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Orphaning Biotech? The Impact of Biosimilars on Biotech Investment

An abbreviated follow-on biologics pathway is inevitable, despite the fact that Congress failed to pass legislation in 2007. Will a FOBs pathway adversely impact money flowing into the biotech industry? Unlikely. The impact of the 1983 Orphan Drug Act may be a good model to consider. (This article first appeared in the RPM Report, January 2008).

By Ramsey Baghdadi

"The follow-on biologics issue holds the potential for undermining the legitimacy of the whole biotechnology industry," says one senior executive at a major pharmaceutical company. "Trying to…create a perpetual exclusivity...

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• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

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• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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