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FDA approves first-in-class oral antibiotic
The drug is the first in a new class of oral antibiotics for uncomplicated urinary tract infections in nearly three decades.
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Regulation & Legislation
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European Pharmaceutical Review Issue 1 2025
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.
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Novo Nordisk industry membership reinstated
The company now has ABPI membership after a two-year suspension involving concerns relating to its compliance with the industry body’s code of conduct.
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European Commission approves Rytelo for LR- MDS-related anaemia
The European marketing authorisation offers a new treatment option for patients with transfusion-dependent anaemia in lower-risk myelodysplastic syndromes (LR-MDS), who are unresponsive to erythropoiesis-stimulating agents.
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Alzheimer’s drug requires strengthened pharmacovigilance approach
Ongoing real-world safety and effectiveness monitoring of the Alzheimer’s drug lecanemab is needed to protect patients long-term, drug safety researchers urge.
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CHMP meeting highlights – February 2025
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of four new medicines plus the extension of therapeutic indications for 16 medicines.
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Preparing for a new era in the rare disease sector
To mark Rare Disease Day 2025, EPR interviewed Christina Gkousgkouni, Head of Rare Diseases for Central South Europe, Sanofi.
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NICE recommends novel immunotherapy for leukaemia
The agency’s decision means eligible adult patients in the UK are set to access the combination immunotherapy as a new treatment option for acute lymphoblastic leukaemia (ALL).
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How could tariffs impact the pharmaceutical industry?
Proposed US tariffs on pharmaceutical imports could disrupt global supply chains, drive up production costs, and exacerbate drug shortages. How will the industry respond?
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Climate crisis and technological innovation shaping pharmaceutical water market
As a significant water consumer to enable production of high-quality medicines, this demand brings both challenges and opportunities for the pharmaceutical industry up to 2033, research suggests.
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EU Urban Wastewater Treatment Directive may compromise EU medicine availability
The directive could lead to nearly €1 billion in additional costs for pharmaceutical companies in Finland alone, states Orion Corporation.
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First-of-a-kind EU approval granted for oral small molecule
The authorisation provides a new disease modifying treatment option for European patients with the progressive condition.
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Unlocking intellectual property potential in European pharma
Joshua Harris, Director, Burford Capital, discusses how patent monetisation, including systems like the Unified Patent Court (UPC), enables European pharmaceutical companies to remain competitive and ensure R&D investment and innovation.
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Novel drug approved for diabetes-related vision loss
The monoclonal antibody treatment is now approved in the US for both diabetic macular oedema and wet, or neovascular age-related macular degeneration.
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Draft regulatory guidance on personalised cancer therapies published
The new draft guidance for personalised cancer therapies addresses the questions that this new regulatory pathway creates, according to the MHRA’s Chief Executive.
