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The University of Michigan and University of South Florida are suing Novartis for patent infringement, claiming that the pharma giant used a complex method of crystal engineering developed by their researchers to design the heart failure drug Entresto, a combination of sacubitril and valsartan. Read More
A new study of cancer drugs awarded FDA accelerated approval debunks the theory that drugmakers benefit financially from postmarket confirmatory trials that support the approval. Read More
Westwood Laboratories’ Azusa, Calif., contract manufacturing facility lacks adequate sterility procedures, according to a Form 483 issued following a March 24 to April 5 inspection. Read More
A narrowly missed primary endpoint didn’t prevent Bayer from touting a phase 3 win for Kerendia (finerenone) as a cardioprotective agent for people with late-stage chronic kidney disease and type 2 diabetes. Read More
FDA’s draft guidance on mitigating drug shortages is inconsistent with the law, would place an unnecessary weight on drug manufacturers and could make drug shortages worse, according to industry stakeholders’ comments. Read More
AstraZeneca’s SGLT-2 inhibitor Farxiga (dapagliflozin) cut the risk of cardiovascular death and worsening heart failure by 16.4 percent relative to placebo, researchers announced at the European Society of Cardiology Congress in Barcelona. Read More
Silbersher can still argue that he is the original source of the public information and that his case against AbbVie should be allowed to proceed. Read More