US FDA raises efficacy questions about Abbott's Humira in UC
This article was originally published in Scrip
While the two placebo-controlled trials supporting an expanded indication for Abbott's anti-tumour necrosis factor (TNF) agent Humira (adalimumab) as a treatment for ulcerative colitis (UC) were adequate, several limitations introduced uncertainty into the strength and robustness of the efficacy findings, US FDA drug and statistical reviewers said on 24 August, declaring that additional studies may be needed for the new indication.
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.