Mike Hennessy Jr.

That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.

The restraint to not target solely the major disease groups has provided good proportion and balance for our industry.

Cell and gene therapies is unequivocally viewed as the biggest opportunity in the bio/pharma space.

Science news can be just so weird, or weirdly useful, that everything else recedes as we ponder whether it is true and what consequences it might bring.

Next year's "FDA Voices" series will cover core topics FDA staff are prioritizing.

The 1VQ papers advocate for the idea that certain post-approval changes should be streamlined and expedited.

While the cost of certain medicines are alarmingly high, they can be considered a bargain measured against a lifetime of traditional costs.

How can we fix the quality manufacturing issues that come with product shortages?

Systemic inefficiencies in the pharmaceutical industry undermine problem-solving efforts.

AI could provide solutions to critical manufacturing inefficiencies.