CHMP

Showing 15 posts of 110 posts found.

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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 …

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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 …

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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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Takeda trials Teva Parkinson’s drug in Japan

January 9, 2015
Sales and Marketing Azilect, CHMP, Copaxone, Parkinson's, Takeda, rasagiline

Takeda has begun late stage trials for Teva’s Parkinson’s disease drug Azilect in Japan, with the hopes of bringing the …

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Ranbaxy launches J&J biosimilar in India

December 5, 2014
Manufacturing and Production, Sales and Marketing CHMP, FDA, India, J&J, JJ, Ranbaxy, Remicade, nlem, nppa

Ranbaxy has launched the first biosimilar of Johnson & Johnson’s Remicade (infliximab) in India, marking the firm’s entry into monoclonal …

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CHMP nods several drugs through

November 24, 2014
Sales and Marketing Boehringer, CHMP, EMA, Esbriet, FDA, Sanofi, nintedanib, ofev

Ten new medicines have been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP), among …

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AZ oncology drug a ‘Phoenix from the flames’

October 27, 2014
Sales and Marketing AstraZeneca, CHMP, EC, lynparza, olaparib, oncology

As the possibility of a deal with Pfizer fades, AstraZeneca is continuing its argument for independence as a key cancer …

Scenesse recommended for rare sun disease in Europe

October 27, 2014
Sales and Marketing CHMP, Clinuvel Pharmaceuticals, EMA, EU, scenesse

The European Medicines Agency is recommending that Scenesse (afamelanotide) be approved for the prevention of severe sun burn in adults …

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