Galecto Announces First Patient Enrolled in Phase 2 Trial of GB1211 in Combination with Atezolizumab for First-Line Treatment of NSCLCGB1211
Galecto Biotech, Inc., a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, announced that the first patient has been enrolled in the Phase 2a GALLANT-1 trial (NCT05240131). GALLANT-1 is formulated to study the...
Quoin Pharmaceuticals Announces Licensing and Distribution Agreement with Leading Rare Disease Company for Greater China
Quoin Pharmaceuticals Ltd., a specialty pharmaceutical company focused on rare and orphan diseases, announced it has obtained a license and distribution agreement with Hong Kong WinHealth Pharma Group Ltd. for its lead product candidate, QRX003 for Netherton Syndrome...
Researchers Link Mutations in Long Neglected Non-Coding Genome to Cancer
Researchers from the Dana-Farber Cancer Institute have found a way to examine more closely into a long-neglected, non-coding portion of the human genome, uncovering mechanisms that might drive or suppress cancer development. Since scientists at the Human Genome...
Rune Labs Secures FDA Clearance for Parkinson’s Disease Monitoring through StrivePD Ecosystem on Apple Watch
Rune Labs, a precision neurology company, announced its StrivePD software ecosystem for Parkinson's disease has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) to gather patient symptom data through quantifications made by Apple Watch. By...
GSK Headed to Regulators with RSV Vaccine
The pursuit for an effective vaccine against the respiratory syncytial virus (RSV) may be at an inflection point. GlaxoSmithKline disclosed positive headline data Friday from a pre-specified efficacy interim analysis of the Phase III trial of its RSV vaccine. The...
Degron Therapeutics Launches into Sizzling Hot Protein Degradation Space
Shanghai-based biotechnology company Degron Therapeutics announced that it has secured $22 million in Series A financing for its unique molecular glue-based targeted protein degradation platform GlueXplorer. Degron plans to use the funds generated from this round of...
Vertex Kidney Disease Drug Scores FDA Breakthrough Therapy Designation
Vertex Pharmaceuticals announced on Wednesday that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to its candidate, inaxaplin (VX-147). Inaxaplin was granted the designation for the treatment of APOL1-mediated focal segment...
Seres Touts Strong Phase III Results Against Recurrent C. Difficile Infection
Massachusetts-based Seres Therapeutics, Inc. announced Tuesday that its Phase III Ecospor IV study exhibited a strong safety profile in addition to statistically significant positive results. The study utilizes an open-label design to determine the potential of...
Pear Therapeutics Announces New Analysis Showing Reduction in Healthcare Resource Utilization and Associated Costs in Patients Using reSET® at Six Months
Pear Therapeutics, Inc., the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs), announced a manuscript accepted for publication and available via pre-print of a real-world study displaying reduced...
Legend Biotech Announces U.S. FDA Clearance of IND Application for Solid Tumor CAR-T, LB1908 for Relapsed or Refractory Gastric, Esophageal and Pancreatic Cancers
Legend Biotech Corporation, a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND)...
Culturally Appropriate Translations for Your Target Audience: In-Country Review (ICR) for Quality Medical Translations
In an industry where mistranslation could put a life at risk, why is it important for language service providers (LSP) to leverage in-country review (ICR) for quality medical translations? When translating medical documents like patient medical records, medication...
Global Roundup: Memo Therapeutics Takes Aim at BKV Infections
Memo Therapeutics, a Switzerland-based antibody discovery and development company, initiated a Phase I study that will evaluate intravenous doses of the experimental MTX-005 that targets BK polyomavirus (BKV) infection in renal transplant patients. The study will...
FDA Pushes Designation Status for Cancer, Hemophilia Treatments
The U.S. Food and Drug Administration (FDA) is on a mission to recuperate from the review lag seen through the early phases of COVID-19 pandemic and has provided special designations for two treatments that could improve the lives of millions with recurrent...
Cybin Submits IND Application to FDA for its Phase 1/2a First-in-Human Trial of CYB003 for the Treatment of Major Depressive Disorder
Cybin Inc, a biopharmaceutical company focused on progressing effective therapeutics for patients, is submitting an Investigational New Drug application to the U.S. Food and Drug Administration for its Phase 1/2a first-in-human clinical trial evaluating CYB003, a...
Exploring the Causal Connection Between COVID-19 and Diabetes
Research involving a causal link between COVID-19 and diabetes has surfaced in a study published in The Lancet Diabetes & Endocrinology in March. Researchers gathered results showing people who suffered from COVID-19 were 40% more likely than controls to develop...
Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® Cosmetic Technology in Dermal Resurfacing Procedures
Apyx Medical Corporation, a manufacturer of medical devices and supplies and the innovator of Helium Plasma Technology, marketed and sold as Renuvion® and J-Plasma® in surgical markets, today announced it has received 510(k) clearance from the U.S. Food and Drug...
FDA Hits Verrica With Third CRL For Lead Drug Candidate VP-102
Verrica Pharmaceuticals has obtained its third Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its New Drug Application for its molluscum contagiosum treatment candidate VP-102. The first CRL was distributed in July 2020 as the FDA...
Inaugural Patient Injected with Vaxinia, Cancer-Killing Oncolytic Virus
Imugene and City of Hope announced this week that the first patient has initiated treatment in a revolutionary Phase I clinical trial, which will evaluate the safety and efficacy of CF33-hNIS (Vaxinia), a cancer-killing virus, in adults with advanced tumors. The...
Altamira Therapeutics Receives Philippines’ FDA Approval of Bentrio Nasal Spray
Altamira Therapeutics Ltd., a company committed to developing therapeutics that address unmet medical needs, announced that Bentrio™ has been approved by the Philippines' Food and Drug Administration (FDA) and is now cleared for commercialization. The product will be...
Why Linguistic Validation for Patient Questionnaires is Important for Clinical Trials
With regulatory documentation presenting an enormous range of requisite communications and regulatory filings, why is linguistic validation for patient questionnaires such an important area of focus for international clinical trials? As an increasing number of...