Clinical Trial News Archive - January 2021
January 4, 2021
- Israeli Ministry of Health Authorizes COVID-19 Vaccine Moderna for Use in Israel
- Moderna Provides COVID-19 Vaccine Supply Update
January 6, 2021
- European Commission Authorizes COVID-19 Vaccine Moderna in Europe
- Serum Institute of India Obtains Emergency Use Authorisation in India for AstraZeneca’s COVID-19 Vaccine
January 7, 2021
- Merus Granted FDA Fast Track Designation of Zenocutuzumab for the Treatment of Patients with Neuregulin 1 Fusion Cancers
- Alnylam Reports Positive Topline Results from HELIOS-A Phase 3 Study of Vutrisiran in Patients with hATTR Amyloidosis with Polyneuropathy
- Novavax Finalizes Agreement with Commonwealth of Australia for 51 Million Doses of COVID-19 Vaccine
January 8, 2021
- United Kingdom Medicines and Healthcare products Regulatory Agency Authorizes Use of COVID-19 Vaccine Moderna
- An In Vitro Study Shows Pfizer-BioNTech COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with a Mutation Associated with Rapid Transmission
January 11, 2021
- Lilly's Donanemab Slows Clinical Decline of Alzheimer's Disease in Positive Phase 2 Trial
- Cytokinetics Granted Orphan Drug Designation for CK-3773274 for the Treatment of Hypertrophic Cardiomyopathy
- Cara Initiates Phase 2 Trial of Oral Korsuva for the Treatment of Pruritus in Patients with Notalgia Paresthetica
January 12, 2021
- U.S. FDA Accepts for Priority Review the Biologics License Application for V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine, for Use in Adults 18 Years of Age and Older
- Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses
- Swissmedic Authorizes COVID-19 Vaccine Moderna for Use in Switzerland
January 13, 2021
January 14, 2021
January 16, 2021
January 20, 2021
January 21, 2021
- Lilly's Neutralizing Antibody Bamlanivimab (LY-CoV555) Prevented COVID-19 at Nursing Homes in the BLAZE-2 Trial, Reducing Risk by up to 80 Percent for Residents
- Heron Therapeutics Announces Publication of Results from EPOCH 1 Follow-On Study of HTX-011 in Patients Undergoing Bunionectomy Surgery
- Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)
January 22, 2021
- Pfizer and BioNTech Reach Agreement with COVAX for Advance Purchase of Vaccine to Help Combat COVID-19
- Novavax and Government of Canada Finalize Advance Purchase Agreement for COVID-19 Vaccine
January 24, 2021
January 25, 2021
- BioNTech and Fosun Pharma Receive Authorization for Emergency Use in Hong Kong for COVID-19 Vaccine
- Moderna COVID-19 Vaccine Retains Neutralizing Activity Against Emerging Variants First Identified in the U.K. and the Republic of South Africa
January 26, 2021
- Myovant Sciences and Pfizer Announce Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination Therapy in Women with Endometriosis
- Regeneron Reports Positive Interim Data with REGEN-COV Antibody Cocktail used as Passive Vaccine to Prevent COVID-19
- Moderna Provides U.S. COVID-19 Vaccine Supply Update
- New Data Show Treatment with Lilly's Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent
January 27, 2021
- In Vitro Studies Demonstrate Pfizer and BioNTech COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with Key Mutations Present in U.K. and South African Variants
- Lilly, Vir Biotechnology and GSK Announce First Patient Dosed in Expanded BLAZE-4 Trial Evaluating Bamlanivimab (LY-CoV555) with VIR-7831 (GSK4182136) for COVID-19
- REGEN-COV Antibody Cocktail Is Active Against SARS-CoV-2 Variants First Identified in the UK and South Africa
January 28, 2021
- Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial
- Amgen's Investigational KRAS G12C Inhibitor Sotorasib Demonstrated Rapid, Deep And Durable Responses In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
January 29, 2021
- Pfizer and BioNTech Publish Data on COVID-19 Vaccine-Induced Antibodies’ Ability to Neutralize SARS-CoV-2 U.K. Strain Pseudovirus in Cell Culture in Science
- COVID-19 Vaccine AstraZeneca Recommended for Use in the EU
- New Amivantamab Data from CHRYSALIS Study Show Robust Clinical Activity and Durable Responses in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer and EGFR Exon 20 Insertion Mutations
- Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial
- COVID-19 Vaccine AstraZeneca Authorised for Use in the EU
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