Glycomine Inc. secured $115 million in a series C financing round to support the advancement of GLM-101 into a phase IIb study in patients with phosphomannomutase-2 congenital disorder of glycosylation (PMM2-CDG).
China’s National Medical Products Administration (NMPA) has accepted Innocare Pharma Ltd.’s NDA for its second-generation pan-tropomyosin receptor kinase inhibitor, zurletrectinib (ICP-723), for treating adults and adolescents with advanced solid tumors harboring neurotrophic tyrosine receptor kinase gene fusions.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accent, Atsena, Celltrion, Immunitybio, Lyell Immunopharma, Precision, Scilex, Valneva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocon, Boehringer, Catalent, Cellino, Cue Biopharma, Daiichi Sankyo, Invo Fertility, Karis, Lisata, Mural Oncology, Naya, Norgine, Oak Hill, Roche, Regeneron, Rege Nephro, Statera, Syros, Theravia, Tivic Health Systems, Wayfinder.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: BMS, Entera, Eyestem, Faron, Hoth, Metavia, Plus, Sanofi, Toragen.
After more than three years of discussion, the World Health Organization’s Intergovernmental Negotiating Body (INB) has agreed on a proposal to prevent, prepare and respond to a pandemic. The plan is born, the INB proposal said, out of inequities around the world that slowed timely and equitable access to health products to respond to the COVID-19 pandemic.
The Abu Dhabi health care company M42 is to make an investment in U.K.-based longevity specialist Juvenescence as a route to moving into drug discovery and development, with the two forming a partnership to work together on products that extend the healthy lifespan and improve the treatment of chronic diseases.
Stem cell implantation is a step closer to becoming the next strategy against Parkinson's disease. Two clinical trials, one in phase I and the other in phase I/II, have demonstrated their safety and potential to restore dopamine production in the brains of patients with this currently incurable neurodegenerative condition. The number of participants in the study is still small, and further research is needed to demonstrate the clinical benefits of these cell therapies.
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