Pfizer, Roivant Unveil Priovant with High Potential TYK2/JAK1 Inhibitor
Pfizer and Roivant Sciences unveiled a new company called Priovant Therapeutics to develop and market new therapies for a wide range of autoimmune diseases with high mortality and morbidity rates. Priovant was initiated in September 2021 when Pfizer partnered with...
FDA Presses Pause on Astellas’ Pompe Disease Therapeutic
The U.S. Food and Drug Administration has placed Astellas Pharma's Phase I/II FORTIS trial on clinical hold after one of its study participants suffered a serious adverse event (SAE). The study, which is assessing the investigational adeno-associated virus gene...
Sanofi-GSK COVID-19 Vaccine Candidate Effective Against Omicron
Positive news continues to roll out for COVID-19 vaccine development and distribution efforts, with Sanofi and GSK announcing the success of their vaccine candidate against the Omicron variant. Outcomes from Stage 2 of the Phase III study of VAT08 including over...
Endologix Reports 12 Month Data from DETOUR 2 Clinical Trial at 2022 Vascular Annual Meeting
Endologix Inc. LLC, a privately held global medical device company devoted to improving patients’ lives with innovative interventional treatments for vascular disease, recently announced the 12-month results from the DETOUR 2 clinical trial. DETOUR 2 was an...
FDA Approves Merck’s Pneumococcal Disease Vaccine for Infants and Children
Merck scored big with a U.S. Food and Drug Administration approval for an expanded indication of Vaxneuvance, a pneumococcal 15-valent conjugate vaccine. The new indication includes children 6 weeks through 17 years of age. The vaccine is now designated for active...
PTC Ready to Take Another Shot at FDA Approval of DMD Drug
In previous years, PTC Therapeutics has attempted to win regulatory approval for its Duchenne Muscular Dystrophy drug, Translarna (ataluren), but the U.S. Food and Drug Administration has rejected the attempts. The company believes it has data that will support...
Terminology Management for Medical Companies: Maintaining Consistency Throughout the Translation Process
With many medical companies working overseas and requiring high volumes of content to be translated, why is terminology management an important localization solution for saving costs and ensuring a high-quality and consistent translation? Translating medical content...
FDA Authorizes Pfizer-BioNTech, Moderna COVID Vaccines for Children 6 Months to 4 Years
Friday morning, the U.S. Food and Drug Administration granted Emergency Use Authorization to two COVID-19 vaccines for use in children ages 6 months to 4 years old: one developed by Moderna, and the other developed by Pfizer and BioNTech. The Pfizer vaccine for this...
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...