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Nature Biotech

NOVEL Health Strategies just published a comprehensive overview of Breakthrough Therapy Designations in Nature Biotechnology.

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Latest Article on Breakthrough Therapy Designations in Nature Biotechnology


As of last month, 41 products have been granted breakthrough therapy designations by the US Food and Drug Administration-drugs against cancer, hepatitis C and monogenetic diseases predominate.

In 2012, the US Food and Drug Administration (FDA) created a new expedited pathway called 'breakthrough therapy designation' (BTD) to facilitate rapid approval of therapies that have shown substantial activity in early trials. As of March 7, the FDA had received 155 BTD applications, of which 41 have been granted BTDs and 3 drugs with 4 BTDs have received marketing authorizations. The new pathway promises faster approval and earlier access to therapies for unmet needs. Despite the popularity of this new process, several areas of uncertainty still exist, especially the data requirements for the designation, the definition of "substantial improvement" and "existing therapies," the scenarios for handling product failures, and the potential impact of the BTD on pricing and reimbursement.

NOTE: As of April 29, 2014, 5 drugs with 6 BTDs have been approved by the FDA. The latest BTDs to be approved are Zykadia for NSCLC and Arzerra for first-line CLL.

The latest and final guidance on BTD was published by the FDA in May 2014. The PDF can be downloaded from here.Breakthrough Therapy Guidance by FDA FINAL

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Breakthrough Therapy Designations (2012-May 2014)

Top Strategy Mishaps of 2011-2012

NOVEL's team analyzed all product launches of 2011 and 2012 and developed a list of top strategy mishaps. This report also presents the lessons learned and implications for future products.

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HEOR, Pricing and Marketing Strategy for Cancer Therapies

Oncology is the highest selling indication for pharmaceutical products. In a recent event NOVEL's team discussed the 10-years trends in oncology drug development.

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Developing GVD for Pricing & Market Access Success

GVD is the single and central strategy resource for pricing and reimbursement of medical products. NOVEL's team recently hosted a webinar on strategies for developing GVDs.

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Economic Models for HTAs, Payers and Providers

Economic models are becoming important tools for demonstrating economic value of new products. In our recent event we presented fundamentals of developing models, interactive design and easy-to-update features.

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