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NICE makes first-of-a-kind recommendation for hearing loss drug
As a novel formulation, the “groundbreaking drug” is expected to improve the quality of life for young cancer patients with hearing loss.
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Therapeutics
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How automation and digital technologies will unlock the full potential of advanced therapies
Automation and digital technologies, combined with workforce training and regulatory advancements, hold the key to transforming the production of advanced therapies. Dr Stephen Ward, Executive Director at CGT Catapult, shares how leveraging these innovations can facilitate the delivery of life-changing therapies to patients at scale, opening new possibilities for treating…
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ICH Q6(R1): test criteria and specifications
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
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Bristol Myers Squibb licenses amyloid-beta antibody programme
The new agreement between Bristol Myers Squibb and BioArctic is set to advance development of anti-amyloid-beta antibody treatments, which have shown symptomatic benefit in Alzheimer's.
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Early allogeneic cell therapy trial results offer hope for sight condition
Based on positive outcomes of the clinical trial, a high dose of the cell therapy is expected to advance to Phase III pivotal trials.
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Adopting AI for R&D in 2025 – what needs to be addressed?
Dr Vladimir Makarov, AI Community lead, The Pistoia Alliance, explains that despite the willingness of the life sciences R&D industry to adopt artificial intelligence (AI), data integrity is a key area that must be addressed to ensure successful integration of this fast-evolving technology.
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Antibody drug has promise as “next frontier” in inflammatory bowel disease
With its best-in-class potential, the biologic could provide a new treatment option for patients with inflammatory bowel disease (IBD), say Teva Pharmaceuticals and Sanofi.
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CHMP recommends novel long-acting HIV treatment
The positive opinion means HIV patients could overcome challenges of taking daily oral regimens, says ViiV Healthcare's Chief Medical Officer.
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Novo Nordisk investing in rare disease with major new manufacturing site
A total of DKK 8.5 billion will fund the new production facility in Odense, Denmark, which is set to facilitate the manufacture of medicines for rare diseases.
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Innovative biologic prefilled syringe approved in EU
The new treatment option provides a convenient alternative to currently available vials of the bispecific antibody for EU patients with common vision conditions.
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Legislative milestone for UK clinical trials
The amended regulatory framework will foster clinical trial design innovation and provide UK life sciences with faster trial approvals.
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Targeting ovarian cancer with a novel antibody therapeutic
Christina Pelizon, International Medical Affairs Head for Oncology at AbbVie discusses the significance and impact of the European Commission’s approval last month of Elahere® (mirvetuximab soravtansine) to treat ovarian cancer.
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Pharmapack Europe 2025: Eco barrier packaging to launch
The innovative line of barrier bottles provides unmatched protection against moisture and oxygen and reduces production costs, LOG Pharma Primary Packaging says.
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ASH 2024: CAR T-cell therapy demonstrates durable benefit in lymphoma
The cell therapy could increase survival in certain lymphomas without requiring patients to undertake subsequent therapy, the new analysis suggests.
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£16 million to fund UK-Switzerland life sciences research
The joint agreement between two key global players in life sciences, the UK and Switzerland, marks a long-term commitment to strengthening research in the sector.
