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Home » Topics » Regulatory

Regulatory
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De novo key on keyboard

FDA releases another batch of regs for de novo decisions

June 17, 2025
By Mark McCarty
It appears the U.S. FDA believes it’s never a bad time to release regulatory information about devices granted market access via the de novo program. The agency recently posted information on the vintage de novo granted in 2018 to Imagen Technologies Inc. for the company’s Osteo Detect algorithm.
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Dyne vHOT in DM1 but shares cool on endpoint switch

June 17, 2025
By Randy Osborne
No Comments
The revised trial protocol that means a delay in filing for U.S. approval of DYNE-101 to treat myotonic dystrophy type 1 (DM1) dented shares of Dyne Therapeutics Inc. (NASDAQ:DYN), which closed June 17 at $10.86, down $2.96, or 21%.
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JAMA OpEd

Too much at stake for dismissed ACIP members to go quietly

June 17, 2025
By Mari Serebrov
No Comments
The 17 members abruptly terminated June 9 from the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) are not going gently into the night. Instead, they’re raging against what could be the dying of the light. The 17 raised their collective voices in a June 16 JAMA opinion piece to decry what’s at stake with Health and Human Services Secretary Robert Kennedy’s efforts, in his words, to “reestablish public confidence in vaccine science” by cleansing ACIP of what he claimed were conflicts due to members’ financial ties to industry.
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Tape measure, apple on scale
Endocrine/metabolic

MBX Biosciences files IND application for MBX-4291 for obesity

June 17, 2025
No Comments
MBX Biosciences Inc. has submitted an IND application to the FDA for MBX-4291, a long-acting glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist prodrug for the treatment of obesity.
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Neurology/psychiatric

Centessa’s OX2R agonist ORX-142 gains IND clearance

June 17, 2025
No Comments
Centessa Pharmaceuticals plc has obtained IND clearance from the FDA to initiate a phase I study of ORX-142 in healthy volunteers. ORX-142 is an investigational, novel, highly potent and selective OX2R agonist being developed for the treatment of select neurological and neurodegenerative disorders.
Read More
U.S. flag on columned building

Advamed presses CMS to require MA plans to honor NTAP program

June 16, 2025
By Mark McCarty
Medicare Advantage plans have been controversial for several reasons, and the Advanced Medical Technology Association has now made the argument that the Centers for Medicare & Medicaid Services should require these plans to replicate the terms of the Medicare new technology add-on program.
Read More
MHRA logo

MHRA advises industry that new requirements are now in place

June 16, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency is reminding industry that several new regulatory requirements are in effect as of June 16, 2025, such as a postmarket surveillance rule that says manufacturers have only 15 days to report serious incidents to the agency.
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Federal judge reinstates funding for NIH DEI grants

June 16, 2025
No Comments
Calling it “incredible news,” Massachusetts Attorney General Andrea Joy Campbell reported June 16 that U.S. District Judge William Young ordered the Trump administration to restore funding for NIH research grants focusing on gender and diversity, equity and inclusion (DEI).
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DNA strand over digital lock and circuit background

BIO 2025: Building biosecurity through public-private partnership

June 16, 2025
By Karen Carey
No Comments
The COVID-19 pandemic sent the world into a tailspin, raising ongoing concerns about biosecurity, a subject that encompassed the better part of the morning June 16, the first day of the Biotechnology Innovation Organization’s annual conference in Boston.
Read More
Hands holding mobile phone

‘Be Part of Research,’ UK government urges with NHS app

June 16, 2025
By Nuala Moran
No Comments
The U.K. government has announced the latest measures to speed up and expand clinical trials, launching Be Part of Research, a central national register where people can search and sign up to take part in studies.
Read More
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