FDA EMDAC backs Janssen's SGLT2 canagliflozin; but CV concerns linger
This article was originally published in Scrip
The US FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) on 10 January backed approval of Janssen's experimental selective sodium glucose co-transporter 2 (SGLT2) inhibitor canagliflozin as a treatment to improve glycemic control in patients with Type II diabetes, despite some concerns about the drug's cardiovascular (CV) and renal safety.
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.