Clinical Trial News Archive - December 2021
December 1, 2021
December 2, 2021
- Preclinical Data Demonstrate Sotrovimab Retains Activity Against Key Omicron Mutations, New SARS-CoV-2 Variant
- Novavax Statement on Omicron Variant Response
December 3, 2021
December 6, 2021
- Biohaven Reports Positive Topline Results from Pivotal Migraine Trial of Intranasal Zavegepant Demonstrating Ultra-Rapid Pain Relief by 15 Minutes
- Galderma Announces New Data Demonstrating the Positive Anti-Inflammatory Effect and Mode of Action of Nemolizumab in Patients with Moderate to Severe Prurigo Nodularis
- Acadia Pharmaceuticals Announces Positive Top-line Results from the Pivotal Phase 3 Lavender Trial of Trofinetide in Rett Syndrome
December 7, 2021
December 8, 2021
- 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
- Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device
December 9, 2021
- uniQure and CSL Behring Announce Primary Endpoint Achieved in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B
- Cytokinetics Announces Receipt of Breakthrough Therapy Designation from FDA for Aficamten
- 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
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
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
December 14, 2021
- Mirikizumab Demonstrates Superiority over Placebo in Phase 3 Maintenance Study in Ulcerative Colitis, Supporting Regulatory Submissions in 2022
- 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
- U.S. FDA Grants Priority Review for Spesolimab for the Treatment of Flares in Patients with Generalized Pustular Psoriasis (GPP)
- 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
- 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
- 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
- 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
- Novavax Announces Initiation of PREVENT-19 COVID-19 Vaccine Phase 3 Trial Booster Study
December 22, 2021
- 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
- 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 29, 2021
December 31, 2021
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