Vir Biotech IDs coronavirus-binding antibodies; shares up 4% premarket
Vir Biotechnology (NASDAQ:VIR) perks up 4% premarket on light volume in reaction to its announcement that it has identified two monoclonal antibodies that bind the coronavirus causing the current outbreak, COVID-19 (formerly 2019-nCov).
The company says it is assessing neutralization with a pseudo-virus and is working with international partners to assess neutralization with the live virus.
FDA clears Baxter metabolic monitoring device
Baxter International (NYSE:BAX) and licensor COSMED announce FDA clearance of Q-NRG+, a portable metabolic monitoring device based on indirect calorimetry technology. It is used to measure resting energy expenditure in spontaneously breathing and ventilated patients in a healthcare facility setting.
Market launch will commence at the ASPEN 2020 Nutrition Science & Practice Conference in Tampa, FL, March 28-31.
Transfer of Otezla OK’d in Canada
Health Canada has signed off on the Marketing Authorization transfer of Otezla (apremilast) from Celgene to Amgen (NASDAQ:AMGN) for plaque psoriasis and psoriatic arthritis.
Amgen acquired global rights in November 2019.
Merck’s Keytruda meets PFS endpoint in TNBC study
Merck (NYSE:MRK) announces that a Phase 3 clinical trial, KEYNOTE-355, evaluating the combination of Keytruda (pembrolizumab) and chemo in patients with metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score at least 10) met one of the dual primary endpoints, progression-free survival (PFS).
In a first-line setting, treatment with the Keytruda combo resulted in a statistically significant increase in PFS compared to chemo alone.
The trial will continue unchanged in order to assess the other primary endpoint of overall survival (OS).
Detailed data will be submitted for presentation at a future medical conference and reviewed with regulatory authorities.
Shares up 1% premarket on light volume.
Elanco to divest European rights to certain Bayer assets
Aimed at securing the regulatory nod in Europe for its previously announced acquisition of Bayer’s (OTCPK:BAYRY) animal health business, Elanco Animal Health (NYSE:ELAN) has agreed to divest EU and UK rights to Bayer’s Drontal and Profender product lines to Vetoquinol SA.
Elanco says its talks with regulators about the transaction are “progressing as planned.”