EU CHMP Decides On New Oncology Drugs & New Treatments for Mastocytosis, Atopic Dermatitis
The European Medicines Agency’s key scientific committee, the CHMP, is deciding this week whether a dozen or so new medicines that are in the final stages of the evaluation process should be approved for marketing across the EU. The committee will discuss 13 initial marketing authorization applications.
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Vanda And Nektar Persevere With Fanapt And Onzeald In EU
The two products that the European Medicines Agency’s key scientific committee, the CHMP, decided last week should not be approved in the EU were Vanda’s schizophrenia treatment Fanaptum (iloperidone), and Onzeald (etirinotecan pegol), a potentially new treatment for breast cancer with brain metastases from Nektar/Daiichi Sankyo Europe. The companies want the CHMP to look again at the negative opinions they received.
EU Marketing Approval In Sight For 11 Drugs After CHMP OK; Thumbs Down For Two
The European Medicines Agency’s key scientific committee, the CHMP, has recommended for approval throughout Europe a total of 11 new drugs. Two medicines received a negative opinion from the committee and the marketing authorization application for one product has been withdrawn. A further eight products are set to receive indication extensions. The medicines that got positive opinions are likely to secure official approval within the next few months.
J&J's Quad HIV Combo Likely To Pass CHMP; EU Market Uptake Is Trickier
Johnson & Johnson's quadruple HIV combination is likely to win a positive recommendation for approval in Europe this week – but clever positioning will be required to secure strong uptake for the combination considering its late entry onto a competitive market place.