Clinical Trial News Archive - May 2020
May 1, 2020
- TG Therapeutics Announces Publication of Ublituximab Phase 2 Clinical Trial Results in Multiple Sclerosis Journal
- Moderna and Lonza Announce Worldwide Strategic Collaboration to Manufacture Moderna’s Vaccine (mRNA-1273) Against Novel Coronavirus
- Gilead’s Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19
May 4, 2020
- Lilly and Junshi Biosciences to Co-develop Antibody Therapies for the Prevention and Treatment of COVID-19
- FDA Approves 54 Emergency INDs for Leronlimab Treatment of Coronavirus – CytoDyn Requests Compassionate Use from FDA for COVID-19 Patients Not Eligible for Participation in Two Ongoing Clinical Trials in U.S. – CytoDyn Targets Enrollment Completion for its 75 Patient, Phase 2 Trial by End of May
- GeneTx and Ultragenyx Announce GTX-102 Granted Fast Track Designation by U.S. FDA for Treatment of Angelman Syndrome
- Relief Therapeutics Holding Drug Aviptadil Enters FDA Trial at University of California Irvine, to Treat COVID-19-Induced Acute Respiratory Distress
May 5, 2020
- DelMar Pharmaceuticals Provides Enrollment Update in Phase 2 Clinical Trial of VAL-083 for Adjuvant Treatment of Brain Tumors
- Akebia Therapeutics Announces Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis
- TG Therapeutics Announces Positive Topline Results from the UNITY-CLL Phase 3 Study Evaluating the Combination of Umbralisib and Ublituximab (U2) for the Treatment of Patients with Chronic Lymphocytic Leukemia
- Pfizer and BioNTech Dose First Participants in the U.S. as Part of Global COVID-19 mRNA Vaccine Development Program
May 6, 2020
- Rebiotix and Ferring Announce World’s First with Positive Preliminary Pivotal Phase 3 Data for Investigational Microbiome-Based Therapy RBX2660
- Sinovac Announces First Animal Study Results of Vaccine Against COVID-19 Published in SCIENCE
- GP (HK)’s World-wide Innovative Drug STC3141 Got Approval for Phase II Clinical Research on COVID-19 ARDS and Phase IB Clinical Research on Sepsis, High-quality Product Contributes to Global Epidemic Prevention & Control
- Relief Therapeutics Holding Drug Aviptadil Enters FDA Trial at NYU Langone Health, New York, to Treat COVID-19-induced Acute Respiratory Distress
- First Patient Dosed in FDA-Approved Phase III Lenzilumab Study for COVID-19
May 7, 2020
- Tonix Pharmaceuticals Enters into Research Collaboration and Exclusive License Agreement with University of Alberta to Develop Novel Horsepox-Based Vaccines, TNX-1810, TNX-1820 and TNX-1830, for the Prevention of COVID-19
- Novant Health Initiates Phase 2b/3 Trial with CytoDyn’s Leronlimab for Severely and Critically Ill COVID-19 Patients
- Evelo Biosciences, Rutgers University, and Robert Wood Johnson University Hospital Announce Submission of IND for a Phase 2 Study of EDP1815 in COVID-19 Patients
- Gilead Announces Approval of Veklury® (remdesivir) in Japan for Patients With Severe COVID-19
May 8, 2020
- U.S. FDA Clears Pluristem’s IND Application for Phase II COVID-19 Study
- FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure
- RedHill Biopharma Receives FDA Approval for COVID-19 Clinical Study with Opaganib in the U.S.
