Drugs.com - Clinical Trials Clinical trial news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
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Janssen Announces Unblinding of Phase 3 CARTITUDE-4 Study of CARVYKTI as Primary Endpoint Met in Treatment of Patients with Relapsed and Refractory Multiple Myeloma
on January 27, 2023 at 7:01 pm
RARITAN, N.J., Jan. 27, 2023. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Phase 3 CARTITUDE-4 study evaluating CARVYKTI (ciltacabtagene autoleucel; cilta-cel) versus pomalidomide, bortezomib, and...
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NEJM publishes data demonstrating clinically meaningful prevention of bleeds and superior bleed protection for efanesoctocog alfa
on January 26, 2023 at 7:01 pm
STOCKHOLM, Jan. 26, 2023. Pivotal study data published in The New England Journal of Medicine (NEJM) continues to highlight the efficacy, safety, and pharmacokinetic profile of efanesoctocog alfa (formerly BIVV001), a potential new medicine for...
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c-Abl Demonstrates Potential as a Key Therapeutic Target in Parkinson's Disease and Related Disorders
on January 25, 2023 at 7:01 pm
BOSTON and ATLANTA, Jan. 25, 2023. Inhibikase Therapeutics, Inc. ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related...
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Health Canada Approval of Phase 2 Clinical Trial with Low-Dose Psilocybin
on January 24, 2023 at 6:01 pm
TORONTO, Jan. 24, 2023. Diamond Therapeutics Inc. ("Diamond"), a drug development company focused on low-dose psychedelic-derived therapies for use in the treatment of mental health, is pleased to announce it has received Health Canada approval to...
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Benitec Biopharma Enrolls First OPMD Subject into the Clinical Development Program
on January 23, 2023 at 8:01 pm
HAYWARD, Calif., Jan. 23, 2023. Benitec Biopharma Inc. (“Benitec” or “the Company”), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA-directed...
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Overdose Deaths Involving Buprenorphine Did Not Proportionally Increase With New Flexibilities in Prescribing
on January 20, 2023 at 11:01 pm
January 20, 2023 -- The proportion of opioid overdose deaths involving buprenorphine, a medication used to treat opioid use disorder, did not increase in the months after prescribing flexibilities were put in place during the COVID-19 pandemic,...
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Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease
on January 20, 2023 at 7:01 pm
TOKYO, Jan. 20, 2023. Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on January 19th for the FORTIS Ph1/2 clinical...
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U.S. Food and Drug Administration Issues Complete Response Letter for Accelerated Approval of Donanemab
on January 19, 2023 at 11:01 pm
Accelerated approval application was based on Phase 2 trial showing amyloid plaque lowering Complete response letter based on limited number of patients with 12-month drug exposure data in the accelerated approval submission; no other...
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Apex Labs Granted Approval for 294 Patient Take Home Psilocybin Clinical Trial
on January 19, 2023 at 7:01 pm
VANCOUVER, BC, Jan. 19, 2023. Apex Labs Ltd. (APEX or the Company), a pharmaceutical company optimizing the standard of mental health care with psilocybin, is pleased to announce its approval by Health Canada to begin APEX-002-A01-03, the world's...
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Janssen and Global Partners to Discontinue Phase 3 Mosaico HIV Vaccine Clinical Trial
on January 18, 2023 at 8:01 pm
Independent, scheduled review of Phase 3 Mosaico study finds investigational vaccine regimen lacks efficacy in preventing HIV No vaccine-related safety issues identified LEIDEN, THE NETHERLANDS, (January 18, 2023) – The Janssen...
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Experimental HIV Vaccine Regimen Safe But Ineffective, Study Finds
on January 18, 2023 at 8:01 pm
January 18, 2023 -- An investigational HIV vaccine regimen tested among men who have sex with men (MSM) and transgender people was safe but did not provide protection against HIV acquisition, an independent data and safety monitoring board (DSMB)...
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FDA Clears Application for Phase 2 Clinical Trial of CYR-064 to Treat Post-Viral Smell Loss
on January 18, 2023 at 8:01 pm
DELRAY BEACH, Fla., Jan. 18, 2023. Cyrano Therapeutics, a biopharmaceutical company developing medicines for patients with hyposmia (smell loss), announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New...
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Probiotic Markedly Reduces Staphylococcus Aureus Colonization in Phase 2 Trial
on January 17, 2023 at 9:01 pm
January 17, 2023 -- A promising approach to control Staphylococcus aureus bacterial colonization in people – using a probiotic instead of antibiotics – was safe and highly effective in a Phase 2 clinical trial. The new study, reported in...
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Comparison of Diuretics Shows No Difference in Heart Failure Survival
on January 17, 2023 at 9:01 pm
January 17, 2023 -- Two drugs widely used to treat adults with heart failure – furosemide and torsemide – showed no difference in their ability to improve patient survival when compared, according to findings from a clinical trial...
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MedRhythms Announces Positive Topline Results from Pivotal Trial in Chronic Stroke
on January 17, 2023 at 6:01 pm
PORTLAND, Maine, Jan. 17, 2023. MedRhythms announced today that the company's pivotal trial for MR-001, a novel digital intervention in development to treat gait deficits in chronic stroke, was successfully completed and met its primary...
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Favorable Preclinical Data for Intranasal Gonorrhea Vaccine Avacc 11
on January 16, 2023 at 7:01 pm
BILTHOVEN, The Netherlands, Jan. 16, 2023, Intravacc, a world leader in translational research and development of preventive and therapeutic vaccines, today announced favorable pre-clinical data for Avacc 11, the prophylactic intranasal gonorrhea...
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Cantargia successfully concludes toxicity study with CAN10 antibody ahead of phase I clinical trial application
on January 13, 2023 at 6:01 pm
LUND, Sweden, Jan. 13, 2023 /PRNewswire/ -- Cantargia (Cantargia AB) today announced that the Good Laboratory Practice (GLP) toxicity study for its anti-inflammatory IL1RAP-binding antibody CAN10 has been concluded. Data from the study show...
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Versanis Announces Initiation of the BELIEVE Global Phase 2b Study of Bimagrumab as a Novel Treatment for Obesity
on January 12, 2023 at 8:01 pm
NEW YORK, Jan. 12, 2023. Versanis Bio ("Versanis"), a clinical-stage biopharmaceutical company advancing novel therapeutics for cardiometabolic diseases, today announced that the BELIEVE Phase 2b study to assess the safety and efficacy of bimagrumab...
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Lipella Pharmaceuticals Announces Successful Top Line Results of Phase 2A Clinical Trial of LP-10
on January 11, 2023 at 6:01 pm
PITTSBURGH, Jan. 11, 2023. Lipella Pharmaceuticals Inc. ("Lipella," "our, "us" or the "Company"), a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing...
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PL8177 Demonstrates Therapeutic Effects in Inflammatory Conditions
on January 10, 2023 at 6:01 pm
CRANBURY, N.J., Jan. 10, 2023. Palatin Technologies, Inc. a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced Frontiers in Immunology...
