EMA
EMA and FDA move closer on inspections
December 12, 2011Manufacturing and Production EMA, FDA
The EMA and US FDA has taken a step closer to mutual recognition of manufacturing site inspections, launching a three-year …
EMA accepts submission of Pfizer’s new arthritis drug
November 21, 2011Research 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 …
Andreas Pott appointed deputy executive director of European Medicines Agency
November 21, 2011Business 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 …
Boehringer agrees Pradaxa kidney function warning
October 30, 2011Sales 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. …
EMA resources stretched by Mediator scandal
October 18, 2011Research 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 …
EMA tightens conflict of interest rules
October 6, 2011Research 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 …
EMA should compare ‘like-for-like’ when assessing new drugs
September 7, 2011Research 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 …
Shared API inspections project declared a success
August 9, 2011Manufacturing 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 …
Pharma regulators consult on drug development initiatives
July 13, 2011Research 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 …
EMA plans adverse event reports for the public
July 12, 2011Research 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 …
EMA publishes details of new pharmacovigilance format
July 4, 2011Research 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 …
European approval for BMS kidney transplant drug Nulojix
June 22, 2011Sales 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 …
Pfizer project is quality-by-design milestone for FDA and EMA
June 21, 2011Manufacturing 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 …
Europe slower than US to approve new cancer drugs
June 17, 2011Sales 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 …
France pulls Takeda diabetes drugs after cancer fears
June 13, 2011Sales 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 …
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