Category Archives: Biotech
FDA: From Risk Aversion to Approval Activism
During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news.
On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based [...]
Also posted in Agency Insight, FDA, Legal, Market Access, Orphan Drugs, People, R&D, Regulatory, Strategy, leadership Tagged access, breakthrough therapies, CDER, Cole Werble, FDA, IMS, Rachel Sherman, Regulatory 2 Comments
AstraZeneca's R&D Trimdown, Points to Shift in The Way Big Pharma Invents
AstraZeneca’s decision to cut 5,050 jobs by 2016 and cease R&D operations at its Alderley Park, UK facility has many wondering where CEO Pascal Soriot plans to take the company. The opening of a new $500 million facility in Cambridge is at once a consolation prize for the UK government’s efforts to placate a skittish [...]
Amid Flu Epidemic a Focus on Vaccine Innovation
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Also posted in Europe, FDA, Manufacturing, R&D, Video Leave a comment

Global Biosimilars Market to Reach $2.4 Billion in 2013