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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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Clinical Development
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MSD to advance investigational Lp(a) inhibitor in nearly $2b deal
The new license agreement will support development of a potential additional treatment option for patients at risk of atherosclerosis.
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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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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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NICE recommends innovative endometriosis pill
Approximately 1,000 eligible NHS patients could benefit from the new endometriosis treatment annually.
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Bristol Myers Squibb to acquire 2seventy bio
The proposed acquisition, worth nearly $300 million, could help to advance cell therapy in the oncology field.
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Investigational plaque psoriasis treatments show promise in late-stage trials
With the Phase III trials demonstrating sustained skin clearance in plaque psoriasis, this could lead to patients accessing more treatment options to manage the autoimmune inflammatory disease.
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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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First-in-human data for gene therapy signals potential in childhood blindness
Developed and manufactured under a Manufacturer’s ‘Specials’ Licence (MSL), the gene therapy could provide a novel treatment option for paediatric patients at the earliest stage of the rare eye disease.
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Water-based reactors offer pharmaceutical industry a safer alternative to toxic solvents
The breakthrough promises to transform pharmaceutical manufacturing by enabling chemical reactions in water, reducing reliance on hazardous organic solvents.
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Innovating bioanalysis to advance oligonucleotide therapeutics
Here, Dr Jinpeng Li at WuXi AppTec reveals the analytical challenges that are hindering advancement of oligonucleotide therapeutics, medicines which have demonstrated clinical promise in the gene therapy space, and discusses promising analytical innovations.
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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.
