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Janet Woodcock

This page shows the latest Janet Woodcock news and features for those working in and with pharma, biotech and healthcare.

FDA clears first generics of Pfizer/BMS’ anticoagulant Eliquis

These approvals mark the first generic approvals of a direct oral anticoagulant,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER). ... Unlike older anticoagulants like warfarin, “direct oral

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Mega-mergers dominate as buoyant markets lift biopharma

This decline isn’t worrying markets, the industry or regulators unduly, however, with FDA stalwart Janet Woodcock promising that the agency will maintain the reforming programme established by the energetic and
FDA will maintain the pace, vows Woodcock, but warns of skills gap

Janet Woodcock. Responding to these trends on Tuesday was one of the agency’s longest serving and most senior officials, Janet Woodcock, director of the FDA’s Center for Drug Evaluation ... A detailed note from SVB seen by FiercePharma reported that
GSK’s Advair Diskus faces first generic in US

In a statement, the director of the FDA’s Center for Drug Evaluation and Research (CDER) – Janet Woodcock (pictured below) – said the approval “is part of our longstanding commitment to advance
FDA reviewer unimpressed with PTC’s Translarna

that the firm was emboldened by the FDA’s approval last year of another DMD therapy from Sarepta - Exondys 51 (eteplirsen) - after Janet Woodcock, head of the agency’s Center for
Endo faces industry-first FDA call to pull its opioid painkiller

The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

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Integrating patient reported outcomes into clinical trials

That idea is now mainstream. “It turns out that what is really bothering the patient and what is really bothering the doctor can be radically different things,” Janet Woodcock, director of ... Woodcock’s views and the research that shaped them have

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