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EMA

Showing 15 posts of 400 posts found.

Roche image

Roche’s Perjeta increases survival

June 27, 2012
Research 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 …

News
roche_glass_building

Roche failed to investigate 80,000 safety incidents

June 25, 2012
Manufacturing 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 …

News
EMA HQ

EMA clarifies antibodies development

June 20, 2012
Manufacturing 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 …

News

Sanofi submits key MS pill for approval

June 12, 2012
Research 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 …

News

FDA approves Roche’s breast cancer drug

June 11, 2012
Sales 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. …

News
mabthera image

EMA backs MabThera despite contamination issue

May 29, 2012
Manufacturing 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 …

News
Pradaxa image

European OK for Pradaxa, but more details required

May 29, 2012
Research 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 …

News

Groundbreaking CF drug recommended in Europe

May 25, 2012
Sales 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 …

News
Gilenya image

Gilenya to stay on US market – but with new safety warnings

May 15, 2012
Sales 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 …

News
Genzyme image

Genzyme boosts capacity following green light for Waterford plant

May 8, 2012
Manufacturing 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 …

News
Gilenya

New safety warnings recommended for Gilenya

April 20, 2012
Medical 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 …

News
avastin

NICE rejects Avastin for breast cancer

April 18, 2012
Sales 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 …

News

EMA backs full access to trial data

April 12, 2012
Business 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 …

News

EMA creates new conflict of interest rules

April 4, 2012
Sales 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 …

News

EMA completes review of Ben Venue-made drugs

March 19, 2012
Manufacturing and Production Ben Venue, EMA, cancer drugs, production

The European Medicines Agency has recommended that manufacturing of two cancer medicines be transferred from Ben Venue Laboratories plant in …

News
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