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Sanofi stops development of lung cancer drug
Sanofi is discontinuing development of tusamitamab ravtansine for certain types of non-small cell lung cancer after a Phase III clinical trial did not meet its endpoint.
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Regs & Legs
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NICE recommends combination therapy for prostate cancer
Lynparza (olaparib), which is being co-developed by AstraZeneca and MSD, showed clinically meaningful benefit when used with abiraterone and prednisone or prednisolone to treat hormone-relapsed metastatic prostate cancer.
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FDA grants priority review to omalizumab for food allergies
If approved, monoclonal antibody omalizumab would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure.
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EU pharmaceutical legislation revisions: what are the implications for biopharma?
Anne Dhulesia and Sean Dyson, Partners at L.E.K. Consulting, discuss the proposed revisions to EU pharma legislation and potential implications for biopharma companies operating in Europe.
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Otsuka to commercialise hereditary angioedema drug in Europe
Japanese company Otsuka Pharmaceutical will pay $65 million is to commercialise Ionis’ hereditary angioedema candidate in Europe.
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European regulators prepare for AI in pharma
A coordinated workplan, which runs to 2028 will help European regulators embrace opportunities for artificial intelligence.
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Year in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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CHMP issues positive option for first gene-editing medicine
If approved, Vertex’s Casgevy (exagamglogene autotemcel) would be the first gene-editing medicine authorised in the European Union.
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Positive results for mRNA vaccine in melanoma patients
A personalised mRNA cancer vaccine in combination with MSD’s Keytruda cut the risk of cancer recurrence by almost half in melanoma patients.
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Astellas secures EC approval for VMS treatment, fezolinetant
Approval of fezolinetant gives patients in Europe a new nonhormonal treatment option to control hot flashes or night sweats associated with menopause.
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Understanding the evidence used in drug product withdrawals
Samantha Lane, Head of Research for the Centre of Pharmacovigilance Sciences at the Drug Safety Research Unit discusses drug product withdrawals and the regulatory shift to a greater reliance on epidemiological and observational research as evidence for these decisions within Europe.
news
EC approves treatment for rare haematological disorder
The European Commission has approved Europe's first treatment for adults with indolent systemic mastocytosis, a rare haematological disorder.
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Europe publishes first list of critical medicines
More than 200 active substances are included on the list, which is seen as an important tool in preventing shortages of critical medicines in the EU/EEA.
article
Nitrosamines analysis with LC/MS-MS
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.
news
FDA approves first cell-based gene therapies for sickle cell disease
The US FDA has approved Vertex’s Casgevy and bluebird bio’s Lyfgenia, for one-time treatment of sickle cell disease in patients 12 years and older.
