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Home » Topics » Regulatory

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Pediatric brain illustration
Neurology/psychiatric

Capsida’s gene therapy for STXBP1 developmental and epileptic encephalopathy gains IND clearance

May 13, 2025
No Comments
Capsida Biotherapeutics Inc. has gained IND clearance from the FDA for CAP-002, its first-in-class, intravenously administered gene therapy for syntaxin-binding protein 1 developmental and epileptic encephalopathy (STXBP1-DEE). Dosing in the phase I/IIa SYNRGY trial will begin in the third quarter of this year.
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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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Gavel and scales

Case draws more refined line for Anti-Kickback violations

May 12, 2025
By Mark McCarty
Device makers may find it difficult to avoid running afoul of the Anti-Kickback Statute, but a recent case in the U.S. Court of Appeals for the Seventh Circuit suggests that the statutory definition of a referral is not set in stone.
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Brain waves

NICE sees room for digital health for chronic tics and Tourette

May 12, 2025
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) endorsed the use of the Orbit system by Mindtech Ltd. as a treatment for tics and Tourette syndrome.
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Digital representation of U.S.-U.K. flags

With trade agreement secured, US and UK await section 232 outcome

May 12, 2025
By Nuala Moran
No Comments
The U.K. became the first country to reach agreement with the U.S. over threatened tariffs in an “economic prosperity deal” that leaves the pharma industry hanging on for the outcome of the U.S. section 232 probe into the implications of pharmaceutical imports for America’s national security.
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Astrazeneca production and manufacture facility

FDA to conduct unannounced inspections at OUS sites

May 9, 2025
By Mark McCarty
The U.S. FDA typically announces its inspections at facilities located outside the U.S. – a courtesy not extended to domestic manufacturing sites. This is about to change per an agency press release quoting commissioner Marty Makary as describing the disparate treatment as a double standard.
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Koreabio Humanase KOH Sungho
Bio Korea 2025

FDA shift from animal testing fuels organoid, organ-on-chip demand

May 9, 2025
By Marian (YoonJee) Chu
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 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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Avmapki-Fakzynja packaging

High-graded low-grade ovarian duo wins for Verastem at FDA

May 9, 2025
By Randy Osborne
No Comments
Verastem Oncology Inc. CEO Dan Paterson said he is “not expecting a huge bolus [of ovarian cancer patients] at the beginning” of Avmapki/Fakzynja’s launch, but momentum will build over time. “Based on our market research, this [drug] is the most likely thing for them to go on next,” he added, noting that patients tend to be on the drug for an average of 18 months.
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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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