Imbiologics Inc. scored a potential ₩430 billion (US$315.5 million) deal with China’s Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd. for Oxtima, an autoimmune disease program with two assets co-developed by Seoul, South Korea-based HK Inno.N Corp.
Adcendo ApS has inked a deal with Multitude Therapeutics Inc. and is licensing Multitude’s phase I-ready antibody-drug conjugate (ADC), ADCE-T02, which targets tissue factor. Under the deal, Copenhagen, Denmark-based Adcendo gains exclusive development and commercialization rights for the ADC globally, excluding greater China (mainland China, Hong Kong, Macao and Taiwan) where Multitude retains all rights.
Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.
Shares of Chinese and South Korean med-tech companies continued to rise after the World Health Organization declared mpox a public health emergency of international concern Aug. 14 after recent outbreaks.
All patients dosed in a phase IIa trial with Tryptamine Therapeutics Ltd.’s (Tryp) oral psilocybin (TRP-8802) trial reported an improvement in fibromyalgia pain severity, sleep, and pain interference.
UCB SA is divesting its mature neurology and allergy business in China, selling those products to CBC Group and Mubadala Investment Co. for $680 million so it can refocus on innovation and partnerships in China. The deal includes UCB’s manufacturing site in Zhuhai in Guangdong province.
All patients dosed in a phase IIa trial with Tryptamine Therapeutics Ltd.’s (Tryp) oral psilocybin (TRP-8802) trial reported an improvement in fibromyalgia pain severity, sleep, and pain interference.
Quantamatrix Inc. is advancing an Ultra-Rapid Antimicrobial Susceptibility Testing sepsis diagnostic test, touted as having the world’s fastest all-in-one antimicrobial technology, to reduce sepsis diagnosis time from days to an average of 13 hours.
TGA opened a consultation for regulation of assistive technologies, a key element of which is to make determinations about the regulatory status of some of these products. While the agency makes clear that some items that are currently unregulated may soon be subject to regulation, one of the more innocuous-seeming articles that may fall under regulation is the common and seemingly innocuous wig.
The ever-contentious issue of drug pricing creates a tug-of-war between biopharma’s innovation machine and the general population’s need for accessible and affordable drugs. BioWorld has covered the issue of drug pricing from insulin caps and the early days of the IRA to failed legal challenges and the recent rollout of the Centers for Medicare & Medicaid Services’ negotiated prices. Read our collection of 2024 stories.
RSS
