Category Archives: Agency Insight

FDA: From Risk Aversion to Approval Activism

By Ben Comer | Published: May 7, 2013

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 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

Ad Agency Encourages Pharma Marketers to Reboot

By Ben Comer | Published: April 16, 2013

People tell you who they are, but we ignore it – because we want them to be who we want them to be. – Don Draper At the beginning of the Reboot Camp – held at New York City’s Alexandria Center on April 12 – Intouch Solutions’ CEO Faruk Capan declared the days of Don Draper [...]

Also posted in Advertising, Emerging Markets, FDA, Marketing, Patient Communication, People, Regulatory, Sales, Strategy, Technology, healthcare, leadership, patient education, social media | Tagged Agency, big data, Crossix, digital health, digital marketing, Fitbit, FuelBand, GE Healthcare, Happtique, Intouch Solutions, mHealth, mobile health, Sanofi | 1 Comment

Tom Abrams: Caronia Won't Stop Off-Label Enforcement

By Jill Wechsler | Published: January 30, 2013

The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.

Also posted in Advertising, E-Media, FDA, Legal, Marketing, Regulatory, leadership, social media | Tagged CBI, FDA, First Amendment, misbranding, off-label, OPDP, Tom Abrams, US v. Caronia | 1 Comment

Adaptive Trial Design and Combo Drugs Needed in Alzheimer’s

By Ben Comer | Published: October 17, 2012

FDA’s head of neurology products told industry execs at the Prix Galien Forum that the agency is open to alternative clinical trial designs in Alzheimer’s disease, and would like to see more combination products in clinical testing.

Also posted in FDA, R&D, Regulatory | Tagged Alzheimer's disease, Clinical Trials, Eli Lilly | Leave a comment

Advancing Pharma's Social Media Listening Analytics

By Ben Comer | Published: September 6, 2012

Big Pharma’s tin ear for social, user-generated content online is softening despite regulatory anxiety. In the quest to better understand what patients and doctors need, pharma – thanks in part to a bevy of third-party service providers – is beginning to recognize and incorporate insights from social media into their development and commercialization programs, according [...]

Also posted in Advertising, E-Media, Marketing, Regulatory, Sales, Strategy, Technology, social media | Tagged Agency, Marketing, Professional Marketing, social media | 5 Comments