Ionis Announces GSK Has Advanced Bepirovirsen Into Phase 3 Development
CARLSBAD, Calif., Feb. 1, 2023 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that GSK has initiated two randomized, double-blind, placebo-controlled Phase 3 studies evaluating the safety and efficacy of bepirovirsen... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 1, 2023 Category: Pharmaceuticals Source Type: clinical trials
Beactica Therapeutics Receives FDA Orphan Drug Designation for BEA-17 for the Treatment of Glioblastoma
UPPSALA, Sweden, Feb. 1, 2023 /PRNewswire/ -- Beactica Therapeutics AB, the Swedish precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BEA-17 for the treatment of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 1, 2023 Category: Pharmaceuticals Source Type: clinical trials
Ionis Receives FDA Fast Track Designation for Olezarsen in Patients with Familial Chylomicronemia Syndrome
FCS is a rare and debilitating genetic disease often leading to significant risk of acute, potentially fatal pancreatitis
If approved, olezarsen would be the first approved treatment for FCS in the U.S.
CARLSBAD, Calif., Jan. 31, 2023... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 31, 2023 Category: Pharmaceuticals Source Type: clinical trials
Aptose Initiates Dosing of Tuspetinib in APTIVATE Expansion Trial in Patients with Acute Myeloid Leukemia
SAN DIEGO and TORONTO, Jan. 30, 2023. Aptose Biosciences Inc. (“Aptose”) today announced the 120 mg monotherapy dosing of patients in the APTIVATE Phase 1/2 clinical trial of tuspetinib (formerly HM43239), an oral, mutation agnostic... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 30, 2023 Category: Pharmaceuticals Source Type: clinical trials
Marburg Vaccine Shows Promising Results in First-in-Human Study
January 30, 2023 -- A newly published paper in The Lancet shows that an experimental vaccine against Marburg virus (MARV) was safe and induced an immune response in a small, first-in-human clinical trial. The vaccine, developed by researchers at the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 30, 2023 Category: Pharmaceuticals Source Type: clinical trials
TROPION-Lung07 Phase 3 Trial Initiated to Evaluate Datopotamab Deruxtecan in Combination with Pembrolizumab in Patients with Previously Untreated Metastatic Non-Small Cell Lung Cancer
TOKYO& BASKING RIDGE, N.J.--(BUSINESS WIRE) January 30, 2023 --Daiichi Sankyo (TSE: 4568) today announced that the first patient has been dosed in the global, randomized TROPION-Lung07 phase 3 trial evaluating datopotamab deruxtecan (Dato-DXd)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 30, 2023 Category: Pharmaceuticals Source Type: clinical trials
Moderna Granted FDA Breakthrough Therapy Designation for mRNA-1345, An Investigational Respiratory Syncytial Virus (RSV) Vaccine Candidate
Designation based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy trial, which demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults
CAMBRIDGE, MA... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 30, 2023 Category: Pharmaceuticals Source Type: clinical trials
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
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... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 27, 2023 Category: Pharmaceuticals Source Type: clinical trials
NEJM publishes data demonstrating clinically meaningful prevention of bleeds and superior bleed protection for efanesoctocog alfa
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... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 26, 2023 Category: Pharmaceuticals Source Type: clinical trials
Nasal Spray Study in Sjogren's Dry Eye Disease
Conditions: Sjogren's Syndrome; Dry Eye Intervention: Drug: Varenicline Nasal Spray Sponsors: University of Pennsylvania; Oyster Point Pharma, Inc. Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 26, 2023 Category: Research Source Type: clinical trials