Lundbeck’s bexicaserin receives Breakthrough Therapy Designation in China for the treatment of seizures in severe rare epilepsies
Accelerated pathway underscores urgent need for innovative solutions for patients with devastating, childhood-onset epilepsies Novel 5HT2C mechanism designed to reduce drug-resistant seizures in children and adults living with Developmental Epileptic Encephalopathies (DEEs) and improve quality of life for patients and their caregivers1 Dual Breakthrough Therapy Designation (BTD) in China and the U.S. underscores Lundbeck's mission to advance...
ISTH marks World Thrombosis Day with urgent global call to action
Thrombosis is the underlying cause of 1 in 4 deaths worldwide each year. The campaign calls for crucial awareness and prevention. CHARLOTTE, N.C., Oct. 13, 2025 /PRNewswire/ -- The International Society on Thrombosis and Haemostasis (ISTH) today marks World Thrombosis Day, a global movement uniting thousands of partners in more than 120 countries. This year's campaign, "From Head to...
Singclean Anti-adhesion Technology With Professor Osama Shawki Shines at FIGO
CAPE TOWN, South Africa, Oct. 13, 2025 /PRNewswire/ -- Singclean Medical, in partnership with Kayan Al-Seha Medical (KSM) and Professor Osama Shawki, successfully made its debut at the FIGO World Congress of Gynecology and Obstetrics 2025, held from October 5–9 at the Cape Town International Convention Centre. Participation at FIGO, marks a key milestone in Singclean's global strategy and...
GC Biopharma Secures CMO Rights for Shingles Vaccine from Curevo Vaccine
YONGIN, South Korea, Oct. 13, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a South Korean biopharmaceutical company, announced today that it has signed an agreement with Curevo Vaccine to secure contract manufacturing (CMO) rights for amezosvatein (development name: CRV-101), a recombinant shingles vaccine currently under clinical development. Under the terms of the agreement,...
Smartee Launches World’s First Sleep Aligner Combining Anti-Snoring Therapy with Teeth Alignment
SHANGHAI, Oct. 13, 2025 /PRNewswire/ -- Smartee Denti-Technology today announced the global launch of the Smartee Sleep Aligners, a clear aligner device designed to help manage obstructive sleep apnoea hypopnoea syndrome (OSAHS) and primary snoring (PS). The new series includes two versions: Smartee SA, which focuses on the treatment of OSAHS and PS, and Smartee SA Plus. The latter can treat...
Everest Medicines Announces NMPA Approval of IND Application for Tumor-Associated Antigen Cancer Vaccine EVM14
EVM14 becomes Everest Medicines' internally developed therapeutic mRNA cancer vaccine to receive IND approvals from both China's National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). EVM14, an off-the-shelf therapeutic mRNA cancer vaccine, is developed based on Everest Medicines' proprietary mRNA platform. It is formulated with mRNA encoding 5 tumor-associated antigens (TAAs) and is designed...
Ascletis Selects a Best-In-Class Once-Monthly Subcutaneously Administered GLP-1R/GIPR Dual Peptide Agonist, ASC35, for Clinical Development
- In head-to-head non-human primate (NHP) studies, average observed half-life of ASC35 was approximately 14 days, 6-fold longer than tirzepatide, which supports once-monthly subcutaneous (SQ) dosing in humans. - In head-to-head NHP studies, drug exposures of ASC35 intravenous (I.V.) and SQ administration were approximately 80% and 70% greater than tirzepatide I.V. and SQ administration, respectively. - ASC35...
Reach Surgical’s OMNIBOT Performs First Urology Robotic Telesurgeries in Latin America
Advancing regional collaboration and surgeon training in remote robotic-assisted surgery SINGAPORE, Oct. 13, 2025 /PRNewswire/ -- Reach Surgical, the Surgical Solutions division of Genesis MedTech, has facilitated the completion of two robotic telesurgeries using its OMNIBOT robotic-assisted system. Operating from Reach Surgical Institute (RSI) in Santiago, Dr. Roberto Vilches and Dr. Marcelo...
C-Ray Therapeutics (Chengdu) Co., Ltd Congratulates Partner Biokin Pharmaceutical on NMPA IND Approval of First Proprietary ARC Drug [177Lu]-BL-ARC001
CHENGDU, China, Oct. 11, 2025 /PRNewswire/ -- C-Ray Therapeutics (Chengdu) Co.,Ltd proudly congratulates its strategic partner, Biokin Pharmaceutical, on receiving implied approval from the National Medical Products Administration (NMPA) for the clinical trial application of -BL-ARC001 Injection, the company's first radiopharmaceutical and a Class 1 innovative biologic. This milestone approval marks Biokin's entry into the fast-growing Radiopharmaceutical Drug Conjugate...
Third Indication for Kelun-Biotech’s TROP2 ADC Sac-TMT Approved for Marketing by NMPA in EGFRm NSCLC Following Progression on EGFR-TKI Therapy
CHENGDU, China, Oct. 11, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company's trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) was approved for marketing by the National Medical Products Administration (NMPA) for its third indication, the treatment of adult patients with epidermal growth...
