Category Archives: Market Access

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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Bringing New Rx Drugs to Market in 2014

by Tom Norton I did something today that I haven’t done in years: I checked out the US pharmaceutical R&D spend versus the rest of the world. Having known since the 80’s that the US owned this space, a quick look at the latest R&D figures confirmed my decades old understanding of the industry’s worldwide […]
Also posted in Biotech, Corporate Responsibility, Emerging Markets, Europe, FDA, Global, Guest Blog, pricing, Strategy | Tagged , , , , , , | 3 Comments

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 […]
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Pharma Seizes Latin American Opportunities

Approximately $12.7 billion has been invested in Latin America’s (LATAM’s) pharmaceutical market through mergers and acquisitions (M&As) in recent years. And with untapped potential identified in countries across the region, companies are expected to seize upon further opportunities to drive future growth, says a new report from GlobalData.
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J.P. Morgan: Pharma's Agenda for 2014

Presenters at the 32nd annual J.P. Morgan Healthcare Conference talked up value-based pricing, emerging market strategies, complex generics and new technology, from bedside devices and genetic sequencers to first-in-class mechanisms of action. Company executives honed in on their chosen therapeutic areas and made the case for aggressive spending in R&D to bring the next generation […]
Also posted in Biotech, Corporate Responsibility, Deals, Emerging Markets, Europe, Events, FDA, Gene therapy, Global, IP, leadership, Legal, Manufacturing, Orphan Drugs, People, pricing, R&D, Regulatory, Safety, Sales, Strategy, Technology | Tagged , , , , , , , , , , , , , , , , , | Leave a comment
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