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.
Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate
Valneva SE, a specialty vaccine company, and Pfizer Inc. reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. Based on these new results, Valneva and Pfizer plan to proceed with inclusion of pediatric participants in their planned...
Ardelyx Continues Battle to Secure Approval for Chronic Kidney Disease Drug
Ardelyx announced the U.S. Food and Drug Administration's Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), provided an interim response to the company's second level of appeal for tenapanor. The OND indicated that more input from the...
Biogen Gives Up on EU Approval of Aduhelm Following CHMP Opinion
Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval after regulators hinted the Alzheimer’s drug did not have sufficient enough data to support potential approval. The Boston-based company disclosed the result of a meeting with the...
AI in Healthcare: Leveraging Patient Data Translations to Tackle Health Inequalities
As advanced AI models continue to transform our abilities to collect, manage, and expedite health data analysis, applying this innovative technology to address health inequalities is emerging as an important focus for patient-centered care and an important application...
Servier On Cusp on New Indication with Robust Data in IDH1-mutated AML
Servier is poised to go to market with a new indication after the Phase III trial of a trial of its leukemia drug in IDH1-mutated acute myeloid leukemia (AML) closed with positive results. The global Agile trial ended with Tibsovo (ivosidenib tablets) in combination...
FDA’s Cancer Advisory Committee to Evaluate Safety of PI3K inhibitors
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers. Dysregulated PI3K signaling helps malignant lymphocytes...
Axsome and Aytu’s Positive Day with the FDA
Amid government crackdowns on pharmaceutical companies and increasingly strict federal guidelines, two companies received positive feedback today on their treatments for depression and Vascular Ehlers-Danlos Syndrome (VEDS). The FDA proposed some postmarketing...
The case for testing Pfizer’s Paxlovid for treating long COVID
Reports of two patients who found relief from long COVID after taking Pfizer Inc's (PFE.N) antiviral Paxlovid, including a researcher who tested it on herself, provide intriguing evidence for clinical trials to help those suffering from the debilitating condition,...
FDA Issues New Guidance to Increase Minority Representation in Clinical Trials
Ethnic diversity in clinical trials has been lacking for years. Multiple companies have recognized this lapse and have made changes accordingly, but less has been done on a larger regulatory scale. Now, the U.S. Food and Drug Administration is urging drugmakers to...
Merck’s Pneumococcal Vaccine Claims FDA Breakthrough Therapy Designation
The U.S. Food and Drug Administration granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) Breakthrough Therapy Designation. The vaccine is for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia. It is...
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