If the FDA follows the advice of its Antimicrobial Drugs Advisory Committee, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will become the first drug approved in the U.S. to treat resistant or refractory cytomegalovirus infection and disease in both solid organ and hematopoietic stem cell transplant recipients. The committee voted 17-0 that the overall benefit-risk assessment favors the use of maribavir for transplant patients with refractory CMV infections both with and without genotypic resistance to the four antivirals currently used off-label to treat the infections – ganciclovir, valganciclovir, foscarnet and cidofovir. Read More
Poseida Therapeutics Inc.’s R&D Day in February – where much of its technology was made public for the first time – created “a flood of interest” in deals and officials were “pretty selective,” said CEO Eric Ostertag, whose remarks came as the company nailed down a whopping research collaboration and exclusive license agreement with Takeda Pharmaceutical Co. Ltd. The arrangement will deploy Poseida’s Piggybac and Cas-CLOVER, as well as biodegradable DNA and RNA nanoparticle delivery technology and other genetic engineering platforms to come up with as many as eight gene therapies. Read More
With a growing number of deals worth $1 billion or more, 2021 values are slowly inching past 2020’s record year, as mergers and acquisitions also move higher, indicating a potentially stronger second half of the year. Read More
Tracon Pharmaceuticals Inc. tapped Biocytogen Pharmaceuticals Co. Ltd.’s wholly owned subsidiary, Eucure Biopharma Co. Ltd., for U.S. rights to CTLA4 antibody YH-001, which it plans to use in immunotherapy studies in combination with its PD-L1 inhibitor. Read More
It looks like Shanghai Miracogen Inc.’s antibody-drug conjugate (ADC) partnership with Synaffix BV is paying off as MRG-004A, an ADC designed to treat solid tumors, has entered a U.S. phase I/II trial to treat solid tumors. Read More
PERTH, Australia – After meeting with the FDA, Medlab Clinical Ltd. is reformulating its cannabinoid pain product into a synthetic formulation because the agency indicated it was more likely to register a synthetic compared to a botanic. Read More
Brii Biosciences Ltd. shared interim data from a phase III trial of its neutralizing monoclonal antibody (mAb) combination therapy for SARS-CoV-2, BRII-196 and BRII-198, that showed a 78% reduction in the risk of hospitalization or death in patients receiving single dose of the cocktail. Read More
Data presented at the American Association for Cancer Research virtual International Conference on Molecular Targets and Cancer Therapeutics, including Hummingbird Bioscience.Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Aim Immunotech, Brii, Celltrion, Covicept, CTI, Cutia, Emphycorp, Inhalon, Kintor, Opthea, Pharmaxis, Redhill, SAB, Scancell, Takeda, Telix, Vaxart, Vyne. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Aipharma Global Holdings, Biontech, Curative, Debiopharm, Dexa Medica, Dr. Falk, Elixirgen, Glaxosmithkline, Hyloris, Janssen-Cilag International, Johnson & Johnson, Lumen, Merck, Mid-Atlantic, Nanoviricides, Neurorx, Pfizer, Relief, Renexxion Ireland, Sandoz, Therapeutic Solutions International, Vaxart.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Astrazeneca, Beigene, Biontech, Celltrion, Cocrystal, Daiichi Sankyo, Himalaya, Intellia, Janssen-Cilag, Johnson & Johnson, Moderna, Pfizer, RDIF, Takeda.Read More
