With the U.S. FDA’s approval of Orlynvah (sulopenem etzadroxil and probenecid) for uncomplicated urinary tract infections, Iterum Therapeutics plc can move on from regulatory delays and prepare to launch only the second FDA-approved treatment for the indication in the past 20 years.
Medtronic plc added a second U.S. FDA pulsed field ablation (PFA) device approval to its scorecard with the agency’s greenlight for its Affera mapping and ablation system with the Sphere-9 catheter. Affera brings the first radiofrequency/PFA device to the cardiac ablation market and ups the ante in the PFA competition.
The Medical Information Working Group again took up a question regarding U.S. FDA-regulated speech, citing the agency’s new misinformation draft guidance as an example of a piecemeal approach to regulated speech.
Privately held Dyno Therapeutics Inc. has added another notch to its adeno-associated virus (AAV) vectors development portfolio in a deal with the Roche Group that includes $50 million up front and ultimately could top $1 billion. Dyno will help in developing next-generation AAV vectors, optimized by artificial intelligence, to target neurological diseases.
For a company that was running out of money, a missed phase III endpoint for its only development product knelled a death blow for Marinus Pharmaceuticals Inc., tanking its stock by 82%. The Radnor, Pa.-based company will no longer develop oral ganaxolone for seizures associated with tuberous sclerosis complex, or for any other indication, as it reduces its workforce and explores strategic alternatives.
The approval of Ascendis Pharma A/S’ hormone replacement therapy Yorvipath (palopegteriparatide) hypoparathyroidism – the first and only treatment for adults with the rare endocrine disease – did little to sate the market’s appetite for new drugs in the indication, where a number of players are busy in various stages of development.
Privately held Dyno Therapeutics Inc. has added another notch to its adeno-associated virus (AAV) vectors development portfolio in a deal with the Roche Group that includes $50 million up front and ultimately could top $1 billion. Dyno will help in developing next-generation AAV vectors, optimized by artificial intelligence, to target neurological diseases.
Early results from REFLECTION, a real-world study, mirrored results for Grail Inc.'s multi-cancer early detection (MCED) assay in clinical trials, according to a presentation at the 2024 Early Detection of Cancer Conference. The study, conducted at U.S. Department of Veterans Affairs (VA) sites, focuses on the real-world application of the Galleri test, which screens for multiple cancers in asymptomatic individuals.
Despite positive findings from an earlier trial, Alto Neuroscience Inc.’s BDNF-targeting candidate, ALTO-100, failed to best placebo in a phase IIb study in major depressive disorder, sending shares of the company to their lowest price since going public in a February 2024 IPO, as investors worried about readthrough to Alto’s biomarker-based approach for treating psychiatric disorders.
Boston Scientific Corp. posted another eye-popping quarterly report, led by a 177% year-over-year increase in its electrophysiology business to $527 million, which exceeded consensus expectations by $99 million. That stunning EP growth follows 125% growth in the second quarter and 70% in the first quarter, all largely attributed to the Farapulse pulsed field ablation system, which achieved unprecedented adoption rates.
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