DUBLIN – To no one's great surprise, UCB SA and Amgen Inc. confirmed Monday that they had received a complete response letter from the FDA for their BLA for Evenity (romosozumab), which is in development for osteoporosis in postmenopausal women.
DUBLIN – Shire plc is challenging Roche Holding AG’s imminent disruption of the hemophilia A market by slapping a preliminary injunction on the Swiss pharma, alleging that the latter’s description of adverse events that occurred in a phase III trial of emicizumab is “inaccurate and misleading” and could compromise patient safety.
DUBLIN – European biotechnology firms engaged in drug discovery and development raised a total of $2.302 billion during the first half of the year, putting the sector on course for a creditable performance for 2017 as a whole.
DUBLIN – U.K. biotech and pharmaceutical industry leaders are hopeful that their hard work in trying to ensure the U.K. maintains its position at the heart of Europe's system of drug regulation is starting to pay dividends.
DUBLIN – Mitoconix Bio Ltd., an Israeli startup commercializing science that emerged from Stanford University's School of Medicine, raised $20 million in series A funding to take forward a first-in-class inhibitor of mitochondrial division for treating Huntington's disease and other neurodegenerative conditions.
DUBLIN – After 18 months in stealth mode, Montreal-based Repare Therapeutics Inc. has emerged with $68 million in series A funding and serious ambitions to become a leader in identifying small-molecule drugs that act on novel targets identified through CRISPR-based induction and screening of mutations that give rise to synthetic lethality.
DUBLIN – Novartis AG looks to be on course to add another significant product to its portfolio of cardiovascular drugs following a positive readout from the Cantos phase III cardiovascular outcomes trial of its interleukin-beta1 (IL-beta1) inhibitor, Ilaris (canakinumab).
DUBLIN – Gamida Cell Ltd. took in $40 million in a new private financing round to enable it to complete an ongoing phase III pivotal trial of its Nicord umbilical cord blood (UCB) expansion technology and to support preparations for its commercialization.
