Verona Pharma plc, of Cardiff, U.K., said it plans to conduct a registered IPO in the U.S. The number of shares and price of the proposed offering have not yet been determined and the company said the proposed offering is expected to start in the first half of next year. Read More
Bristol-Myers Squibb Co., of New York, said the European Commission approved Opdivo (nivolumab) to treat adult patients with relapsed or refractory classical Hodgkin lymphoma following autologous stem cell transplant and treatment with Adcetris (brentuximab vedotin, Seattle Genetics Inc.). Read More
Bavarian Nordic A/S, of Copenhagen, said it completed enrollment in a phase III study designed to demonstrate noninferiority between its investigational, nonreplicating smallpox vaccine, Imvamune, and ACAM2000, the current U.S. licensed, and replicating, smallpox vaccine. Read More
Researchers have been able to grow human intestinal organoids that included enteric nervous system tissue, marking the first time an organoid has contained an integrated peripheral nervous system. Organoids, stem cell-derived tissue cultures containing multiple cell types, are far more similar to the organs they model than classical cell cultures. Read More
Calling all drug companies – the FDA wants your quality manufacturing data. The agency is launching a voluntary phase of its quality metrics reporting program in hopes of learning more about certain quality metrics and associated analytics. Read More
Last week’s phase III blowup of Eli Lilly and Co.’s solanezumab (sola) in Alzheimer’s disease (AD) struck up a familiar dirge in the failure-strewn space, and set experts to debating – again, still – the amyloid beta hypothesis, as companies that have chosen to pursue other routes continued to laud their approaches and ever-ambitious big pharma snatched up another player in the space. Read More
Two cases of cerebral edema, both ending in death, led Juno Therapeutics Inc. to put a clinical hold on a phase II trial of its chimeric antigen receptor (CAR) T-cell therapy, JCAR015, for the second time in five months. Read More
HONG KONG – Chinese pharmaceutical companies in areas around the capital of Beijing are expecting to take a hit to their bottom lines for an unusual reason: pollution. Drug manufacturers in the province that neighbors Beijing were ordered to “temporarily” halt operations to address severe smog in the capital. Read More
Feeding mice a high-fat diet to the point where they developed diet-induced obesity led to microbiome changes that were remarkably persistent. Read More
PERTH, Australia – Following its IPO in August, Melbourne-based Adalta Pty Ltd. inked two deals this month, and is now moving to the clinic with its human version of the shark antibody platform, the i-body. Read More
