Will Chugai's European marketing authorization application for satralizumab be fast-tracked when the company files for approval? The European Medicines Agency's drug evaluation committee, the CHMP, will decide this week.
The tracker below provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that are known to have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision since January 2018.
This latest edition has an update relating to July 2019. A fast-track request for the planned MAA for satralizumab, which...
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While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.
PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.
Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.
The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.
Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.
The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.
