Clinical Trial News Archive - December 2021
December 1, 2021
- Insightec Announces FDA Clearance For Exablate Prostate To Treat Prostate Tissue
- Sage Therapeutics and Biogen Announce Positive, One-Year Zuranolone 50 mg Data in the Ongoing Open-Label SHORELINE Study in Patients with MDD
December 2, 2021
- Preclinical Data Demonstrate Sotrovimab Retains Activity Against Key Omicron Mutations, New SARS-CoV-2 Variant
- Novavax Statement on Omicron Variant Response
- ViaCyte's Stem Cell-Derived Treatment for Type 1 Diabetes Shows Promising Results in Two Published Studies
December 3, 2021
- I-Mab Announces First Two Patients Dosed in U.S. Phase 2 Combination Trial of Uliledlimab with Atezolizumab in Patients with Selected Advanced Solid Tumors
- Lilly's Bamlanivimab with Etesevimab Authorized as the First and Only Neutralizing Antibody Therapy for Emergency Use in COVID-19 Patients Under the Age of 12
December 6, 2021
- Biohaven Reports Positive Topline Results from Pivotal Migraine Trial of Intranasal Zavegepant Demonstrating Ultra-Rapid Pain Relief by 15 Minutes
- Johnson & Johnson COVID-19 Booster, Administered Six Months After Two-Dose Regimen of BNT162b2, Shows Substantial Increase in Antibody and T-cell Responses
- Galderma Announces New Data Demonstrating the Positive Anti-Inflammatory Effect and Mode of Action of Nemolizumab in Patients with Moderate to Severe Prurigo Nodularis
- Merck Announces Pause in Enrollment for Two Phase 3 Clinical Trials of Investigational, Once-Monthly, Oral Islatravir for Pre-Exposure Prophylaxis (PrEP) of HIV-1 infection
- Acadia Pharmaceuticals Announces Positive Top-line Results from the Pivotal Phase 3 Lavender Trial of Trofinetide in Rett Syndrome
December 7, 2021
- Preclinical Studies Demonstrate Sotrovimab Retains Activity Against the Full Combination of Mutations in the Spike Protein of the Omicron SARS-CoV-2 Variant
- Medicago and GSK Announce Positive Phase 3 Efficacy and Safety Results for Adjuvanted Plant-Based COVID-19 Vaccine Candidate
- MHRA Approves XEVUDY (sotrovimab), GlaxoSmithKline and Vir Biotechnology's Monoclonal Antibody Treatment for Patients with COVID‑19
December 8, 2021
- PARI Nebulizer Successfully Delivers Pulmotect's PUL-042 against COVID-19 in Two Phase 2 Studies
- Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device
- Pfizer and BioNTech Provide Update on Omicron Variant
- Evusheld (formerly AZD7442) Long-Acting Antibody Combination Authorised for Emergency Use in the US for Pre-Exposure Prophylaxis (Prevention) of COVID-19
December 9, 2021
- Iterion Therapeutics Announces Initiation of Phase 1 Clinical Trial to Study Tegavivint in Combination with Osimertinib in Epidermal Growth Factor Receptor-Positive Non-Small Cell Lung Cancer
- A New Class of Antiviral Therapy Could Treat COVID-19
- uniQure and CSL Behring Announce Primary Endpoint Achieved in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B
- Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older
- World Health Organization Strategic Advisory Group of Experts (SAGE) Interim Recommendation Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster
December 10, 2021
- New Data From the Phase II CITYSCAPE Trial Show Encouraging Results With Genentech’s Novel Anti-TIGIT Tiragolumab Plus Tecentriq
- Arvinas and Pfizer Announce PROTAC® Protein Degrader ARV-471 Continues to Demonstrate Encouraging Clinical Benefit Rate in Patients with Locally Advanced or Metastatic ER+/HER2- Breast Cancer
- Stem Cell Infusions May Help Muscular Dystrophy, according to Journal of American Physicians and Surgeons
- UCB Announces Positive Phase 3 Results for Rozanolixizumab in Generalized Myasthenia Gravis
December 11, 2021
- Janssen Presents Updated Results Evaluating First-in-Class Talquetamab (GPRC5DxCD3 Bispecific Antibody) in Heavily Pretreated Patients with Multiple Myeloma
- Genentech Presents Pivotal Data at ASH 2021 for Novel Cancer Immunotherapy Mosunetuzumab
- New REGN5458 (BCMAxCD3) Phase 1 Data Show 75% Response Rate at Highest Dose Levels Studied in Patients with Heavily Pretreated Multiple Myeloma
- Valemetostat Pivotal Data Shows Promising Response Rates in Patients with Adult T-Cell Leukemia/Lymphoma
December 12, 2021
- Loxo Oncology at Lilly Announces Updated Data from the Phase 1/2 BRUIN Clinical Trial for Pirtobrutinib at the American Society of Hematology Annual Meeting
- New Data from CARTITUDE-1 Study Show Continued Deep and Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) in Treatment of Heavily Pretreated Patients with Multiple Myeloma
December 13, 2021
- Largest Study to Date Demonstrates Most Blood Cancer Patients Benefit From a Third Primary Dose of mRNA COVID-19 Vaccine
- New Data from MajesTEC-1 Study Show Continued Deep and Durable Responses of Teclistamab (BCMAxCD3 Bispecific Antibody) in Treatment of Heavily Pretreated Patients with Multiple Myeloma
- Merck Announces Clinical Holds on Studies Evaluating Islatravir for the Treatment and Prevention of HIV-1 Infection
December 14, 2021
