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Citeline Engage

Citeline Engage: Recruit

By Pharma Intelligence 15 Nov 2019

Case Study: A Top 5 CRO partners with Informa Pharma Intelligence to mitigate risk, identify and recruit untapped investigators, and accelerate timelines

HBW Insight

Vitamin D, Omega-3 No Help For Diabetics Against CKD, VITAL Data Show

By Eileen Francis 13 Nov 2019

Article

In latest study casting doubt on the nutrients' effect on chronic illness, researchers find vitamin D and fish oil ineffective in staving off type 2 diabetics' kidney failure. Editorial also published in JAMA says further research is needed to analyze the nutrients’ possible benefits to diabetics with chronic kidney disease.

Topic Clinical trials

Pink Sheet

Amarin's Vascepa: US FDA Panel To Scrutinize Breadth Of CV Risk Reduction

By Sue Sutter 13 Nov 2019

Analysis

REDUCE-IT enrolled a higher risk group than the broad population targeted by Amarin’s proposed indication statement, agency says; although reviewers conclude an interaction between the mineral oil placebo and statins cannot be excluded, any impact would have been small and unlikely to change overall treatment effect.

Topic Drug review FDA

HBW Insight

Novartis Wins Second Landmark German Case, This Time For Probiotics

By David Ridley 13 Nov 2019

Article

Following a landmark win against the German government for the Rx-to-OTC switch of desloratadine last month, Novartis has again secured a victory in the German Higher Court system, this time to continue marketing its Biosan probiotics range in the country.

Topic Company analysis Policy and regulation

Generics Bulletin

Aurobindo Is Company Of The Year At GGB Awards

By David Wallace 13 Nov 2019

Article

Aurobindo has taken home the awards for Company of the Year and Acquisition of the Year at the Global Generics & Biosimilars Awards 2019, held in Frankfurt, Germany. Accord also received two awards, among a host of other recognized companies.

Topic Biosimilars

Generics Bulletin

Lupin Offloads Kyowa For $525m But Not Exiting Japan

By Vibha Ravi 13 Nov 2019

Analysis

Lupin plans to invest in acquisitions and organic growth in the US and India after selling Japanese subsidiary Kyowa Pharma for an enterprise value of around $525m to Japan private equity group Unison Capital. But the Indian firm stresses it is not exiting Japan and will continue to look for marketing partnerships.

Topic Deal trends Strategy

Scrip

Five Trials To Look Out For At The AHA Meeting

By Alex Shimmings 13 Nov 2019

Article

Philadelphia is due to host the American Heart Association (AHA) meeting for the first time from 16-18 November, with the conference taking place in its condensed three-day format for just the second time. Scrip takes a look at the expected highlights.

Topic Clinical trials Company analysis Research

Medtech Insight

Senators Question FDA's Proposed Progressive Approval Pathway For Devices

By Sue Darcey 13 Nov 2019

Article

US Democratic Sens. Elizabeth Warren of Massachusetts and Patty Murray of Washington State recently sent a letter to FDA officials Brett Giroir and Jeff Shuren that raises doubts about a planned bill calling for a progressive approval pathway for medical devices.

Topic FDA Policy and regulation

Medtech Insight

FDA Will Have To Scrape By On Continuing Resolution Funding Through December, Legislative Experts Predict

By Sue Darcey 13 Nov 2019

Article

While a government agency shutdown due to lack of agreement between Congress and the Trump administration over funding for the US Food and Drug Administration and other federal agencies seems less likely this year than last, the FDA will still have carry out its 2020 mission in the short term on 2019 continuing resolution funding – probably through December – legislative experts say.

Topic FDA Policy and regulation

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