Kura Oncology Inc. and Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, met the primary endpoints in the phase II registrational Komet-001 trial in patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML), and Kura expects to submit its NDA to the U.S. FDA in the second quarter of 2025.
Eli Lilly and Co.’s end last year to its PI3Kα inhibitor program didn’t mean the pharma player was giving up on the target – far from it, as signaled by the potential $2.5 billion deal signed recently to take over Scorpion Therapeutics Inc. and gain rights to phase I/II-stage STX-478 for breast cancer and other solid tumors. The list of developers at work in the space includes Roche AG plus smaller entities such as Celcuity Inc., Menarini Group, Onkure Therapeutics Inc., Relay Therapeutics Inc. and Totus Medicines Inc.
In keeping with the trend in med tech to return to basics, Becton, Dickinson and Co. plans to split off its biosciences and diagnostic solutions unit to create two pure-play companies. The ‘New BD’ or RemainCo. will be a focused medical technology company that will include the current company’s medication delivery, specimen management, patient monitoring, pharmaceutical systems, urology, critical care, peripheral intervention and surgery businesses.
Globus Medical Inc. reported it is buying Nevro Corp. in an all-cash transaction. Under the terms of the agreement, which was unanimously approved by the boards of both companies, Globus will acquire all shares of Nevro for $5.85 per share. The transaction represents a total equity value of approximately $250 million.
The U.S. FDA’s device center hasn’t issued news bulletins or guidances in the past week, but the march of device recalls continues apace in the month of February.
Curently the only available blood test to tell which women are at risk of postpartum depression (PPD) is the one that confirms their pregnancy – and a one in seven chance of developing the condition which can have long-term implications for both mother and child. Research out of the University of Virginia and Weill Cornell Medicine could soon change that by identifying biomarkers in the third trimester of pregnancy that indicate which women have the greatest risk of developing PPD.
Europe has more oncology startups than the U.S., but many more U.S. companies scale up to the later growth stage. Given the proven links between patent ownership and access to finance, that critical gap is in part because U.S. companies hold nearly twice as many patents as European counterparts, according to an analysis by the European Patent Office.
When the U.S. CDC and FDA recently removed several webpages and datasets from their websites in compliance with a directive from the Office of Personnel Management, they broke the law and harmed public health and research, according to a lawsuit filed Feb. 4 by Doctors for America.
Touting its novel approach for treating glaucoma, Qlaris Bio Inc. reported promising top-line data from two phase II studies testing QLS-111 in patients with primary open-angle glaucoma and ocular hypertension, showing the drug met all primary and secondary endpoints, reducing intraocular pressure with a clean safety profile that could encourage patients to remain on treatment.
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