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EMA

Showing 15 posts of 400 posts found.

Clinical trials image

Clinical studies still not being published

March 4, 2014
Research and Development, Sales and Marketing ABPI, EMA, alltrials, clinical trials, csr

Half of all trials registered on a US clinical study database are not being published in public journals. This is …

News
Novartis image

Novartis extends trial transparency

February 27, 2014
Medical Communications, Research and Development, Sales and Marketing EFPIA, EMA, Goldacre, Novartis, alltrials, transparency

Novartis has become the latest pharmaceutical company to allow greater scrutiny of its clinical trial data.

News
lilly image

Lilly’s diabetes drug matches Victoza

February 26, 2014
Research and Development, Sales and Marketing EMA, FDA, Victoza, dulaglutide, lilly

Eli Lilly’s once-weekly diabetes candidate dulaglutide has matched Novo Nordisk’s established once-daily Victoza (liraglutide) when it comes to lowering blood …

News
GSK image

CHMP breathes new life into GSK, Teva and Novartis

February 24, 2014
Research and Development, Sales and Marketing CHMP, COPD, EMA, GSK, Gilead, Teva, asthma, onoro

The CHMP has given its backing to a number of new treatments for respiratory diseases, which include two from London-based …

News
Gilead image

‘Compassionate’ use of hep C combo

February 24, 2014
Research and Development, Sales and Marketing CHMP, EMA, Gilead, hep C, ledipasvir, sovaldi

A key adviser to the European regulator has said that Gilead Sciences’ fixed-dose combination of Sovaldi and ledipasvir can be …

News
dina_tsiambaou_ema

EMA hires Accenture IT head

February 19, 2014
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Dina Tsiambaou, EMA, IT

The European Medicines Agency (EMA) has welcomed Dina Tsiambaou as the new head of its Information Technology department. Tsiambaou joins …

Appointment

Aveo and Astellas part ways

February 17, 2014
Sales and Marketing Astellas, Aveo, Boehringer, EMA, tivozanib

Aveo Oncology and Astellas Pharma are to abandon their three-year old collaboration and licence agreement for investigational tyrosine kinase inhibitor …

News
Abbvie image

AbbVie ‘pleased’ with first year

February 3, 2014
Sales and Marketing AbbVie, Abbott, CLL, EMA, HIV, Humira

Rheumatoid arthritis treatment Humira – as expected – has driven AbbVie in its first year as a standalone company, accounting …

News
BMS image

EMA to review daclatasvir

January 9, 2014
Sales and Marketing BMS, EMA, daclatasvir, hep C

European regulators are to conduct a speedy investigation into one of Bristol-Myers Squibb’s investigational drugs for chronic hepatitis C virus …

News
fda image

FDA and EMA team up for generic drug inspections

January 6, 2014
Manufacturing and Production EMA, FDA, GMP, Taylor, manufacturing

The regulatory authorities in the US and EU have taken another step towards harmonisation by agreeing to pool their resources …

News
ema building

EMA identifies GMP transgressors in public database

January 6, 2014
Manufacturing and Production Database, EMA, GDP, GMP

The European Medicines Agency has continued its march towards increased transparency by publishing – for the first time – the …

News
EMA image

Thyroid cancer, TB resistance drugs top EMA approvals

December 23, 2013
Sales and Marketing EMA, TB, thyroid

The European Medicines Agency has shown the green light to a new treatment for thyroid cancer and one for drug …

News
Sanofi image

Priority review for Gaucher drug

December 12, 2013
Sales and Marketing EMA, FDA, Gaucher, Genzyme, Sanofi

The FDA is to conduct a speedy investigation into Sanofi’s twice-daily oral candidate for Gaucher disease, which means that Cerdelga …

News

API imports in the EU: gauging the FMD’s impact

December 9, 2013
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing API, EMA, FMD, Taylor, manufacturing, supply chain

The deaths of dozens of patients as a result of the contaminated heparin incident in 2008 casts a long shadow …

Feature
iclusig image

EMA in new Iclusig probe

December 9, 2013
Sales and Marketing Ariad, EMA, iclusig, leukaemia

Europe’s medicines regulator has begun a new review of Ariad Pharmaceuticals’ leukaemia drug Iclusig, looking in particular at the risk …

News
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