Clinical Trial News Archive - November 2021
November 1, 2021
- Bionomics Receives FDA Clearance of IND for Evaluation of BNC210 in a Phase 2 Social Anxiety Disorder PREVAIL Study
- Janssen Announces Extension of U.S. FDA BLA PDUFA Date for BCMA CAR-T Ciltacabtagene Autoleucel
- Novavax Files for COVID-19 Vaccine Authorization with Health Canada and Completes Submission for Rolling Review to European Medicines Agency
- Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia
November 2, 2021
- Ionis initiates pivotal Phase 3 clinical study of olezarsen in patients with severe hypertriglyceridemia
- Filament Health Announces FDA Authorization of Clinical Trial with First-ever Direct Psilocin Administration and First-ever Psychedelic Botanical Drug Candidates
November 3, 2021
- Natera Validates Prospera With Quantification in Multi-Site, Prospective Trifecta Study
- Novavax Files COVID-19 Vaccine for Provisional Approval in New Zealand
November 4, 2021
- US Food and Drug Administration Declines Emergency Use Authorization for Zyesami (aviptadil) for Patients with Critical COVID-19 with Respiratory Failure
- Montefiore-Einstein Researchers Test Whether Molnupiravir Can Prevent COVID-19
- Amylyx Pharmaceuticals Announces Participants Dosed in the Global Phase 3 PHOENIX Study of AMX0035 in ALS
- Novartis Iptacopan Meets Primary Endpoints in Phase II Study in Rare Kidney Disease C3 Glomerulopathy (C3G)
- Novavax Files COVID-19 Vaccine for Emergency Use Listing with World Health Organization
- Merck and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, Receives Authorization in the U.K.
November 5, 2021
- GSK Announces Positive Phase III Efficacy and Safety Data for Daprodustat in Patients with Anemia Due to Chronic Kidney Disease
- Pfizer’s Covid-19 Oral Antiviral Treatment Paxlovid Reduces Risk of Hospitalization and Death
November 8, 2021
- Diamond Therapeutics Announces First Patient Dosed in Clinical Trial Evaluating Low-Dose Psilocybin
- New Phase 3 Analyses Show That a Single Dose of REGEN-COV® (casirivimab and imdevimab) Provides Long-term Protection Against COVID-19
November 9, 2021
- Moderna Files to Expand the Conditional Marketing Authorization for its COVID-19 Vaccine in the European Union to Include Children Ages 6-11 Years
- Merck and Ridgeback Announce U.S. Government to Purchase 1.4 Million Additional Courses of Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults
- INOVIO Receives U.S. FDA Authorization to Proceed with INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800, in the U.S.
- Amylyx Pharmaceuticals Announces Results from PEGASUS Trial of AMX0035 in Alzheimer’s Disease at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference
- Iterion Therapeutics Announces Initiation of Phase 1/2 Clinical Trial to Study Tegavivint in Pediatric Cancers
November 10, 2021
- SOFIE gets greenlight from U.S. FDA to proceed to Phase II Pancreatic Cancer Study
- Everest Medicines and Gilead Sciences Jointly Announce Phase 2b Study of Sacituzumab Govitecan Conducted in China of Patients With Metastatic Triple-Negative Breast Cancer Meets Primary Overall Response Rate Endpointc
- Valneva Announces European Commission Approval of Advance Purchase Agreement for up to 60 Million Doses of Inactivated COVID-19 Vaccine VLA2001
November 11, 2021
- Elevar Therapeutics Receives Orphan Drug Designation from FDA for Rivoceranib for the Treatment of Hepatocellular Carcinoma (HCC)
- Allarity Therapeutics’ Oral PARP Inhibitor, Stenoparib, Demonstrates Pre-clinical Antiviral Activity Against Delta Variant of Coronavirus
- Developing Alzheimer's Symptoms Will Be Used In Clinical Trial Aiming To Prevent Memory Loss
November 12, 2021
- LUMYKRAS (sotorasib) Receives Positive Opinion From EMA CHMP For Patients With KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer
- Primary Endpoint Met in COMET-TAIL Phase III Trial Evaluating Intramuscular Administration of Sotrovimab for Early Treatment of COVID-19
November 15, 2021
- BioArctic develops new antibody treatment for ALS
- Moderna Announces Positive Data from Phase 2 Study of mRNA VEGF-A Therapeutic in Patients Undergoing Coronary Artery Bypass Grafting Surgery
- AZD8601 EPICCURE Phase II Trial Demonstrated Safety and Tolerability in Patients with Heart Failure
