Clinical Trial Corner: Dr. Vladimir Misik Introduces CSOFT’s Newest Series
After participating in CSOFT’s Coffee and Conversations podcast in 2021, I felt honored being asked by Shunee Yee, the President and CEO of CSOFT and CSOFT Health Sciences, to write a blog series on pertinent topics in global clinical trials by showcasing my expertise...
Sanofi Wins FDA Approval for First ASMD Drug
Sanofi announced that Xenpozyme (olipudase alfa-rpcp) won FDA approval for adult and pediatric patients with the rare genetic disease acid sphingomyelinase deficiency (ASMD), often referred to as Niemann-Pick disease. In its announcement, the FDA noted that...
ImmunoGen Provides Update on Pivotal CADENZA Study of Pivekimab Sunirine in Frontline Blastic Plasmacytoid Dendritic Cell Neoplasm
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, provided an update on the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab) in blastic plasmacytoid dendritic cell neoplasm...
FDA Allows Patient Enrollment to Resume in Monotherapy Dose Escalation of Emavusertib in TakeAim Leukemia Study
Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, announced that the U.S. Food and Drug Administration (FDA) has notified Curis that it may resume enrollment of additional patients in...
iCAD Customers in the U.S. and Europe Increasingly Adopting Company’s Full Suite of Breast AI Technologies via Subscription Model
iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, announced that a growing number of hospitals and imaging centers in the U.S. and Europe are increasingly choosing to adopt iCAD’s Breast AI...
Journal of Pharmaceutical Analysis Articles Highlight the Potential of Nanotechnology to Detect Clinically Useful Biomolecules
The advent of nanotechnology has led to exciting innovations across all fields of healthcare. While drug delivery and disease treatment are the most discussed medical applications of nanotechnology, recent studies published in Volume 12 Issue 3 of Journal of...
Medical Patent Application Translations: Meeting International Language Requirements for Patent Applications
How can medical device patent application translations help companies maintain a competitive edge in global markets? While medical device patents help prevent other companies from importing, replicating, or using your device domestically, they need to be validated in...
Baxter Broadens Efforts to Increase Awareness, Education and Support of Kidney Health in Black Communities
Baxter International, Inc. (NYSE:BAX), a global medtech leader, announces the national expansion of its partnership with international not-for-profit organization The Links, Incorporated (The Links) to continue bringing awareness and resources for the disproportionate...
SELLAS Life Sciences’ Highly Selective CDK9 Inhibitor, GFH009, Demonstrates Cancer Cell Growth Inhibition in Preclinical In Vitro Model of Neuroendocrine Prostate Cancer Cell Line
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, announced results from a new preclinical in vitro study...
Todos Medical Initiates MonkeyPox Diagnostic Case Studies After Being Approached by 4 Patients, Including 3 Women
Todos Medical Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, announced that its Atlanta-area CLIA/CAP-certified clinical laboratory Provista Diagnostics, Inc. has initiated a MonkeyPox diagnostic case study series evaluating...
Teleflex to Expand Its Surgical Portfolio with Differentiated Stapling Technology for Bariatric Surgery Signs Definitive Agreement to Acquire Standard Bariatrics
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, announced it has entered into a definitive agreement to acquire Standard Bariatrics, Inc. which has commercialized an innovative powered stapling technology for bariatric surgery....
Sorrento Therapeutics Announces China National Medical Products Administration (NMPA) IND Clearance of STI-1558, An Oral Mpro Inhibitor for Phase I Trial In COVID-19 Patients
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced the NMPA clearance of a Phase I study of its oral main viral protease (Mpro) inhibitor, STI-1558, in subjects with COVID-19 in a MAD study in China. In a previously announced Australia Phase I study in...
Odyssey Health Achieves Positive Safety Outcomes for Concussion Drug in Multiple Ascending Dosing Trial
Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, announced the successful completion of safety measures for their Phase I Multi-Day Ascending Dosing (MAD) clinical...
Blue Water Vaccines Announces Exploration of Its Virus-Like Particle (VLP) Platform for Use in Monkeypox Vaccine Candidate
Blue Water Vaccines Inc. (“BWV” or “Blue Water Vaccines” or “the Company”), a biopharmaceutical company developing transformational vaccines to address significant global health challenges, announced that the company plans to explore the potential to develop a novel...
Evoke Pharma and EVERSANA Expand Patient Access to GIMOTI® With New Telehealth SolutionPatients With Symptoms of Diabetic Gastroparesis Now Have Direct-to-Patient Treatment Support Powered by UpScriptHealth
Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company primarily focused on treatments for gastrointestinal (GI) diseases, and Eversana™, an independent provider of global commercial services to the life science industry, today announced that Evoke,...
Zynex Announces First Enrollments in Apheresis Donation Clinical Trial with Second Generation Fluid Monitoring System
Zynex, Inc. (Nasdaq: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, announced it has started enrollments in an ongoing apheresis...
Relief Therapeutics and Acer Therapeutics Announce that the European Commission Has Granted Orphan Drug Designation for ACER-001 in Maple Syrup Urine Disease
Relief Therapeutics Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), and its collaboration partner, Acer Therapeutics Inc. (Nasdaq: ACER) (Acer), announced that the European Commission has granted orphan medicinal product designation in the EU to ACER-001 (sodium...
e-Labeling Translations: IFU Localization for Global Markets
What makes e-labeling translations so important in the medical devices industry? With new frontiers in med device markets emerging globally, instructions for use (IFUs) are a requirement in most markets, which makes e-labeling translations for IFUs a necessary...
Pasithea Therapeutics Announces Results of Preclinical Study Demonstrating Tolerizing Vaccine Efficacy in Relapsing-Remitting Model of Multiple Sclerosis
Pasithea Therapeutics Corp. (Nasdaq: KTTA) (Pasithea or the Company), a biotechnology company focused on the discovery, research, and development of new and effective treatments for psychiatric and neurological disorders, announced positive results from a preclinical...
Biora Therapeutics Announces Successful Completion of Device Performance Study in Ulcerative Colitis Patients for its Targeted Therapeutics Platform
Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutics, announced topline results from its recently completed study PM-602: A Scintigraphic Study to Evaluate the Localization and Delivery Function of a Drug Delivery System...