Monthly Archives: October 2012

Europe: Health Commissioner's Sudden Exit Spotlights Regulation Crisis

The sudden departure of EC Health Commissioner John Dalli tops an already difficult year for the European pharma regulators, writes Reflector. The abrupt departure of Health Commissioner John Dalli in highly controversial circumstances comes on top of an extremely difficult year for the European Medicines Agency (EMA). At the same time, one of the main […]
Posted in Strategy | Tagged , , , | Leave a comment

Ethics in Drug Innovation: The First Hurdle is Trust

By Ansis Helmanis Ethics is a matter of trust, which in the regulatory space requires transparency and openness among all stakeholders, including patients and industry.  This was the consensus of FDA Commissioner Margaret Hamburg and European Medicines Agency (EMA) Executive Director Guido Rasi, both of whom shared the podium with Nobel Laureate Professor Elie Wiesel […]
Posted in Europe, Events, FDA, Global, Guest Blog, healthcare, leadership, Market Access, Patient Communication, pricing, Regulatory | Tagged , , , , , , , , | Leave a comment

Locating the Human Ghost in the Digital Machine

Featured panelists at ExL’s annual Digital Pharma East conference this week included practicing physicians, vocal ePatients, social media gurus and digital marketing consultants with plenty of hours logged in big pharma boardrooms.
Posted in E-Media, Events, Marketing, Patient Communication, patient education, People, Sales, social media, Strategy, Technology | Tagged , , , | 1 Comment

Adaptive Trial Design and Combo Drugs Needed in Alzheimer’s

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.
Posted in Agency Insight, FDA, R&D, Regulatory | Tagged , , | Leave a comment

Whistleblower Case Highlights FDA Confidentiality Concerns

By David L. Rosen New stories earlier this year (1) reported that FDA scientists have been suspected of leaking confidential, commercial, and trade secret information to the media.
Posted in FDA, Guest Blog, Legal, Op-Ed, Regulatory | Tagged , , , , | Leave a comment
  • Categories

  • Meta