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.
PTC Announces Results of Real-World Study
PTC Therapeutics announced today the results of its real-world study for patients diagnosed with Becker muscular dystrophy (BMD) and Duchenne muscular dystrophy (DMD) who switched between prednisone to EMFLAZA® (deflazacort) after the U.S. Food and Drug...
FDA Clears Baxter’s AK 98 Hemodialysis Machine
Baxter International announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its Artifical Kidney 98 (AK 98) dialysis machine. The next-gen, easy-to-use, portable machine is designed to administer hemodialysis (HD) treatments. Gavin...
FDA Grants Orphan Drug Designation to Alkermes for Treatment of Mucosal Melanoma
Alkermes today (3/11) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for its nemvaleukin alfa, an investigational engineered interleukin-2 (IL-2) variant immunotherapy for treatment of mucosal melanoma, a rare type of...
FDA Grants IND Clearance for Melior Pharmaceuticals’ COVID-19 Therapy
The U.S. Food and Drug Administration (FDA) cleared Melior Pharmaceuticals' Investigational New Drug (IND) application for it's COVID-19 therapeutic candidate, tolimidone. Taken as an oral pill once a day, Tolimidone is a novel lyn kase activator designed to treat...
FDA Clears Valkyrie Thoracic Fixation System
The U.S. Food and Drug Administration (FDA) cleared Able Medical Devices' thoracic fixation system called Valkyrie, a breakthrough and fully disposable bioactive sternal plating system. The medical device is intended to stabilize and fixate chest wall fractures as...
First CAR-T by Gilead and Kite Approved by FDA
Gilead Sciences and Kite Pharma's Yescarta (axicabtagene ciloleucel), the first chimeric antigen receptor (CAR) T-cell therapy approved by the U.S. Food and Drug Administration (FDA) for adult patients diagnosed with follicular lymphoma (FL). Follicular lymphoma is...
FDA Provides Guidance on Switches to Container Closure
The U.S. Food and Drug Administration (FDA) provided guidance that addresses changes to the supply chain due to COVID-19, including its regulatory process for manufacturing and controls (CMS) and chemistry. Materials like glass vials, stoppers, test swabs, and...
COA Translations: Empowering the Voice of Patients of Diverse Backgrounds
Over the last several years, patient-centricity has been a key theme in the healthcare sphere for improving drug therapies and medical devices for patients all around the world. To better serve patients, life science companies are putting in more effort on listening...
FDA Grants Fourth Breakthrough Device Designation for MedAlliance’s Sirolimus Drug-Eluting Balloon
The U.S. Food and Drug Administration (FDA) granted MedAlliance its fourth Breakthrough Device Designation for SELUTION SLR™, a sustained limus release drug-eluting balloon (DEB) catheter, to treat atherosclerotic lesions found in native coronary arteries. MedAlliance...
Boehringer Ingelheim and G1 Therapeutics Announce COSELA Now Commercially Available in US
Boehringer Ingelheim and G1 Therapeutics have announced that the injection of COSELA™ (trilaciclib) is now commercially available in the US. COSELA, the only U.S. Food and Drug Administration (FDA)-approved treatment that is meant to decrease the incidence of...
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