Physicians aren’t the only ones who see prior authorization (PA) practices as a significant problem, but John Brooks, deputy administrator at CMS, told a med tech audience that a renewed focus on Medicare Advantage plans’ use of PA will not yield tangible results overnight.
Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.
First quarter 2025 results presentations were the first chance analysts have had to quiz pharma companies in public about their exposure to the threat of U.S. import tariffs and what action they are taking to mitigate the risks. BioWorld reporters have listened in to the analyst meetings and filleted out responses to the tariff question by CEOs and senior executives, to get an overview of how the sector as a whole is responding. One thing is very clear: While pharmaceuticals are for now exempt from tariffs, the industry has been bracing for their imposition whilst at the same time lobbying strongly against them, on the grounds that drug shortages could result.
Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health (CDRH), covered several programmatic areas in a May 1 trade association meeting, such as the CDRH early alert program.
Sen. Amy Klobuchar (D-Minn.) spoke to an industry meeting in Washington and expressed concerns about the situation at the U.S. FDA, but she also blasted the tariffs put in place by the Trump administration as lacking the proper statutory authority.
In a paradigm shift from private-sector partners, the U.S. Department of Health and Human Services (HHS) and the NIH announced May 1 the development of Generation Gold Standard, a next-generation, universal vaccine platform that uses a beta-propiolactone-inactivated, whole-virus to target pandemic-prone viruses.
Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.
Clinical results offered at the recent meeting of the American Urological Association in Las Vegas signal that better treatments may lie ahead for non-muscle invasive bladder cancer.
Dimerix Ltd. sealed an exclusive license agreement with Amicus Therapeutics Inc. for commercialization of its phase III kidney disease candidate, DMX-200, in a deal valued at AU$940 million (US$601.22 million).
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