Australia’s Therapeutic Goods Administration (TGA) has approved CSL Ltd.’s Andembry (garadacimab) for preventing recurrent hereditary angioedema attacks, marking the first global approval for the drug that was discovered and developed in Australia by CSL scientists.
With positive results from a phase III study, ITM Isotope Technologies Munich SE said it has reached a landmark. The clinical trial of ITM-11, a synthetic, targeted radiotherapeutic agent for treating inoperable, progressive grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumors, met its primary endpoint of prolonging progression-free survival when compared to the mTOR inhibitor everolimus, a targeted molecular therapy and a standard of care.
Some favorable and some not-so-great results from separate midstage trials testing the anti-dickkopf homolog 1 antibody sirexatamab in combo regimens for two types of gastrointestinal tumors vexed Leap Therapeutics Inc. (NASDAQ:LPTX), shares of which ended Jan. 28 at 66 cents, down $1.60, or 71%.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Alvotech, Biogen, Cartesian, Corstasis, Eisai, Immunitybio, Invivyd, Merck, Teva, Vanda.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adagene, Akero, Allakos, Alligator, Bicara, BMS, Exelixis, Immunomet, Pfizer, Sapience, Sarepta, Triumvira, Veru.
Lantheus Holdings Inc. is making waves in M&A with its second big deal of the month – and year – the acquisition of Evergreen Theragnostics Inc. for $250 million in cash up front and up to an additional $752.5 million in contingent payments. The transaction follows announcement of a definitive agreement to acquire Life Molecular Imaging Ltd., a subsidiary of Life Healthcare Group Holdings Ltd., on Jan. 13 for $350 million in cash at closing and a further $400 million in milestone payments.
Litigation against companies in the life sciences has far too often covered those who were not injured by the device or drug, but there are signs that this tide is shifting.
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