Another US loss for Xarelto: FDA rejects stent thrombosis indication
This article was originally published in Scrip
Johnson & Johnson subsidiary Janssen and its partner Bayer HealthCare acknowledged on 28 June that the FDA is not ready to give its OK to Xarelto (rivaroxaban) as a treatment to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS), despite the medicine's US approval in six other indications – even being the most prescribed oral anticoagulant in the nation.
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.