Category Archives: Safety

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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FDA Gets More Funding, IPAB Gets Less

After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014 last week, just before the latest funding extension ran out. In this period of ever-tighter government outlays, the Food and Drug Administration did fairly well in gaining additional funds, along with user fee revenues that had been put on […]
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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, Market Access, Orphan Drugs, People, pricing, R&D, Regulatory, Sales, Strategy, Technology | Tagged , , , , , , , , , , , , , , , , , | Leave a comment

Europe's New Clinical Trials Rules: Questions Remain about Data Transparency

Although a broad compromise was reached in late December on the future shape of the European Union’s clinical trials rules, there are still many details to be resolved – including on that perennial issue of data transparency. In mid-December, Glenis Willmott, the UK socialist who is piloting discussions on the proposal in the European Parliament, […]
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FDA Push for TRF Therapies Will 'Disrupt Pain Market'

FDA’s push for abuse-resistant opioid formulations will disrupt the pain market, say analysts Frost & Sullivan. The opioid market is currently dominated by non-tamper resistant formulations (TRFs), but FDA’s promotion of TRF therapies “could well result in the departure of non-TRF therapies from the market and shake up its structure.” Unless FDA mandates TRF therapies, […]
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