US FDA to seek panel's advice on 'complicated' matters with Novartis gouty arthritis drug
This article was originally published in Scrip
While Novartis' Phase III trials of Ilaris (canakinumab) demonstrated statistically significant decreases in pain intensity versus triamcinolone and the risk of new flare ups in patients with gouty arthritis, the drug was associated with an increased risk of serious infections and neutropenia, elevations in uric acid and triglycerides and a possible decline in renal function, US FDA drug reviewers said in briefing documents released 17 June ahead of an advisory committee meeting.
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.