Clinical Trial News Archive - December 2020

December 1, 2020

• Moleculin Announces FDA Approves 3 Rare Pediatric Disease Designations for WP1066
• Pfizer and BioNTech Submitted Application for Conditional Marketing Authorization for COVID-19 Vaccine to the EMA

December 2, 2020

• Lilly Announces 650,000 Additional Doses of Neutralizing Antibody Bamlanivimab (LY-CoV555) Purchased by U.S. Government to Treat COVID-19
• Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19
• Pfizer Doses First Participant in Phase 3 Study Evaluating anti-TFPI Investigational Therapy, Marstacimab, for People With Severe Hemophilia A and B With or Without Inhibitors

December 3, 2020

• Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate

December 4, 2020

• Lilly and UnitedHealth Group Partner on Pragmatic Study of Neutralizing Antibody Bamlanivimab (LY-CoV555) for COVID-19
• Magenta Therapeutics and bluebird bio Announce a Phase 2 Clinical Trial Collaboration to Evaluate Magenta’s MGTA-145 for Mobilizing and Collecting Stem Cells in Adults and Adolescents with Sickle Cell Disease
• Moderna Announces Amendment to Supply Agreement with the Ministry of Health of Israel to Supply Additional Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
• Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates

December 5, 2020

• Regeneron's BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1
• Updated Results from the Phase 1 Study of the BCMAxCD3 Bispecific Teclistamab Show Preliminary Efficacy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma
• Janssen Presents First Data from the Phase 1 Study of the GPRC5DxCD3 Bispecific Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma
• Syros Presents New Data From Phase 2 Clinical Trial of SY-1425 and Announces Plans to Initiate Registration-Enabling Trial in MDS and Randomized Phase 2 Trial in AML

December 6, 2020

• Magrolimab Demonstrates Clinical Responses in Ongoing Phase 1b Trial of Previously Untreated Acute Myeloid Leukemia Patients

December 7, 2020

• Canada Exercises Increased Option for Total of 40 Million Doses of mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)
• Pfizer Reports Positive Clinical Data for BCMA-CD3 Bispecific Antibody (PF-06863135) in Multiple Myeloma
• Canada Exercises Increased Option for Total of 40 Million Doses of mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)
• INOVIO Doses First Subject in Phase 2 Segment of its INNOVATE Phase 2/3 Clinical Trial for INO-4800, its DNA Medicine to Prevent COVID-19

December 8, 2020

• Amgen's Sotorasib Granted Breakthrough Therapy Designation For Advanced Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation
• Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
• U.S. FDA Accepts for Priority Review the Biologics License Application for Pfizer’s Investigational 20-valent Pneumococcal Conjugate Vaccine for Adults 18 Years of Age and Older
• Novartis Investigational STAMP Inhibitor Asciminib (ABL001) Shows Superior MMR Rate to Bosulif®* in Chronic Myeloid Leukemia Trial
• Sojournix Advances Phase 2 Clinical Trial of SJX‑653 for Menopausal Hot Flashes
• Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
• AZD1222 Oxford Phase III Trials Interim Analysis Results Published in The Lancet

December 9, 2020

• Lilly's Tirzepatide Significantly Reduced A1C and Body Weight in People with Type 2 Diabetes
• Mycovia Pharmaceuticals, Inc. Announces Positive Topline Results from Phase 3 VIOLET Studies of Oteseconazole in Patients with Recurrent Vulvovaginal Candidiasis

December 10, 2020

• Sanofi to Resume Dosing in Fitusiran Clinical Studies in the U.S.
• Moderna Announces First Participants Dosed in Phase 2/3 Study of COVID-19 Vaccine Candidate in Adolescents
• INOVIO and Advaccine Announce First Dosing of Subject in Phase 2 Clinical Trial for COVID-19 DNA Vaccine Candidate INO-4800 in China
• Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S.
• Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

December 11, 2020

• Sanofi and GSK Announce a Delay in Their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine Programme to Improve Immune Response in the Elderly
• Update on The University of Queensland COVID-19 Vaccine
• U.S. Government Exercises 1st Option for Additional 100 Million Doses of Moderna’s COVID-19 Vaccine Candidate
• Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