May 11, 2020
- Acer Therapeutics to Develop Emetine as Potential COVID-19 Treatment in Collaboration with National Center for Advancing Translational Sciences, One of the National Institutes of Health
- Relief Therapeutics Announces Filing of IND for Phase 2/3 Clinical Trial of Inhaled RLF-100 Targeting Early COVID-19 Lung Injury
May 12, 2020
May 13, 2020
- Bristol Myers Squibb and bluebird bio Provide Regulatory Update on Idecabtagene Vicleucel (ide-cel, bb2121) for the Treatment of Patients with Multiple Myeloma
- Janssen’s BCMA CAR-T Therapy JNJ-4528 Showed Early, Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma
- Genentech to Present First Clinical Data on Novel Anti-TIGIT Cancer Immunotherapy Tiragolumab at ASCO
- Merck’s Novel HIF-2α Inhibitor Showed an Objective Response Rate of Nearly 30% in Patients with von Hippel-Lindau (VHL) Disease-Associated Clear Cell Renal Cell Carcinoma
- Sunovion Discontinues Dasotraline Program
May 14, 2020
- Neuraptive Therapeutics Announces FDA has Granted Fast Track Designation to NTX-001 Clinical Development Program for Treatment of Patients with Peripheral Nerve Injuries
- Pfizer Announces Positive Top-Line Results From Phase 3 Lot Consistency Study of 20-Valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naive Adults 18 Through 49 Years of Age
- MorphoSys and Incyte Announce Long-term Follow-up Results from L-MIND Study of Tafasitamab in Patients with r/r DLBCL
May 15, 2020
- STI-1499, A Potent Anti-SARS-CoV-2 Antibody, Demonstrates Ability To Completely Inhibit In Vitro Virus Infection In Preclinical Studies
- Pfizer’s New Phase 1b Results of Gene Therapy in Ambulatory Boys with Duchenne Muscular Dystrophy (DMD) Support Advancement into Pivotal Phase 3 Study
- Investigational ChAdOx1 nCoV-19 Vaccine Protects Monkeys Against COVID-19 Pneumonia
May 18, 2020
- Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harboring Exon 20 Insertion Mutations
- Janssen Presents First Data from Phase 1 Study of BCMAxCD3 Bispecific Teclistamab in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma
- Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
- Samsung Bioepis Announces 24-week Interim Results from a Phase 3 Trial of SB11, Proposed Ranibizumab Biosimilar
May 20, 2020
- Gilead and Galapagos Announce Positive Topline Results of Phase 2b/3 Trial of Filgotinib in Moderately to Severely Active Ulcerative Colitis
- INOVIO's COVID-19 DNA Vaccine INO-4800 Demonstrates Robust Neutralizing Antibody and T Cell Immune Responses in Preclinical Models
May 21, 2020
- New Longer-Term Data Reinforce Safety of Genentech’s Satralizumab in Adults and Adolescents With Neuromyelitis Optica Spectrum Disorder (NMOSD)
- Kadmon Announces Positive Topline Results of Pivotal Trial of Belumosudil (KD025) in Chronic Graft-Versus-Host Disease
- Apellis Announces Plans to Submit NDA for Pegcetacoplan in Paroxysmal Nocturnal Hemoglobinuria (PNH)
- AstraZeneca Advances Response to Global COVID-19 Challenge as it Receives First Commitments for Oxford’s Potential New Vaccine
May 25, 2020
May 26, 2020
- IAVI and Merck Collaborate to Develop Vaccine Against SARS-CoV-2
- Merck and Ridgeback Bio Collaborate to Advance Development of Novel Antiviral Candidate, EIDD-2801
- Merck to Announce Multiple Scientific Efforts to Combat COVID-19
- Anivive Repurposes Veterinary Drug GC376 for COVID-19 And Submits Pre-IND to FDA
May 27, 2020
- Novartis Announces New Late-Breaking Ofatumumab Data at EAN Underscoring Commitment to Advancing Treatment of Relapsing Forms of Multiple Sclerosis (RMS)
- DREAMM-2 and DREAMM-6 Data at ASCO Reinforce the Potential of GSK’s Investigational Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma
- Genentech Initiates Phase III Clinical Trial of Actemra Plus Remdesivir in Hospitalized Patients With Severe COVID-19 Pneumonia
- ImmunityBio & NantKwest Sign COVID-19 Joint Development, Manufacturing and Marketing Agreement; ImmunityBio Selected for ‘Operation Warp Speed’ to Develop Novel Adenovirus COVID-19 Vaccine
May 28, 2020
May 29, 2020
- BeiGene Presents Phase 3 Data on Tislelizumab Combined with Chemotherapy for the Treatment of Patients with Advanced Squamous Non-Small Cell Lung Cancer at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program
- Amgen Presents New AMG 510 Clinical Data Across Multiple Solid Tumors During ASCO20 Virtual Scientific Program
- Sumitovant Biopharma Announces Myovant Sciences’ Additional Positive Efficacy and Cardiovascular Safety Data from Phase 3 HERO Study of Once-Daily, Oral Relugolix in Advanced Prostate Cancer and Publication in the New England Journal of Medicine
- Investigational Magrolimab in Combination With Azacitidine Demonstrates Durable Activity in Previously-Untreated Myelodysplastic Syndrome and Acute Myeloid Leukemia
- Moderna Announces First Participants in Each Age Cohort Dosed in Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
May 31, 2020
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