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Welcome to your Pharma Intelligence advantage

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Our trusted Pharma Intelligence brands

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

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HBW Insight

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

By Eileen Francis 13 Nov 2019

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

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Pink Sheet

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

By Sue Sutter 13 Nov 2019

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

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HBW Insight

Novartis Wins Second Landmark German Case, This Time For Probiotics

By David Ridley 13 Nov 2019

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

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Generics Bulletin

Aurobindo Is Company Of The Year At GGB Awards

By David Wallace 13 Nov 2019

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

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Generics Bulletin

Lupin Offloads Kyowa For $525m But Not Exiting Japan

By Vibha Ravi 13 Nov 2019

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

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Scrip

Five Trials To Look Out For At The AHA Meeting

By Alex Shimmings 13 Nov 2019

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

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Medtech Insight

Senators Question FDA's Proposed Progressive Approval Pathway For Devices

By Sue Darcey 13 Nov 2019

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

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Medtech Insight

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

By Sue Darcey 13 Nov 2019

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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Scrip

Embracing China 2.0: AZ, Merck KGaA Set Up Funds, J&J Steps Up Digital Push

By Brian Yang 13 Nov 2019

AstraZeneca has pledged $1bn to a healthcare fund to support local innovation in China, joining big pharma peers J&J and Merck KGaA in fresh moves to embrace this market, where a new wave of digital technology transformation and fast-shifting trends now favor novel new therapies and the rise of local health start-ups.

Topic Digital Health

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In Vivo

How Proximity Creates Partnerships

By William Looney 08 Nov 2019

Former Amgen R&D lead Sean Harper talks exclusively to In Vivo about his new role as a venture capitalist, joining veteran industry investor Beth Seidenberg as co-founder of Los Angeles-based Westlake Village BioPartners.

Topic Business strategies Deal trends

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HBW Insight

Homeopathic Market Doesn't 'Disappear' - FDA Forced To Act

By Malcolm Spicer 08 Nov 2019

"This was an area that the agency thought was just going to disappear on its own," says Freddie Ann Hoffman, who chaired FDA homeopathic working group that helped develop CPG adopted in 1988 to allow sales of homeopathics to continue without pre-market approval.

Topic FDA Policy and regulation

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HBW Insight

Zantac Recall And EU Regulatory Issues Hurt Sanofi In Q3

By Tom Gallen 08 Nov 2019

Recalling Zantac in North America over contamination concerns and tightening regulatory requirements in Europe combined to impede growth at Sanofi Consumer Healthcare in Q3. New CEO Paul Hudson says he is still taking time to get to know the business before making any strategic moves.

Topic Policy and regulation

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Medtech Insight

Laboratory For Advanced Medicine Appoints New CEO, Prepares To Scale Liquid Biopsy Pipeline

By Catherine Longworth 08 Nov 2019

With a new CEO at its helm, Laboratory for Advanced Medicine is preparing to take on the cancer-diagnostics market. Former AncestryDNA executive Kenneth Chahine has joined the company as it plans to drive global commercialization of its artificial intelligence liquid biopsy pipeline.

Topic Cancer Company analysis

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Pink Sheet

HIV PrEP Patent Dispute Escalates As HHS Files Suit Against Gilead

By Mandy Jackson 08 Nov 2019

Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.

Topic Infectious diseases

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Latest headlines

Medtech Insight

15 Nov 2019

QUOTED. 15 November 2019. Krishna Rocha-Singh.

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Scrip

15 Nov 2019

Women In High Places: Slow Progress In Pharma

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Scrip

15 Nov 2019

Levorphanol Write-Down Dents Zydus in Q2 But Saroglitazar Expectations Build

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Medtech Insight

14 Nov 2019

QUOTED. 14 November 2019. William Osborn.

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Pink Sheet

14 Nov 2019

How To Make Cross-Country Collaborations On Pricing Work

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Scrip

14 Nov 2019

No Alarm At Almirall Despite Stake Sale

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Pink Sheet

14 Nov 2019

Oncology Pilot To Highlight Disagreements Between US FDA And Sponsor For Advisory Committees

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Pink Sheet

14 Nov 2019

Cadila Retreats From US Injectables Market After Tough FDA Inspection

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Pink Sheet

14 Nov 2019

Acting Commissioner Giroir Emphasizes 'Transitional' Period, Suggesting Time At US FDA Will Be Short

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Pink Sheet

14 Nov 2019

GSK Seeks To Halt Boehringer Promos That 'Denigrate' Effectiveness Of Ellipta, Diskus Inhalers

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Pink Sheet

14 Nov 2019

Amarin’s Vascepa Positioned For Broad CV Risk Reduction Claim Following US FDA Panel Nod

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Scrip

14 Nov 2019

AZ, Omron Take China ‘Patient Journey’ Alliance Global

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Scrip

14 Nov 2019

Executives On The Move: Santhera Pharmaceuticals Announces Its Next CEO And Checkmate And Imago Bring Aboard Business Leaders

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In Vivo

14 Nov 2019

Market Access 2020: Understanding US Payer Expectations

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Scrip

14 Nov 2019

Sanofi Pasteur Head Loew On The Vaccine Unit's Future Growth Drivers

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Prostate Cancer Awareness Month brings attention to the men living with this disease

Pink Sheet: Q3 Hot Picks Article Pack

November 2019 is Lung Cancer Awareness Month

Post-ESMO Podcast 2019

Insight into NASH Pricing Strategies

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