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.
EMA Launches Draft for EU Electronic Product Information (ePI)
Following the European Medicines Agency (EMA) and the European Commission and Heads of Medicines Agencies’ (HMA) release of principles outlining a standardized approach to electronic product information (ePI) last year, the EMA is holding a stakeholder consultation to...
Extensive Clinicom Interview: ‘Stigma-Eraser’ and Saving Lives
CSOFT Health Sciences sat down with Dr. Nelson M. Handal, President and Chairman of Clinicom, in our newest podcast episode of Coffee & Conversations to discuss the value of Clinicom’s digital assessment tool in enhancing patient care and eliminating misdiagnoses....
FDA Approves New Pfizer Pneumococcal Vaccine for Adults
A new pneumococcal 20-valent conjugate vaccine by Pfizer, PREVNAR 20™, has been approved for adults by the FDA in efforts to strengthen the prevention of disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes. The authorized vaccine not...
Effective Cardiovascular Results from Lipoprotein Apheresis
A study conducted by the Centre of Nephrology, Apheresis and Dialysis in Germany concluded that Lipoprotein apheresis (LA) is a safe and effective treatment for high-risk dyslipidemia and lowers Cardiovascular rates. The study concluded that LA decreases levels of...
First Alzheimer’s Treatment by Biogen Approved by FDA
The U.S Food and Drug Administration (FDA) has approved Biogen’s aducanumab treatment for Alzheimer's which aims to eliminate the sticky deposits of amyloid beta found in the brains of patients in the initial stages of the disease. In spite of controversy and...
Regeneron COVID-19 Antibody Therapy Approved for Injection
In a move to combat treatment delay, as well as to meet the demand for antibody drugs, the U.S has approved Regeneron Pharmaceutical’s lower dose COVID-19 antibody cocktail that can be administered through injection. The therapy, REGEN-COV, is now permitted to...
FDA Authorizes Cognoa Pediatric Autism (ASD) Diagnosis Device
The U.S Food and Drug Administration (FDA) authorized the marketing of unique autism diagnostic device developed by Cognoa to help diagnose autism spectrum disorder (ASD) in young children between 18 months and 5 years of age. Using a machine learning- based software...
Possible Link Between Myocarditis in Young Males and Pfizer Vaccine
Israel’s Ministry of Health has found a possible link between myocarditis (heart inflammation) in males aged 16-30 and the second Pfizer vaccine. In examining the matter, the Ministry has disclosed the findings of its commissioned study stating that among the total 5...
FDA Approves Amgen’s Lumakras for Lung Cancer Mutation
The U.S. Food and Drug Administration (FDA) has given Amgen’s Lumakras (sotorasib) accelerated approval as a treatment for patients diagnosed with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) - the first FDA approved treatment...
Fennec Pharmaceuticals Resubmits NDA for PEDMARK™
Fennec Pharmaceuticals has resubmitted their New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARK™, a unique sodium thiosulfate formulation. PEDMARK is designed to prevent ototoxicity caused by cisplatin chemotherapy in patients under...
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