The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently refused marketing authorization for Nezglyal (leriglitazone).
In 2022, the European Medicines Agency (EMA) recommended 89 medicines for marketing authorization: including six advanced therapy medicinal products and eight biosimilars.
The European Medicines Agency (EMA) will provide up to five selected advanced therapy medicinal products (ATMPs) with enhanced regulatory support - and in the process hopes to learn how to improve the regulatory processes for other ATMP drugs in the future.
Charles River Laboratories, International Inc. has received regulatory approval - in the form of Good Manufacturing Practice (GMP) certification - to commercially produce allogeneic cell therapy drug products for distribution in Europe, from the European...
The European Medicines Agency (EMA) recommended 92 medicines for marketing authorization in 2021: 54 of which had a new active substance which had never been authorized in the EU before.
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.
Biogen will ask the European Medicines Agency (EMA) to re-examine its Alzheimer’s drug application, following the agency’s recommendation to refuse authorization of the drug in the EU.
The European Medicines Agency’s human medicines committee (CHMP) has recommended granting an extension of indication for the Pfizer/BioNTech COVID-19 vaccine to include use in children aged 5 to 11.
Biogen says it is disappointed with feedback received from a European Medicines Agency committee on its aducanumab Marketing Authorization Application: but pledges to continue to engage with the regulator as it considers its next steps.
Moderna has submitted data for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of its COVID-19 vaccine.
The European Medicines Agency’s human medicines committee (EMA CHMP) has this week approved additional manufacturing capacity for Pfizer/BioNTech and Moderna COVID-19 vaccines.
The European Medicines Agency has brought forward a key meeting to assess the Pfizer/BioNTech COVID-19 vaccine: with its committee now convening a week earlier than scheduled.
Celltrion receives EMA marketing authorisation for Remsima SC, the first subcutaneously-administered option for delivery of infliximab, a treatment for rheumatoid arthritis.
The EMA has accepted to review Mylan’s trastuzumab and pegfilgrastim biosimilars amid remediation efforts at biomanufacturing partner Biocon’s fill and finish plant in India.
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.
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.
Hospira, recently acquired by Pfizer, announced Monday the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets, following the patent expiry of J&J’s Remicade.
Reference drugs in biosimilar trials now only need to be “representative” of a product cleared in the EEA not approved themselves under guidelines issued by the EMA this week.
Johnson & Johnson (J&J) has called on the US FDA to prevent biosimilars being given the same non-proprietary names as their original biologics, while the European Generics Association maintains the practice is “proven to be safe” and “supported...
