Roivant Sciences Ltd. CEO Matt Cline said the firm’s unit Immunovant Inc. with FcRn blocker batoclimab has established “frankly a new bar” in myasthenia gravis (MG) as the New York-based firm reported top-line results from its phase III study and first data from period 1 of the phase IIb study with the same drug in chronic inflammatory demyelinating polyneuropathy. The data look promising, and Immunovant intends to use the findings to help advance second-generation FcRn prospect IMVT-1402 in both indications. Potentially registrational trials are planned. The U.S. FDA has granted IND clearance.
Black Diamond Therapeutics Inc. is getting $70 million up front and could earn up to $710 million in milestone payments in a deal with Servier for phase I-stage BDTX-4933, a small-molecule candidate targeting both RAS mutations and RAF alternations for treating solid tumors, including non-small-cell lung cancer.
Oxford Biotherapeutics Ltd. is partnering with Roche AG to expand the current field of tumor antigens that can be drugged with antibodies, as part of a potential $1 billion-plus agreement. The agreement will see Oxford Biotherapeutics apply its membrane protein discovery platform to search for novel cancer cell antigens, which will be validated through the research collaboration, with Roche then taking the lead in advancing any resulting antibody programs.
Mucormycosis, a fungal infection caused by fungi from the order Mucorales, can cause severe disease, especially in immunocompromised subjects. These fungi are ubiquitous and can be found in environmental sources such as crop residues and soil. Among the multiple factors that increase the risk of mucormycosis infection are immunosuppression and diabetes mellitus.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bayer, Grin, Idorsia, Nurix, Pep-Therapy, Travere, Vtv, Xeris.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allarity, Astrazeneca, Avidity, Capricor, Dyne, Greenwich, Incyte, Orca, Sutro, Zentalis.
The U.S. foreign aid cuts and freezes that are taking place under President Donald Trump are putting at risk the global public health gains that have been made against diseases such as malaria, HIV and tuberculosis over the past two decades, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus said at a March 17 media briefing, as he called on other countries to step up and fill the gap.
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