“Despite predictions that our actions would increase rates and destabilize markets, the opposite has happened,” says CMS Administrator Seema Verma.

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.