CHMP

Showing 15 posts of 100 posts found.

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Takeda’s subcutaneous vedolizumab nabs CHMP nod for maintenance of ulcerative colitis and Crohn’s

February 28, 2020
Medical Communications, Sales and Marketing CHMP, EMA, Takeda, vedolizumab

Takeda’s subcutaneous formulation of its gut-selective biologic vedolizumab has secured recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal …

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AbbVie’s Venclyxto pins down CHMP approval for treatment-naive chronic lymphocytic leukaemia

February 3, 2020
Sales and Marketing AbbVie, CHMP, EMA, Venclyxto, pharma

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has awarded recommendation to AbbVie’s Venclyxto (venetoclax), …

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Genmab’s Darzalex secures CHMP recommendation in Europe for front-line multiple myeloma

December 13, 2019
Medical Communications, Sales and Marketing CHMP, Genmab, darzalex, pharma

The Committee for Medicinal Products for Human Use (CHMP), an advisory panel for the European Medicines Agency, has given its …

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EMA’s CHMP recommends new dosing schedule for Opdivo in melanoma

September 25, 2019
Research and Development, Sales and Marketing BMS, Bristol-Myers Squibb, CHMP, EMA, melanoma, opdivo, pharma

Bristol-Myers Squibb has revealed that its blockbuster immunotherapy drug Opdivo (nivolumab) has secured recommendation from the EMA’s Committee for Medicinal …

Bayer’s Vitravki poised to become first tumour-agnostic therapy in EU following CHMP recommendation

July 30, 2019
Manufacturing and Production, Sales and Marketing Bayer, CHMP, Cancer, EU, Vitrakvi, pharma

Bayer’s oral TRK inhibitor Vitrakvi (larotrectinib) could be set to become the European Union’s first drug approved in a tumour-agnostic …

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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 …

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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 …

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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, …

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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 …

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 …

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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 …

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 …

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 …

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 …

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 …

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