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Policy & Regulation
EVENTS
09 February 2012
London
28 February 2012
Pestana Chelsea Bridge Hotel London
04 March 2012
The Marriott World Center, Orlando, Florida
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Well ahead of its PDUFA deadline of 8 March, the US FDA on January 30 gave Roche's Genentech arm the green light to sell vismodegib as the first nonsurgical treatment for advanced basal cell carcinoma (BCC). The company said that the once-a-day capsule will be on the US market under the trade name Erivedge before mid-February. Last month Roche filed for approval of the drug with the EMA ( scripintelligence.com, 23 December 2011 ). It is intended for the small group of BCC patients for whom the ...
 
The headline number when AstraZeneca announced its full-year 2011 results on February 2 was not the sales or earnings numbers, but the 7,300 further job losses from R&D, sales and marketing, and manufacturing ( scripintelligence.com, 3 February 2012 ). The AstraZeneca share price finished the day ...
Janssen Cilag has failed to convince NICE, the health technology appraisal institute for England and Wales, that its oral prostate cancer drug Zytiga (abiraterone), provides enough benefit to justify thecost. Today's draft recommendations come despite the offer of a patient access scheme and NICE's ...
 
Three months ago, Medivation announced encouraging top-line results for the prostate cancer androgen receptor signalling inhibitor it is developing in conjunction with Astellas Pharma ( scripintelligence.com, 3 November 2011 ). On February 1 it released more details of the findings of its AFFIRM ...
Priorities for the European Medicines Agency in the drug safety area this year include a new urgent referral procedure, guidance on post-authorisation efficacy studies, and more effective ways of detecting and acting on significant safety signals. The EMA will also be preparing for the inaugural ...
 
Priorities for the European Medicines Agency in the drug safety area this year include a new urgent referral procedure, guidance on post-authorisation efficacy studies, and more effective ways of detecting and acting on significant safety signals. The EMA will also be preparing for the inaugural ...
Janssen Cilag has failed to convince NICE, the health technology appraisal institute for England and Wales, that its oral prostate cancer drug Zytiga (abiraterone), provides enough benefit to justify the cost. Today's draft recommendations come despite the offer of a patient access scheme and ...
 
Three months ago, Medivation announced encouraging top-line results for the prostate cancer androgen receptor signalling inhibitor it is developing in conjunction with Astellas Pharma ( scripintelligence.com, 3 November 2011 ). On February 1 it released more details of the findings of its AFFIRM ...
Priorities for the European Medicines Agency in the drug safety area this year include a new urgent referral procedure, guidance on post-authorisation efficacy studies, and more effective ways of detecting and acting on significant safety signals. The EMA will also be preparing for the inaugural ...
 
Realizing that a catastrophe in one nation, as evidenced by the March 2011 earthquake-tsunami-nuclear crisis in Japan, can result in a major threat to drugs and other goods in the global supply chain – which is growing increasingly more complex – the Obama administration last week laid out a new ...
Moves towards implementing a Europe-wide system for verifying the authenticity of medicines are gathering pace as representatives of the pharmaceutical industry and distributors prepare to sign an agreement on what they say will be a "practical and cost-effective solution" to implementing the ...
 

2012 Scrip 100: Survival of the fittest
29 December 2011

It’s finally here. For a while, a dark cloud has been looming ominously over the industry and, on ...

2012 Scrip 100: Successful trial outcomes – peering into the crystal ball
29 December 2011

With rising trial costs and shrinking budgets, pharma companies are working more diligently than ...

2012 Scrip 100: Work-Life balance tops salary for pharma employees
28 December 2011

Four years ago, Scrip 100 surveyed a broad and representive sample of those working in the ...

The recent Phase III results from the TENERE study of Sanofi 's Aubagio (teriflunomide) comparing ...

Dx by dt: diagnostic intent over time
03 February 2012
Mike Ward
If Roche acquires Illumina, as it seems fairly intent on doing despite repeated messages of ...

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