PharmExec Blog

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 company with a stage three compound (pimavanserin) targeting Parkinson’s disease-related psychosis.

A month ago, Acadia met with FDA to discuss the proper design of a new phase III trial intended to confirm the results of a previous, 17-month study that met its primary endpoints. A confirmation trial was needed, Acadia presumed, since the first phase III trial of pimavanserin, conducted in 2009 at half the dose of the successful trial, had failed. Acadia had already begun to enroll patients in the confirmation trial – which represented an $18 million commitment – when it met with FDA in April to get the agency’s blessing.

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Posted in Agency Insight, Biotech, FDA, Legal, Market Access, Orphan Drugs, People, R&D, Regulatory, Strategy, leadership | Tagged , , , , , , , | 2 Comments

Catch On to Content Marketing

Pharma should have a head start in the content marketing race, but familiar fears are holding it back, writes Peter Houston.

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Peter Houston

You know this: digital marketing means you have the potential to get your message in front of more people than ever before; search and social media offer reach on an unparalleled scale. According to global internet analytics firm Comscore, there are 13.7 billion searches conducted on Google every month. With 60% of US consumers saying they looked for health information online in the last year, that’s a lot of potential patients. Read More »

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Posted in Europe, Global, Guest Blog, Marketing, Op-Ed | Leave a comment

PhRMA Dismayed by Global IPR Report

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Posted in Global, Guest Blog, IP, Regulatory | Tagged , , , | Leave a comment

Will Congress Provide Sequester "Flexibility" for User Fees?

Just about every federal program and affected interest group is pressing for relief from the 8% across-the-board cuts in funding imposed by the budget sequestration mandate. Recent fast action on Capitol Hill to curb personnel furloughs of air traffic controllers by the Federal Aviation Administration, though, has spurred lobbying for similar treatment across many fronts.

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Posted in FDA, Legal, Regulatory, healthcare | Tagged , , , | Leave a comment

PCORI Launches Clinical Research Network to Support Trials, Outcomes Research

The new National Patient-Centered Clinical Research Network funded by the Patient-Centered Outcomes Research Institute (PCORI) aims to provide patients and clinicians with useful information on treatment options and outcomes. By encouraging more comparative clinical effectiveness research (CER),  the program also has potential to support development of new drugs and devices, explained PCORI executive director Joe Selby, in unveiling the program April 23. This prospect has generated enthusiasm for CER, along with concerns about how patient medical data could be misinterpreted and lead to erroneous conclusions.

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