China’s NMPA has approved Carsgen Therapeutics Holdings Ltd.’s NDA for its B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy, zevorcabtagene autoleucel (CT-053, zevor-cel), for treating adults with relapsed or refractory (r/r) multiple myeloma (MM) who have progressed after at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent.
Taiwan’s Formosa Pharmaceuticals Inc. and Aimmax Therapeutics, Inc. said the U.S. FDA approved APP-13007 (clobetasol propionate ophthalmic suspension 0.05%), a twice-daily corticosteroid eye drop for postoperative eye pain and inflammation. Read More
In a move to build up its dominance in the radiopharma market, Telix Pharmaceuticals Ltd. said it plans to acquire radioisotope production technology firm Artms Inc. and its advanced cyclotron-based isotope production platform, manufacturing plant and stockpile of ultra-pure rare metals. Read More
Pharmaust Ltd.’s monepantel met its primary safety endpoints and showed positive signals of potential efficacy in a phase I trial in patients with motor neuron disease (MND)/amyotrophic lateral sclerosis (ALS). With these results, the company will now progress to a pivotal phase II/III trial by midyear, Pharmaust CEO Michael Thurn told BioWorld. Read More
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022. Read More
A new spinout from Monash University in Melbourne, Australia, is tackling biology to better understand immune cell function and to find targets that were thought to be undruggable. Read More
The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer. Read More
In a move to widen global access to its Qdenga dengue vaccine, Takeda Pharmaceutical Co. Ltd. is partnering with India’s Biological E. Ltd. to manufacture Qdenga (TAK-003). Read More
On March 4, 2024, several groups of scientists discussed the challenges of investigating the effects of HIV in the central nervous system (CNS) at the oral abstract session on neuropathogenesis of HIV held during the 31st Conference on Retroviruses and Opportunistic Infections (CROI), in Denver. A cure for HIV will require eliminating the virus in all its reservoirs, those tissues where HIV remains latent but retains the capacity for reactivation and replication. However, despite antiretroviral therapy (ART), the virus could continue to replicate continuously at a low level in some reservoirs, including the CNS. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Akeso, Beigene, Innovent, Pharmaust, Recce. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Antibe, Arcutis, Astellas, Astrazeneca, Beigene, Biocon, Boostimmune, Fibrogen, Isotherapeutics, Janssen, J&J, Nona, Nuance, Recce, Sato, Shoreline Biosciences, Telix Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Aribio, Beigene, Carsgen, Everest, Jacobio, Liscure, Mabwell, SN Bioscience. Read More
