Clinical Trial News Archive - March 2021
March 1, 2021
- Athenex Receives FDA Complete Response Letter for Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer
- Athenex Receives FDA Complete Response Letter for Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer
- Cormedix Receives Complete Response Letter From FDA for Defencath™ Catheter Lock Solution
- FibroGen Provides Regulatory Update on Roxadustat
- INOVIO Announces Positive Results from REVEAL 1, a Phase 3 Pivotal Trial Evaluating VGX-3100, its DNA-based HPV Immunotherapy for the Treatment of High-grade Precancerous Cervical Dysplasia Caused by HPV-16 and/or HPV-18
- Merck Provides Update on Keytruda (pembrolizumab) Indication in Metastatic Small Cell Lung Cancer in the US
- Further Update on US Regulatory Review of Roxadustat in Anemia of Chronic Kidney Disease
March 2, 2021
- Arena Pharmaceuticals Reports Topline Results from Olorinab Phase 2b CAPTIVATE Clinical Trial
- AstraZeneca Advances Mass Global Rollout of COVID-19 Vaccine Through COVAX
March 3, 2021
- On Target Laboratories Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Pafolacianine Sodium Injection for Identification of Ovarian Cancer During Surgery
- Vir Biotechnology and GSK Provide Update on NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalised Adults with COVID-19
- Provention Bio Announces Publication of Extended Follow-up Data from the Pivotal "At-Risk" TN-10 Study of Teplizumab in Science Translational Medicine
March 4, 2021
March 5, 2021
- Loxo Oncology at Lilly Announces Publication of Pirtobrutinib (LOXO-305) Phase 1/2 Data in The Lancet
- Ocuphire Announces Publication of MIRA-1 Phase 2b Results in Optometry and Visual Science Demonstrating Reduction of Pharmacologically Induced Mydriasis
- CytoDyn’s Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19 Patients Treated with Leronlimab
March 6, 2021
March 7, 2021
March 8, 2021
- Valneva and Pfizer Announce Initiation of Phase 2 Study for Lyme Disease Vaccine Candidate
- BioMarin Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to Valoctocogene Roxaparvovec, Investigational Gene Therapy for Hemophilia A
- Merck Presents Results from Phase 1 Trial Evaluating Investigational Islatravir Subdermal Implant for the Prevention of HIV-1 Infection at CROI 2021
March 9, 2021
- ViiV Healthcare Presents Positive Proof-of-Concept Findings for GSK3640254, a Novel, Investigational Maturation Inhibitor for the Treatment of HIV
- Gilead’s Investigational Lenacapavir Demonstrates Sustained Long-Acting Efficacy Through Week 26 in Data Presented at CROI
March 10, 2021
- Lilly's Bamlanivimab and Etesevimab Together Reduced Hospitalizations and Death in Phase 3 Trial for Early COVID-19
- Vir Biotechnology and GSK Announce VIR-7831 Reduces Hospitalisation and Risk of Death in Early Treatment of Adults with COVID-19
March 11, 2021
- FDA Grants Fast Track Designation to Spectrum Pharmaceuticals’ Poziotinib
- Nuvation Bio Granted Orphan Drug Designation for NUV-422 for the Treatment of Patients with Malignant Gliomas
- Novavax Confirms High Levels of Efficacy Against Original and Variant COVID-19 Strains in United Kingdom and South Africa Trials
March 12, 2021
March 13, 2021
March 14, 2021
March 15, 2021
- Gilead and Merck Announce Agreement to Jointly Develop and Commercialize Long-Acting, Investigational Treatment Combinations of Lenacapavir and Islatravir in HIV
- Ocuphire Announces MIRA-2 Phase 3 Registration Trial for the Reversal of Mydriasis Meets Primary Endpoint
March 16, 2021
- AstraZeneca to Supply the US with up to Half a Million Additional Doses of the Potential COVID-19 Antibody Treatment AZD7442
- Medicago and GSK Start Phase 3 Trial of Adjuvanted COVID-19 Vaccine Candidate
- Lilly's Mirikizumab Helps Patients Achieve Clinical Remission and Improves Symptoms in Adults with Ulcerative Colitis in 12-Week Phase 3 Induction Study
- FibroGen Initiates LELANTOS-2 – Second Phase 3 Clinical Study of Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy
March 18, 2021
March 20, 2021
March 22, 2021
- AZD1222 US Phase III trial Met Primary Efficacy Endpoint in Preventing COVID-19 at Interim Analysis
- Genentech Provides Update on Tominersen Program in Manifest Huntington’s Disease
March 23, 2021
- Adults with Obesity Treated with Semaglutide 2.4 mg Achieved and Maintained a Significant Amount of Weight Loss in a 68-Week Trial
- CureVac’s COVID-19 Vaccine Candidate, CVnCoV, Demonstrates Protection Against SARS-CoV-2 B.1.351 Variant (South African Variant) in Preclinical Challenge Study
- Pfizer Initiates Phase 1 Study of Novel Oral Antiviral Therapeutic Agent PF-07321332 Against SARS-CoV-2
- Phase 3 Trial Shows REGEN-COV (casirivimab with imdevimab) Antibody Cocktail Reduced Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patient
March 24, 2021
- Daré Bioscience Announces Initiation of Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder
- GSK Starts the First Phase 3 Study with a Long-Acting Anti-IL-5 Treatment for Patients with Severe Asthma
- Results from Pfizer’s Phase 3 Jade Compare Study of Abrocitinib in Moderate to Severe Atopic Dermatitis Published in New England Journal of Medicine
- Myovant Sciences and Pfizer Announce Positive Data from Phase 3 LIBERTY Randomized Withdrawal Study of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids
- Results from Pfizer’s Phase 3 Jade Compare Study of Abrocitinib in Moderate to Severe Atopic Dermatitis Published in New England Journal of Medicine
March 25, 2021
- Joint FDA Advisory Committee Votes on Application for Tanezumab for the Treatment of Osteoarthritis Pain
- AZD1222 US Phase III Primary Analysis Confirms Safety and Efficacy
- Bristol Myers Squibb Announces RELATIVITY-047, a Trial Evaluating Anti-LAG-3 Antibody Relatlimab and Opdivo (nivolumab) in Patients with Previously Untreated Metastatic or Unresectable Melanoma, Meets Primary Endpoint of Progression-Free Survival
March 26, 2021
March 29, 2021
- ORYZON Enrolls First Patient in PORTICO, a Phase IIb Clinical Trial with Vafidemstat in Borderline Personality Disorder
- Lilly, Vir Biotechnology and GSK Announce Positive Topline Data from the Phase 2 BLAZE-4 Trial Evaluating Bamlanivimab with VIR-7831 in Low-Risk Adults with COVID-19
March 30, 2021
- Moleculin Receives FDA Approval of Fast Track Designation for Annamycin in the Treatment of Sarcoma Lung Metastases
- CytoDyn’s Leronlimab Decreased Mortality at 14 Days by 82% With Statistically Significant P-Value of 0.0233 Amongst Critically Ill COVID-19 Patients
March 31, 2021
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