The vaccine, branded Arexvy, was approved by the U.S. Food and Drug Administration in June but the Centers for Disease Control and Prevention (CDC) did not recommend RSV shots for adults under 60 years.
Tag Archive for: European Union
The European Union’s drugs regulator has rejected Eisai and Biogen’s breakthrough treatment for early Alzheimer’s disease, it said on Friday, in a blow to the drugmakers as take-up in the U.S. has been slower than expected.
The key opinion leaders (KOLs) interviewed by GlobalData have shared optimistic views on Dupixent, noting that its novel pathway presents anti-mucous effects, which is an additive value, supplementing its anti-eosinophil effects. KOLs have also communicated that the data presented in the clinical trials brings a great advantage to the asset and to the COPD space, perhaps even over other biologics in the COPD pipeline,” notes GlobalData Pharma Analyst Asiyah Nawab.
Today Sanofi and partner Regeneron won European Union approval for wider use of their Dupixent injection in patients with a chronic lung disease, a rare case of the EU clearing a drug faster than the United States.
AstraZeneca said on Monday that the European Union drug regulator has accepted a market authorization application for its investigational COVID-19 prevention drug, sipavibart, for an accelerated assessment.
ARS Pharmaceuticals said the European Medicines Agency (EMA) has recommended the approval of its needle-free emergency treatment, EURneffy, for allergic reactions.
EU antitrust regulators has accused Indian drugmaker Alchem International of taking part in a pharmaceutical cartel to fix prices of a key ingredient, which could lead to a hefty fine for the company.
The European Commission launched a probe into China’s public procurement of medical devices, the latest in a series of moves that ratchet up trade tensions ahead of President Xi Jinping’s visit to Europe next month.
The European Union’s medicines regulator has delayed it decision on Eisai and partner Biogen’s Alzheimer’s disease drug that was expected this week, the Japanese company said today.
Lawmakers in a EU parliamentary committee on Tuesday voted to extend the exclusivity period for new medicines compared to an initial draft, seeking to address concerns expressed across the bloc’s pharma industry as part of a wider regulatory overhaul.