News out of the Heart Rhythm Society 2024 meeting May 16-19 highlighted the rapid disruption pulsed field ablation (PFA) devices have wrought in cardiac arrhythmia treatment, so it is little surprise to see that PFAs are among the top five technologies with transformative potential identified by Clarivate plc in its Medical Technologies to Watch in 2024 report. The impact of the other four – continuous glucose monitors (CGM) for diabetes, neurostimulation devices, surgical robotics and renal denervation – has been just as revolutionary, if longer in being realized.
Altrubio Inc. secured up to $225 million in an oversubscribed series B financing round, led by BVF Partners LP. The full amount is dependent on Altrubio meeting certain undisclosed milestones. New investors RA Capital Management, Cormorant Asset Management and Soleus Capital, and existing investors Amoon Fund and Blackstone Multi-Asset Investing, as well as other new and existing investors, also participated in the financing round.
The Department of Health and Human Services (HHS) has no rulemaking authority over the 340B prescription drug discount program, the U.S. Court of Appeals for the District of Columbia Circuit said May 21 as it handed the government its second big loss in the ongoing debate over whether drug manufacturers have to give unlimited contract pharmacies the steep discounts the program provides to certain health care providers.
Pheon Therapeutics Ltd. is poised to start the first of three clinical trials of its lead antibody-drug conjugate (ADC), after closing a $120 million series B. The company is taking a “three-pronged approach” in order to stake out as much of the ground as it can for its next-generation ADC, which delivers an in-house-designed topoisomerase inhibitor to a novel undisclosed transmembrane protein target.
The U.S. Trade Representative (USTR) once again called out the usual cast of characters in this year’s Special 301 Report for not playing by the rules when it comes to protecting intellectual property. And once again, industry asked the USTR to go further by placing new players on the list.
The U.S. FDA approved the country’s first two interchangeable biosimilars, or copy products, of Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 20, to treat four eye-related conditions. The FDA granted the approvals to U.S.- and India-based Johnson & Johnson Services Inc./Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf; M-710) and South Korea’s Samsung Bioepis Co. Ltd.’s Opuviz (aflibercept-yszy; SB-15).
Citing the need to protect the public interest, the U.S. Department of Health and Human Services ordered an immediate government-wide funding suspension May 15 of Ecohealth Alliance Inc. while formal debarment proceedings are pending against the New York-based nongovernmental organization.
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
To strengthen its cancer pipeline, South Korea’s Dong-A ST Co. Ltd. made a strategic investment of ₩25 billion (US$18.45 million) in Seocho-gu, Seoul-based Idience Co. Ltd., a cancer-focused subsidiary of Ildong Pharmaceutical Co. Ltd. on May 20.
The Cleveland Clinic Foundation (CCF) has found itself on the wrong end of an enforcement action by a federal attorney’s office, which had alleged that CCF had made false statements to the government regarding three grant awards.
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