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Author Archives: Ben Comer
Takeaways from the Post-Approval Summit
Dr. Richard Gliklich, president of Quintiles Outcome and a professor at Harvard Medical School, highlights the most prominent post-approval issues and risks coming out of this year’s Post-Approval Summit, held on May 7th-8th.
Brand managers prodding products across the regulatory finish line to commercialization are finding themselves in yet another race, instead of in [...]
Xofigo Approval Keeps the Ball Rolling For Bayer Oncology
US-based Bayer Healthcare Pharmaceuticals, as its executives were quick to point out, has now received three new approvals for cancer indications in the last eight months.
Posted in Strategy Leave a comment
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 [...]
Posted in Agency Insight, Biotech, 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
FT Healthcare Conference: Society as Stakeholder