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EMA

Showing 15 posts of 400 posts found.

EMA accepts submission of Pfizer’s new arthritis drug

November 21, 2011
Research and Development, Sales and Marketing EMA, Pfizer, tofacitinib

The European Medicines Agency has accepted Pfizer’s arthritis drug tofacitinib for review.Tofacitinib is a novel, oral JAK inhibitor being studied …

News

Andreas Pott appointed deputy executive director of European Medicines Agency

November 21, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, Europe

The European Medicines Agency’s new executive director Guido Rasi has appointed Andreas Pott as deputy executive director. Pott’s appointment follows …

Appointment

Boehringer agrees Pradaxa kidney function warning

October 30, 2011
Sales and Marketing AF, EMA, Pradaxa, renal function

Boehringer Ingelheim is to alert doctors in Europe of the need to check patients’ kidney function before prescribing anticoagulant Pradaxa. …

News

EMA resources stretched by Mediator scandal

October 18, 2011
Research and Development, Sales and Marketing EMA, Mediator

The European Medicines Agency has been forced to use ‘considerable resources’ to deal with a flood of enquiries over Mediator …

News
European Parliament

EMA tightens conflict of interest rules

October 6, 2011
Research and Development, Sales and Marketing EMA

The European Medicines Agency is tightening up its conflict of interest rules with a new ‘experts database’. This will allow …

News
EMA

EMA should compare ‘like-for-like’ when assessing new drugs

September 7, 2011
Research and Development EMA, clnical trials, research and development news

The European system of comparing drugs against placebo and not against a comparator is flawed, according to a new LSE …

News

Shared API inspections project declared a success

August 9, 2011
Manufacturing and Production API, EMA, FDA, TGA, pharma manufacturing news, regulatory inspections

A two-year facility inspection programme carried out by regulators in the USA, Europe and Australia has been deemed a success …

News
US Food and Drug Administration

Pharma regulators consult on drug development initiatives

July 13, 2011
Research and Development Companion Diagnostics, EMA, FDA, Pharmacogenomics, biomarkers, research and development news

Pharma regulators in the US and Europe have put out separate consultations on issues affecting how medicines are developed. The …

News

EMA plans adverse event reports for the public

July 12, 2011
Research and Development, Sales and Marketing EMA, adverse events, patient information

The EMA will start producing monthly adverse event reports for the public as part of its plans to open up …

News

EMA publishes details of new pharmacovigilance format

July 4, 2011
Research and Development, Sales and Marketing EMA, pharmacovigilance

Pharma companies have been given the highly-specific electronic formats in which they will soon have to submit information on medicines …

News

European approval for BMS kidney transplant drug Nulojix

June 22, 2011
Sales and Marketing BMS, EMA, Nulojix, transplant

European regulators have followed their US counterparts in granting marketing authorisation for a drug which aims to prevent kidney transplant …

News

Pfizer project is quality-by-design milestone for FDA and EMA

June 21, 2011
Manufacturing and Production EMA, FDA, Quality by Design, pharma manufacturing news

A pilot project set up earlier this year to encourage the adoption of quality-by-design in pharmaceutical manufacturing has passed its …

News

Europe slower than US to approve new cancer drugs

June 17, 2011
Sales and Marketing EMA, FDA, FDA approvals, new drug approvals

The European Medicines Agency approves fewer new oncology drugs than its US counterpart and takes nearly twice as long to …

News
Takeda Actos (pioglitazone)

France pulls Takeda diabetes drugs after cancer fears

June 13, 2011
Sales and Marketing Actos, Competact, EMA, Takeda

The French medicines agency has moved to prevent two Takeda diabetes drugs from being prescribed after fears they could increase …

News
EMA's Guido Rasi

Rasi nominated to be EMA chief

June 10, 2011
Research and Development, Sales and Marketing EMA, Guido Rasi, Thomas Lönngren

The European Medicines Agency has nominated Italy’s Guido Rasi to be its next head, after a protracted and messy search. …

News
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