| |OCTOBER 20248ANTENGENE BAGS THAILAND FDA APPROVAL TO COMMERCIALIZE XPOVIOGOVT EXPLORES RANDOM TESTING OF IMPORTED MEDICAL DEVICESAntengene Corporation Limited, a top creative, internationally-operating biopharmaceutical company focused on finding, creating, and selling top-of-the-line medications for cancer, revealed that the Thailand Food and Drug Administration has given the green light to a New Drug Application (NDA) for Xpovio (selinexor).Two signs are for the treatment of adult patients with multiple myeloma (MM): one is with bortezomib and dexamethasone after one prior therapy, and the other is with dexamethasone after four prior therapies and refractory disease. The latter must have shown progression on the last therapy and resistance to specific types of drugs.Featuring a unique way of working, Xpovio is the first orally-available, selective XPO1 inhibitor in the world, and has been approved in nine APAC markets. The approval of Xpovio in Thailand will bring new treatments to the medical care of MM patients in the country, benefiting numerous patients and their families. As of now, Xpovio has also been incorporated into national healthcare insurance or reimbursement programs in China, Australia, Singapore, and South Korea.The ASEAN area, known for its consistent economic expansion and a population of over 600 million, has emerged as a key market opportunity for worldwide biomedical progress. The rising number of elderly people in ASEAN has raised the total burden of diseases on individuals and communities, resulting in a greater need for new treatments. POThe government is considering overseeing the quality of imported medical devices through a risk-based method in which random samples will be selected for quality testing, with entire shipments of critical diagnostic kits being tested.The government has released a document to help port officers make decisions on monitoring port quality during imports using a risk-based approach."The monitoring of quality of the imported drugs, cosmetics and medical devices is of paramount importance to the public health," it said."This guidance document has been prepared for the Port Officer to implement a risk-based approach at various levels for monitoring the quality of the imported consignments to provide high degree of assurance for the safety of public health," it further said.This recommendation suggests using a three-tiered risk-based strategy for sampling, involving desktop inspection/visual inspection, field-based testing with tools like the Minilab, and laboratory testing if necessary."It is recommended that the testing shall be considered as final for taking action," it said.In the event that the Port officer of CDSCO or custom officer receives information or evidence indicating questionable quality of a product, it must be sampled and tested as per the document. All items such as vaccines, blood products, critical diagnostic kits, condoms, and re-import cases will have 100 percent of samples sent for testing. POTOP STORIES
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