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Research And Early Development At Roche, A Work In Progress: An Interview With Mike Burgess

 
• By Michael Goodman

The acting head of Roche pharma research and early development stepped into the job amid major personnel changes in the pharma organization and the consolidation and streamlining of pRED. He spoke with the “The Pink Sheet” about his group’s priorities and the inevitable short-term hit to research productivity.

The past six months have been the most transformative for Roche R&D since the parent company took full control of Genentech Inc.in 2009 [See Deal]. In June, Roche announced the closure of its 80-year-old Nutley N.J. R&D site and the opening of a translational clinical research center in New York City Also see "Roche Shakes Up R&D, Closes Nutley Operations" - Pink Sheet, 26 June, 2012.. In August, it appointed Daniel O’Day head of its pharmaceuticals division, replacing Pascal Soriot who left the company to take the CEO spot at AstraZenecaPLC Also see "AZ Taps Outsider Soriot As CEO, While Roche Anoints 25-Year Veteran O'Day To Head Pharma Division" - Pink Sheet, 28 August, 2012..

With the closure of Nutley and the consolidation of Roche Pharma Research and Early Development (pRED) at sites in Switzerland and Germany, the Swiss pharma kept its pledge to streamline...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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EU Pharma Reform Package Clears Big Political Hurdle After Council Adopts Position

 
• By Neena Brizmohun

The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
• By Eliza Slawther

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.

Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.