Ultromics Ltd. secured a strategic investment from the American Heart Association's Go Red for Women Venture Fund to advance the use of its technology to help clinicians better identify women suffering from heart failure with preserved ejection fraction (HFpEF). The condition goes undiagnosed in millions of women, who are disproportionately affected by HFpEF. Ultromics’ Echogo Heart Failure software analyzes routine ultrasound scans to quantify heart function and identify patterns that signal HFpEF.
The FDA’s final guidance for the use of real-world evidence (RWE) was touted by FDA commissioner Marty Makary as opening the door to the use of existing de-identified data in premarket device submissions, but the final guidance lends also clarifies a couple of points about when an investigational device exemption will be needed for RWE studies.
The U.S. FDA announced Dec. 15 that it will take a more relaxed approach regarding the use of real-world evidence (RWE) in drug and device application reviews. Specifically, new guidance for device premarket applications will not require identifiable individual patient data collected from real-world data sources, and the agency indicated it intends to consider similarly updating guidance regarding submissions for drugs and biologics.
The U.S. CDC has adopted the recommendations of its Advisory Committee for Immunization Practices (ACIP) regarding the hepatitis B virus (HBV) vaccine scheduling for infants, determining that immunization should be an individual-based decision rather than the universal birth dosing practice that has been in place for the past 30 years.
Addition Therapeutics came out of stealth mode to highlight its Precise RNA-Mediated Insertion of Transgenes (PRINT) gene therapy platform. The system is based on research of retrotransposons by Kathleen Collins’ laboratory at University of California, Berkeley, that was spun out into Addition in 2021.
Harbour Biomed has added another collaboration to its end-of-year dealmaking, this time with Bristol Myers Squibb Co. (BMS) to develop multispecific antibodies. Harbour is getting about $90 million up front, but milestones could eventually top $1 billion.
Medline Inc. returned to the public markets with a blockbuster IPO of $6.26 billion, reportedly this year’s largest IPO globally. The upsized offering of more than 216 million shares at $29 per share will allow the medical supply giant to devote the entirety of the proceeds from its initially proposed 179 million shares toward repayment of debt.
Much has been made of the recent skyrocketing of Medicare spending on skin substitutes, but a new enforcement action by the U.S. Department of Justice might help to explain some of those spending increases.
Monte Rosa Therapeutics Inc. plans a signal-verifying phase II trial next year after making known the positive interim data from an ongoing phase I/II trial testing molecular glue degrader MRT-2359 in combination with androgen receptor (AR) inhibitor Xtandi (enzalutamide, Astellas Pharma Inc.). The investigation targeted heavily pretreated patients with metastatic castration-resistant prostate cancer bearing AR mutations.
Two large deals and an acquisition, totaling about $4.64 billion in all, are helping wrap up what’s turning out to be a strong year. Through the first 11 months of 2025, biopharma dealmaking was robust with a collective value of $261.14 billion, the highest January through November total of the past seven years and well above 2024’s $201.35 billion. These three December deals helped revive the surge in dealmaking that had cooled in November.
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