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EMA validates Gilead’s marketing application for Elvitegravir for treatment of HIV infection
18 June 2012 | By Gilead Sciences
Gilead Sciences announced that its MAA for elvitegravir has been validated by the EMA...
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Genzyme submits applications to FDA and EMA for approval of LEMTRADA™ (alemtuzumab) for multiple sclerosis
12 June 2012 | By Sanofi
Genzyme is developing LEMTRADA in MS in collaboration with Bayer HealthCare...
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Novo Nordisk receives positive opinion on recombinant factor XIII from the European regulatory authorities
25 May 2012 | By Novo Nordisk
Novo Nordisk receives a positive opinion on recombinant factor XIII product (rFXIII)...
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GSK receives positive opinion from European CHMP for pazopanib
25 May 2012 | By GlaxoSmithKline
Positive opinion recommending marketing authorisation for Votrient®...
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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...
