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Rather than pursuing a new regulatory pathway, Q’Apel said it is discontinuing the recalled system “as part of its strategic shift toward newer technologies.”

The medical device maker is partnering with IRCAD, a surgical education and research institute, to train medical personnel in cardiovascular, neuroscience and minimally invasive specialties.

On the sidelines of BIO2025, Julie Gilmore, head of Lilly Gateway Labs, shares her thoughts on the $1.3 billion Verve Therapeutics buy, where Lilly’s therapeutic puck is potentially going and how the company is leveraging its unprecedented success in obesity to support young biotechs.

Severe adverse events, including seizure and loss of consciousness, were potentially linked to the issue, based on 56 reports Dexcom received.

In combination with Eli Lilly’s tirzepatide, marketed as Zepbound for obesity, Scholar Rock’s monolonal antibody helped patients lose the same amount of weight as patients on tirzepatide alone while preserving more muscle mass.

Speaking at BIO 2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory landscape.

The U.K.-based biotech is set to enter mid-stage studies for its depression drug this year, while two other GABAA modulators are poised for clinical trials in 2026.

Industry watchers responded mostly positively to the commissioner’s new voucher program, but worries remain over staffing cuts at the agency.

EY’s 2025 Biotech Beyond Borders report provides a sobering snapshot of the industry’s financial health, with more and more companies facing cash runways of less than one year. The analyst firm’s leaders urge a return to basics for biotech.

The uninsurance rate for working adults fell from over 20% in 2013 to 11% in 2023. But federal policies like Medicaid cuts threaten that improvement, according to the Commonwealth Fund.