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Bumper December meeting sees CHMP recommend 15 new medicines


Bumper December meeting sees CHMP recommend 15 new medicines
14th December 2020
The European Medicines Agency’s (EMA) committee for Medicinal Products for Human Use (CHMP) recommended 15 new medicines for approval in its final meeting of the year.
First to score a recommendation was AstraZeneca/Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of metastatic HER2-positive breast cancer, following an accelerated review of the anti-HER2 therapy.
The CHMP also recommended Dynavax’s Heplisav (hepatitis B surface antigen) for active immunisation against hepatitis B virus infection and ViiV Healthcare’s Rukobia (fostemsavir) for the treatment of multidrug resistant HIV-1 infection.
Up next, the CHMP adopted a positive opinion for Bristol Myers Squibb’s Inrebic (fedratinib) for the treatment of primary myelofibrosis and myelofibrosis secondary to polycythaemia vera, as well as essential thrombocythaemia. ....

Mylan Kixelle , Dynavax Heplisav , Bristol Myers Squibb Inrebic , Astrazeneca Daiichi Sankyo Enhertu , Lenalidomide Krka , Eli Lilly Retsevmo , Seagen Tukysa , Astrazeneca Lumoxiti , European Medicines Agency , Medicinal Products , Human Use , Daiichi Sankyo , Viiv Healthcare , Bristol Myers Squibb , Eli Lilly , Celltrion Healthcare , Xeris Pharmaceutical Ogluo , Sunitinib Accord , மருத்துவ ப்ராடக்ட்ஸ் , மனிதன் பயன்பாடு , தய்ச்சி சாங்கியோ , பிரிஸ்டல் மைஸ் ஸ்க்விப்ப் , எலி லில்லி ,