The U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar product referencing Novo Nordisk A/S’ Novolog (insulin aspart), a rapid-acting diabetes medication.
“Pharmaceuticals will be tariffed, probably at the end of the month,” U.S. President Donald Trump said, as he provided a few more details about his proposed global biopharma sector tariff. “We’re going to start off with a low tariff and give the pharmaceutical companies a year or so to build. And then we’re going to make it a very high tariff.”
The continuing proliferation of U.S. state privacy law drew the attention of developers of med-tech wearables for some time, but a recent Senate hearing delivered the news to Congress that a failure to preempt it will slow digital health innovation to a crawl.
It’s been more than seven years in coming, but the U.S. FDA is at last making public at least some of the complete response letters (CRLs) it’s sent to drug and biologic sponsors to notify them of deficiencies in their approval applications.
The U.S. Commerce Department isn't expected to complete its Section 232 investigation to build a national security case for imposing tariffs on biopharmaceuticals until the end of the month, but that didn’t stop President Donald Trump from once again teasing a “very, very high” tariff for medicines and their ingredients.
Patent reform in the U.S. revolves largely around the subject matter eligibility question, but Congress is reluctant to intervene – a predicament addressed recently by Andrei Iancu, formerly the director of the U.S. Patent and Trademark Office.
President Donald Trump signed House Resolution 1, the final version of which does not impose a moratorium on state legislation governing the use of AI. The bill does, however, restore the full deductibility of research and development expenses, which will be retroactive to 2022 for businesses that gross $31 million or less per year.
Finding they were “arbitrary and capricious” under the Administrative Procedures Act, the District Court for the District of Columbia vacated a White House Office of Personnel Management memo and a subsequent Department of Health and Human Services’ guidance intended to implement President Donald Trump’s Day 1 executive order pertaining to gender ideology.
The U.S. Health and Human Services and the Justice Departments are bringing more resources to their crack down on False Claims Act (FCA) violations involving drugs, medical devices and Medicare fraud.
The House of Representatives passed H.R. 1, also known as One Big Beautiful Bill, which will restore personal income tax cuts that expired in 2022. However, the bill also restores research and development tax credits, a provision that drew immediate praise from industry.
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