- Mirikizumab Demonstrates Superiority over Placebo in Phase 3 Maintenance Study in Ulcerative Colitis, Supporting Regulatory Submissions in 2022
- Rational Vaccines Announces a Clinical Study of the Frequency of Symptomatic Herpes Simplex Type 1 and 2 (HSV-1 and HSV-2) Virus in HIV Patients
- INOVIO Highlights Key Updates on Phase 3 Program for VGX-3100, its DNA-based Immunotherapy for the Treatment of Cervical HSIL Caused by HPV-16 and/or HPV-18
- Pfizer Announces Additional Phase 2/3 Study Results Confirming Robust Efficacy of Novel COVID-19 Oral Antiviral Treatment Candidate in Reducing Risk of Hospitalization or Death
December 15, 2021
- Jazz Pharmaceuticals Announces First Patient Enrolled in Phase 2b Clinical Trial Evaluating Novel Suvecaltamide (JZP385) for Once-Daily Treatment of Adults with Essential Tremor
- Positive Phase II Study Data Suggest ARAKODA (tafenoquine) Numerically Improved Clinical Recovery in Patients with Mild-Moderate COVID-19 Disease
- U.S. FDA Grants Priority Review for Spesolimab for the Treatment of Flares in Patients with Generalized Pustular Psoriasis (GPP)
- GSK and Sanofi Announce Positive Preliminary Booster Data for Their COVID-19 Vaccine Candidate and Continuation of Phase III Trial per Independent Monitoring Board Recommendation
- Novavax Statement on PREVENT-19 Phase 3 Clinical Trial Results Publication in the New England Journal of Medicine
December 16, 2021
- Forma Therapeutics’ Investigational Olutasidenib in Combination with Azacitidine Yields Durable Complete Remission in Patients with mIDH1 Acute Myeloid Leukemia
- Merck and Ridgeback Announce Publication of Phase 3 Study of Molnupiravir, an Investigational Oral Antiviral COVID-19 Treatment, in the New England Journal of Medicine
- Kodiak Sciences Completes Enrollment in BEACON Phase 3 Clinical Trial of KSI-301 in Patients with Retinal Vein Occlusion
- Axcella Therapeutics Announces Initiation of AXA1125 Long COVID Phase 2a Clinical Trial
- Kineret (anakinra) receives positive opinion from the CHMP for treatment of patients with COVID-19 pneumonia
- Evusheld Long-Acting Antibody Combination Retains Neutralising Activity Against Omicron Variant in Independent FDA Study
- Johnson & Johnson Statement on its COVID-19 Vaccine Following CDC ACIP Meeting
December 17, 2021
- Senhwa's Silmitasertib Receives US FDA Orphan Drug Designation for the Treatment of Medulloblastoma
- Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine
- Pfizer and Biontech Provide Update on Ongoing Studies of COVID-19 Vaccine
December 20, 2021
- Moderna Announces Preliminary Booster Data and Updates Strategy to Address Omicron Variant
- Targovax ASA: ONCOS-102 achieves 25.0 months median overall survival in first line mesothelioma
- World Health Organization Grants Second Emergency Use Listing for Novavax COVID-19 Vaccine
December 21, 2021
- Lilly's Lebrikizumab Demonstrated Significant Skin Improvement and Itch Relief When Combined with Topical Corticosteroids in People with Atopic Dermatitis in Third Phase 3 Study
- Gilead Announces Clinical Hold on Studies Evaluating Injectable Lenacapavir for HIV Treatment and Prevention Due to Vial Quality Concerns
- MindMed Provides Status Update on IND for Phase 2b Trial of LSD for the Treatment of Generalized Anxiety Disorder
- Novavax Announces Initiation of PREVENT-19 COVID-19 Vaccine Phase 3 Trial Booster Study
December 22, 2021
- Lipocine announces patient dosed in its phase 2 study with LPCN 1148 for management of liver cirrhosis
- Pfizer Receives U.S. FDA Emergency Use Authorization for Novel COVID-19 Oral Antiviral Treatment Paxlovid
- Novavax Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies
December 23, 2021
- SARS-CoV-2 vaccination creates a strong, persistent T-cell response
- Newly Published Results Showed Spesolimab Significantly Improved Signs and Symptoms of Flares in Rare, Life-Threatening Skin Disease, Generalized Pustular Psoriasis
- Patritumab Deruxtecan Granted U.S. FDA Breakthrough Therapy Designation in Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
- Evusheld Long-Acting Antibody Combination Retains Neutralising Activity Against Omicron Variant in Studies from Oxford and Washington Universities
- Investigational Alzheimer’s Disease Therapy Lecanemab Granted FDA Fast Track Designation
- Vaxzevria Significantly Boosted Antibody Levels Against Omicron
- Radius Announces Update on Tymlos (abaloparatide) Label
- Merck and Ridgeback’s Molnupiravir Receives U.S. FDA Emergency Use Authorization for the Treatment of High-Risk Adults With Mild to Moderate COVID-19
December 27, 2021
December 28, 2021
December 29, 2021
December 30, 2021
- Jazz Pharmaceuticals Announces First Patient Enrolled in Phase 2 Clinical Trial Evaluating JZP150 for Once-Daily Treatment of Adults with Post-Traumatic Stress Disorder
- Johnson & Johnson COVID-19 Vaccine Demonstrates 85 Percent Effectiveness against Hospitalization in South Africa when Omicron was Dominant
December 31, 2021
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