Author Archives: Ben Comer

After Delays, Project DataSphere Rolls Out

An industry and academic data-sharing project went live on Tuesday, nearly a year after the platform was expected to launch. Visitors to the site – no credentials needed – can register and access de-identified clinical data from the comparator arms of nine oncology trials, with more to come. Project DataSphere, the newest data transparency and […]
Posted in Biotech, Corporate Responsibility, Europe, FDA, Global, IP, leadership, Legal, R&D, Strategy, Technology | Tagged , , , , , , , , , | Leave a comment

Allergy Shots in a Pill?

Allergy season’s dank fecundity might be welcomed in many parts of America this year. Anything that’s warmer. But the worst allergy sufferers might soon be headed back to the doctor’s office for another round of allergy shots. Or perhaps not. ALK-Abelló, a Denmark-based specialty pharmaceuticals company focused solely on allergy immunotherapy products, expects FDA to […]
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New Fees Made FDA Worse for Generic Drug Approvals, Says GPhA Chairman

‘Actions’ don’t speak louder than words in dealing with FDA’s backlog of generic drug applications, says newly-elected GPhA Board Chairman Craig Wheeler. When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary intent was to provide FDA with the additional resources necessary to expedite the review process […]
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Love Potion #9: The Hypoactive Sexual Desire Disorder Pipeline

New products in development for women distressed by a lack of sexual desire and satisfying sexual experiences are causing a stir, but not for the reasons one might expect. Do women have less of a right than men to combat sexual disorders with pills? That’s the question eight national and international women’s advocacy groups asked […]
Posted in FDA, healthcare, leadership, Market Access, Patient Communication, R&D, Regulatory, Safety, Strategy | Tagged , , , , , , , , , | 1 Comment

Compliance Congress: Walking the Line

Pharma industry executives, FDA officials and Department of Justice attorneys speaking last week at CBI’s 11th annual Pharmaceutical Compliance Congress (PCC) offered solutions and threats to companies hoping to avoid enforcement actions.
Posted in Advertising, compliance, Emerging Markets, FDA, Global, Legal, Manufacturing, Marketing, People, Regulatory, Sales, Strategy, Technology | Tagged , , , , , , , , , , , , , | Leave a comment
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