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Home » Authors » Nuala Moran

Articles by Nuala Moran

Linkgevity founders Carina Kern, CEO (left), and Serena Kern-Libera, COO (right), at the Francis Crick Institute in London
Newco news

Linkgevity targets aging as it joins startup accelerator KQ Labs

Jan. 24, 2025
By Nuala Moran
Newco Linkgevity Ltd. has won backing from the KQ Labs accelerator program at the Francis Crick Institute in London, enabling it to take forward the lead program, an anti-necrotic drug for treating acute kidney injury, and to further develop its AI-driven system for identifying aging-related therapeutic targets.
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Arctic Therapeutics explores Alzheimer’s with $28M series A

Jan. 22, 2025
By Nuala Moran
Icelandic genomics company Arctic Therapeutics has closed a €26.5 million (US$27.6 million) series A, enabling it to assess if its lead drug AT-001, designed to treat a rare inherited amyloid disease, also could be used to treat more common forms of dementia, including Alzheimer’s disease. The program is currently in a phase IIb/III European trial in cystatin C amyloid angiopathy, an ultra-rare disease found only in Iceland that is caused by the L68Q mutation in the cystatin C gene.
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Hope in OTC as Iecure’s in vivo gene editing trial shows first response

Jan. 21, 2025
By Nuala Moran
A 6.5-month-old boy with the rare inherited urea cycle disorder ornithine transcarbamylase (OTC) deficiency has responded positively in a targeted in vivo gene editing trial, in which a correct copy of a defective gene was inserted at a precise locus in the genome.
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EMA investigating potential semaglutide link to eye disease

Jan. 17, 2025
By Nuala Moran
The EMA has started a review of Novo Nordisk A/S’ GLP-1 receptor agonist, semaglutide, after the Danish regulatory agency raised the possibility it causes an increased risk of suffering from an acute eye condition. After the first report in July 2024, the Danish regulator had received, by Dec. 10, 2024, a total of 19 reports of non-arteric anterior ischemic neuropathy, a rare condition that affects the small blood vessels at the front of the optic nerve. This can lead on to sudden vision loss and visual field defects.
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EU flag, pills, syringe

46 NCEs, 28 biosimilars among 114 drugs cleared by EMA in 2024

Jan. 16, 2025
By Nuala Moran
The EMA recommended the highest number of approvals in the last 15 years in 2024, giving the nod to 114 drugs. That is amongst the highest number in the 30 years of the agency’s existence, said Steffen Thirstrup, the EMA’s chief medical officer.
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JPM: CBER’s Marks ‘reassured’ as FDA to refine warnings on CAR Ts

Jan. 15, 2025
By Nuala Moran
The U.S. FDA is to temper the alert it put out in November 2023 pointing to a potential risk of CAR T therapies causing de novo malignancies. “There was this issue of possible safety concerns with T-cell lymphomas, with these CAR T cells. I think this year, we are feeling reassured in this regard,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), told the Alliance for Regenerative Medicine briefing at the J. P. Morgan Healthcare Conference on Jan. 13.
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DNA in drug capsules

Alliance for Regenerative Medicine: Field growing, cost still an issue

Jan. 14, 2025
By Nuala Moran
The accelerating pace of U.S. FDA approvals for cell and gene therapies is “great for the field and great news for the patients,” but questions remain over commercialization, with “costs remaining stubbornly high.” That was the glass half-full summary of Tim Hunt, president of the industry group, the Alliance for Regenerative Medicine, reprising progress in 2024, and looking forward to the prospects for further growth and the potential impact of the incoming Trump administration in 2025.
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Two arrows in opposite directions

Galapagos splits, keeps cell therapies; spinout takes small molecules

Jan. 13, 2025
By Nuala Moran
Galapagos NV is abandoning its small molecule roots to focus on cell therapy and at the same time splitting in two, with the spinout company, dedicated to acquiring a portfolio of assets, taking the lion’s share of the capital.
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Gilead, Leo Pharma join in $1.7B deal for STAT6 program

Jan. 13, 2025
By Nuala Moran
Gilead Sciences Inc. is moving further into inflammatory diseases in a potential $1.7 billion deal with Leo Pharma A/S around a preclinical oral signal transduction and activator of transcription 6 (STAT6) program that the Danish dermatology specialist has been working on since 2018.
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Blood samples in lab
Drug design, drug delivery & technologies

Proteomics study explores how protein changes influence disease

Jan. 13, 2025
By Nuala Moran
Fourteen global pharma companies are getting together to conduct the largest proteomics study to date, analyzing 600,000 blood samples held in the UK Biobank to assess the levels of 5,400 different proteins.
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