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.
Despite the June 9 gutting of the U.S. CDC’s Advisory Committee for Immunization Practices, the Department of Health and Human Services said the committee’s June 25-27 meeting will continue as scheduled. But a new panel has yet to be named, and typically ACIP members have a lot of behind-the-scenes work to do before a meeting.
Alys Pharmaceuticals Inc. has submitted a clinical trial application (CTA) to Germany’s Paul-Ehrlich-Institut (PEI) to initiate a phase I/Ib study of ALY-301 in healthy volunteers and patients with cold urticaria, a subtype of chronic inducible urticaria.
Myosin Therapeutics Inc. has obtained IND clearance by the FDA for MT-125. A phase I study will evaluate MT-125 in combination with standard-of-care radiation in patients with newly diagnosed IDH wild type, MGMT unmethylated glioblastoma.
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.
Australia’s Therapeutic Goods Administration initiated court proceedings against Philips Electronics Australia Ltd. over sound abatement foam used in CPAP machines marketed under the Respironics brand.
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