Shares of Lyra Therapeutics Inc. soared more than 310% on data from its second phase III trial testing drug-device candidate LYR-210 in patients with chronic rhinosinusitis, with results from the Enlighten 2 study showing statistical significance on primary and key secondary endpoints and offering hopes of a regulatory pathway ahead.
Abbott Laboratories recently received FDA clearance for Tendyne, its transcatheter mitral valve replacement system. The news comes on the heels of Edwards Lifesciences Corp. securing a CE mark for its Sapien M3 system and is a boon for mitral valve therapies amid ongoing frustrations about the slow adoption of TMVR technologies.
The U.S. Department of Justice is reshuffling its enforcement focus for the coming three years per a May 12 memo attributed to Matthew Galeotti, director of the department’s criminal division. Galeotti said federal attorneys should avoid prosecutorial adventurism in an effort to strike what he described as “an appropriate balance” between enforcement and “unnecessary burdens on American enterprise.”
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Iradimed, Reflow Medical.
Asian health care-focused private equity firm Quadria Capital announced the final close of its Fund III with $1.07 billion in total commitments to transform health care across Asia, which is expected to drive 40% of global health care growth by 2030.
A dynamic chart of the latest executive orders (EOs) from the Trump administration that have been published in the Federal Register and that directly impact the biopharmaceutical and medical technology sectors.
RSS
