Clinical Trial News Archive - December 2020
December 1, 2020
- Amicus Therapeutics Initiates Rolling Biologic License Application to the U.S. Food and Drug Administration for AT-GAA in Late-Onset Pompe Disease
- 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
December 4, 2020
- Lilly and UnitedHealth Group Partner on Pragmatic Study of Neutralizing Antibody Bamlanivimab (LY-CoV555) for COVID-19
- 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)
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
December 7, 2020
- Canada Exercises Increased Option for Total of 40 Million Doses of mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)
- Canada Exercises Increased Option for Total of 40 Million Doses of mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)
- Daré Bioscience Announces Positive Topline Results From DARE-BVFREE, a Phase 3 Trial of DARE-BV1 in Patients Diagnosed with Bacterial Vaginosis
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)
- Novartis Investigational STAMP Inhibitor Asciminib (ABL001) Shows Superior MMR Rate to Bosulif®* in Chronic Myeloid Leukemia Trial
- 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
- Moderna Announces First Participants Dosed in Phase 2/3 Study of COVID-19 Vaccine Candidate in Adolescents
- 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
- 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
December 14, 2020
- 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
December 16, 2020
- Novavax Announces Agreement with Government of New Zealand for 10.7 Million Doses of COVID-19 Vaccine
- BioLineRx Announces Final Results from Phase 2a COMBAT/KEYNOTE-202 Triple Combination Study of Motixafortide in Second Line Metastatic Pancreatic Cancer (PDAC)
December 17, 2020
- Moderna Receives FDA Advisory Committee Vote Supporting Emergency Use for Moderna’s Vaccine Against COVID-19 in the United States
- 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
- 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
December 20, 2020
December 21, 2020
- 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
- Pfizer and BioNTech to Supply the U.S. with 100 Million Additional Doses of COVID-19 Vaccine
December 28, 2020
December 29, 2020
December 30, 2020
December 31, 2020
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