Clinical Trial News Archive - October 2020
October 1, 2020
- Pfizer Receives FDA Fast Track Designation for Duchenne Muscular Dystrophy Investigational Gene Therapy PF-06939926
- Gilead Sciences Update on Supply and Distribution of Veklury (remdesivir) in the United States
October 2, 2020
- COVID-19 Vaccine AZD1222 Clinical Trial Resumed in Japan, Follows Restart of Trials in the UK, Brazil, South Africa and India
- RDIF Announces Delivery of the First Batch of Sputnik V Vaccine to Venezuela for Clinical Trials
- Regeneron Confirms that REGN-COV2 Antibody Cocktail Provided to President Trump Under Compassionate Use Request
October 5, 2020
- Amgen Announces Positive Topline Phase 2 Results For Investigational KRAS G12C Inhibitor Sotorasib In Advanced Non-Small Cell Lung Cancer
- Iovance Biotherapeutics Provides Update for Lifileucel in Metastatic Melanoma
October 6, 2020
- Oncternal Therapeutics Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for TK216 for Treatment of Ewing Sarcoma
- BioNTech and Pfizer Initiate Rolling Submission to European Medicines Agency for SARS-CoV-2 Vaccine Candidate BNT162b2
October 7, 2020
- Lilly Provides Comprehensive Update on Progress of SARS-CoV-2 Neutralizing Antibody Programs
- Pfizer and Sangamo Dose First Participant in Phase 3 Study Evaluating Hemophilia A Gene Therapy Treatment SB-525
October 8, 2020
- Merck Announces Week 96 Data from Phase 2b Study Evaluating Islatravir in Combination With Doravirine in Adults With HIV-1 Infection
- Lilly Announces Arrangement for Supply of Potential COVID-19 Antibody Therapy for Low- and Middle-Income Countries
- Final Results of National Institute of Allergy and Infectious Diseases’ ACTT-1 Trial Published in New England Journal of Medicine Expand Clinical Benefits of Veklury® (remdesivir) for the Treatment of COVID-19
- Amgen, Cytokinetics And Servier Announce Topline Results From GALACTIC-HF, A Phase 3 Trial Of Omecamtiv Mecarbil In Patients With Heart Failure
- NIH Clinical Trial Testing Hyperimmune Intravenous Immunoglobulin Plus Remdesivir to Treat COVID-19 Begins
October 9, 2020
- COVID-19 Long-Acting AntiBody (LAAB) Combination AZD7442 Rapidly Advances into Phase III Clinical Trials
- Pfizer Canada and BioNTech Initiate Rolling Submission to Health Canada for SARS-CoV-2 Vaccine Candidate BNT162b2
October 12, 2020
- Vir Biotechnology and GSK Announce Global Expansion to Phase 3 of COMET-ICE Study Evaluating VIR-7831 for the Treatment of COVID-19
- Altimmune And UAB Announce Publication Of Compelling Pre-Clinical Data For AdCOVID™ Intranasal COVID-19 Vaccine Candidate
- Phase 2b/3 Trial Shows Efficacy of Filgotinib for the Induction and Maintenance of Remission in Moderately and Severely Active Ulcerative Colitis
- Ministry of Health and Prevention of the UAE Approves Phase III Clinical Trials of the Sputnik V Vaccine in the UAE
- Avenue Therapeutics Receives Complete Response Letter from the FDA for IV Tramadol
- Johnson & Johnson Temporarily Pauses All Dosing in Our Janssen COVID-19 Vaccine Candidate Clinical Trials
- Mirikizumab Shows Continued Symptom Improvement and Reduction of Intestinal Inflammation in Patients with Crohn's Disease in 52-Week Phase 2 Trial
October 13, 2020
- Vaxart Announces Dosing First Subject in Phase 1 Clinical Trial of Its Oral Tablet COVID-19 Vaccine
- AnaptysBio Reports Positive Topline Data from GALLOP Phase 2 Clinical Trial of Imsidolimab in Moderate-to-Severe Generalized Pustular Psoriasis (GPP)
- Sermonix Doses First Patient in Phase 2 Clinical Trial Collaboration Studying Lasofoxifene in Combination With Eli Lilly and Company’s Abemaciclib
- Moderna Announces Initiation of Rolling Submission to Health Canada for mRNA Vaccine Against COVID-19 (mRNA-1273)
- NIH Study Aims to Identify Promising COVID-19 Treatments for Larger Clinical Trials
October 14, 2020
- Moderna Receives Confirmation of Eligibility for Submission of Marketing Authorization Application to the European Medicines Agency for mRNA Vaccine Against COVID-19 (mRNA-1273)
- Vaxart Announces Positive Hamster Challenge Study Data for its Oral COVID-19 Vaccine
- RedHill Biopharma Announces FDA Orphan Drug Designation for RHB-204 for the Treatment of NTM Infections
October 15, 2020
- Sanofi and Translate Bio mRNA COVID-19 Vaccine Candidate Induced High Antibody Levels in Preclinical Studies
- CanSinoBIO Announces a Supply Agreement with Mexico on the Advance Purchase for COVID-19 Vaccine
- FDA Authorizes Phase 1 Trial of ImmunityBio’s Novel COVID-19 Vaccine Candidate hAd5; Dual Construct is Designed to Drive Both T Cell and Antibody Immunity
- Gilead Sciences Statement on the Solidarity Trial
October 16, 2020
