Mari Serebrov

Regulatory Editor at BioWorld

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Articles

Makary’s vision for slimmed-down US FDA somewhat reassuring

3 days ago | bioworld.com | Mari Serebrov

Makary’s vision for slimmed-down US FDA somewhat reassuringNearly three weeks into the job, U.S. FDA Commissioner Marty Makary provided a comprehensive overview of his vision for the much-reduced agency, even as he’s taking first steps to implement his agenda. BioWorld BioWorld MedTech Regulatory U.S. FDA Policy
Budget woes ahead for US life sciences sector?

1 week ago | bioworld.com | Mari Serebrov

Budget woes ahead for US life sciences sector? The next major shock wave to hit the U.S. biopharma and med-tech industries could be the fiscal 2026 federal budget. Nearly one-third of the discretionary budget for the Department of Health and Human Services (HHS) could be wiped out, according to the White House Office of Management and Budget’s “pre-decisional” budget proposal, or passback, for HHS. BioWorld BioWorld MedTech Regulatory U.S. FDA NIH Policy
New Trump order zeroes in on drug prices

1 week ago | bioworld.com | Mari Serebrov

New Trump order zeroes in on drug pricesIn a blast from the past, U.S. President Donald Trump signed an executive order April 15 to deliver on his 2016 campaign promises and strengthen or reinstate efforts of his first administration to drive down prescription drug prices. BioWorld Regulatory Small molecule U.S. FDA Legislation Policy
Biopharma tariffs becoming more than a threat

1 week ago | bioworld.com | Mari Serebrov

Biopharma tariffs becoming more than a threat U.S. tariffs on biopharmaceuticals have advanced beyond administration talking points.As a precursor to tariffs, Commerce Secretary Howard Lutnick initiated an investigation under section 232 of the Trade Expansion Act to determine the effects on national security of importing prescription drugs, according to a request for public comments scheduled to be published in the April 16 Federal Register.
Pharma tariffs becoming more than a threat

1 week ago | bioworld.com | Mari Serebrov

Home » Pharma tariffs becoming more than a threat BioWorld briefs for April 14, 2025. BioWorld MedTech briefs for April 14, 2025. At first glance, it appears that biopharmaceuticals dodged the latest U.S. tariff bullet; med-tech, not so much. According to the executive order President Donald... Researchers have developed a new compound that can prevent long COVID symptoms in mice that could lead to a future drug for the debilitating condition in humans....
Loss of experience at US FDA raises concerns as impacts felt

2 weeks ago | bioworld.com | Mari Serebrov

Loss of experience at US FDA raises concerns as impacts felt“We’ve lost 1,000 person-years of expertise in a few weeks,” former U.S. FDA Commissioner David Kessler said in an April 9 House Oversight and Government Reform hearing as he discussed the impact of the termination of 3,500 FDA employees the previous week, on top of the 1,000 who were let go or offered retirement in February. BioWorld BioWorld MedTech Regulatory U.S. FDA Policy
Many US tariffs paused, pharma warned, EU put on notice

2 weeks ago | bioworld.com | Mari Serebrov

Many US tariffs paused, pharma warned, EU put on noticeThe on-again, off-again U.S. tariffs are off again, at least for now, for more than 75 countries that have reached out to the Trump administration to negotiate instead of retaliating. The 90-day pause will provide some breathing room for the med-tech industry.
Much-needed predictability lacking in US biosimilar market

2 weeks ago | bioworld.com | Mari Serebrov

Much-needed predictability lacking in US biosimilar marketIll-considered government policies, pharmacy benefit manager market abuses and an unpredictable future are casting doubt on the long-term sustainability of the U.S. biosimilar market, Craig Burton, the executive director of the Biosimilars Council, told a House Ways & Means subcommittee April 8. BioWorld Regulatory Biosimilar U.S. FDA Legislation Medicare NIH Policy
US court says no to NIH indirect rate cut, another suit filed

2 weeks ago | bioworld.com | Mari Serebrov

US court says no to NIH indirect rate cut, another suit filedThe nationwide preliminary injunction keeping the U.S. NIH from slashing its indirect cost rate to a flat 15% has become permanent. In issuing the permanent injunction and final judgment April 4 in three challenges to the rate change, Judge Angel Kelley, of the U.S. District Court for the District of Massachusetts, said the NIH’s Feb. 7 notice that it would begin imposing the 15% rate Feb.
Biopharma exempt from US reciprocal tariffs, but not untouched

3 weeks ago | bioworld.com | Mari Serebrov

Biopharma exempt from US reciprocal tariffs, but not untouchedAt first glance, it appears that biopharmaceuticals dodged the latest U.S. tariff bullet; med-tech, not so much. According to the executive order President Donald Trump signed in the Rose Garden late yesterday, pharmaceuticals are one of the few things exempt from the new country-by-country reciprocal tariffs that will be going into effect over the next week.