The European Medicines Agency has also recommended that EU member states go ahead and approve Tiofarma’s midazolam nasal spray Nasolam for convulsive seizures, while a review of a lidocaine/prilocaine product from French firm International Drug Development has been stopped after the applicant withdrew its decentralized marketing authorization application.
The anxiolytic etifoxine can continue to be given to patients with anxiety disorders provided they have not previously experienced severe dermatological or hepatic side-effects after taking the drug, the European Medicines Agency has advised.
Following a benefit/risk review triggered by the French regulator ANSM in mid-2021, the EMA’s human drugs committee, the CHMP, assessed...
Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Expanded confidential pricing for pharmaceuticals is intended to help manage medicines expenditure, according to Amgros, the procurement agency that will negotiate the prices.
Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.
