Clinical Trial News Archive - July 2020
July 1, 2020
- Rhythm Pharmaceuticals Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Setmelanotide for Treatment of POMC and LEPR Deficiency Obesities
- Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate Against SARS-CoV-2
July 4, 2020
July 6, 2020
- ObsEva Announces Positive Results from two Phase 3 Studies, PRIMROSE 1 and 2, of Yselty® (linzagolix) for the Treatment of Uterine Fibroids
- Myovant Sciences Presents Additional Data on Relugolix Combination Therapy from Phase 3 LIBERTY Studies in Women with Uterine Fibroids and from Ovulation Inhibition Study
- Regeneron Announces Start of REGN-COV2 Phase 3 COVID-19 Prevention Trial in Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)
- Idorsia Announces Positive Results in the Second Phase 3 Study of Daridorexant
- Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19
July 7, 2020
- ViiV Healthcare Announces Superior Efficacy of Investigational, Long-Acting Injectable Formulation of Cabotegravir Dosed Every Two Months Over Daily Oral PrEP
- Novavax Announces $1.6 Billion Funding from Operation Warp Speed
- Regeneron Announces Manufacturing and Supply Agreement for BARDA and U.S. Department of Defense for REGN-COV2 Anti-Viral Antibody Cocktail
July 8, 2020
- Moderna Completes Enrollment of Phase 2 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273)
- The New England Journal of Medicine Publishes Final Results from Phase 1/2 Study of Tofersen for a Genetic Form of ALS
- Gilead Sciences Statement on the Initiation of Clinical Testing of an Inhaled Solution of Remdesivir for Potential Outpatient Treatment of COVID-19
July 9, 2020
- Moderna and ROVI Announce Collaboration for OUS Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate
- LEO Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of Biologics License Application (BLA) for Tralokinumab for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis
- Bayer’s Finerenone Meets Primary Endpoint in Phase III FIDELIO-DKD Renal Outcomes Study in Patients With Chronic Kidney Disease and Type 2 Diabetes
July 10, 2020
- Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19
- Atox Bio Announces a Positive Effect of Reltecimod on Resolution of Organ Dysfunction in Phase 3 ACCUTE Trial for Patients with Necrotizing Soft Tissue Infection (“Flesh Eating Disease”)
July 13, 2020
July 14, 2020
- Albireo Enrolls First Patient in Phase 3 Clinical Trial of Odevixibat in Biliary Atresia
- Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Phase 1 Study of Its mRNA Vaccine Against COVID-19 (mRNA-1273)
- Experimental COVID-19 Vaccine Safe, Generates Immune Response
July 17, 2020
July 20, 2020
- COVID-19 Vaccine AZD1222 Showed Robust Immune Responses in All Participants in Phase I/II Trial
- Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data
- Pfizer and BioNTech Announce Agreement with the United Kingdom for 30 Million Doses of mRNA-based Vaccine Candidate against SARS-CoV-2
July 21, 2020
July 22, 2020
July 23, 2020
- MyoKardia Announces Receipt of Breakthrough Therapy Designation from FDA for Mavacamten for the Treatment of Symptomatic, Obstructive Hypertrophic Cardiomyopathy
- Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate
July 26, 2020
July 27, 2020
- Phase 3 Clinical Trial of Investigational Vaccine for COVID-19 Begins
- Moderna Announces Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Begins
July 28, 2020
- Momenta Pharmaceuticals Announces FDA Rare Pediatric Disease Designation for Nipocalimab in HDFN
- Corcept Therapeutics Initiates Phase 3 Trial of Relacorilant in Patients with Cushing’s Syndrome of Adrenal Origin
- Experimental COVID-19 Vaccine Protects Upper and Lower Airways in Nonhuman Primates
- Pfizer and BioNTech Choose Lead mRNA Vaccine Candidate Against COVID-19 and Commence Pivotal Phase 2/3 Global Study
July 29, 2020
- BARDA Procures Regeneron's REGN-EB3 Investigational Ebola Treatment for National Preparedness
- AbbVie Announces Positive Phase 3 Data for Atogepant in Migraine Prevention
- Ridgeback Biotherapeutics LP Announces Priority Review of Biologics License Application for Ansuvimab Ebola Treatment
July 30, 2020
- Nirsevimab Reduced Respiratory Syncytial Virus Infections and Hospitalisations in Preterm Infants in Phase IIb Trial
- Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Robust Protection in Pre-Clinical Studies
July 31, 2020
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