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Jentadueto™ tablets recommended for approval in the treatment of adults with Type 2 Diabetes in Europe
25 May 2012 | By Boehringer Ingelheim
Boehringer Ingelheim and Eli Lilly and Company has received a positive opinion from the EMA...
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Genzyme announces regulatory approvals of expanded Waterford, Ireland manufacturing plant
3 May 2012 | By Sanofi
FDA and the EMA approve 2nd operation for filling and finishing product...
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Rapid micro methods and EMA’s post approval change management protocol
26 April 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the second paper in our continuing series on Rapid Microbiological Methods that will appear in European Pharmaceutical Review during 2012. In my last article, we discussed a number of myths or misconceptions associated with the validation and implementation of rapid microbiological methods (RMMs). In fact, most RMM myths…
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Genzyme demonstrates depth of MS pipeline at AAN with results from Miltiple Sclerosis Phase III trials
20 April 2012 | By Sanofi
Full CARE-MS II results for Alemtuzumab to be unveiled...
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Novartis drug Jakavi(TM) recommended by CHMP for EU approval to treat patients with the life-threatening blood cancer myelofibrosis
20 April 2012 | By Novartis
Upon approval, Jakavi(TM) (INC424, ruxolitinib) will be the first EU approved JAK inhibitor developed to treat patients with myelofibrosis, a rare blood cancer...
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FORXIGA® (dapagliflozin) Receives Positive CHMP Opinion in the European Union for the Treatment of Type 2 Diabetes
20 April 2012 | By Bristol-Myers Squibb Company
Bristol-Myers Squibb Company and AstraZeneca announced that the CHMP of the EMA has recommended approval of FORXIGA® (dapagliflozin) tablets...
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Genzyme announces FDA approval of Framingham manufacturing plant
24 January 2012 | By Sanofi
The FDA has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme® (agalsidase beta)...
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Novartis drug Signifor® recommended by CHMP
20 January 2012 | By Novartis
If approved, Signifor would be the first approved medication targeting Cushing's disease...
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CHMP recommends EU approval to update Novartis drug Glivec® label to include three year treatment for GIST patients after surgery
20 January 2012 | By Novartis
Update of the Glivec® (imatinib)* label...
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Genzyme announces European approval of Framingham manufacturing plant
18 January 2012 | By Sanofi
Sanofi & Genzyme announced that the EMA has approved its manufacturing plant in Framingham....
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Pfizer announces EMA acceptance of regulatory submission for Tofacitinib for the treatment of Rheumatoid Arthritis
21 November 2011 | By Pfizer
Pfizer Inc. announced that its Market Authorisation Application for tofacitinib...
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Boehringer Ingelheim implements additional guidance supporting appropriate use of Pradaxa® (dabigatran etexilate) in Europe
27 October 2011 | By Boehringer Ingelheim
Update across Europe on Pradaxa®...
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European CHMP adopts positive opinion for Eviplera(R)
23 September 2011 | By Gilead Sciences, Inc.
CHMP, has adopted a positive opinion on the company's Marketing Authorisation Application for the once-daily single-tablet regimen, Eviplera(R)...
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EMA accepts marketing authorization application for Ridaforolimus, investigational mTOR inhibitor
18 August 2011 | By
Merck to pay ARIAD $25 million milestone payment for acceptance of filing...
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Pfizer announces EMA acceptance of regulatory submissions for two investigational cancer therapies
17 August 2011 | By Pfizer
EMA accepted Pfizer’s regulatory submissions for review of two investigational compounds...
