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CHMP recommends Novartis' CAR-T therapy Kymriah for EU approval pharmafile
July 06, 2018
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Medicines Agency (EMA) approve Novartis’ CAR-T therapy Kymriah (tisagenlecleucel, formerly CTL019).
CAR-T race heads to Europe as Gilead, Novartis drugs score CHMP backing fiercepharma
July 02, 2018
Months after Novartis and Gilead Sciences won their CAR-T approvals in the U.S., the companies have scored CHMP recommendations for Kymriah and Yescarta in Europe.
Novartis’ Aimovig leads CHMP recommendations pharmatimes
June 06, 2018
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has endorsed nine medicines for approval at its May meeting,
CHMP takes negative view on Sarepta’s DMD therapy pharmatimes
May 07, 2018
Sarepta has indicated that there could be a delay to getting its Duchenne muscular dystrophy therapy Exondys approved in Europe, revealing that the European Medicine Agency’s Committee for Medicinal Products for Human Use’s trend vote was negative.
Three medicines step closer to EU approval pharmatimes
May 03, 2018
Three medicines treating HIV, pain and cancer have been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal ...
CHMP rejects AB Science’s ALS drug pharmatimes
April 24, 2018
AB Science’s share price has taken a hit after European Medicine Agency's advisors rejected approval of masitinib for amyotrophic lateral sclerosis.
Mylan, Biocon receive CHMP opinion for Semglee, biosimilar insulin glargine expressbpd
January 30, 2018
Marketing applications for Semglee have been submitted in Australia, Canada, and the US and are planned for key emerging markets
Vertex Receives CHMP Positive Opinion for ORKAMBI for Children with Cystic Fibrosis americanpharmaceuticacreview
November 13, 2017
Positive CHMP opinions are recommendations for approval to the European Commission, which has the authority to approve medicines for the European Union.
Roche’s OCREVUS (ocrelizumab) gains positive CHMP opinion for relapsing forms of multiple sclerosis roche
November 13, 2017
Roche Corporation today announced that CHMP uses OCREVUS to take positive comment characteristics in patients with clinically or radiographically defined active forms of multiple sclerosis
AstraZeneca’s Faslodex receives CHMP opinion for advanced breast cancer treatment pharmaceufical-technology
October 18, 2017
Advanced / metastatic breast cancer refers to Stage III and IV breast cancer

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