December 12, 2020

• U.S. CDC Committee of Independent Health Experts Recommends Vaccination with Pfizer and BioNTech COVID-19 Vaccine for Persons Ages 16 Years and Older

December 14, 2020

• CureVac Commences Global Pivotal Phase 2b/3 Trial for COVID-19 Vaccine Candidate, CVnCoV
• Moderna Confirms Supply Agreement with the Ministry of Health to Supply Singapore with mRNA Vaccine Against COVID-19 (mRNA-1273)
• Pfizer and BioNTech Provide Data from German Phase 1/2 Study Further Characterizing Immune Response Following Immunization with Lead COVID-19 Vaccine Candidate BNT162b2
• The Sputnik V Vaccine’s Efficacy is Confirmed at 91.4% Based on Data Analysis of the Final Control Point of Clinical Trials

December 15, 2020

• INOVIO to Develop DNA-encoded Monoclonal Antibody (dMAb®) Candidates to Treat COVID-19 with Funding from the Defense Advanced Research Projects Agency (DARPA) and the Department of Defense's (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)

December 16, 2020

• Novavax Announces Agreement with Government of New Zealand for 10.7 Million Doses of COVID-19 Vaccine
• Valneva Initiates Phase 1/2 Clinical Study of Inactivated, Adjuvanted COVID-19 Vaccine Candidate

December 17, 2020

• Moderna Receives FDA Advisory Committee Vote Supporting Emergency Use for Moderna’s Vaccine Against COVID-19 in the United States
• Albireo Initiates Global Phase 3 Clinical Trial of Odevixibat in Alagille Syndrome
• Vir Biotechnology and GSK Announce Start of NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalised Adults with COVID-19
• New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

December 18, 2020

• New SARS-CoV-2 Neutralizing Antibody BI 767551 Enters Clinical Phase
• Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S.
• Update on US Regulatory Review of Roxadustat in Anemia of Chronic Kidney Disease
• Lilly to Begin Pragmatic Study of Neutralizing Antibody Bamlanivimab (LY-CoV555) for COVID-19 in New Mexico

December 19, 2020

• U.S. CDC Advisory Committee on Immunization Practices Recommends Vaccination with Moderna’s COVID-19 Vaccine for Persons 18 Years and Older

December 20, 2020

• Genentech’s Faricimab Meets Primary Endpoint and Shows Strong Durability Across Two Global Phase III Studies for Diabetic Macular Edema, a Leading Cause of Blindness

December 21, 2020

• CureVac and the University Medical Center Mainz Start Phase 3 Clinical Trial for COVID-19 Vaccine Candidate, CVnCoV, in Healthcare Workers
• Janssen Initiates Rolling Submission of a Biologics License Application to U.S. FDA for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma
• Pfizer and BioNTech Receive CHMP Positive Opinion for their COVID-19 Vaccine
• Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine
• Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

December 23, 2020

• Health Canada Authorizes Moderna COVID-19 Vaccine in Canada
• Revive Therapeutics Provides Update on FDA Phase 3 Clinical Trial for Bucillamine in COVID-19 with Plans on Emergency Use Access
• Pfizer and BioNTech to Supply the U.S. with 100 Million Additional Doses of COVID-19 Vaccine
• Merck Announces Supply Agreement with U.S. Government for Initial Doses of Investigational Biological Therapy MK-7110 for the Treatment of Patients with Severe and Critical COVID-19

December 24, 2020

• INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet's EClinicalMedicine

December 28, 2020

• Aprea Therapeutics Announces Results of Primary Endpoint from Phase 3 Trial of Eprenetapopt in TP53 Mutant Myelodysplastic Syndromes (MDS)
• Novavax Announces Initiation of PREVENT-19 Pivotal Phase 3 Efficacy Trial of COVID-19 Vaccine in the United States and Mexico

December 29, 2020

• Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®

December 30, 2020

• AstraZeneca’s COVID-19 Vaccine Authorised for Emergency Supply in the UK

December 31, 2020

• Moderna Confirms 40 Million COVID-19 Vaccine Dose Supply Agreement with the Government of the Republic of Korea
• Moderna Announces Publication of Results from the Pivotal Phase 3 Trial of the Moderna COVID-19 Vaccine in The New England Journal of Medicine