo (celiprolol) Following Type B FDA Meeting
June 11, 2021
- New Pivotal Data at EHA 2021 Reinforces Sutimlimab as a First-in-Class Investigational C1s Inhibitor with the Potential to be the First Approved Treatment for Hemolysis in People with Cold Agglutinin Disease
- 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
- GSK and iTeos Therapeutics Announce Development and Commercialisation Collaboration for EOS-448, an anti-TIGIT Monoclonal Antibody, Enabling Novel Next-Generation Immuno-Oncology Combinations
- 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
- Axsome Therapeutics Announces Planned NDA Submission for AXS-14 for the Management of Fibromyalgia
- COVID-19 Vaccine AstraZeneca Effective Against Delta (‘Indian’) Variant
June 16, 2021
- Biogen Announces Topline Results From Phase 2 Study of Gosuranemab, an Anti-Tau Antibody, for Alzheimer’s Disease
- CureVac Provides Update on Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV
- REGEN-COV™ (casirivimab and imdevimab) Phase 3 RECOVERY Trial Meets Primary Outcome, Improving Survival in Hospitalized COVID-19 Patients Lacking an Immune Response to SARS-CoV-2
June 17, 2021
June 21, 2021
- Theravance Biopharma, Inc. Announces Top-Line Results From Phase 2 Study of Nezulcitinib In Patients Hospitalized With Acute Lung Injury Due to COVID-19
- 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 22, 2021
- Xentria Announces the Initiation of a Clinical Trial for XTMAB-16 for the Treatment of Sarcoidosis
- Dicerna Initiates Patient Dosing in ESTRELLA Phase 2 Clinical Trial of Belcesiran for the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease
- Emalex Biosciences Announces Completion of Patient Enrollment in Phase 2b Clinical Trial Evaluating Ecopipam (EBS-101) for Pediatric Patients with Tourette Syndrome
June 23, 2021
- Seal Rock Therapeutics Announces Initiation of Phase 1 Clinical Trial of ASK1 Inhibitor SRT-015 for NASH
- 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
- Resolve Therapeutics Receives FDA Approval to Initiate Phase 2 Clinical Trial of RSLV-132 in Long Covid Patients
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
- Veru Enrolls First Patient in Phase 3 VERACITY Clinical Trial of Sabizabulin (VERU-111) in Metastatic Castration Resistant and Androgen Receptor Targeting Agent Resistant Prostate Cancer
- 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
- Intellia and Regeneron Announce Landmark Clinical Data Showing Deep Reduction in Disease-Causing Protein After Single Infusion of NTLA-2001, an Investigational CRISPR Therapy for Transthyretin (ATTR) Amyloidosis
- Lilly's SURPASS-1 Results Published in The Lancet Show Tirzepatide's Superior A1C and Body Weight Reductions Versus Placebo in Adults with Type 2 Diabetes
June 27, 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 29, 2021
June 30, 2021
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