CHMP
Janssen secures two positive CHMP opinions for Imbruvica label expansions
July 1, 2019Sales and Marketing CHMP, EMA, Europe, Janssen, imbruvica, pharma
Janssen’s Imbruvica (ibrutinib) has racked up two positive recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human …
AZ and MSD’s Lynparza secures CHMP nod in first-line BRCA-mutated ovarian cancer
April 29, 2019Sales and Marketing AstraZeneca, CHMP, Cancer, MSD, lynparza, ovarian cancer, pharma
AstraZeneca and MSD’s Lynparza (olaparib) has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use …
CHMP recommendation for bluebird bio’s gene therapy in β-thalassaemia
April 1, 2019Research and Development, Sales and Marketing Bluebird Bio, CHMP, EMA, Zynteglo, gene therapy, β-thalassaemia
Massachusetts-based bluebird bio has taken a significant leap forward in its pursuit of regulatory authorisation for its first gene therapy, …
Novartis withdraw marketing application for heart drug
December 17, 2018Sales and Marketing CHMP, EMA, MI, Novartis, pharma
Swiss multinational Novartis has withdrawn a European Medicines Agency (EMA) marketing application for canakinumab for the prevention of serious events …
First-ever all-oral drug for sleeping sickness recommended for approval by EMA committee
November 20, 2018Manufacturing and Production, Sales and Marketing CHMP, EMA, Europe, Sanofi, fexinidazole, pharma, sleeping sickness
Sanofi’s fexinidazole, the first all-oral therapy for the treatment of human African trypanosomiasis (HAT), or sleeping sickness, has secured a …
Sarepta’s Exondys 51 hit with negative CHMP opinion in Duchenne muscular dystrophy
September 24, 2018Research and Development, Sales and Marketing CHMP, Duchenne Muscular Dystophy, EMA, Europe, Exondys 51, pharma, sarepta
Sarepta Therapeutics has been rocked by a hurdle in its pursuit of regulatory approval in Europe, as the company revealed …
CHMP recommend white blood cell growth stimulator biosimilar to EMA
July 30, 2018Sales and Marketing Amgen, CHMP, EMA, Neulasta, biosimilar, chemotherapy, pegfilgrastim
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of two separate …
CHMP recommends Novartis’ CAR-T therapy Kymriah for EU approval
July 5, 2018Sales and Marketing CAR-T, CHMP, EMA, EU, Kymriah, Novartis, pharma
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Medicines Agency (EMA) approve Novartis’ CAR-T …
Novo Nordisk’s diabetes drug recommended for expanded indication in Europe
June 27, 2017Research and Development, Sales and Marketing CHMP, EMA, EU, Novo Nordisk, Victoza
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given its recommendation to expand the indication of Novo …
Humira set to face new European biosimilar rival
June 26, 2017Sales and Marketing CHMP, EMA, Samsung Bioepis
A position opinion from the EMA for Samsung Bioepis’ biosimilar of Humira looks set to unleash a second rival to …
EU recommendation for Lilly’s soft tissue cancer drug
September 19, 2016Sales and Marketing CHMP, EMA, Eli Lilly, Lartruvo, soft tissue sarcoma
The Committee for Medicinal Products for Human Use (CHMP) has recommended Eli Lilly’s Lartruvo (olaratumab) for treatment of adults with …
CHMP issues positive opinion for Orencia Rheumatoid Arthritis treatment
July 25, 2016Manufacturing and Production, Sales and Marketing BMS, CHMP, Orencia, rheumatoid arthritis
Bristol-Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) has released a positive opinion of …
Shire receives positive EU opinion for pancreatic cancer drug
July 25, 2016Research and Development, Sales and Marketing CHMP, EU, Pancreatic cancer, Shire
Shire has announced that the EU regulator’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion …
MSD gets CHMP positive opinion for keytruda to treat advanced lung cancer
June 28, 2016Manufacturing and Production, Research and Development, Sales and Marketing CHMP, EMA, MSD, Merck & Co, keytruda, lung cancer
MSD (Merck & Co) said its anti-programmed death-1 (PD-1) therapy, Keytruda (pembrolizumab) to treat lung cancer has secured a positive …
Genmab’s CLL drug gets negative opinion from EMA committee
June 24, 2016Medical Communications, Research and Development, Sales and Marketing Arzerra, CHMP, CLL, EMA, Genmab, blood cancer
Genmab A/S (Nasdaq Copenhagen: GEN) said its drug Arzerra (ofatumumab) received a negative opinion by the Committee for Medicinal Products …
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