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Home » Topics » Regulatory

Regulatory
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U.S. flag, stethoscope

Industry supportive of CMS move to tighten MA plans’ coverage

Feb. 5, 2025
By Mark McCarty
Medicare Advantage plans have drawn criticism for deviating somewhat from Medicare coverage policies, a question CMS took up in a recent draft rule. In comments to the docket, the Medical Device Manufacturers Association said it sees a need to throw a lasso around such practices, alleging that they may result in beneficiaries receiving more limited coverage than they would in fee-for-service care.
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Illustration of pancreas, close up of islet
Endocrine/metabolic

Cour’s CNP-103 gains IND clearance for type 1 diabetes

Feb. 5, 2025
Cour Pharmaceuticals Development Co. Inc. has obtained IND clearance from the FDA for CNP-103, a nanoparticle in development to address the underlying autoimmunity of type 1 diabetes. A first-in-human phase Ib/IIa trial will begin later this year and will enroll adults (aged 18-35 years) and pediatric patients (aged 12-17) who have stage III or newly diagnosed (within the last 6 months) type 1 diabetes as well as C-peptide >0.2 ng/mL.
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Microscopic image of acute myeloid leukemia (AML) cells.
Cancer

Oral KAT2A/B degrader gets go-ahead for acute myeloid leukemia

Feb. 5, 2025
Auron Therapeutics Inc. has received FDA clearance of its IND application for its oral KAT2A/B degrader AUTX-703 in hematological malignancies. A phase I proof-of-concept trial in acute myeloid leukemia (AML) will open enrollment this quarter, supported by a recently completed $27 million series B financing.
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Yen currency symbols spilling out of drug capsule

Drug pricing scheme in Japan gets more confusing

Feb. 4, 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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Red wooden approved stamp

TGA clears CSL’s garadacimab to prevent hereditary angioedema

Feb. 4, 2025
By Tamra Sami
Australia’s Therapeutic Goods Administration (TGA) has approved CSL Ltd.’s Andembry (garadacimab) for preventing recurrent hereditary angioedema attacks, marking the first global approval for the drug that was discovered and developed in Australia by CSL scientists.
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Sen. Raphael Warnock at RFK confirmation hearing

Kennedy advances toward confirmation as HHS secretary

Feb. 4, 2025
By Mari Serebrov
Robert F. Kennedy Jr. moved a step closer Feb. 4 to becoming the next secretary of the U.S. Department of Health and Human Services (HHS). The Senate Finance Committee voted 14-13 along party lines to send Kennedy’s nomination to the Senate floor for confirmation. While “no” votes were expected from the 13 Democrats serving on the committee, a big question mark had hung over which way Sen. Bill Cassidy, R-La., would vote, given the comments he made at two committee hearings on the nomination. In the end, Cassidy voted along with his 13 Republican colleagues, offering no comment on his vote at the meeting.
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MHRA logo

MHRA offers guidance on regulated, unregulated digital health apps

Feb. 4, 2025
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency has provided guidance on what does and does not constitute a regulated digital mental health technology, but developers should be aware that promotional claims could push a product from the unregulated to the regulated category.
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Ribbons of digital data

South Korea issues world’s first generative AI medical device guideline

Feb. 4, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.
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Illumina sign, building

China blacklists Illumina as part of US tariffs counter

Feb. 4, 2025
By Marian (YoonJee) Chu
The Chinese government blacklisted several American companies, including gene sequencing-focused biotechnology firm Illumina Inc. and fashion brand PVH Corp., citing threats to China’s “national sovereignty, security and development interests.”
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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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