FDA approval and regulation of medical devices: a primer

This article gives an overview of medical device classification in the U.S. and of the regulations governing the FDA’s review of application to market medical devices.

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Advancing evidence-based indication prioritization to navigate disease segmentation landscape

Innovation in genomic technologies over the past two decades has ushered in an explosion of new drug targets for drug discovery.

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Latin American market presents attractive opportunities in innovation and generics, but adaptability is key

The combined populations of the three most populous countries in Latin America – Brazil, Mexico, and Colombia – account for more than 350 million people. Pharmaceutical companies have long sought access to the growing market in Latin America and many have faced difficulties in doing so.

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Taiwan Biopharma: Is Industry Underexplored or Just Underachieving?

While debate continues around how much BioPharma innovation is actually taking place in Asia, Taiwan is pitching itself as an under-explored location where innovation is available for those who take the time and effort to uncover it.

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DCAT Week '16: Pharmaceutical Outsourcing - The Markets and Supply Strategies for Fine Chemicals, APIs, and Drug Products

The balance between internal manufacturing and development and external sourcing for APIs, fine chemicals, and drug products is a difficult task to manage. This is further complicated by the increasing M&A activity and complexities within the supply chain forcing each company to strongly evaluate their partners and what they choose to produce in house or source through 3rd party vendors.

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