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Home » Topics » Regulatory

Regulatory
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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.
Read More
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 for VNS therapy coverage reconsideration of TRD

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.
Read More
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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Empty conference room

Vaccines meeting to go on in wake of ACIP demolition

June 10, 2025
By Mari Serebrov
No Comments
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.
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Female hands holding heart on cardiogram
Cardiovascular

Nuevocor’s NVC-001 cleared to enter clinic for dilated cardiomyopathy

June 10, 2025
No Comments
Nuevocor Pte. Ltd. has obtained IND clearance by the FDA for NVC-001, an AAV-based gene therapy.
Read More
Dermatologic

Alys Pharmaceuticals submits CTA for ALY-301 for cold urticaria

June 10, 2025
No Comments
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.
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Microscopic image showing histology of a glioblastoma multiforme
Cancer

Myosin Therapeutics’ MT-125 gains IND clearance for glioblastoma

June 10, 2025
No Comments
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.
Read More
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