Tag Archives: Personalized medicine

Drug-Diagnostic Development Stymied by Payer Concerns

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy and clinical utility of companion diagnostic tests. Even for the handful of drugs approved by the Food and Drug Administration with labeling that links prescribing to specific biomarker measures, health plan operators, […]
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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 […]
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, Safety, Sales, Strategy, Technology | Also tagged , , , , , , , , , , , , , , , , | Leave a comment

October Sees 'Tsunami of Lobbying and Legislation' in Europe

April might be – as T S Eliot suggested – the cruellest month, but for pharmaceuticals in Europe, this October is certainly a contender to win an award as the busiest month. When the penultimate day of the month offered a breakthrough agreement to start discussions between European Union ambassadors and the European Parliament on […]
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Myriad Decision: Praise and Perils for Biotechnology Patent Policy

The Supreme Court decision blocking patents on naturally-occurring genes has generated predictions of doom for biotech innovation, along with expectations of more healthy competition in discovering new treatments and diagnostics. Although some commentators regarded the decision, Association for Molecular Pathology v. Myriad Genetics, as a “major reversal” in longstanding patent policy, many leaders of the […]
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Woodcock Urges Forward March Toward Personalized Medicine

New approaches for conducting clinical trials and developing therapies that actually prevent and cure disease are key to the future of effective drug therapy, according to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER). Personalized medicine has achieved mainstream status, accounting for more new drug approvals and promising pipeline candidates, […]
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