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CHMP

Showing 15 posts of 100 posts found.

European nod for Sanofi drugs

November 19, 2012
Research and Development, Sales and Marketing CHMP, Sanofi

Two of Sanofi’s key drugs have cleared the penultimate hurdle to approval in Europe with a recommendation from the CHMP. …

News
Eliquis image

Eliquis receives nod in AF

September 24, 2012
Sales and Marketing BMS, CHMP, Eliquis, Pfizer, Pradaxa, Xarelto

Bristol-Myers Squibb and Pfizer have received a boost with the CHMP’s recommendation that their co-marketed oral anticoagulant Eliquis should gain …

News
Cialis image

New possibility for Lilly erectile drug

September 24, 2012
Sales and Marketing CHMP, Cialis, ED, hyperplasia, lilly

Eli Lilly’s erectile disfunction (ED) brand Cialis has been recommended to treat benign prostatic hyperplasia (BPH) in Europe. If the …

News
Afinitor image

Afinitor’s new UK indication launched

September 20, 2012
Sales and Marketing Afinitor, CHMP, Novartis, breast cancer

Novartis’ cancer drug Afinitor has been made available in the UK for patients with the most common form of advanced …

News
EMA building

Salmonson is new chair of CHMP

September 19, 2012
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CHMP, EMA, MPA, Salmonson

Dr Tomas Salmonson has been elected chair of the Committee for Medicinal Products for Human Use (CHMP) for a three-year …

News
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 …

News

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 …

News

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 …

News
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 …

News

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 …

News

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 …

News

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

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