- Merck Presents Three-Year Survival Data for Keytruda (pembrolizumab) in Combination With Chemotherapy and Updated Phase 1/2 Data for Investigational Quavonlimab (MK-1308) in Combination With Keytruda in Advanced Non‑Small Cell Lung Cancer
- NIH Begins Large Clinical Trial to Test Immune Modulators for Treatment of COVID-19
October 17, 2020
October 19, 2020
- Nucleus Networks Initiates First-in-Human Trial of Symvivo’s Oral COVID-19 Vaccine Candidate, bacTRL-Spike™
- Inventiva Receives FDA Fast Track Designation in MPS VI for its Clinical-Stage Asset Odiparcil
October 20, 2020
- FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPARδ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies
- Aclaris Therapeutics Announces First Patient Dosed in Phase 2a Clinical Trial of ATI-1777, an Investigational Topical “Soft” JAK 1/3 Inhibitor, for the Treatment of Moderate to Severe Atopic Dermatitis
- CytoDyn Receives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial
October 21, 2020
- Myovant Sciences Presents Additional Data on Relugolix Combination Therapy from Studies in Endometriosis and Uterine Fibroids
- Trevi Therapeutics Provides Clinical Trial Updates for Haduvio
- Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine
- ViiV Healthcare Announces Analysis Showing no Antiretroviral Therapy Interruptions Due to COVID-19 Across its Clinical Development Programme for Investigational, Long-Acting Cabotegravir and Rilpivirine
- ImmunityBio, NantKwest Announce First Patient Dosed in Phase 1 Clinical Trial of Novel COVID-19 Vaccine Candidate hAd5
October 22, 2020
- Moderna Completes Enrollment of Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273)
- An Open Letter from Merdad Parsey, Chief Medical Officer, Gilead Sciences
- Omeros Reports Final Efficacy and Safety Data from the Narsoplimab Pivotal Trial in HSCT-TMA
October 23, 2020
- CureVac Reports Positive Preclinical Data for its COVID-19 Vaccine Candidate CVnCoV
- FDA Authorises Restart of the COVID-19 AZD1222 Vaccine US Phase III Trial
- Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S.
October 26, 2020
- Moderna Announces Supply Agreement with the Ministry of Public Health to Supply Qatar with mRNA Vaccine Against COVID-19 (mRNA-1273)
- ANA Therapeutics Begins Phase 2/3 Clinical Trial of Proprietary Oral Niclosamide Formulation to Treat COVID-19
- Revive Therapeutics Provides Update on FDA Phase 3 Clinical Trial for Bucillamine in COVID-19
- Statement—NIH-Sponsored ACTIV-3 Trial Closes LY-CoV555 Sub-Study
- Forte Biosciences, Inc. Announces the FDA Has Granted Fast Track Designation to FB-401 for the Treatment of Atopic Dermatitis
- Leronlimab Shows Early, but Promising Clinical Responses in First Two Patients Recovering from Stroke
October 27, 2020
- Novavax Provides Phase 3 COVID-19 Vaccine Clinical Development Update
- Olipudase Alfa Demonstrated Significant Improvement in Lung Function and Spleen Volume in Patients with ASMD
- UK Medicines and Healthcare products Regulatory Agency Begins Rolling Review of Moderna’s mRNA Vaccine Against COVID-19 (mRNA-1273)
- Russian Application of Sputnik V Vaccine for WHO Vaccine Prequalification Among the First Applications Submitted
- FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer’s Abrocitinib, an Oral Once-Daily JAK1 Inhibitor, for Patients 12 and Up with Moderate to Severe Atopic Dermatitis
October 28, 2020
- Regeneron's COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention
- Data for Lilly's Bamlanivimab (LY-CoV555) in COVID-19 Outpatients Published in New England Journal of Medicine
- Astellas Receives U.S. FDA Fast Track Designation for ASP5354, an Investigational Near-Infrared Fluorescence Imaging Agent
- Boehringer Ingelheim Begins Phase 2 Clinical Trial of a Targeted Therapy to Help People with Severe Respiratory Illness from COVID-19
- Lilly Announces Agreement with U.S. government to Supply 300,000 vials of Investigational Neutralizing Antibody Bamlanivimab (LY-CoV555) in an Effort to Fight COVID-19
- GeneTx and Ultragenyx Announce Positive Interim Phase 1/2 Data on Investigational GTX-102 Demonstrating Improvement in Patients with Angelman Syndrome
October 29, 2020
October 30, 2020
- Algernon Pharmaceuticals Announces Green Light From Data and Safety Monitoring Board to Continue its Multinational 2b/3 Human Study of Ifenprodil for Treatment of COVID-19
- REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements
- RDIF and União Química File Documents for Registration of Sputnik V Vaccine with Regulator in Brazil
- Rhythm Pharmaceuticals Announces Publication of Results from Phase 3 Clinical Trials of Setmelanotide in The Lancet Diabetes & Endocrinology
- BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization
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