Bimagrumab 3rd Novartis drug to win FDA 'breakthrough' designation
This article was originally published in Scrip
Novartis has won its third breakthrough therapy designation from the US FDA, which granted the status to the Swiss drug maker's investigational muscle-wasting disease drug bimagrumab (BYM338), a fully human monoclonal antibody.
You may also be interested in...
Bimagrumab failed in a pivotal late stage clinical trial last year for an orphan muscle wasting disorder. Novartis now wants to assess its potential in obesity, an area not exactly renowned for its pharmaceutical successes.
With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.
Allergan CEO Brent Saunders vows not to engage in price gouging and says his firm will limit cost increases to single-digit percentages, occurring only once per year. But it's unclear whether Saunders will stand as a lone wolf in the industry or if others will make similar pledges.