Dec. 11 Quick Takes: FDA reveals clearer path for Entresto NDA; plus cancer group files MFN suit, Sinovac, and Merck approvals in China, aducanumab, Atox, and ImmunoGen 

Documents suggest FDA panel could smile on Entresto label expansion
In briefing documents released ahead of FDA’s advisory committee meeting to review an NDA for Entresto sacubitril/valsartan from Novartis AG (NYSE:NVS; SIX:NOVN), the agency said overall benefit-risk considerations may support the drug's approval to treat an expanded heart failure indication, despite its miss on the primary endpoint of the Phase III PARAGON-HF trial. The agency signaled a willingness to consider both prespecified and post hoc analyses showing that Entresto led to reduced heart failure events compared with valsartan alone in patients with left ventricular ejection fraction (LVEF)  ≥45%.

More pushback for Trump drug pricing scheme
The Community Oncology Alliance, an association that advocates for community cancer centers, Friday asked a federal court to immediately halt the Trump administration’s most favored nation Medicare drug pricing rule. The suit, filed in the U.S. District Court for the District of Columbia, is similar to separate suits filed by BIO and PhRMA which assert that the rule, which caps Medicare Part B drug prices at the lowest price paid by any developed country, was finalized in violation of laws that require public notice-and-comment periods...