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Home » Topics » Regulatory

Regulatory
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Neuronata-R

Corestemchemon preps US BLA filing for stem cell ALS therapy

June 9, 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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Product recall concept image

FDA rapidly lists raft of class I device recalls

June 6, 2025
By Mark McCarty
The U.S. FDA posted notice of six class I device recalls between June 3 and June 5, 2025, four of which are for corrections.
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Ozempic pen and packaging

EMA warns Ozempic linked to ‘very rare’ side effect

June 6, 2025
By Nuala Moran
No Comments
The EMA’s safety committee has issued a warning that the GLP-1 receptor agonist Ozempic (semaglutide, Novo Nordisk A/S) can cause an acute eye condition in which the optic nerve is damaged by a sudden loss of blood supply. After reviewing several large epidemiological studies, clinical trial and in-market data, EMA’s Pharmacovigilance Risk Assessment Committee has concluded non-anterior ischemic optic neuropathy is a “very rare” side effect of Ozempic, that “may affect up to one in 10,000 people taking semaglutide.
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Cancer

EMA’s COMP recommends orphan drug designation for Hemispherian’s GLIX-1 for glioma

June 6, 2025
No Comments
The EMA’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending European orphan drug designation for Hemispherian AS’s GLIX-1 for the treatment of glioma.
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Laptop displaying FDA logo

FDA’s device center playing guidance catch-up

June 5, 2025
By Mark McCarty
The U.S. FDA’s Center for Devices and Radiological Health is recovering from a guidance drought that spanned several months in the first part of calendar year 2025, starting with a guidance on the Q-sub process.
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Regulatory, financial hurdles the gap between science and access

June 5, 2025
By Mari Serebrov
No Comments
Children with solid tumors who relapse are being treated with the same chemotherapy they would have been given 40 years ago, as “there have been no major approvals for pediatric solid tumors,” Catherine Bollard, senior vice president and chief research officer at Children’s National Hospital, said at a June 5 FDA roundtable on cell and gene therapies (CGTs). The problem isn’t the science. Bollard said many groups are working on curative CGTs “for these children who have lost all other hope for survival.” The real gap is that “big pharma doesn’t see the business model because it’s a rare disease,” she added.
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Pregnant woman

EMA: New clinical guideline includes pregnant, breastfeeding patients

June 5, 2025
By Nuala Moran
No Comments
The EMA has issued a new guideline on how to include and/or retain pregnant and breastfeeding women in clinical trials, in a move that it says “marks a change in the paradigm.” The aim is to ensure that trial sponsors generate robust clinical data in these populations.
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Eye wireframe illustration
Ocular

Chinese IND clearance for anti-IGF-1R antibody NTB-003 for thyroid eye disease

June 5, 2025
No Comments
Biocytogen Pharmaceuticals (Beijing) Co. Ltd. and Nanjing Chia Tai Tianqing Pharmaceutical Co. Ltd. have announced IND clearance by China’s National Medical Products Administration (NMPA) for NTB-003 (formerly BCG-009) for thyroid eye disease.
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Mesothelioma
Immuno-oncology

Oncovita’s Mvdeltac designated orphan drug for pleural mesothelioma

June 5, 2025
No Comments
Oncovita SAS’s lead oncolytic virus candidate, Mvdeltac, has been awarded orphan drug designation by the FDA.
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Telemedicine at the root of false claims conviction for more than $1B

June 4, 2025
By Mark McCarty
U.S. Medicare coverage of telehealth and telemedicine sometimes seems to lag inappropriately, but fears of fraud were borne out in a conviction obtained recently by the Department of Justice.
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