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5:17 PM May 17, 2019

Cutting through the noise: the handful of pricing proposals the Trump administration or Congress may enact

Scores of proposals for reducing the cost of drugs are swirling around Congress, the White House and the U.S. Department of Health and Human Services, but only a few merit attention outside the...

12:24 PM May 17, 2019

Pushing China to the forefront: When a first-in-China regulatory strategy makes sense

As reforms in China shorten clinical and regulatory timelines for biotechs across the board, the country has a growing chance to become the first stop for regulatory approvals of first-in-class drugs.

6:26 AM May 17, 2019

Takeda shaves years off PRO development, brings patient voice to fatigue measures in cancer

Takeda has sidestepped the FDA qualification process for patient-reported outcomes by building on validated tools to develop a PRO for fatigue in hematologic malignancies. The approach enabled the...

5:48 PM May 16, 2019

Leaning on exosomes, model-informed drug development gets closer to tailoring doses to each patient

Model-informed drug development is poised to move into personalized dosing, with a little help from exosomes. An August FDA workshop aims to shed light on when and how to use these precision...

5:00 PM May 16, 2019

Abeona tackles gene therapy’s problems in cystic fibrosis with chimeric AAVs

As it builds up its preclinical pipeline, Abeona is switching gears to create chimeric AAV vectors that it hopes will do a better job than naturally occurring ones of dialing in the right...