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.
Moderna and Pfizer are seeking FDA approval for second COVID-19 boosters.
Moderna formally requested the FDA grant emergency authorization for a second booster shot of its COVID-19 vaccine for all adults over 18 who have received approved vaccines. Earlier this week, Pfizer and its partner BioNTech also requested authorization for a second...
COVID-19 Update: The Diabetes Connection, WHO Concerned about BA.2
Viral infections can have a broad range of side effects, such as myocarditis, and COVID-19 is no different. There is evidence that COVID-19 infection might be linked to an increase in diabetes, particularly Type 1 diabetes, an autoimmune disease most commonly...
FDA approves Four Cancer Clinical Trials
Several biopharma companies celebrate the U.S. Food and Drug Administration’s approval for clinical trials involving therapeutics for cancer treatment, including Sonnet BioTherapeutics and Adagene. Sonnet BioTherapeutics evolved into a clinical biopharmaceutical...
Arrowhead Files for Regulatory Clearance to Initiate Phase 1/2a Study of ARO-RAGE for Treatment of Asthma
Arrowhead Pharmaceuticals, Inc. has announced that it has filed an application for clearance to initiate a Phase 1/2a clinical trial of ARO-RAGE, the company’s investigational RNA interference (RNAi) therapeutic designed to reduce production of the receptor for...
CDE Approves the Inclusion of Hexvix® in the Clinical Real-world Evidence Pilot Study
Asieris Pharmaceuticals, in accordance with advice from the National Medical products Administration Center for Drug Evaluation (CDE), has approved the inclusion of Asieris’s drug Hexvic®, a drug for the diagnosis of bladder cancer, in the clinical real-world world...
Supporting Patient Centricity in Clinical Trials Through Advanced NLP AI
As anyone working within the clinical trial space will know, a crucial phase of the early trial process is pre-screening patients to match to a specific clinical trial and the importance of patient centricity throughout this process. The pre-screening process has...
Hoth Therapeutics: Orphan Drug Designation for HT-KIT
Hoth Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to HT-KIT to treat mastocytosis. Mastocytosis is a rare condition caused by an abnormal accumulation and activation of mast cells in the skin, bone...
C4 Therapeutics: Orphan Drug Designation for CFT8634
C4 Therapeutics (C4T) has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to CFT8634 to treat soft tissue sarcoma. Soft tissue sarcoma is a rare type of cancer that begins in the tissues that connect, support, and...
7 Hills Pharma: FDA Fast Track Designation for 7HP349
7 Hills Pharma has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s lead clinical-stage immunostimulant 7HP349, combined with a CTLA-4 inhibitor, to treat unresectable or metastatic malignant melanoma if...
Genmab: Orphan Drug Designation for Epcoritamab
Genmab A/S has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the investigational medicine epcoritamab (DuoBody®-CD3xCD20) to treat follicular lymphoma (FL). FL is usually a slow-growing or indolent form of...
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