Two weeks before the midterm election, the Trump administration announced a sweeping plan to subject physician-administered drugs in Medicare Part B to foreign price controls. The ANPR “demonstration project” would subject half of the country to the mandatory pricing scheme but will ripple through the entire Medicare program.

Evofem Biosciences is on the cusp of releasing a revolutionary birth control product. But before the FDA gives its approval, this small biopharma has to navigate two very different clinical trials.

A discussion regarding the challenging decisions Pfenex made in the past year regarding its biosimilar pipeline and the company’s efforts getting its teriparatide follow-on ready for the 505(b)(2) pathway.

The larger BioHealth Capital Region, of which the I-270 biotech corridor is a part, currently ranks as the fifth largest biotech hub in the U.S. with 39,000 people employed by the industry.

Falsified medicines are a critical challenge to the safety of patients and to the reputation of the pharmaceutical industry. Serialization is a major step toward drug safety across the EU but has brought with it a set of challenges that national authorities and companies are tackling.