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MHRA issues first UK guidance on phage therapies
MHRA’s publication is intended to support European developers of phage-based medicinal products to effectively navigate related regulations.
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CHMP meeting highlights – May 2025
The EMA’s committee has granted positive opinions for ten new treatments, including medicines for oncology indications and rare diseases.
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FDA approval marks shift in diabetic retinopathy treatment
The ocular injection, now granted its third FDA approval, offers a more convenient treatment option for patients with vision loss.
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BioNTech pledges major UK investment
BioNTech’s commitment aligns with the UK Government’s Plan for Change, which involves accelerating growth of the pharmaceutical industry.
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Novo Nordisk CEO to exit role
Current market conditions in the pharmaceutical industry have driven the change to its executive leadership team, according to Novo Nordisk.
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UK immigration reform – implications for life sciences
This article offers key industry perspectives on the UK government’s recent immigration whitepaper and highlights the challenge of balancing economic growth and attracting skilled talent.
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World-first approval supports AstraZeneca’s sustainability goals
Approval of the novel tool marks progress for both respiratory disease patients in the UK and reducing the global environmental impact of inhaled medicines.
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Tackling EU supply chain challenges while boosting innovation
Medicines for Europe calls for continued progress of pharmaceutical reforms such as the Critical Medicines Act, to support production of essential medicines in the region.
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Landmark UK-India trade deal insufficient for life sciences, says industry body
The multi-billion-pound deal provides a boost to the UK’s economy, however it lacks provision to aid the country’s growth ambitions, states the ABPI.
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Improving EU’s regulatory framework for enhanced pharma competitiveness
Despite its potential to become a more attractive destination for drug developers, new research insists the EU market makes improvements such as faster regulatory approvals and closer collaboration.
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FDA approves novel therapy for chronic skin condition
The US approval could improve outcomes for eligible patients with previously limited options for managing the inflammatory skin condition.
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European Commission Alzheimer’s drug approval marks advancement for EU patients
Lecanemab is the only approved Aβ monoclonal antibody that highly binds to and clears toxic protofibrils with high selectivity.
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NICE recommends new combination breast cancer drug
The agency’s recommendation could provide eligible breast cancer patients with a treatment that analysis suggest is to likely to work as well as two medicines already recommended by NICE.
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New analysis sets stage for improved UK clinical trials
Observations from the report will help the MHRA to strengthen clinical research and lay the foundation for accelerated innovation and medicine delivery to patients in the UK.
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EMA proposes streamlined approach for biosimilar development
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
