Category Archives: Biotech

Challenges to the Specialty Business Model

By Emily O’Connor, Jillian Scaife, and Ryan P. Million Biopharmaceutical drug discovery companies have progressively tailored their pipelines to specialty therapeutic areas and smaller patient populations. However, the specialty business model has lately shown signs of strain and outright constraints in continued scalability. Agents such as Gleevec, Zaltrap, and Sovaldi have been under fire from […]
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Increase of Biosimilars Will Have “Negative Impact”

A new report from GlobalData states that the increase of biosimilars will have a negative impact on the biologics market after 2019. The report cites patent expirations of branded biologics and regulatory clarification as reasons for the prediction that biosimilars will capture the market share after 2019.
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What Does ‘Off Label’ Mean in 2014?

by Tom Norton Years ago, while sitting in an Rx company lunch room, I was listening to one of the company’s top sales reps discuss the commercial progress a recently launched prescription was making. The rep said that the product was selling “OK” under its FDA approved, indicated therapeutic area. However, he quietly said, “It’s […]
Also posted in FDA, Guest Blog, healthcare, Legal, Market Access, Marketing, pricing, Regulatory, Strategy | Tagged , , | 1 Comment

Q&A: Nathan Tinker, New York Biotechnology Association

While at the 2014 New York BIO Conference (NYBIO), Applied Clinical Trials‘ Moe Alsumidaie spoke to Nathan Tinker, Executive Director at the New York Biotechnology Association, about challenges in early phase development. The New York Biotechnology Association is dedicated to the development and growth of New York State-based bioscience related industries and institutions. Moe Alsumidaie: How […]
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Rise in IPOs Eases Pharma's Investment Woes

Private equity and venture capital (PEVC) deal activity decreased from 1063 in 2010 to 480 in 2013, according to a new Frost & Sullivan report. And the pharma, biotech and healthcare equipment sectors experienced a much sharper decline in investor interest than the healthcare technology and provider segments, the report adds. But there is a […]
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