CHMP
Biogen says European regulatory committee adopts positive view for Tysabri
June 1, 2016Medical 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 …
Shire gets positive opinion from EMA on rare gastrointestinal disease treatment
May 27, 2016Medical 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 …
EMA recommends Biogen’s MS treatment Zinbryta
May 3, 2016Research 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) …
Actelion’s Uptravi and rare bleeding disorder drug get positive EMA decisions
February 1, 2016Sales 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, 2016Manufacturing 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 …
Three AstraZeneca drugs recommended by EMA committee
December 21, 2015Sales 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 …
EMA backs GSK’s malaria vaccine for use in Africa
July 24, 2015Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CHMP, Committee for Medicinal Products for Human USE, EMA, European Medicines Agency, GSK, WHO, malaria, world health organization
GSK has taken a significant step forward toward being the first company to bring a malaria vaccine to market, after …
EMA waves through a raft of drug recommendations
June 26, 2015Research 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 …
Big-name generics among new CHMP recommendations
April 27, 2015Sales 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 …
EMA committee recommends five drugs for approval
March 30, 2015Sales 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. …
Takeda trials Teva Parkinson’s drug in Japan
January 9, 2015Sales 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 …
Ranbaxy launches J&J biosimilar in India
December 5, 2014Manufacturing 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 …
CHMP nods several drugs through
November 24, 2014Sales 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 …
AZ oncology drug a ‘Phoenix from the flames’
October 27, 2014Sales 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, 2014Sales 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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