Drugs

Accelerate Drug Development by 500 Days: McKinsey

A McKinsey white paper says a “holistic” transformation of the drug development process could result in accelerating the development timeline by 500 days and reducing cost by 25%. “While there is no silver bullet,” the report says, “drug developers can make a concerted effort to apply and integrate multiple innovations that can transform development. In our estimation, it should be possible to bring medicines to the market 500 days faster, which would create a competitive advantage within increasingly crowded asset classes and bring much-needed therapies to patients sooner.”

The report lists five pillars that form the basis of development excellence:

patient- and healthcare-professional-centered design thinking, incorporated end-to-end from program and trial design to trial execution, approval, and launch;
process redesign, both cross-functionally and within R&D groups, that improves speed of development and builds on research insights;
digital and technology enablement that allows automation of highly repetitive processes alongside generation of new insights and data;
advanced analytics (including predictive modeling), informed through internal and external data sources, that improves decision-making quality and speed; and
agile ways of working, with a working model optimized for speed and decision making across the portfolio.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome