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EMA recommends Vitrakvi for EU marketing authorisation
The EMA has announced its approval for marketing authorisation in the EU for Vitrakvi (larotrectinib), used to treat solid tumours with a specific gene mutation.
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European Medicines Agency (EMA)
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EMA grants AR-501 with Orphan Drug Designation
Orphan Drug Designation has been given to AR-501 for the treatment of lung infection in patients with cystic fibrosis.
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US and EU enter Mutual Recognition Agreement for drug manufacturing inspections
The FDA and EMA have agreed to rely on each other’s assessment of pharmaceutical manufacturing sites to reduce duplicative work.
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EU releases guidance for medicine shortages
The EU has issued two guidance documents intended to advise the pharmaceutical industry and patients during medicinal shortages.
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Clinical trial sponsors called to publish results on EU database
All sponsors of clinical trials conducted in the European Union have been reminded of their obligation to make summaries of trial results.
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FDA approves treatment for rare neurological disorder
An injection to treat NMOSD has been given approval by the FDA and has received orphan drug designation.
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EMA releases medicinal approval recommendations
The EMA has given its approval recommendation to three drugs and announced negative opinions for approval on others.
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More countries added to the EU-US mutual recognition agreement
Luxembourg and the Netherlands have been included in the mutual recognition agreement between the EU and the FDA in the US.
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Concerns around Annex 1
This article expresses the opinions of a pharmaceutical microbiologist on the proposed revisions to the EU Good Manufacturing Practice Annex 1 in terms of current industry practice and future innovation in sterile product manufacturing.
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Sartorius Stedim Biotech introduces new SIMCA® 16 software for multivariate data analytics
Leading international partner to the biopharmaceutical industry Sartorius Stedim Biotech (SSB) has today announced that the new SIMCA® 16 software for multivariate data analytics is available from its subsidiary Sartorius Stedim Data Analytics.
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Long-lasting opioid treatment recommended by an EMA committee
Marketing authorisation has been recommended in the EU by an EMA committee for Sixmo (buprenorphine) as a substitution treatment for opioid dependence.
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EMA restricts use of multiple sclerosis medicine, Lemtrada
Following reports of immune-mediated conditions and problems with the heart and blood vessels (including fatal cases), the EMA (European Medicines Agency) has started a review of the multiple sclerosis medicine, Lemtrada.
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Preparing for a no-deal Brexit
The pharmaceutical industry has increasingly voiced its concerns about the possibility of a no-deal Brexit and its impact on supplies and access to medicines. Here, the European Medicines Agency (EMA) gives some last-minute advice to pharma companies ahead of March 2019.
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European Medicines Agency forced to pay London lease
The European Medicines Agency (EMA) has lost a High Court case, meaning it will have to pay the remaining 20 years left on the lease...
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Cancer drug with accelerated approval fails Phase III trial
Results did not confirm the clinical benefit of Lartruvo in combination with doxorubicin compared to doxorubicin alone…
