PARADIGM-HF study shows 20% reduced risk of CV death and heart failure hospitalization compared to ACE inhibitor enalapril.
Labeling for Novartis AG's heart failure drug Entresto (sacubitril/valsartan) reflects strong efficacy and an emphasis on dose titration to reduce the risk of angioedema and hypotension.
Approval was based on the 8,442-patient PARADIGM-HF study, which compared the combination product to the ACE inhibitor enalapril in chronic...
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Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
Pfizer is in active discussions with Trump on MFN pricing and collaborating with peers on direct sales as an approach to lower drug prices, CEO Albert Bourla said.
The billionaire investor said during a recent conference that brand drug manufacturers want to work with his Cost Plus Drug Co., but are afraid the PBMs will retaliate.
The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.
