UK – AbbVie’s Rinvoq recommended by NICE for Crohn’s disease

The authorisation, which makes Rinvoq the first oral Janus Kinase (JAK) inhibitor available for this indication in England and Wales, specifically applies to patients...

Europe – Guidance for industry to prevent and mitigate medicine shortages

EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact . Medicine...

Europe – EMA annual report 2022 published

EMA published its annual report 2022 today. The report provides an overview of the Agency’s activities to protect and promote public and animal health in the...

Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 12...

Review of hydroxyprogesterone started EMA has started a review of medicines containing hydroxyprogesterone following concerns about the safety and effectiveness of these medicines. In the...

Europe – Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling...

EMA’s safety committee, PRAC, is reminding healthcare professionals that the use of fluoroquinolone antibiotics, given by mouth, injection or inhalation, is restricted due to the...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master...

The following legal obligations apply to holders of UK marketing authorisations (MA). These include those that cover the whole of the UK, or are...

UK – Otsuka’s Lupkynis receives NICE green light

Recommendation applies across England and Wales and the treatment is available now Otsuka Pharmaceuticals has revealed that the National Institute for Health and Care Excellence...

Europe – Review of transparency rules for the EU Clinical Trials Information System (CTIS)

EMA has opened a public consultation to review the  transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union...

Europe – European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and...

Today, the Commission is proposing to revise the EU's pharmaceutical legislation - the largest reform in over 20 years - to make it more agile, flexible,...

UK – NICE approval for Janssen’s Darzalex combination

Recommendation concerns routine use across the NHS as therapy for multiple myeloma The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that the National...

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