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Questions Raised About Invokana Label Expansion For Cv Risk Reduction - Latest News


With FDA panel backing, Novo Nordisk prepares for semaglutide's potential launch

Novo Nordisk ... raises questions about the validity of the numbers. Given that the Sustain-6 outcomes trial was relatively brief, with fewer patients than a trial designed to prove CV benefits, Novo ... read more

Amarin Slides as Bulls Battle Bears After Fish-Oil Results

Full results for Amarin Corp.’s Vascepa fish-oil pill for high-risk cardiovascular patients ... patients with high risk prior to label expansion in 2019 or early 2020. “Sub-analyses partially ... read more

Amarin's Mineral Menace

The FDA briefing documents raised questions about the mineral ... the FDA said Amarin had to show a reduction in major cardiovascular events in the REDUCE-IT study prior to gaining the label expansion ... read more

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EMDAC Wants Cardiovascular Outcomes for Vascepa

When it came to the main point of discussion, and the potential efficacy of Vascepa at reducing cardiovascular risk, there were many questions raised. Committee member ... vote in the 10/16 Panel on ... read more


Pacira Pharmaceuticals, Inc. Reports Second Quarter 2017 Financial Results

EXPAREL achieved statistical significance for its co-primary endpoints of opioid reduction and postsurgical pain ... believes data from these two studies will satisfy the questions previously raised ... read more

The Rise And Fall Of Natrecor For Congestive Heart Failure: Implications For Drug Policy

Recent revelations of unexpected side effects of widely prescribed medications have raised questions about several aspects ... If “indication expansion” were considered akin to off-label promotion, ... read more

Predictive policing: mapping the future of policing?

New predictive policing technologies seem to promise crime reduction. But predictive policing also threatens ... pre-emptive interventions and the evasion of alternative approaches to crime, risk ... read more

Lannett (LCI) Q2 2019 Earnings Conference Call Transcript

Please note that we have included additional information regarding the company's recent and planned product launches, cost reduction plans and other financial ... We will then open the call for ... read more

Parsabiv NDA Fails; Implications For Amgen

Multiple questions are raised by the current P.I. for Aranesp and Epogen ... What is clear is that the label expansion that CV events are diminished with Repatha use looks to be a 2018 event, even if ... read more

‘Bench To Behavior’: Translating Comparative Effectiveness Research Into Improved Clinical Practice

Vaccination against polio, the concept that mild-to-moderate hypertension requires treatment, the use of statins to prevent cardiovascular ... with the drug has raised worrisome questions about its ... read more

Lannett (LCI) Q2 2019 Earnings Conference Call Transcript

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