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BioWorld - Thursday, June 12, 2025
Home » Topics » Regulatory

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Money sack with British pound symbol

NHS deploying Histosonics' Edison to slash health care red tape

June 11, 2025
By Mark McCarty
The U.K.’s National Health Service reported June 10 that patients in the U.K. will be the first in Europe to enjoy the benefits of the Edison ultrasound histotripsy for ablation of liver cancer tumors as part of an effort to bring products to market more quickly to deal with unmet needs.
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Doctor with illustration of kidneys

MFDS clears world’s first ECG-based AI kidney disease software

June 11, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety on June 9 approved Vuno Inc’s AI-based Med-DeepECG Kidney software as a non-invasive method to screen for kidney dysfunction.
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ABPI: UK’s rebate rates ‘send a terrible message’ to global investors

June 11, 2025
By Nuala Moran
No Comments
The U.K. government has doubled the rate that pharmaceutical companies must repay on sales of branded drugs, under the statutory rebate scheme, to a record 31.3%. Only 1-2% of total sales of branded drugs fall under the statutory scheme, but the increase is seen as a sign that an ongoing review of the voluntary scheme is not going well.
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Blister drug pack atop globe

US drug security will come at a price

June 11, 2025
By Mari Serebrov
No Comments
When it comes to the U.S. biopharma market, pricing seems to be the driving focus of most congressional conversations – and government contracts. Rep. Cliff Bentz, R-Ore., hit pause on that conversation at a June 11 House subcommittee hearing on the drug supply chain, when he asked if the U.S. is sacrificing security for price.
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Molecular research art concept
Inflammatory

Monte Rosa’s molecular glue degrader MRT-8102 gains IND clearance for inflammatory conditions

June 11, 2025
No Comments
Monte Rosa Therapeutics Inc. has gained IND clearance from the FDA for MRT-8102, a NEK7-directed molecular glue degrader being developed to treat inflammatory conditions linked to NLRP3, IL-1β and IL-6 dysregulation.
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Enflonsia

Merck wins FDA approval in pediatric RSV and steps into CDC uncertainty

June 11, 2025
By Lee Landenberger
No Comments
With the U.S. FDA’s approval of Enflonsia (clesrovimab) to prevent respiratory syncytial virus (RSV) infection lower respiratory tract disease in newborns and infants, Merck & Co. Inc. steps into a space of competition and regulatory shifts. The preventive, long-acting monoclonal antibody (MAb) will take its place in the market alongside the blockbuster Beyfortus (nirsevimab) from Sanofi SA and Astrazeneca plc. The MAb for pediatric use brought in about $1.77 billion in 2024.
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LEX Diagnostics VELO system

Lex seeks FDA clearance ahead of $100M Quidelortho takeover

June 10, 2025
By Shani Alexander
Lex Diagnostics Ltd. has submitted dual applications to the U.S. FDA seeking 510(k) clearance and CLIA waiver status for its Velo system, an ultra-fast point-of-care molecular diagnostics platform. The move comes after the recent news from Quidelortho Corp. that it intends to acquire Lex for $100 million following U.S. regulatory approval of the technology.
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Female sitting on floor in dark room

Livanova petitions CMS to drop CED mandate for VNS for depression

June 10, 2025
By Mark McCarty
London-based Livanova plc. has petitioned the U.S. CMS to cover vagus nerve stimulation device for treatment-resistant depression without the need for a clinical trial — a change that would eliminate the costly and cumbersome coverage with evidence development mechanism.
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Neuronata-R

Corestemchemon preps US BLA filing for stem cell ALS therapy

June 10, 2025
By Marian (YoonJee) Chu
No Comments
Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that first gained approval in South Korea in 2014 to delay the progression of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder also known as Lou Gehrig’s disease.
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Flag of South Korea with skyscrapers in the background

Korea pharma exports rise to quarterly high of $2.5B in Q1

June 10, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.
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