With more drugs for Alzheimer’s disease (AD) gaining FDA approval and an aging population at increased risk of dementia, the need for AD diagnostics is only going to grow. An estimated 6.7 million Americans live with Alzheimer’s today, with that number projected to hit 14 million by 2060, according to the CDC.

While U.S. politics continues to delay Senate confirmation of the NIH director, other crucial positions at the agency that don’t require Senate action are being filled. Acting NIH Director Lawrence Tabak announced Aug. 2 that he has named Jeanne Marrazzo as director of the agency’s National Institute of Allergy and Infectious Diseases (NIAID).

While U.S. politics continues to delay Senate confirmation of the NIH director, other crucial positions at the agency that don’t require Senate action are being filled. Acting NIH Director Lawrence Tabak announced Aug. 2 that he has named Jeanne Marrazzo as director of the agency’s National Institute of Allergy and Infectious Diseases (NIAID).

The old adage of “what goes up must come down” rarely applies to U.S. FDA user fees. Most of the fiscal 2024 fees, which go into effect Oct. 1, continue in an upward slope. Under the PDUFA agreement, the fees for NDAs/BLAs are surging 25%. All but one of the MDUFA fees are going up 9.5%; the lone exception is growing by 18%. The MDUFA hikes are building on top of this year’s hefty increases. In the generics realm, the drug master file fee is going up 21%, but other fees increases are in the single digit range. Biosimilars, however, are the exception to the rule, with all the BsUFA fees seeing big drops.

The European Union and the U.S. have wrapped up a data privacy framework that covers broad swaths of both economies, including the transmission of clinical trial data across the Atlantic Ocean. Drug and device makers that want to make use of this framework and thus jettison the contractual clause to ensure data privacy may find compliance with this new framework much more efficient in the long run, but will have to do a lot of compliance work on the front end to achieve those efficiencies.

Ultromics Ltd.’s Echogo Heart Failure system detects heart failure with preserved ejection fraction (HFpEF) from a single apical four-chamber video clip, according to a study published in JACC Advances. The study follows a consensus statement from American College of Cardiology which said that although there are now effective therapies to treat HFpEF, there is an increasing urgency for accurate diagnosis as the number of patients with HFpEF is on the rise, accounting for more than 50% of all heart failure cases.

A huge sigh of relief from the life sciences industry greeted U.S. President Joe Biden’s executive order that’s intended to shore up domestic manufacturing of products developed with taxpayer support. “It’s like the Titanic, [but] we just missed the iceberg,” Joseph Allen, executive director of the Bayh-Dole Coalition, told BioWorld. The fear for the past few years has been that the administration would follow in the wake of the Department of Energy, which broadly expanded the current Bayh-Dole U.S. manufacturing preference.

The first participants are being treated in a clinical trial assessing a neuromodulation system developed by Magnus Medical Inc. to treat depression. The system employs the recently FDA-cleared Saint neuromodulation technology that saw remarkable results in a clinical trial for treating major depressive disorder (MDD). The new Open Label Optimization (OLO) clinical trial is evaluating the effectiveness of this platform in conjunction with the medtech’s Magnus Neuromodulation System.