Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Candel, Carsgen, Eisai, Halozyme, Mitsubishi, Teva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alvotech, Adalvo, Advanz, Amoytop, Awakn, Coeptis, Drug Farm, Formosa, Iteos, Juno, Monarch, Snap, Solvonis, TQ.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biohaven, Cumberland, EMD Serono, Evommune, GSK, Inflarx, Irlab, Octapharma, Ono, Spero, Strand, Veru.
Nibec Co. Ltd. announced May 28 the signing of a potential $435 million license deal for NP-201, its phase II-ready peptide-based pulmonary fibrosis therapy candidate, with an undisclosed U.S.-based biotech company.
A court decision blocking President Donald Trump’s reciprocal and trafficking tariffs was hardly a day old before the U.S. Court of Appeals for the Federal Circuit stepped in late May 29 to grant a temporary stay while it considers the administration’s appeal. The stay adds further uncertainty to the path ahead for drug and device companies.
Researchers in the U.K. have overthrown the orthodox view that childhood cancers have a low mutation burden, opening up new drug targets and opportunities for repurposing existing therapies. In particular, a high mutation rate is associated with a response to cancer immunotherapy. But although PD-1 checkpoint inhibitors are approved for treating pediatric cancers with a high level of microsatellite instability mutations, in general it is thought childhood tumors are not amenable to immunotherapy.
Asian health care-focused private equity firm Quadria Capital announced the final close of its Fund III with $1.07 billion in total commitments to transform health care across Asia, which is expected to drive 40% of global health care growth by 2030.
Investors found in an 8-K filing by Intellia Therapeutics Inc. the news of one case of liver-enzyme elevation in the ongoing phase III Magnitude study with nexiguran ziclumeran (nex-z, NTLA-2001), and in reaction pushed shares of the firm (NASDAQ:NTLA) down to close May 29 at $7.45, a loss of $2.21, or 23%, after the stock traded as low as $6.90 during the day.
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