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Home » Authors » Mari Serebrov

Articles by Mari Serebrov

US HHS calls for MFN pricing commitments

May 20, 2025
By Mari Serebrov
No Comments
The U.S. Department of Health and Human Services (HHS) put biopharma companies on notice May 20: It’s time to commit to reducing prescription drug prices to reflect most-favored-nation (MFN) pricing in accordance with President Donald Trump’s May 12 executive order. HHS said it expects manufacturers to commit to aligning their U.S. prices for all brand products across all markets that don’t currently have generic or biosimilar competition with the lowest price of a set of economic peer countries.
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Street a bit uneasy ahead of Urogen adcom

May 19, 2025
By Mari Serebrov
No Comments
With a PDUFA date less than four weeks away, Urogen Pharma Inc. has been having a rough ride on the Street since the U.S. FDA released a joint briefing document for the May 21 Oncologic Drugs Advisory Committee meeting on UGN-102 (mitomycin).
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Pills arranged in dollar sign

US threat of most-favored-nation Rx pricing intensifies

May 15, 2025
By Mari Serebrov
No Comments
Recognizing the potential legal challenges to U.S. President Donald Trump’s executive order calling for most-favored-nation (MFN) prescription drug pricing and the limits of that order, several congressional Democrats introduced a bill in both the House and Senate May 14 that could make MFN pricing the law of the land and extend it to both government health programs and private insurance.
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RFK at Senate HELP meeting 5-14

Kennedy on HELP hot seat over budget, cuts and layoffs

May 14, 2025
By Mari Serebrov
No Comments
U.S. Health and Human Services Secretary Robert Kennedy made his first appearance May 14 before the Senate Health, Education, Labor and Pensions (HELP) Committee since his January confirmation hearing. Chaos, testy arguments, accusations and surprising agreements ensued.
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Speech bubbles

HHS asks for input on which regs to kill

May 13, 2025
By Mari Serebrov
No Comments
As the U.S. Department of Health and Human Services (HHS) and its agencies begin weeding out old regulations, the department is requesting public input to help identify and eliminate outdated or unnecessary regulations.
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US lawmakers call for action in addressing PBM practices

May 13, 2025
By Mari Serebrov
No Comments
In a continuing déjà vu, the Senate Judiciary Committee held yet another hearing May 13 on pharmacy benefit managers (PBMs), focusing on a lack of transparency.
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Drug capsule and dollar sign

Little bite from voluntary most-favored nation Rx pricing order

May 12, 2025
By Mari Serebrov
No Comments
After a week of hype, the most-favored nation (MFN) drug pricing executive order (EO) U.S. President Donald Trump signed May 12 has a lot of bark but little bite, as one analyst put it. Brian Abrahams, head of global healthcare research at RBC Capital Markets LLC, said the EO is unlikely to rattle the biopharma sector, even though it lacked the certainty to completely remove the MFN overhang. “We see reason for relief and, alongside improving FDA clarity and limited tariff risk, expect biopharma to be viewed as increasingly investable,” Abrahams said.
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Judge's gavel with US flag

Sun shines on Leqselvi at Federal Circuit

May 9, 2025
By Mari Serebrov
No Comments
Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd.
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US court reversed in safe harbor overreach

May 9, 2025
By Mari Serebrov
No Comments
Finding that a lower court went too far with an injunction that ignores the Hatch-Waxman safe harbor protections for drug development, the U.S. Court of Appeals for the Federal Circuit handed Avadel CNS Pharmaceuticals LLC a win of sorts.
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Sun shines on Leqselvi at Federal Circuit

May 8, 2025
By Mari Serebrov
No Comments
Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd.
Read More
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