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Home » Topics » Regulatory

Regulatory
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Hourglass on glowing circuit board, symbolizing time and technology

California AG advisory tightens down on AI in health care

Feb. 4, 2025
By Mark McCarty
U.S. federal law is still lacking where AI is concerned, but California’s attorney general issued a bulletin that elevates the legal hazards of AI in medical use. The bulletin says that AI tools may not supplant a physician’s decision-making, a provision that would seem to render some FDA-cleared products illegal there.
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Hair and scalp under magnifying glass
Dermatologic

HCW-9302 gains IND clearance for first-in-human study in alopecia areata

Feb. 4, 2025
HCW Biologics Inc. has received clearance of its IND application from the FDA to initiate a first-in-human phase I trial to evaluate HCW-9302 in patients with moderate to severe alopecia areata.
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Yen currency symbols spilling out of drug capsule

Drug pricing scheme in Japan gets more confusing

Feb. 3, 2025
By Tamra Sami
Japan’s drug pricing scheme has gotten more complicated, and pharma companies should brace themselves for annual price cuts. Industry has been pushing back against the annual price reductions to no avail, Ray Fujii, managing director of LEK’s San Francisco office told BioWorld. Although 2025 is a mid-year revision in Japan, and not a formal price revision year, the system for considering drug prices has gotten more confusing with a new formula for determining price cuts.
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RFK Senate-hearing2 1-29

One vote could keep RFK from getting out of committee

Feb. 3, 2025
By Mari Serebrov
Whether Robert F. Kennedy Jr. (RFK) advances in his quest to become the top health care voice in the Trump administration could come down to one vote – that of Sen. Bill Cassidy. The Louisiana doctor is one of 14 Republican members of the Senate Finance Committee, which is scheduled to vote Feb. 4 on whether to send Kennedy’s nomination as Health and Human Services secretary to the full Senate for confirmation. If all 13 Democrats on the committee vote against it, one no vote from a Republican could stop the process.
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Hand cupping ear to illustration hearing loss

Essilorluxottica receives US, EU, green light for OTC Audio Glasses

Feb. 3, 2025
By Shani Alexander
Essilorluxottica SA received U.S. FDA clearance for its over-the-counter Nuance Audio Glasses, which combines sight and sound technologies, to help people improve their vision and hearing. The device also received a CE mark certification under the Medical Devices Regulation from the EU authorities.
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European Union flag with wooden gavel

MDCG lends clarity to the definition of an in vitro diagnostic

Feb. 3, 2025
By Mark McCarty
The EU’s Medical Device Coordination Group issued a guidance on the types of products that qualify as in vitro diagnostics (IVDs), including some important distinctions even in instances in which a given analyte is the subject of two tests.
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Novo Nordisk to appeals court: Hurry up, please, on IRA challenge

Jan. 31, 2025
By Mari Serebrov
Now that Novo Nordisk A/S’ blockbuster semaglutide franchise has been selected as one drug for the next round of the CMS price negotiation, the Bagsværd, Denmark-based company is asking a U.S. appellate court to expedite its consideration of Novo’s challenge to the negotiations and the way CMS is implementing the program.
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Post-CRL, Symbravo hurrah at last for Axsome in migraine

Jan. 31, 2025
By Randy Osborne
Complete response letter hurdles overcome and U.S. FDA clearance in hand, Axsome Therapeutics Inc. will disclose pricing in about four months, closer to the launch of Symbravo to treat adult migraine with or without aura.
Read More
EMA icons

Leqembi review stalls again at European regulator

Jan. 31, 2025
By Nuala Moran
EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to examine safety data that have recently become available.
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Female researcher wearing mask and safety glasses holding dropper

APACMed sees urgent need to harmonize regs for LDTs across APAC

Jan. 31, 2025
By Tamra Sami
Harmonized regulations for laboratory-developed tests (LDTs) across Asia Pacific are sorely needed at a time when LDTs continue to play a critical role in addressing unmet needs in the region, according to a recent whitepaper developed by APACMed.
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