Author Archives: Julian Upton

Baxter Receives Third FDA Warning for Misleading Promotional Material

FDA issued a warning letter to Baxter International for making “misleading efficacy claims” about its lung drug Araplast NP, which is contraindicated in individuals with selective IgA deficiencies and prescribed to patients who are at increased risk of emphysema. FDA’s letter, dated Aug. 3, takes issue with claims in a brochure aimed at physicians that [...]
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And What Exactly is a Stakeholder?

Pharma’s uncritical use of the word ‘stakeholder’ has increased to the point where it can refer to almost anyone connected to the industry. But this can have serious consequences, warns Reflector. Like it or not (and frankly, I don’t), stakeholders are here to stay in European pharmaceutical affairs. Don’t get me wrong. I’ve no objection to [...]
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Patients Want to Talk. Do You?

Why are companies rushing to the web when traditional engagement with patient groups remains so under-exploited, asks Jacky Law. It used to be so easy. Patients listened to doctors, doctors listened to pharma and everyone was happy. There was even a time when payers listened to pharma, reimbursing their prices with very few questions asked. Now [...]
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Europe: Resisting the Anticompetitive Crusade

It’s been another rocky few weeks for pharma in Europe. Particularly for big brand name companies. But necessity is proving the mother of invention, says Pharm Exec’s Brussels correspondent, Reflector. AstraZeneca suffered a serious setback at the start of July when the European General Court ruled that it had illegally prevented generic competition. The case dates [...]
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The Bizarre European Political Bazaar

Pharm Exec Europe’s Brussels correspondent Reflector is exasperated by some of the European Union’s more unusual institutional arrangements. A senior Spanish diplomat told Reflector recently that, on the face of it, the European Union is a crazy set-up. He was talking about some of its bizarre institutional arrangements — such as a Commission composed of 27 [...]
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