CHMP

Showing 15 posts of 100 posts found.

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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 …

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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 …

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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 …

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 …

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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Biogen says European regulatory committee adopts positive view for Tysabri

June 1, 2016
Medical Communications, Research and Development, Sales and Marketing Biogen, CHMP, EMA, Tysabri, multiple sclerosis

Biogen (Nasdaq: BIIB) said the European regulatory committee has backed the approval of a variation to the marketing authorization for its …

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Shire gets positive opinion from EMA on rare gastrointestinal disease treatment

May 27, 2016
Medical Communications, Research and Development, Sales and Marketing CHMP, EMA, Revestive, Shire, gastrointestinal, paediatric, short bowel syndrome, treatment

Shire (LSE: SHP) has announced that it has received a positive opinion from the European Medicines Agency’s (EMA) Committee for …

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EMA recommends Biogen’s MS treatment Zinbryta

May 3, 2016
Research and Development, Sales and Marketing Biogen, CHMP, EMA, daclizumab, zinbryta

The Committee for Medicinal Products for Human Use (CMHP) has recommended the granting of a marketing authorisation for Zinbryta (daclizumab) …

EMA inside

Actelion’s Uptravi and rare bleeding disorder drug get positive EMA decisions

February 1, 2016
Sales and Marketing CHMP, EMA, Uptravi, pulmonary arterial hypertension, selexipag

The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMA, has issued positive opinions on …

Samsung beats pharma to develop first EU-approved Enbrel biosimilar

January 18, 2016
Manufacturing and Production Benepali, CHMP, EMA, Enbrel, Samsung, Samsung Bioepis, etanercept, positive opinion

Samsung Bioepis – the collaboration between Samsung Biologics and Biogen Idec, has become the first company to have a biosimilar …

EU flag

Three AstraZeneca drugs recommended by EMA committee

December 21, 2015
Sales and Marketing AstraZeneca, Brilique, CHMP, EMA, Portrazza, Tagrisoo, lesinurad, lilly

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended several new drugs in its latest meeting, including …

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EMA waves through a raft of drug recommendations

June 26, 2015
Research and Development, Sales and Marketing AbbVie, Alexion, CHMP, EMA, Novartis, Novo Nordisk, brett wells

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended several treatments for marketing …

EM HQ

Big-name generics among new CHMP recommendations

April 27, 2015
Sales and Marketing CHMP, EMA, European Medicines Agency, Lyrica, pregabalin

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended 11 new medicines for approval, among them several …

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EMA committee recommends five drugs for approval

March 30, 2015
Sales and Marketing Boehringer, CHMP, EMA, Eisai, Europe, Gardasil, Lenvima, Merck, akynzio, jardiance, lilly

Cancer and diabetes treatments are among those given the go ahead in the latest round of approvals by the EMA. …

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