More than a week ahead of its priority PDUFA date, the U.S. FDA has greenlit the first dual HER2-targeted bispecific antibody specifically for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The approval went to Jazz Pharmaceuticals plc for Ziihera (zanidatamab), an injection given to adults every two weeks. The treatment was designed to have a more favorable profile than competitors, where drugs targeting HER2 such as Astrazeneca plc’s Enhertu (trastuzumab deruxtecan) and Roche Holding AG’s Herceptin (trastuzumab) are options, as well as checkpoint inhibitors such as Merck & Co Inc.’s Keytruda (pembrolizumab). Read More
Rising from a $51 million series A round a year ago to a $1.1 billion acquisition, Kate Therapeutics Inc. has stepped under the umbrella of Novartis AG, which gains preclinical adeno-associated virus-based gene therapies for neuromuscular diseases. Read More
Kura Oncology Inc. and Kyowa Kirin Co. Ltd. have joined hands in a global strategic collaboration worth $1.49 billion to develop and commercialize ziftomenib, Kura’s selective oral menin inhibitor for treating patients with acute myeloid leukemia (AML) and other hematologic malignancies. Read More
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases. Read More
An international consortium of thousands of scientists is creating the Human Cell Atlas, a three-dimensional map of all the cells in the body. The goal is to understand all the cells that make up human tissues, organs and systems, which will enable multiple medical applications. This collection of cell maps is openly available for navigation at single-cell resolution, identified through omics analyses that reveal the tridimensional distribution of each cell. Read More
The BioWorld Drug Developers Index (BDDI) continued its downward spiral through the fall, going from a modest 1.11% decline at the end of August to a 6.2% dip in September and an 11.3% loss by October’s close. Read More
It’s difficult to fathom that the health of half the world’s population is underserved. But it’s a hard truth. Women’s health has traditionally focused on what Seema Kumar, the CEO of Cure, coined as the “bikini zone.” However, reproduction and breast health are a drop in the bucket when it comes to women’s health. In this multipart, in-depth series, BioWorld provides insight into the oft-overlooked space of women’s health, exposing the disparities in research and funding while looking toward future opportunities for bridging the gender gap in health care. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amacathera, Argenx, Melt, Newamsterdam, Novo Nordisk, Painreform, Pasithea, Quralis, Sage, Uvax, Virion. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 23andme Holding, Ampersand, Alligator, Exscientia, Flagship, Mirador, Montai, Novartis, Orion, Pfizer, Recursion, Vyriad. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpha, Capricor, Immunesensor, Ocugen, Pfizer, UCB. Read More
