Clinical Trial News Archive - December 2022
December 1, 2022
- Y-mAbs Announces Complete Response Letter for Omburtamab Biologics License Application
- Valneva and Pfizer Report Six-Month Antibody Persistence Data in Children and Adults for Lyme Disease Vaccine Candidate
- Regeneron ESMO IO Presentations Highlight Potential of Fianlimab and Libtayo® (cemiplimab) in Multiple Solid Tumor Types
- NaxSwab OTC naloxone nasal swab demonstrates faster absorption and higher early exposures against other naloxone products in clinical study
- Neuvivo’s NP001 for Treatment of ALS Slows Disease Progression Through Regulation of Microbial Translocation
December 5, 2022
- Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years
- Istesso Announces FDA Fast Track and Orphan Drug Designation for MBS2320
December 6, 2022
- Emergent BioSolutions Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for Over-the-Counter Narcan (naloxone HCl) Nasal Spray
- Breakthrough Therapy Designation Granted for Revumenib for the Treatment of Patients with Relapsed or Refractory KMT2A-Rearranged Acute Leukemia
- Pfizer and Clear Creek Bio to Collaborate on a Research Program Targeting SARS-CoV-2 Papain-Like Protease
December 7, 2022
- U.S. FDA Accepts for Priority Review the Biologics License Application for Pfizer’s Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV Disease in Older Adults
- Diamond Therapeutics completes Phase I clinical study of low-dose psilocybin in healthy human subjects
December 8, 2022
- Novartis Investigational Iptacopan Provides Clinically Meaningful Increases in Hemoglobin Levels in Complement-Inhibitor-Naïve Patients with PNH
- Capivasertib Plus Faslodex Reduced the Risk of Disease Progression or Death by 40% Versus Faslodex in Advanced HR-Positive Breast Cancer
- Moderna Receives FDA Emergency Use Authorization for Omicron-Targeting Bivalent COVID-19 Booster Vaccine in Children 6 Months Through 5 Years of Age
- Datopotamab Deruxtecan Showed Encouraging and Durable Efficacy in Patients with Heavily Pretreated HR-Positive, HER2-Low or Negative Metastatic Breast Cancer
- Camizestrant Significantly Delayed Disease Progression in Advanced ER-Positive Breast Cancer, Adding at Least 3.5 Months Benefit Versus Faslodex
- Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years
- Bocox for Erectile Dysfunction Announced by the Cellular Medicine Association
December 9, 2022
- Datopotamab Deruxtecan Showed Promising Responses as Monotherapy and in Combination with Imfinzi in Patients with Metastatic Triple-Negative Breast Cancer in Two Early Trials
- WHO adopts antibodies created by Lankenau researchers as a standard to ensure quality control of polio vaccines worldwide
December 10, 2022
- Pfizer Presents Updated Favorable Elranatamab Data from Pivotal Phase 2 MagnetisMM-3 Trial
- Janssen Presents New Data for Talquetamab, a First-in-Class GPRC5DxCD3 Bispecific Antibody, Suggesting Durable Responses in Patients with Heavily Pretreated Multiple Myeloma
December 11, 2022
December 12, 2022
- Odronextamab (CD20xCD3) Demonstrates High and Durable Complete Response Rate among Patients with Relapsed/Refractory Follicular Lymphoma in Pivotal Phase 2 Trial
- Genentech Presents New Data Demonstrating the Potential of Glofitamab and Mosunetuzumab as Fixed-Duration, Off-The-Shelf Treatment Options for Lymphoma
- Linvoseltamab (BCMAxCD3) Initial Pivotal Phase 2 Data Show Clinically Meaningful Responses in Patients with Heavily Pre-treated Multiple Myeloma
- Frontage Partners with Eisai and Biogen to Complete the Clarity AD study for the Alzheimer's Drug, Lecanemab
December 13, 2022
- Endocarditis in Patients with Cocaine or Opioid Use Disorder Saw Marked Increase Between 2011 to 2022
- Moderna and Merck Announce mRNA-4157/V940, an Investigational Personalized mRNA Cancer Vaccine, in Combination with KEYTRUDA (pembrolizumab), Met Primary Efficacy Endpoint in Phase 2b KEYNOTE-942 Trial
- Novartis Presents Pivotal Phase III APPLY-PNH Data at ASH Demonstrating Investigational Oral Monotherapy Iptacopan Superiority Over Anti-C5
December 14, 2022
- Positive Interim Data from Phase IIb Clinical Trial of STP705 in Adults with Cutaneous Squamous Cell Carcinoma
- NIH-Funded Study Finds Hepatitis C Treatment Gap for Individuals With Alcohol Use Disorder
- Ebola Vaccine Regimens Safe, Immunogenic in Adults and Children
December 15, 2022
- Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 GLOW Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-negative Locally Advanced Unresectable or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers
- Dupixent Approved by European Commission as the First and Only Targeted Medicine Indicated for Prurigo Nodularis
December 16, 2022
- NIH Launches Harm Reduction Research Network to Prevent Overdose Fatalities
- Synaptogenix Announces Topline Results from NIH-Sponsored Phase 2 Clinical Trial of Bryostatin-1 for Advanced Alzheimer's Disease
- AbbVie Submits Supplemental New Drug Application to Support New Indication of Linzess for Functional Constipation in Children and Adolescents
December 19, 2022
- Anti-TIGIT Domvanalimab-Containing Study Arms Improve Progression-Free Survival Compared to Anti-PD1 Alone in Phase 2 Non-Small Cell Lung Cancer Study
- Soligenix Initiates Phase 2 Clinical Trial of SGX302 (synthetic hypericin) for the Treatment of Mild-to-Moderate Psoriasis
December 20, 2022
December 23, 2022
December 24, 2022
December 26, 2022
December 27, 2022
December 28, 2022
- U.S. FDA Accepts for Review the Biologics License Application for Pfizer’s Investigational Pentavalent Meningococcal Vaccine Candidate (MenABCWY) in Adolescents
- Clearmind Medicine Announces First Clinical Center to Join Its Clinical Trial for Alcohol Use Disorder
December 29, 2022
- Pfizer Announces Positive Top-Line Results from Phase 3 Study of Hemophilia B Gene Therapy Candidate
- FDA Grants Appeal for Ardelyx's Xphozah
December 30, 2022
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