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CHMP

Showing 15 posts of 110 posts found.

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Janssen secures two positive CHMP opinions for Imbruvica label expansions

July 1, 2019
Sales 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 …

News
credit_-_daniel_leal-olivas-afp

AZ and MSD’s Lynparza secures CHMP nod in first-line BRCA-mutated ovarian cancer

April 29, 2019
Sales 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 …

News
credit_-_daniel_leal-olivas-afp

CHMP recommendation for bluebird bio’s gene therapy in β-thalassaemia

April 1, 2019
Research 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, …

News
novartis_outside_1

Novartis withdraw marketing application for heart drug

December 17, 2018
Sales 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Swiss multinational Novartis has withdrawn a European Medicines Agency (EMA) marketing application for canakinumab for the prevention of serious events …

News

First-ever all-oral drug for sleeping sickness recommended for approval by EMA committee

November 20, 2018
Manufacturing 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 …

News
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Sarepta’s Exondys 51 hit with negative CHMP opinion in Duchenne muscular dystrophy

September 24, 2018
Research 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 …

News
White blood cells

CHMP recommend white blood cell growth stimulator biosimilar to EMA

July 30, 2018
Sales 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 …

News
kymriah

CHMP recommends Novartis’ CAR-T therapy Kymriah for EU approval

July 5, 2018
Sales 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 …

News

Novo Nordisk’s diabetes drug recommended for expanded indication in Europe

June 27, 2017
Research 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 …

News

Humira set to face new European biosimilar rival

June 26, 2017
Sales 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 …

News
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EU recommendation for Lilly’s soft tissue cancer drug

September 19, 2016
Sales 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 …

News
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CHMP issues positive opinion for Orencia Rheumatoid Arthritis treatment

July 25, 2016
Manufacturing 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 …

News
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Shire receives positive EU opinion for pancreatic cancer drug

July 25, 2016
Research 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 …

News
msd

MSD gets CHMP positive opinion for keytruda to treat advanced lung cancer

June 28, 2016
Manufacturing 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 …

News
cancer

Genmab’s CLL drug gets negative opinion from EMA committee

June 24, 2016
Medical 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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