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Home » Newsletters » BioWorld

BioWorld

Nov. 21, 2024

View Archived Issues
Illustration of cancer in the bile ducts

FDA approves biliary tract cancer treatment from Jazz

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

Novartis acquires gene therapy developer Kate Therapeutics for $1.1B

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
Global handshake silhouette

Kura, Kyowa Kirin to co-develop ziftomenib in $1.49B deal

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

NMPA clears Alpha’s oral EGFR-TKI for NSCLC with brain metastases

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
D-rendered image showing atlas of human embryonic skeletal development

More than 100M cells included in the human cell atlas

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
Stock-crashes.png

Drug developer stocks slide further in fall, despite gains from Exelixis and Xencor

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
Group of multigenerational, multiracial women

Healing the health divide: BioWorld reports on women’s health space

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

Appointments and advancements for Nov. 21, 2024

New hires and promotions in the biopharma industry, including: Biolojic, Bluejay, Lexicon, Preveceutical, Umoja. Read More

Financings for Nov. 21, 2024

Biopharmas raising money in public or private financings, including: Abivax, Forte, Lineage, Karolinska, Modus, Valora. Read More

In the clinic for Nov. 21, 2024

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

Other news to note for Nov. 21, 2024

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 actions for Nov. 21, 2024

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

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