South Korea’s Ministry of Food and Drug Safety (MFDS) has given innovative medical device designation for Te Bios Co. Ltd.’s artificial cornea, C-Clear, bringing it one step closer to becoming the first artificial cornea to be approved in the country.

Antengene Corp. Ltd. has gained the first greenlight in Asia for the oral exportin 1 (XPO1) inhibitor selinexor, in-licensed from Karyopharm Therapeutics Inc., after South Korea’s Ministry of Food and Drug Safety gave the thumbs up for its NDA. The drug has been approved in Korea to treat relapsed or refractory multiple myeloma (MM) and relapsed and refractory diffuse large B-cell lymphoma (DLBCL) in combination with dexamethasone.

The FDA has posted a final rule for its intended use policy for devices, drugs and biologics, which formalizes the elimination of the totality-of-the-evidence approach to determining the manufacturer’s intended use. While the final rule says that mere knowledge of off-label use cannot be the sole determinant of the manufacturer’s intended use, the rule still allows the FDA to infer intended use by “any relevant source of evidence,” a term that may be sufficiently squishy to be functionally equivalent to the controversial totality-of-the-evidence standard.

Post-traumatic stress disorder (PTSD) affects about 8 million Americans a year, disrupting lives with nightmares, memory loss, feelings of isolation and other negative effects. Treatment typically involves psychotherapy, but many patients do not find relief. To that end, the FDA has granted breakthrough device designation to Evren Technologies Inc. for its noninvasive Phoenix earbud device for treating PTSD.

China’s National Health Commission has just released a new set of regulations to evaluate the clinical value of both approved drugs and those still in trials as part of its efforts to improve the market standards.

Rapid changes, a traditionally conservative approach and a chronic lack of regulatory transparency could undo a lot of the progress that Japan has made in the past few years to speed up approvals and all but eliminate a punishing drug lag that, for decades, held back the development of the country’s biopharma sector.