Gone from the American Society of Clinical Oncology (ASCO) meeting were the packed halls of McCormick Place in Chicago and the excited bustle of scientists reacquainting with each other at the always data-rich event. ASCO’s annual confab, held online because of the COVID-19 pandemic, still managed to pull off what former president Howard Burris called a “resounding success,” with about 40,000 registrants, similar to previous years. Read More
Eli Lilly and Co. said June 1 the first patients have been dosed in a phase I test of LY-CoV555, a potential antibody treatment for COVID-19, with results expected by June 30. Should it prove safe, the candidate could quickly move into a phase II trial to assess its efficacy, Ajay Nirula, vice president of immunology at Lilly, told BioWorld. Read More
Two phase III stumbles of Iterum Therapeutics plc’s sulopenem have cast the company’s future in doubt. The latest problem is the failure of the penem anti-infective compound, with oral and I.V. formulations, failing to achieve statistical noninferiority relative to ertapenem in treating complicated urinary tract infection (cUTI). Read More
SUZHOU, China – After growing rapidly in recent years, China’s pharma market will begin to see that growth slow, but market watchers said it is not necessarily all bad news. Read More
Blue chip public biopharmaceutical companies continued their positive trajectory in May, with the BioWorld Biopharmaceutical index recording an 8% jump in valuation and contributing to its year-to-date performance of approximately 17%. Read More
The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review. Read More
Allogene Therapeutics Inc. investors will have to wait for an update in the second half of this year to find out more about whether off-the-shelf ALLO-501 can durably stand up to autologous CAR T-cell therapies, but early data disclosed at the American Society of Clinical Oncology meeting is creating buzz in the meantime. Read More
Shares of Adaptimmune Therapeutics plc (NASDAQ:ADAP) rocketed to $11.07 Friday, up $127% or $6.21, on updated data rolled out at the American Society of Clinical Oncology (ASCO) meeting, held virtually this year. Read More
The juggernaut that is Daiichi Sankyo Co. Ltd.’s Enhertu continued to roll into this weekend’s American Society of Clinical Oncology virtual meeting, bringing momentum from its December FDA approval for HER2-positive breast cancer, along with fresh data from three new studies in other indications. Read More
In data taken from three expansion cohorts of Exelixis Inc.’s phase Ib study of Cabometyx and Tecentriq in patients with locally advanced or metastatic solid tumors, a 27% objective response rate was seen in those with immune checkpoint inhibitor-pretreated non-small-cell lung cancer. Read More
New hires and promotions in the biopharma industry, including: Biond, Celyad, Iteos, Neoleukin, Oxford Biomedica, Samumed, Sanifit, Swanbio, Trisalus. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology’s annual meeting May 29-31, including: Ascentage, Celyad, Engeneic, Faron Immutep, Innovent, Kazia, Nanobiotix, Nkmax, Taiho, Treos. Read More
Biopharmas raising money in public or private financings, including: Adaptimmune, Allogene, Baudax Bio, Biolinerx, Calliditas, Cleveland Biolabs, Nabriva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Accord, Altimmune, ANI, Astrazeneca, Aveo, Compugen, Cytodyn, Eli Lilly, Genentech, Henlius, Hutchison China (Chi-Med), J&J, Longeveron, Merck, Mundipharma, Myovant, Myr, Opko. Read More
