EMA
EMA launches speedy pilot
March 21, 2014Sales and Marketing BIA, EMA, MHRA, NICE, early access, trials
The European Medicines Agency (EMA) has launched an initiative aimed at speeding up the drug approval process and wants help …
Clinical studies still not being published
March 4, 2014Research 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 …
Novartis extends trial transparency
February 27, 2014Medical 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.
Lilly’s diabetes drug matches Victoza
February 26, 2014Research 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 …
CHMP breathes new life into GSK, Teva and Novartis
February 24, 2014Research 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 …
‘Compassionate’ use of hep C combo
February 24, 2014Research 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 …
EMA hires Accenture IT head
February 19, 2014Manufacturing 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 …
Aveo and Astellas part ways
February 17, 2014Sales 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 …
AbbVie ‘pleased’ with first year
February 3, 2014Sales 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 …
EMA to review daclatasvir
January 9, 2014Sales 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 …
FDA and EMA team up for generic drug inspections
January 6, 2014Manufacturing 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 …
EMA identifies GMP transgressors in public database
January 6, 2014Manufacturing and Production Database, EMA, GDP, GMP
The European Medicines Agency has continued its march towards increased transparency by publishing – for the first time – the …
Thyroid cancer, TB resistance drugs top EMA approvals
December 23, 2013Sales 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 …
Priority review for Gaucher drug
December 12, 2013Sales 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 …
API imports in the EU: gauging the FMD’s impact
December 9, 2013Manufacturing 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 …
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