Capsida Biotherapeutics Inc. has obtained IND clearance from the FDA for CAP-003, an intravenously administered gene therapy, for Parkinson’s disease associated with GBA mutations (PD-GBA). A phase I/II trial will begin dosing in the third quarter of this year.
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.
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.
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.
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.
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.
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.
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.
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.
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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