Clinical Trial News Archive - June 2023
June 1, 2023
- Update on Brazikumab Development Programme
- Phase 3 Studies of Pfizer’s Novel Antibiotic Combination Aztreonam-Avibactam (ATM-AVI) Offer New Treatment Hope for Patients with Multidrug-Resistant Infections and Limited Treatment Options
- NIH’s ComboMATCH Initiative Will Test New Drug Combinations Guided by Tumor Biology
- Ionis Announces Positive Donidalorsen Late-Stage Clinical Progress in HAE
- Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in Lupus Nephritis
- Janssen COVID-19 Vaccine No Longer Authorized for Emergency Use
- Study Finds Surgical Treatment of Sleep Apnea More Effective than CPAP Therapy in Preventing the Onset of Type 2 Diabetes
June 2, 2023
June 3, 2023
- Trial Shows Potential for Chemotherapy-free Treatment of HER2-positive Early Breast Cancer
- Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma
- Janssen Presents First-Ever Results from Dual Bispecific Combination Study Showing 96 Percent Overall Response Rate in Patients with Relapsed or Refractory Multiple Myeloma
June 4, 2023
- New Long-Term Data from the CHRYSALIS Study Show Median Progression-Free Survival Not Reached after 33.6 Months of Follow-Up with First-Line Use of RYBREVANT® (amivantamab-vmjw) and Lazertinib Combination Therapy in Patients with Treatment-Naïve EGFR-Mutated Advanced Non-Small Cell Lung Cancer
- Servier Presents Transformational Data from Pivotal Phase 3 INDIGO Trial of Vorasidenib in Recurrent or Residual Grade 2 IDH-Mutant Diffuse Glioma
June 5, 2023
- Biogen Provides Update on Parkinson’s Disease Clinical Development Program
- Datopotamab Deruxtecan Combinations Showed Encouraging Tumour Responses in Patients with Advanced Non-Small Cell Lung Cancer in TROPION-Lung02 Phase Ib Trial
- Ultragenyx and Mereo BioPharma Announce Positive Data from the Ongoing Phase 2/3 Orbit Study of Setrusumab (UX143) in Osteogenesis Imperfecta (OI)
- Coherus Announces Positive Final Overall Survival Results of JUPITER-02 Phase 3 Trial Evaluating Toripalimab in Nasopharyngeal Carcinoma
June 6, 2023
- Janssen Presents Longer-Term Data for Tecvayli Showing a Duration of Response of 22 Months in Patients with Relapsed or Refractory Multiple Myeloma
- FDA Announces Additional Steps to Modernize Clinical Trials
June 7, 2023
June 8, 2023
- Nirsevimab Unanimously Recommended by FDA Advisory Committee for the Prevention of RSV Lower Respiratory Tract Disease in Infants
- New Data Show Genentech’s Subcutaneously Administered Crovalimab Achieved Disease Control and Was Well-Tolerated in People With Paroxysmal Nocturnal Hemoglobinuria (PNH)
June 9, 2023
- Positive Results From Pivotal Trials of exa-cel for Transfusion-Dependent Beta Thalassemia and Severe Sickle Cell Disease Presented at the 2023 Annual European Hematology Association (EHA) Congress
- FDA Advisory Committee Votes Unanimously to Confirm the Clinical Benefit of Leqembi® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
- Danicopan as Add-On to Ultomiris or Soliris Improved Hemoglobin Levels and Maintained Disease Control in Patients with PNH Experiencing Signs or Symptoms of Clinically Significant Extravascular Hemolysis
June 12, 2023
- Many long COVID patients suffer from persistent inflammation, study finds
- Food-Drug Interactions Could be Impactful for Some Lung Cancer Patients
June 13, 2023
- Valneva Announces Publication of its Chikungunya Vaccine Candidate Phase 3 Data in The Lancet
- Inventiva Announces Positive Topline Results From the Investigator-Initiated Phase II Clinical Trial Evaluating Lanifibranor in Patients with T2D and NAFLD
- Only 1 in 4 Adolescent Treatment Facilities Offer Buprenorphine for Opioid Use Disorder
- Intraocular Corticosteroids Best for Treating Complications of Chronic Inflammatory Eye Condition
- NIH and FDA Leaders Call for More Research, Lower Barriers to Improve and Implement Drug-Checking Tools Amid Overdose Epidemic
- Tetra Pharm Technologies announces successful In-Vitro drug release test of new analgesic compound
June 14, 2023
- Men Died of Overdose at 2-3 Times Greater a Rate Than Women in the U.S. in 2020-2021
- Vial Partners with Nielsen BioSciences, Inc. in Phase III Clinical Trial for the Treatment of Common Warts
June 15, 2023
- Skyrizi Met Primary and Key Secondary Endpoints in 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients
