DUBLIN – The EMA's Committee for Human Medicinal Products (CHMP) closed out 2017 with recommendations for three new drug approvals and for one new biosimilar, along with positive recommendations for five products approved under the generic, hybrid or informed consent pathways, plus two line extensions.
DUBLIN – Remynd NV could earn up to €350 million (US$412 million) in up-front, research and milestone payments from a licensing deal with Novo Nordisk A/S focused on its preclinical diabetes drug candidate ReS39.
DUBLIN – Two years after a failed effort to develop the cannabinoid product Sativex (nabiximols) as a therapy for cancer pain in the U.S., GW Pharmaceuticals plc and Otsuka Pharmaceutical Co. Ltd. are finally terminating an alliance that dates back more than a decade.
DUBLIN – The B-cell antigen CD19 is, of course, the target of choice for the first wave of chimeric antigen receptor T-cell (CAR T-cell) therapies to secure FDA approval this year. ADC Therapeutics Sarl and Morphosys AG both reported clinical data at the American Society of Hematology Annual Meeting in Atlanta this week, which also confirms its potential as a target for antibody-based therapies as well – but only in the context of engineered antibodies that have additional properties beyond what conventional antibodies can offer.
DUBLIN – Xenikos BV aims to move its T-Guard cocktail of two antibody-drug conjugates into a pivotal phase III trial in acute graft-vs.-host disease (aGVHD) early next year, on the back of data from an open-label phase I/II trial, in which 12 of 18 treated patients (67 percent) remained alive at six months.
DUBLIN – Allergy specialist Alk-Abelló A/S grossed DKK698.9 million (US$111 million) in an accelerated bookbuilding process to fund its new strategy. The Hørsholm, Denmark-based firm priced the discounted offering of 92,076 AA shares and 920,760 B shares at DKK690 per share on Thursday. The new shares, which represent just over 9 percent of its post-money share capital, will be admitted for listing on Nasdaq Copenhagen next Wednesday.
DUBLIN – In a final flourish to its first year of trading, Idorsia Ltd., the Swiss firm spun out of Actelion Ltd., banked a massive $230 million milestone as Johnson & Johnson Co. pulled the trigger on an option to co-develop its phase II hypertension drug aprocitentan (ACT-132577).
DUBLIN – Zelluna Immunotherapy AS is the latest contender to throw its hat into the immuno-oncology ring, but the Oslo, Norway-based startup can draw on several decades' worth of clinical research in its effort to build a pipeline of cell and biologic therapies based on proprietary T-cell receptors (TCRs) against important tumor antigens.
DUBLIN – The founders of the U.K.-listed gene editing technology firm Horizon Discovery plc, Alberto Bardelli and Chris Torrance, have re-emerged in a new startup that has a therapeutic focus.
DUBLIN – Shares in Auris Medical AG (Nasdaq:EARS) plummeted more than 60 percent during premarket trading Tuesday on news that its lead drug candidate, AM-111, missed the primary endpoint of a phase III trial, called Healos, in patients who experienced sudden deafness.
