Positive data from two studies treating early breast cancer with CDK4/6 inhibitors presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago showed progress is helping patients live longer. The two treatments and companies, Novartis AG and Eli Lilly and Co., are nearly head-to-head competitors in the niche indication. Read More
HER2-targeting bispecific antibody zanidatamab, in development by Jazz Pharmaceuticals plc and Zymeworks Inc., produced better antitumor responses than current standard of care when used as a second-line treatment for biliary tract cancer (BTC) in a pivotal phase IIb study, bringing it closer to becoming the first therapy to target HER2-expressing BTC. Read More
Impressive data continue to roll out for Day One Biopharmaceuticals Inc.’s tovorafenib in pediatric low-grade glioma, with results from 69 evaluable patients with relapsed or progressive disease showing a 67% overall response rate, as measured by Response Assessment for Neuro-Oncology High-Grade Glioma, in the phase II Firefly-1 trial. Read More
Despite the title of the Sunday, June 4 lead-off presentation at the American Society of Clinical Oncology (ASCO) meeting in Chicago, there was little room left for doubt about the increasingly important place of artificial intelligence (AI) in drug development. Read More
ITM SE has closed a €255 million (US$272 million) round to prepare for market entry, as its lead targeted radiopharmaceutical ITM-11 nears the end of phase III development in the treatment of neuroendocrine tumors of gastroenteric or pancreatic origin. Read More
Canbridge Pharmaceuticals Inc. obtained marketing approval from China’s NMPA for CAN-108 (Livmarli; maralixibat chloride oral solution) to treat cholestatic pruritus in 1-year-old or older patients with Alagille syndrome, a development that the company touted for how quickly it followed similar approvals elsewhere. Read More
An unexpected burst of early summer heat and three nights of Taylor Swift performances at nearby Soldier Field didn’t deter tens of thousands of cancer vaccine and therapy developers from swarming Chicago’s McCormick Place for the first full day of presentations at the American Society of Clinical Oncology (ASCO) meeting, one of the year’s biggest cancer conferences. Read More
Free, no-prescription-required access to naloxone has reduced deaths from opioid overdoses by 11% in some communities, but they only work if someone with the reversal agent is available when a person overdoses. Resilient Lifescience Inc. hopes to save those lives, too. The company is developing a wearable patch that monitors vital signs and automatically administers naloxone when needed. In this edition of the BioWorld Insider podcast, Brad Holden, CEO of Resilient Lifescience, explained how the device works for overdoses as well as other potential applications for the new technology.
New hires and promotions in the biopharma industry, including: Ambrx, Excision, Immodulon, Mesoblast, Ocugen, Replimune, RS, Variant, Vaxxas. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Athersys, Aurinia, Biontech, Bluejay, Connect, Eli Lilly, LoMedivir, Neurotrauma, Novartis, Oncoc4, Pfizer, Realta, Scisparc, Skye. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affyxell, Avacta, Celltrion Cero, Cerus, Daewoong, Erytech, Indivior, Lotus, Neurogastrx, Novavax, Nrx, Pherecydes, Phoenix, Rani, Selvita, Synlogic, Teva, Vaxequity. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Regent, Avadel, Bioinvent, Canbridge, Daiichi Sankyo, Foghorn, Hemogenyx, Innovent, Kyverna, Springworks, Theratechnologies. Read More
