EU CHMP
Denecimig, Novo Nordisk’s prophylaxis treatment for hemophilia A, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
The European Medicines Agency has begun evaluating the EU marketing applications for a new batch of drugs, including products from Incyte, Sanofi and Novo Nordisk that target hidradenitis suppurativa, rabies and hemophilia A, respectively.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
Ohtuvayre is off to a great start in the US but Verona's new owner MSD has pulled the EU marketing application from the European Medicines Agency for the closely-watched chronic obstructive pulmonary disease drug.
While the European Medicines Agency’s human medicines committee voted in favor of EU approval for 10 new products, it reaffirmed its previous decision not to grant Aqneursa new active substance status.
The European Medicines Agency has recommend approving Teizeild, paving the way for the first disease modifying treatment for type 1 diabetes in the EU.
The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.
The sponsors of a number of drugs could this week learn whether the European Medicines Agency will recommend in favor of approving their products. And while teplizumab was approved in the US in 2022, Sanofi told the Pink Sheet why it waited to submit the drug for regulatory review in the EU.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
The European Medicines Agency’s human medicines committee, the CHMP, has recommended Insmed’s Brinsupri and Sanofi’s Wayrilz for pan-EU approval but turned down Sanofi’s Rezurock based on trial results that cast doubt on the drug’s efficacy.
Kashiv BioSciences/Alvotech/Advanz Pharma’s biosimilar version of omalizumab is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Corcept’s relacorilant, Ascendis’s navepegritide and J&J’s icotrokinra are all investigational products that are now under review for potential marketing authorization in the EU as well as in the US.
Insmed’s first-in-class bronchiectasis drug, brensocatib, is among the products that are up for an opinion by the European Medicines Agency’s human medicines committee this week on whether they should be approved for use in the EU.
This second of a two-part series of articles on accelerated assessments and priority reviews explores why the EU mechanism remains underused compared to its US counterpart, how it might be improved, and how sponsors can improve their chances of securing an expedited drug review in Europe.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
The European Medicines Agency’s human medicines committee has recommended 14 new drugs for marketing approval, including treatments for RSV, menopause, diabetes, and generalized myasthenia gravis.
The sponsors of seven new medicines nearing the end of their EU regulatory review are due – or possibly due – to appear before the European Medicines Agency’s human medicines committee, the CHMP, to address remaining concerns about their marketing applications.
The European Medicines Agency is this week expected to recommend whether EU marketing approval should be granted to myriad new products, including therapies for bronchiectasis, RSV, menopause-related symptoms and type 2 diabetes.
Insulin efsitora alfa, Eli Lilly’s once-weekly, subcutaneous treatment for type 2 diabetes, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.