Sarepta ‘confident’ on 2014 eteplirsen NDA; no FDA handshake on dystrophin surrogate
This article was originally published in Scrip
The confidence expressed by Sarepta Therapeutics' CEO on 24 July the firm would be able to submit a new drug application (NDA) to the US FDA in the first half of 2014 for eteplirsen in Duchenne muscular dystrophy (DMD) had early-morning investors wild with excitement – with shares rising 21% in premarket trading.
You may also be interested in...
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.
Hillary Clinton's plan to rein in high prices of older medicines, which includes creating a federal panel that has authority to impose fines, may grab headlines, but some analysts think it's unlikely to get very far in a divided Washington.