Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cel-Sci, Novavax, Pharming.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abtherx, Genentech, Innate Pharma, Repertoire Immune, Roche, Rondo, Sanofi.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Ascletis, Braintree, BMS, Cellenkos, Unity.
In all practicality, U.S. FDA Commissioner Marty Makary’s recently announced policy directive removing industry representatives from the agency’s advisory committees may have little effect on the makeup of the drugs and devices committees, which typically include them as nonvoting members.
Tightening of U.S. regulation and capital is leading Chinese biotechs to alternative and new models of financing, ranging from cross-border licensing deals, M&As, the so-called newco model and overseas listings.
Named after Swiss mountains, Granite Bio AG emerged from stealth with $70 million in funds through a series B to advance two immunology treatments incubated at Versant Ventures.
Synthetic Design Lab Inc., which emerged from stealth with a $20 million seed round and a platform technology aimed at advancing the antibody-drug conjugate (ADC) space, began with its founders identifying a single clear goal: how to deliver more payload to a target cancer cell.
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