Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.
Hanmi Pharmaceutical Co. Ltd. announced Oct. 27 that its glucagon-like peptide-1 receptor agonist, efpeglenatide (HM-11260C), met the co-primary endpoints in a phase III study of obese adults without diabetes.
Microbiotix Co. Ltd. has obtained IND approval from the Korean Ministry of Food and Drug Safety (MFDS) for MP-101, a bacteriophage therapy for patients with acute pneumonia. A phase I study in adult patients with Pseudomonas aeruginosa-induced pneumonia is expected to enroll its first patient within the year.
Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with SYH-2061 injection for the treatment of IgA nephropathy and other complement-mediated diseases.
Mode Sensors AS received U.S. FDA 510(k) clearance for its Re:Balans hydration monitoring system. The wearable patch sensor allows for the continuous monitoring of body hydration to detect fluid imbalances using thoracic bioimpedance technology to deliver automatic, accurate data to help physicians in fluid management.
India’s Central Drugs Standard Control Organization (CDSCO) posted a draft guidance for medical device software, providing some clarity about the agency’s expectations for this class of products even if it seems to break no new ground.
The Advanced Medical Technology Association has updated its code of ethics for interactions with health care professionals, which includes some much-needed updates that address both the burgeoning reliance on data and the increasing emphasis on the part of U.S. regulators on data security.
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