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.
Horizon Therapeutics plc Receives European Commission (EC) Approval of UPLIZNA® (inebilizumab)
Horizon Therapeutics plc announced the European Commission (EC) approval of UPLIZNA® (inebilizumab) as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G seropositive...
European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With Microsatellite Instability-High
Merck , known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR)...
World’s First FDA Approved Cold Ablative Fiber Laser Makes US Debut
Acclaro Corporation breaks new ground in medical devices for aesthetics with their revolutionary UltraClear™ system. This disruptive technology features a no downtime, painless treatment to address a full spectrum of skin conditions including pigmentation, enlarged...
XVIVO Submits an IDE Application to US FDA for Its Innovative Heart Technology
XVIVO announced the filing of an Investigational Device Exemption (IDE) application to the US Food & Drug Administration (FDA). It will support an initial FDA regulatory approval to conduct the "PRESERVE Clinical Trial: A Prospective, Multi-center, Single-Arm,...
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Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval after regulators hinted the Alzheimer’s drug did not have sufficient enough data to support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...
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