Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
Nurix Therapeutics Announces Clearance of Investigational New Drug Application For NX-1607 Supporting Plans to Expand Enrollment to U.S. Clinical Sites
Nurix Therapeutics, Inc., a clinical stage biopharmaceutical company developing targeted protein modulation drugs, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the company's Investigational New Drug (IND)...
BriaCell Enters Research Agreement to Identify Novel Targets for Cancer Treatment
BriaCell Therapeutics Corp., a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, today announced a research collaboration agreement with Harvard Medical School in support of a project led by Joan S. Brugge, PhD, a faculty...
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...
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