EMA
Astellas submits new prostate cancer drug to EMA
June 28, 2012Research and Development, Sales and Marketing Astellas, EMA, Medivation, NICE, Zytiga, enzalutamide
Astellas has submitted its investigational prostate cancer drug enzalutamide to the European Medicines Agency. Enzalutamide is a once-daily pill that works …
Roche’s Perjeta increases survival
June 27, 2012Research and Development, Sales and Marketing EMA, FDA, Herceptin, Perjeta, Roche, breast cancer
Roche’s new drug Perjeta has scored another trial success by increasing overall survival in certain breast cancer patients. The new …
Roche failed to investigate 80,000 safety incidents
June 25, 2012Manufacturing and Production, Sales and Marketing EMA, MHRA, Roche, pharmacovigilance
The European Medicines Agency is investigating Roche after ‘deficiencies’ in the manufacturer’s pharmacovigilance processes came to light. It has emerged …
EMA clarifies antibodies development
June 20, 2012Manufacturing and Production, Research and Development, Sales and Marketing CMPHU, EMA, RA, antibodies
European regulators have issued final guidance on how pharma manufacturers should develop drugs containing monoclonal antibodies. Typically used in treatments …
Sanofi submits key MS pill for approval
June 12, 2012Research and Development, Sales and Marketing Bayer, EMA, FDA, Genzyme, Lemtrada, MS, Sanofi
Sanofi has submitted its multiple sclerosis pill Lemtrada for regulatory reviews in the US and Europe. Lemtrada (alemtuzumab), originally developed …
FDA approves Roche’s breast cancer drug
June 11, 2012Sales and Marketing EMA, FDA, Perjeta, Roche, breast cancer
US regulators have approved Roche’s new breast cancer drug after granting it a priority review to speed up the process. …
EMA backs MabThera despite contamination issue
May 29, 2012Manufacturing and Production EMA, MabThera, Phil Taylor, Roche, manufacturing
The European Medicines Agency has completed a safety review of Roche’s MabThera convened after bacterial contamination was discovered in bioreactors …
European OK for Pradaxa, but more details required
May 29, 2012Research and Development, Sales and Marketing Boehringer, CHMP, EMA, Europe, Pradaxa
The European Medicines Agency says that Boehringher’s Pradaxa can stay on the market, but will need more safety information. The …
Groundbreaking CF drug recommended in Europe
May 25, 2012Sales and Marketing CHMP, EMA, Kalydeco, Vertex, cystic fibrosis
The first-in-class treatment for cystic fibrosis Kalydeco has been recommended by the EMA’s medicines committee. Kalydeco (ivacaftor) promises to be …
Gilenya to stay on US market – but with new safety warnings
May 15, 2012Sales and Marketing EMA, FDA, Novartis, PML, gilenya
The FDA says that Novartis’ multiple sclerosis pill Gilenya should stay on the market, but has added new safety warnings …
Genzyme boosts capacity following green light for Waterford plant
May 8, 2012Manufacturing and Production EMA, FDA, Genzyme, Sanofi, Waterford
Sanofi subsidiary Genzyme has doubled its capacity to fill-and-finish two of its drugs for rare disorders following approval of a …
New safety warnings recommended for Gilenya
April 20, 2012Medical Communications, Sales and Marketing EMA, Novartis, gilenya
A safety review of Novartis’ MS treatment Gilenya has concluded the drug should stay on the market, but that patients …
NICE rejects Avastin for breast cancer
April 18, 2012Sales and Marketing EMA, NICE, Roche, avastin, breast cancer
In a blow for Roche, NICE has turned down its cancer drug Avastin because of ‘too many uncertainties’ over cost …
EMA backs full access to trial data
April 12, 2012Business Services, Research and Development, Sales and Marketing EMA, clinical trial data, data disclosure, regulatory affairs, transparency
The European Medicines Agency says it wants to open up access to full clinical trial data, but warns that some …
EMA creates new conflict of interest rules
April 4, 2012Sales and Marketing EMA, Lonngren, conflict of interest
The European Medicines Agency has introduced new rules to tighten up conflicts of interest, and have less reliance on pharma …
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