The European Commission has granted Orphan Medicinal Product designation for zatolmilast an investigational treatment for Fragile X syndrome (FXS), a leading cause of inherited intellectual disability and autism.
Dutch biopharmaceutical company, Pharming Group PV, has sent its first commercial shipments of a drug to treat a rare, primary immunodeficiency, to the US.
The Dutch company Pharming Group N.V. has switched its rare disease drug leniolisib from an accelerated assessment to a regular review with the European Medicines Agency (EMA).
Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.
Celltrion receives EMA marketing authorisation for Remsima SC, the first subcutaneously-administered option for delivery of infliximab, a treatment for rheumatoid arthritis.
The EMA demands drug developers to change the name of medicines containing liposomal, following reports of ‘serious medication errors’, some leading to death.
With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.
EMA assembles pharmaceutical developers to strengthen antimicrobial pipelines while, in the meantime, a study found the world’s rivers dangerously contaminated.
European member states have selected Amsterdam as the post-Brexit home of the European Medicines Agency, following a secret ballot vote in Brussels yesterday.
The EMA has expanded the list of excipients that drug firms must declare on product labels in a bid to address safety concerns about undeclared components.
Post-Brexit relocation will, at best, delay approvals and, at worst, limit drug availability and put European patients at greater risk of side effects and death according to the EMA.
Biocon says its insulin plant in Malaysia has been awarded a European GMP certificate after an inspection by Ireland’s Health Products Regulatory Authority (HPRA).
The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.
Regulators in Europe, Japan and the US say they have aligned clinical data requirements for new antibiotics to encourage industry to develop drugs for infections caused by resistant bacteria.
The European Commission has urged UK Pharma firms to check how Brexit will impact their drugs, pointing out that EU law requires that authorisation holders have a base in a member state or EEA country.
update - US FDA declines to comment on potential investigation
Clot busting drugs derived from human urine are no more likely to be contaminated with Zika virus than other medicines according to research by the EMA.
European authorities want to revise the guidelines covering first-in-human studies in light of the French trial in which one man died and others were hospitalised earlier this year.
Inadequate record keeping at Merck & Co.’s contract manufacturer has delayed the European launch of its hepatitis C drug Zepatier (elbasvir and grazoprevir).
The EU needs to better define mercury limits for drugs and dietary supplements say Polish researchers who want pharmaceuticals in Europe to be tested more regularly.
Drugmakers will be able to upload drug safety data to a single website from next year after a database developed by the EMA has been deemed fit for purpose by independent auditors.
The EMA's assessment of new drugs must be independent of pharmaceutical industry influence as an example to others, according to the Access to Medicines Foundation (AMF)
The UK Government should seek licenses to use off-patent drugs in new indications according to MPs who say there is no incentive for pharma firms to apply for such approvals after a product goes generic.
The European Commission (EC) can order the withdrawal of medicines that are not produced in accordance with GMP without having to prove they pose a specific health risk after a ruling in the EU Court of Justice.
As the worldwide pharma supply chain gets even more complex, the US FDA is looking to leverage its existing relationship with its EMA (European Medicines Agency) counterparts to boost drug quality with a new initiative.
As the European Medicines Agency (EMA) has implemented the majority of elements of the new pharmacovigilance legislation, the agency is now reporting that the main objectives of the legislation are largely being achieved.
The EMA and TGA have agreed to share full assessment reports related to marketing authorisations of orphan drug in the latest regulatory collaboration intended to save time and resources.
The EMA (European Medicines Agency) has cut what it charges small and medium-sized enterprises (SMEs) and micro businesses to help them comply with regulations once their drugs are approved.
European regulators have been accused of making “no attempt” to counter misuse of prescription drugs in comparison with North American efforts to reformulate and restrict addictive drugs, according to a Canadian firm testing the abuse potential of medicines.
Simon Sturge leaves Boehringer Ingelheim to head Merck's biosimilars unit, as well as the European Medicines Agency, Shire and EFPIA in this week's People on the Move column.
In calling an unregistered product ‘fake,’ the Ghanaian FDA has sparked a media war with industry, but are critics using this as an excuse to knock the regulators whilst importers gain undeserved sympathy? in-Pharmatechnologist’s Dan Stanton believes...
