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FDA’s Robyn Bent On The Evolution of Patient-Focused Drug Development

 
• By Brenda Sandburg

The director of the agency’s patient-focused drug development program talks to the Pink Sheet about how the program has improved the development and evaluation of new drugs, initiatives underway, and plans to standardize and harmonize the process.

PFDD decade
Director of US FDA's patient-focused drug development program talks about its accomplishments and future initiatives • Source: Shutterstock

The pharmaceutical industry and patient advocacy groups have been avidly following the progress of the US Food and Drug Administration’s patient-focused drug development program since its launch 10 years ago. The goal of PFDD is to help ensure that patients’ experiences, perspectives, needs and priorities are incorporated throughout the drug development process and regulatory evaluation.

Under a commitment made in the 2012 reauthorization of the Prescription Drug User Fee Act (PDUFA V), the agency began...

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Animal Testing Alternatives: US Pharmacopeia On Its Testing Transition

 
• By Eliza Slawther

In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.

Lawyers Weigh In On ‘Sunshine’ Clause In EU Pharma Reform Package

 
• By Eliza Slawther

The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.

EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 
• By Eliza Slawther

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”

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• By Sarah Karlin-Smith

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
• By Neena Brizmohun

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EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.