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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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US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

Could EU Collective Procurement Counter US Most Favored Nation Policy?

 
• By Francesca Bruce

Joint procurement, if used by member states to respond to potential pricing and access challenges caused by a US most favored nations pricing policy, would cause more uncertainty for pharmaceutical companies, warn industry representatives.