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12:53 PM Mar 25, 2019

Is personalized medicine doomed worldwide if biosimilars fail in the U.S.?

Europe is way ahead of the U.S. in biosimilar approvals and establishing a sustainable competitive marketplace, and it is not clear that the U.S. can even catch up. But over-protecting the U.S....

9:15 PM Mar 22, 2019

Baby steps beyond beta amyloid

Companies are taking steps -- baby steps -- to test new targets in pathways such as neuroinflammation and neuroprotection as a means to treat Alzheimer’s disease.

6:34 PM Mar 22, 2019

A frequentist and a Bayesian walk into a trial

In the stand-off between Bayesians and frequentists, the latter own the show for pivotal trials. But with non-profits leading the drive, Bayesians are poised to enter late-stage development via...

2:21 PM Mar 22, 2019

Manufacturing new modalities

Cell and gene therapies won’t enter the mainstream of medicine until manufacturing processes become far more efficient, according to FDA Commissioner Scott Gottlieb and FDA Center for Biologics...

6:57 PM Mar 21, 2019

Regulating regeneration in Europe

As Europe rethinks its policies on regenerative medicine, the question is whether it can regain its footing in a competitive field it once led, given the in-built inconsistencies across the EU’s...