Final phase II data showing improved survival rates in cervical cancer is giving Nykode Therapeutics ASA even more confidence in taking vaccine candidate VB10.16 further into oncology. The company had been considering targeting head and neck cancer for months. Now, with these new data, it said it’s fully behind focusing on PD-L1 patients with up to one prior line of systemic therapy. Read More
As investors await phase II/III data from Gritstone Bio Inc.’s closely watched trial with Granite, an individualized neoantigen vaccine for microsatellite-stable colorectal cancer, Wall Street was busy handicapping odds for firm’s new approach, given the struggles by personalized methods generally. Read More
Antitumor immunotherapy has notched big wins, but in a small proportion of patients. And one possible explanation for why is that approved immunotherapies are not yet planting their flag on most of the battlefields where tumors and the immune system engage in combat. At the opening AACR 2023 plenary session, Ralph DeNardo celebrated the successes of the current, mostly T-cell-based approaches, but also encouraged his colleagues to think more broadly about the antitumor immunity. Read More
Zephyrm Biotechnologies Co. Ltd. raised ¥200 million (US$29 million) in a series B financing to support phase I and II trials of the company’s human pluripotent stem cell candidates to treat lung diseases, degenerative joint diseases such as osteoarthritis, CNS diseases, inherited retinal degenerations and retinal degenerative diseases. The money will also be used for the construction of its technology platform and cell manufacturing bases. Read More
Australia’s Department of Health is seeking input from the public on the country’s health technology assessment process that informs decisions about what drugs or devices should be reimbursed and under what circumstances a therapy should be subsidized and at what cost to the taxpayer. Read More
30 Technology Ltd. has divested its wound care business, leaving it to focus on pharmaceutical applications of its patented nitric oxide-generating chemistry in the treatment of antibiotic-resistant respiratory infections. Read More
The annual U.S. budget scrum is well underway in Washington, with drug pricing a persistent theme on Capitol Hill. Lawrence Tabak, acting director of the National Institutes of Health (NIH), said NIH’s view is that federal government exercise of march-in rights “is not the instrument to regulate drug pricing” as it would alienate drug makers and their investors, but Tabak vowed that the appropriate use of march-in rights is the subject of intense focus at the Department of Health and Human Services. Read More
Danco Laboratories LLC’s Mifeprex (mifepristone) and Genbiopro Inc.’s generic got another temporary reprieve April 19 from a court order that would tighten access to the abortion drug. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, Alzamend, Alzheon, Anixa, Arch, Autobahn, Biolinerx, Clearside, FSD, Lisata, Madrigal, Merus, Nova Mentis, Plus, Renovion, Sellas, Technoderma. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Direct, Everest, Finch, Keyuan Xinhua, Maxion, Nona, Shanghai, Sinopia. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Adverum, Avenue, Basilea, Biosyngen, Gamida, Huidagene, Hutchmed, Hyloris, Madrigal. Read More
