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.

Although Argenica Therapeutics Ltd.’s stroke drug, ARG-007, saw mixed results in top-line phase II data, new data in functional outcomes studies showed signs the drug helped patients think more clearly, regain independence, and enjoy a better quality of life after stroke.

India’s Central Drugs Standard Control Organization (CDSCO) posted a draft guidance for medical device software, providing some clarity about the agency’s expectations for this class of products even if it seems to break no new ground.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 largest study ever conducted on light therapy for Parkinson’s disease has found that long-term use of Symbyx Biome Pty Ltd.’s non-invasive, at-home photobiomodulation (PBM) devices significantly improved mobility, anxiety, and overall symptom severity.

Adocia SA is looking to further apply its Biochaperone formulation technology to metabolic disorders, Olivier Soula, Adocia co-founder and CEO told BioWorld, the firm having recently gained positive top-line phase III results of Tonghua Dongbao Pharmaceutical Co. Ltd.’s THDB-0206 injection (Biochaperone Lispro) in diabetes patients in China.

Stem cells are a promising therapeutic modality to fight aging and age-related disease, speakers at the Bio-Plus Interphex Korea 2025 said. Progress in cell-based longevity medicine is being made, they added, although safety, ethical and regulatory issues are ongoing challenges.

Ena Respiratory Pty Ltd. raised an AU$34 million (US$22.4 million) series B round to advance INNA-051, its nasal spray for symptomatic viral respiratory infections, to phase II trials. New investors in the Melbourne-headquartered company include the Gates Foundation and Flu Lab. Existing investors Brandon Capital, Uniseed and Stoic Venture Capital also participated in the round.

SK Biopharmaceuticals Co. Ltd. and Eurofarma Laboratórios SA launched a new joint venture (JV) called Mentis Care Inc. Oct. 21, dedicated to developing an AI-powered platform for epilepsy management.

Takeda Pharmaceutical Co. Ltd. agreed to codevelop and commercialize up to three of Innovent Biologics Co. Ltd.’s immuno-oncology (I-O) and antibody-drug conjugate (ADC) candidates with the signing of a $11.4 billion deal, including $1.2 billion paid up front.

SK Biopharmaceuticals Co. Ltd. and Eurofarma Laboratórios SA launched a new joint venture called Mentis Care Inc. Oct. 21, dedicated to developing an AI-powered platform for epilepsy management.