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.
HUYABIO’s Hiyasta (HBI-8000) Approved to Treat R/R PTCL
HUYABIO International has announced regulatory approval of Hiyasta® (HBI-8000) monotherapy by the Ministry of Health, Labour and Welfare (MHLW) of Japan for the treatment of relapsed or refractory (R/R) Peripheral T-cell lymphoma (PTCL). This approval is based on...
Livtencity Approved for Treatment of Post-Transplant CMV
Takeda Pharmaceutical’s Livtencity (maribavir) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with post-transplant cytomegalovirus (CMV) who have displayed resistance to other common antiviral drugs such as...
NEUROMARK™ Granted FDA Clearance to Combat Chronic Rhinitis
The U.S. Food and Drug Administration (FDA) has given clearance to Neurent Medical’s NEUROMARK™ Rhinitis Neurolysis Therapy™ (RNT), a proprietary system which provides physicians access to the first in-office treatment for those suffering from chronic rhinitis....
Pfizer/MPP Agreement Establishes Global Supply of Treatment
Pfizer has announced that it has reached a licensing agreement with the Medicines Patent Pool (MPP), an UN-backed public health organization, enabling them to sign agreements with multiple manufacturers that will allow them to supply over half the world’s population...
SDFA Approves BRUKINSA for Adults with Mantle Cell Lymphoma
The Saudi Food and Drug Authority (SFDA) has granted approval to BRUKINSA (zanubrutinib), a joint venture by BeiGene and NewBridge Pharmaceuticals, for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received a prior therapy. Upon...
CHMP Recommends Avacopan for Treatment of GPA/MPA Vasculitis
For patients suffering from either of the predominant variations of ANCA-associated vasculitis, granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has...
vMap: Vektor Medical’s Heart Map System Gains FDA Clearance
The U.S. Food and Drug Administration (FDA) has cleared Vektor Medical’s vMap system, a groundbreaking system that when paired with standard ECG practice, has the ability to construct a model of the patient’s heart electrophysiological activity using input from only a...
MEI Pharma and Kyowa Kirin’s Zandelisib Given ODD Status
The U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to Zandelisib, a drug produced in collaboration between MEI Pharma and Kyowa Kirin Inc for the treatment of follicular lymphoma (FL). Developed as a once-daily, oral investigational...
Plus Therapeutic’s Rhenium-186 Gains Fast Track Designation
The U.S. Food and Drug Administration (FDA) has given Plus Therapeutics Inc. a Fast Track Designation for Rhenium-186 NanoLiposome (186 RNL), a novel drug for the treatment of leptomeningeal metastases (LM). As a rare complication of cancer, LM primarily occurs with...
Pops Self-Care Platform Gains Australian Clearance
The Therapeutic Goods Administration, Australia’s regulatory body, has given clearance to Pops, a digital health company dedicated to addressing chronic conditions including diabetes. Pops, which has already been commercialized in the United States, gained prominence...
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