Clinical Trial News Archive - February 2021
February 1, 2021
- Pfizer and BioNTech Publish Preclinical Data from Investigational COVID-19 Vaccine Program in Nature
February 2, 2021
- Bristol Myers Squibb Announces Positive Topline Results from Second Pivotal Phase 3 Psoriasis Study Showing Superiority of Deucravacitinib Compared to Placebo and Otezla (apremilast)
- Data Presented at WORLDSymposium Reinforces Robust Rare Disease Pipeline and Highlights Additional Clinical Data for Investigational Avalglucosidase Alfa in Pompe Disease
February 3, 2021
- COVID-19 Vaccine AstraZeneca Confirms 100% Protection Against Severe Disease, Hospitalisation and Death in the Primary Analysis of Phase III Trials
- Singapore Health Sciences Authority (HSA) Approves Interim Authorization of COVID-19 Vaccine Moderna For Use
- Novavax and Government of Switzerland Announce Agreement in Principle to Supply COVID-19 Vaccine
- HERTHENA-Lung01 Phase 2 Study of Daiichi Sankyo’s Patritumab Deruxtecan Initiated in Patients with EGFR-Mutated NSCLC
February 4, 2021
- Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
- Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization
February 5, 2021
February 8, 2021
February 9, 2021
February 11, 2021
- Amicus’ AT-GAA Shows Clinically Meaningful & Significant Improvements in Both Musculoskeletal and Respiratory Measures in Late-Onset Pompe Disease Compared to Standard of Care in Pivotal Phase 3 PROPEL Study
- New Phase III Data Show Genentech’s Faricimab Is the First Investigational Injectable Eye Medicine to Extend Time Between Treatments up to Four Months in Two Leading Causes of Vision Loss, Potentially Reducing Treatment Burden for Patients
- U.S. Government Purchases Additional 100 Million Doses of Moderna’s COVID-19 Vaccine
- Qatar Ministry of Public Health Issues Emergency Use Authorization for COVID-19 Vaccine Moderna
February 12, 2021
- Pfizer and BioNTech to Supply the United States with 100 Million Additional Doses of COVID-19 Vaccine
- Canada Purchases Additional 4 Million Doses of Moderna’s COVID-19 Vaccine
February 15, 2021
- Novavax Announces Expanded Collaboration and License Agreement with SK Bioscience for 40 Million Doses of COVID-19 Vaccine for South Korea
- AstraZeneca COVID-19 Vaccine Authorised for Emergency Use by the World Health Organization
February 16, 2021
- Moderna Provides U.S. COVID-19 Vaccine Supply Update
- Johnson & Johnson Announces Submission of European Conditional Marketing Authorisation Application to the EMA for its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
- FDA Grants Sotorasib Priority Review Designation For The Treatment Of Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
February 17, 2021
- Pfizer Initiates Pivotal Phase 2 MagnetisMM-3 Trial of BCMA-CD3 Bispecific Antibody Elranatamab (PF-06863135) in Multiple Myeloma
- Pfizer and BioNTech to Supply the European Union with 200 Million Additional Doses of COMIRNATY®
- In Vitro Study Published in The New England Journal of Medicine Demonstrates Sera from Individuals Immunized with the Pfizer- BioNTech COVID-19 Vaccine Neutralize SARS-CoV-2 with South African Variant Spike Mutations
- European Commission Purchases Additional 150 Million Doses of COVID-19 Vaccine Moderna
- Tirzepatide Significantly Reduced A1C and Body Weight in People with Type 2 Diabetes in Two Phase 3 Trials from Lilly's SURPASS Program
February 18, 2021
- Efanesoctocog Alfa Granted FDA Fast Track Designation for Treatment of Hemophilia A
- Pfizer and BioNTech Commence Global Clinical Trial to Evaluate COVID-19 Vaccine in Pregnant Women
- Novavax Announces Memorandum of Understanding with Gavi for Cumulative Supply to COVAX Facility of 1.1 Billion Doses of COVID-19 Vaccine
February 19, 2021
- Pfizer and BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA
- Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
- Astellas Announces Positive Topline Results from Two Phase 3 Pivotal Global Trials of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Postmenopausal Women
February 22, 2021
- Voluntary Withdrawal of Imfinzi Indication in Advanced Bladder Cancer in the US
- Novavax Completes Enrollment of PREVENT-19, COVID-19 Vaccine Pivotal Phase 3 Trial in the United States and Mexico
February 23, 2021
February 24, 2021
February 25, 2021
- Aquestive Therapeutics Reaffirms Near-Term NDA Resubmission For Libervant™ (Diazepam) Buccal Film Following FDA Feedback
- Independent Data Monitoring Committee Finds Clear Efficacy for REGEN-COV (casirivimab with imdevimab) in Phase 3 COVID-19 Outpatient Outcomes Trial
- Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants
- Novavax and Takeda Finalize License Agreement for Novavax’ COVID-19 Vaccine Candidate in Japan; Takeda Initiates Phase 1/2 Trial in Japan
February 26, 2021
- Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
- Tezepelumab is the First Biologic to Consistently and Significantly Reduce Exacerbations in Broad Population of Severe Asthma Patients
- Lilly Announces Additional Doses of Neutralizing Antibody Therapy Purchased by U.S. Government to Treat COVID-19
February 27, 2021
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