- Health Canada Authorizes Booster Dose of Moderna’s COVID-19 Vaccine in Individuals 18 Years of Age and Older
- Late-Breaking Phase 2 Data for Investigational Oral Factor XIa Inhibitor Milvexian Suggest Favorable Antithrombotic Profile Across a Wide Range of Doses
November 16, 2021
- Viatris and Biocon Biologics Announce Launch of Interchangeable SEMGLEE (insulin glargine-yfgn) Injection and Insulin Glargine (insulin glargine-yfgn) Injection
- Pfizer Seeks Emergency Use Authorization for Novel COVID-19 Oral Antiviral Candidate Paxlovid
November 17, 2021
- Unique glioblastoma treatment sees encouraging early results during phase 1 clinical trials
- Update on Regulatory Review of Aducanumab in the European Union
- Novavax Confirms European Medicines Agency Review of COVID-19 Vaccine Filing for Conditional Marketing Authorization
- ORYZON Enrolls First Patient in EVOLUTION, a Phase IIb Clinical Trial with Vafidemstat in Schizophrenia
November 18, 2021
- U.S. Food and Drug Administration Approves Longeveron’s Lomecel-B for Rare Pediatric Disease Designation to Treat Life-Threatening Infant Heart Condition
- Reata Pharmaceuticals Receives Fast Track Designation From the FDA for Omaveloxolone for the Treatment of Friedreich’s Ataxia
- The Lancet Neurology Publishes Pivotal Phase 3 PROPEL Study Results of AT-GAA in Late-Onset Pompe Disease
- Tryp Therapeutics Provides Update on Clinical Hold for Phase 2a Study for Eating Disorders
- Merck Provides Update on Phase 2 Clinical Trial of Once-Weekly Investigational Combination of MK-8507 and Islatravir for the Treatment of People Living with HIV-1
- Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed FLT3-ITD Positive AML
- Novavax Statement on Publication of Positive Results from First Study of Co-administered COVID-19 and Influenza Vaccines
- Moderna Announces First Participant Dosed in Phase 2/3 Study of its mRNA Respiratory Syncytial Virus (RSV) Vaccine
- TROPION-Breast01 Phase 3 Trial of Datopotamab Deruxtecan Initiated in Patients with Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
- New Analyses of Two AZD7442 COVID-19 Phase III Trials in High-Risk Populations Confirm Robust Efficacy and Long-Term Prevention
- Ionis Initiates Phase 3 Clinical Program of Donidalorsen in Patients with Hereditary Angioedema
November 19, 2021
- Moderna Announces FDA Authorization of Booster Dose of COVID-19 Vaccine in the U.S. for Adults 18 Years and Older
- Pfizer and BioNTech Receive Expanded U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster to Include Individuals 18 and Older
- Repurposed ALS Drug Shows Promise in Mouse Model of Rare Childhood Genetic Disorder
November 21, 2021
November 22, 2021
- SyneuRx Announces Oral COVID-19 Twindemic Antiviral Drug Candidate Pentarlandir Has Entered Final Portion of FDA Phase II Testing
- Provention Bio Provides Regulatory Update for Teplizumab At-Risk Type 1 Diabetes Approval Pathway
- REGENXBIO Announces Orphan Drug Designation Granted To RGX-202, A Novel Gene Therapy Candidate For The Treatment Of Duchenne Muscular Dystrophy
- Follow-Up Data From Phase 3 Trial of Pfizer-BioNTech COVID-19 Vaccine Support Safety and High Efficacy in Adolescents 12 Through 15 Years of Age
November 23, 2021
November 24, 2021
- Kintor Pharma Receives IND Clearance by NMPA for KX-826's Pivotal Study to Treat Male Alopecia Patients
- Nasus Pharma Announces Clinical Data Demonstrating Efficacy of Taffix, Intranasal Antiviral Protection Against Common Cold and Upper Respiratory Infection
November 25, 2021
November 26, 2021
- Starpharma releases positive DEP phase 2 interim results in prostate cancer
- Merck and Ridgeback Biotherapeutics Provide Update on Results from MOVe-OUT Study of Molnupiravir, an Investigational Oral Antiviral Medicine, in At Risk Adults With Mild-to-Moderate COVID-19
- Moderna Announces Strategy to Address Omicron (B.1.1.529) SARS-CoV-2 Variant
November 29, 2021
- Novel Herbal Drug by Xantho Biotechnology Seeks To Be New First-Line Atopic dermatitis Treatment
- Bristol Myers Squibb’s Applications for Deucravacitinib for the Treatment of Moderate to Severe Plaque Psoriasis Accepted by U.S. Food and Drug Administration and Validated by European Medicines Agency
- Johnson & Johnson to Evaluate Its COVID-19 Vaccine Against New Omicron COVID-19 Variant
November 30, 2021
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