CHMP

Showing 15 posts of 110 posts found.

uniQure's Glybera

EMA recommends first new gene therapy

July 24, 2012
Business 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, 2012
Sales 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, 2012
Sales 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 …

Pradaxa image

European OK for Pradaxa, but more details required

May 29, 2012
Research 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, 2012
Sales 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, 2012
Sales 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, 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 …

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 …

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 …

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 …

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 …

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 …

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) …

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 …

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 …

The Gateway to Local Adoption Series

Latest content