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CHMP

Showing 14 posts of 104 posts found.

AstraZeneca diabetes drug recommended in Europe

April 23, 2012
Sales 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 …

News

Eric Abadie resigns as chair of the CHMP

April 5, 2012
Business 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 …

Appointment

EMA confirms verdict on Ben Venue facility

February 28, 2012
Manufacturing 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 …

News
EMA image

EMA to open up drug evaluation process

February 22, 2012
Medical 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 …

News

Novartis’ Signifor recommended in Europe

January 20, 2012
Research 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 …

News
Gilenya image

EMA to review safety of MS drug Gilenya

January 20, 2012
Research 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 …

News

AstraZeneca’s thyroid cancer drug gets CHMP nod

November 21, 2011
Sales 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) …

News

CHMP roundup

May 24, 2011
Sales 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 …

News

European recommendation for GSK’s lupus drug Benlysta

May 23, 2011
Sales 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 …

News
Boehringer Ingelheim

Boehringer’s Pradaxa recommended for expanded European licence

April 18, 2011
Sales and Marketing Boehringer Ingelheim, CHMP, Pradaxa

Pradaxa is on course to expand its European licence with a recommendation from the CHMP for a new indication in …

News
Roche's Avastin (bevacizumab)

Avastin’s breast cancer use to continue in Europe

March 2, 2011
Sales and Marketing CHMP, Cancer, European Commission, Roche, avastin, bevacizumab, breast cancer, docetaxel, paclitaxel

Roche’s Avastin will remain on the market as a treatment for breast cancer, but only in combination with paclitaxel, the …

News

Novartis’ Lucentis recommended for wider EU licence

October 25, 2010
Sales and Marketing CHMP, Genentech, Lucentis, Novartis, diabetic macular edema, ranibizumab

Novartis’ Lucentis has been recommended for approval in Europe to treat people suffering from vison loss due to diabetes. The …

News

Merck will appeal EMA’s Movectro decision

October 12, 2010
Sales and Marketing CHMP, EMA, Merck KGaA, Merck Serono, Movectro

Merck KGaA is poised to appeal the EMA’s decision on its MS treatment Movectro after the regulator rejected the drug …

News

European green light for Allergan’s Ozurdex

May 25, 2010
Sales and Marketing Allergan, CHMP, Ozurdex, macular oedema

European authorities have given the green light for Ozurdex, a treatment for adults with a potentially serious eye disease. Ozurdex …

News

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