Tag Archives: InterMune

Who Dares to Stop the European Transparency Bandwagon?

Who is Trying to Stop the European Transparency Bandwagon? Reflector, EPE, October 14 2013 The data-transparency bandwagon is rolling rapidly across Europe, energetically propelled by regulators, health campaigners, and generic manufacturers. Much of the research-based industry is stepping out of the way of what looks like an unstoppable juggernaut, hoping at best to nudge it […]
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FDA’s New Breakthrough Designation Process: A Patient Perspective

With the FDA holding its first patient-focused drug development meeting in October of last year, regulators are starting to take notice of the impact disease-based organizations can have in improving drug trial design for new therapies—particularly for rare diseases. According to Teresa Barnes, Vice President of Patient Outreach & Program Support for the Coalition for […]
Posted in FDA, Orphan Drugs, People, R&D, Regulatory, Strategy | Also tagged , , , , , , , , , , , , , , , , | Leave a comment

InterMune Denied Approval for Lung Treatment

Image via Wikipedia Biotech firm InterMune took an ugly hit on Tuesday as news broke that its lung disease drug Esbriet (pirfenidone) will require additional clinical studies, and won’t be getting the seal of approval from FDA any time soon. The news caused InterMune’s stock to drop a staggering 78 percent, according to Reuters. Analysts […]
Posted in FDA, Strategy | Also tagged , , , , , | 1 Comment
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