Celloram Inc., the U.S. subsidiary of the Seoul, South Korea-based Medpacto Inc., signed a €160 million (US$175.88 million) licensing deal with Genfit SA to develop Celloram’s inflammasome inhibitor, CLM-022, for liver disease. Read More
Top-line results show a disappointing placebo effect that resulted in Sumitomo Pharma Co. Ltd./Otsuka Pharmaceutical Co. Ltd.’s ulotaront (SEP-363856) missing the primary endpoints in both the Diamond (Developing Innovative Approaches for Mental Disorders) 1 and Diamond 2 trials in schizophrenia. Read More
Hangzhou and New Jersey-based cancer biotech Adlai Nortye Ltd. – formerly Hangzhou Nuotai Pharmaceutical Co. Ltd. – announced plans to list on Nasdaq with its U.S. IPO filed on July 27. Read More
Japanese pharmaceutical company Astellas Pharma Inc. is scouting for more novel targeted protein degrader (TPD) therapeutics, having added a research and licensing deal with Peptidream Inc. to its shopping cart filled with TPD promises. Read More
Viage Therapeutics Inc. – formerly Digestome Therapeutics Inc. – on July 26 unveiled positive data from its phase I study on DGX-001 for mild cognitive impairment in Alzheimer’s disease (AD) and Parkinson’s (PD). The randomized, double-blind, placebo-controlled study demonstrated changes in brain activity according to quantitative electroencephalography (qEEG) measurements in 68 healthy volunteers dosed with single ascending and multiple ascending doses. Read More
Although huge strides have been made with antiretroviral therapy (ART) and prevention since HIV was first reported 42 years ago, there is still not an effective preventive vaccine or a scalable cure for those living with HIV. But broadly neutralizing antibodies (bNAbs) look to be a further step down the pathway to a cure, speakers said during the International AIDS Society meeting held July 23 to 26 in Brisbane, Australia. Read More
Broadly neutralizing antibodies (bNAbs) have the potential to prevent HIV, and more researchers are turning to bNAbs as an alternative to antiretroviral therapy (ART), speakers said during the International AIDS Society meeting held July 23 to 26 in Brisbane, Australia. However, for a cure, the viral reservoir that is formed in the early stages of HIV remains an obstacle, and recent studies suggest that controlling or eliminating the HIV reservoir with bNAbs might be possible. Read More
South Korean pharmaceutical company Hanmi Pharmaceutical Co. Ltd. may have found its footing after its misstep with Sanofi SA in 2020 for efpeglenatide, its glucagon-like peptide-1 (GLP-1) receptor agonist. On July 31, Hanmi announced that the once-dropped drug would be developed to treat obesity in the Korean population, submitting an IND application to the MFDS on July 28 to examine the once-a-week injection efpeglenatide in a phase III trial. Read More
Clinical data in the first half of 2023 is up 1.51% compared to the same time period last year. So far in 2023 BioWorld reported on 1,810 drugs in phase I-III, compared to 1,783 in the first half of 2022. The number of trial updates is down 13.6% from the 2,095 in 2021, but more than 2020’s 1,799 and 2019’s 1,477. Read More
A lot of biosimilar sponsors and wannabes are watching as the biosimilar competition in the U.S. unfolds to challenge the all-time biggest-selling drug, Humira from Abbvie Inc. In this episode, BioWorld Regulatory Editor Mari Serebrov and Tom Newcomer, vice president and head of U.S. market access at Samsung Bioepis, discuss the biosimilars landscape. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Alterity, Ascletis, Astrazeneca, Daiichi Sankyo, Essex, Immuron, Immutep, Pharmabcine, Recce, Remegen, Sunho, Takeda, Triastek. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Amarin, Astellas, Lotus, Peptidream. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: ADC, Beigene, Biocon, Daiichi Sankyo, GC, Hanchorbio, Hansoh, Incannex, Innocare, Jiangsu Recbio, Mabwell, Opthea, Overland, Scynexis, Sinopharm, SN. Read More
