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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All sponsors of clinical trials conducted in the European Union have been reminded of their obligation to make summaries of trial results.
An injection to treat NMOSD has been given approval by the FDA and has received orphan drug designation.
The EMA has given its approval recommendation to three drugs and announced negative opinions for approval on others.
Luxembourg and the Netherlands have been included in the mutual recognition agreement between the EU and the FDA in the US.
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.
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.
Marketing authorisation has been recommended in the EU by an EMA committee for Sixmo (buprenorphine) as a substitution treatment for opioid dependence.
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.
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.
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...
Results did not confirm the clinical benefit of Lartruvo in combination with doxorubicin compared to doxorubicin alone…
The MHRA have announced another sartan-containing drug product over fears that it is contaminated with the carcinogen N‑nitrosodiethylamine...
The US FDA has announced that it will confirm the capability of five more countries to carry out good manufacturing practice (GMP)...
Amglidia is a new formulation of glibenclamide, specifically developed for use in newborns, toddlers and children...
NICE has issued its final appraisal decision recommending reimbursement of Lenvima for the treatment of progressive, locally advanced or metastatic, differentiated thyroid carcinoma...