- Avenge Bio Receives FDA Orphan Drug Designation for AVB-001 for the Treatment of Mesothelioma
June 16, 2023
June 19, 2023
June 20, 2023
- Xylazine Appears to Worsen the Life-Threatening Effects of Opioids in Rats
- Low-Dose Aspirin May Increase Risk of Anemia in Older Adults
- Milestone Pharmaceuticals Announces Publication of Results from Phase 3 RAPID Clinical Trial of Etripamil Nasal Spray in Patients with PSVT in The Lancet
- Clarity commences COMBAT theranostic prostate cancer trial in the US
June 21, 2023
- PTC Therapeutics Shares Positive Interim Data for PTC518 from PIVOT-HD Clinical Trial in Huntington's Disease Patients
- PureTech Initiates Phase 2a Clinical Trial of LYT-300 (Oral Allopregnanolone) for the Potential Treatment of Anxiety Disorders
- uniQure Announces Update on U.S. Phase I/II Clinical Trial of AMT-130 Gene Therapy for the Treatment of Huntington’s Disease
- MAPS PBC Announces National Institute on Drug Abuse to Share Data for New Drug Application for MDMA-Assisted Therapy for Treatment of PTSD
- GSK Shares Positive Data for Arexvy, its Respiratory Syncytial Virus (RSV) Older Adult Vaccine, Indicating Protection Over Two RSV Seasons
June 22, 2023
- Potential Treatment for Rare Autoimmune Disorder Adapted From CAR-T Therapy
- Alzamend Neuro Announces Positive Phase IIA Clinical Trial Results for AL001
- Pelareorep Selected for Inclusion in Phase 3 Pancreatic Cancer Trial
June 23, 2023
- Data Shows Nearly 19% Weight Loss in People with Overweight or Obesity in Boehringer Ingelheim and Zealand Pharma Phase II Trial with Survodutide (BI 456906)
- Lilly's Phase 2 Results Published in the New England Journal of Medicine Show Orforglipron, a Once-Daily Oral Nonpeptide GLP-1 Receptor Agonist, Achieved up to 14.7% Mean Weight Reduction at 36 Weeks in Adults with Obesity or Overweight
- Researchers Show How a Tumor Cell’s Location and Environment Affect Its Identity
- Hepcludex (bulevirtide) Demonstrates Sustained Efficacy and Safety Profile in People With Chronic Hepatitis Delta Virus at 96 Weeks
- FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
June 24, 2023
- Emergent BioSolutions Announces FDA Acceptance of Biologics License Application for AV7909 Anthrax Vaccine Candidate
- New Data Show Once-Weekly Insulin Icodec Met Additional Endpoints in Adults with Type 2 Diabetes in Phase 3a Trials
June 26, 2023
- Lilly's Phase 2 Retatrutide Results Published in The New England Journal of Medicine Show the Investigational Molecule Achieved up to 17.5% Mean Weight Reduction at 24 weeks in Adults with Obesity and Overweight
- New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
- Research and Pipeline Research Pfizer Provides Update on GLP-1-RA Candidate Danuglipron Clinical Development Program for Adults with Obesity and Type 2 Diabetes Mellitus
- Positive Topline Data in Phase 2b Osteoarthritis Trial with EP-104IAR
June 27, 2023
- GSK Receives US FDA Fast Track Designation for Investigational Vaccine Against Gonorrhoea
- Theriva Biologics Announces Orphan Drug Designation Granted by the U.S. FDA for VCN-01 for the Treatment of Pancreatic Cancer
June 28, 2023
- Genprex Receives Fast Track Designation for REQORSA Immunogene Therapy in Combination with Tecentriq for the Treatment of Small Cell Lung Cancer
- Alvotech Provides Regulatory Update on Second Biologics License Application for AVT02
June 29, 2023
- Zenocutuzumab (Zeno) Granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration for the Treatment of NRG1+ Pancreatic Cancer
- PTC Therapeutics Announces Results from MIT-E Clinical Trial of Vatiquinone for the Treatment of Mitochondrial Disease Associated Seizures
- Akebia Therapeutics Announces Positive Top-Line Results of Phase 4 IMPACT Study of Auryxia for Dialysis Patients
- BioXcel Therapeutics Announces Positive Topline Results From TRANQUILITY II Phase 3 Trial of BXCL501 for Acute Treatment of Alzheimer’s Disease-Related Agitation
June 30, 2023
- Ipsen and GENFIT Announce Positive Results from Phase III ELATIVE Trial of Elafibranor in Patients with Primary Biliary Cholangitis, a Rare Cholestatic Liver Disease
- Capricor Therapeutics Announces Positive 24-Month Results from Ongoing HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy
- Clinical Trial Data of Novel Metabolic Mechanism in Migraine: CER-0001, a Ketogenic Investigational Agent
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