CHMP
EMA recommends first new gene therapy
July 24, 2012Business Services, Research and Development, Sales and Marketing CHMP, EMA, Glybera, uniQure
Glybera is now on the cusp of becoming the first gene therapy treatment to be approved in the West. The …
Afinitor recommended in Europe for breast cancer
June 22, 2012Sales and Marketing Afinitor, CHMP, Cancer, Novartis, breast
A European committee is recommending Novartis’ Afinitor to treat women with a certain type of breast cancer. The CHMP says …
Landmark CF treatment set for European approval
May 30, 2012Sales and Marketing CHMP, Europe, Kalydeco, Vertex, cystic fibrosis
A European committee is recommending the approval of Vertex’s first-in-class treatment for cystic fibrosis. Kalydeco (ivacaftor) is a landmark in …
European OK for Pradaxa, but more details required
May 29, 2012Research and Development, Sales and Marketing Boehringer, CHMP, EMA, Europe, Pradaxa
The European Medicines Agency says that Boehringher’s Pradaxa can stay on the market, but will need more safety information. The …
Recommendations for two Eisai epilepsy drugs
May 28, 2012Sales and Marketing CHMP, Eisai, Zonegra, epilepsy
European regulators are likely to approve two of Eisai’s epilepsy drugs after advisers recommended both of them.First-in-class Fycompa (perampanel) has …
Groundbreaking CF drug recommended in Europe
May 25, 2012Sales and Marketing CHMP, EMA, Kalydeco, Vertex, cystic fibrosis
The first-in-class treatment for cystic fibrosis Kalydeco has been recommended by the EMA’s medicines committee. Kalydeco (ivacaftor) promises to be …
AstraZeneca diabetes drug recommended in Europe
April 23, 2012Sales and Marketing AstraZeneca, CHMP, FDA, Merck, WHO, diabetes
AstraZeneca and Bristol-Myers Squibb’s new type II diabetes treatment Forxiga has received a positive opinion by European regulators. The European …
Eric Abadie resigns as chair of the CHMP
April 5, 2012Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CHMP, Eric Abadie
Dr Eric Abadie has told the European Medicines Agency that he is resigning as chair of the Committee for Medicinal …
EMA confirms verdict on Ben Venue facility
February 28, 2012Manufacturing and Production Ben Venue, CHMP, EMA, Sanofi
The European Medicines Agency has officially removed Ben Venue Laboratories’ troubled Bedford facility as an approved location for the manufacture …
EMA to open up drug evaluation process
February 22, 2012Medical Communications, Sales and Marketing CHMP, EMA, FDA
The European Medicines Agency will publish ongoing drug evaluations in an effort to make its processes more transparent. The Agency …
Novartis’ Signifor recommended in Europe
January 20, 2012Research and Development, Sales and Marketing CHMP, Cushing's disease, Novartis, Signifor
A European committee has recommended Novartis’ Signifor for the treatment of a rare, debilitating endocrine disorder. The European Committee for …
EMA to review safety of MS drug Gilenya
January 20, 2012Research and Development, Sales and Marketing CHMP, EMA, Novartis, gilenya
The European Medicines Agency has begun a review into the safety of Novartis’ multiple sclerosis drug Gilenya. This follows concerns …
AstraZeneca’s thyroid cancer drug gets CHMP nod
November 21, 2011Sales and Marketing AstraZeneca, CHMP, Caprelsa, vandetanib
AstraZeneca’s thyroid cancer pill Caprelsa has taken a step closer to European approval after being recommended by the CHMP.Caprelsa (vandetanib) …
CHMP roundup
May 24, 2011Sales and Marketing CHMP, EMA, Fampyra, Vibativ, Victrelis, Xgeva, Yervoy
The latest products to be recommended for European approval include MSD’s Victrelis, Astellas Pharma Europe’s Vibativ, Amgen Europe’s Xgeva and …
European recommendation for GSK’s lupus drug Benlysta
May 23, 2011Sales and Marketing Benlysta, CHMP, GlaxoSmithKline, Lupus
GlaxoSmithKline’s first-in-class lupus drug Benlysta has been given a major boost by regulators in the European Union. The European Medicines …
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