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You are here: Home / Archives for BioPharma / Med Device Co.

PIE Legislation Officially Introduced in Congress

The Pharmaceutical Information Exchange (PIE) Act of 2017 has recently been introduced by Rep. Brett Guthrie (R-KY). This bill aims to improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between […]

more info 04/17/2017View Related Articles
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Value-Based Contracting for Biopharmaceuticals Moves Forward

The Network for Excellence in Health Innovation (NEHI)'s recent White Paper outlines the opportunities for, and obstacles to, value-based contracting, and provides recommendations for moving forward. Read more and find out how to download here. (Source: NEHI, 3/23/17) […]

more info 03/29/2017View Related Articles
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Asthma Biomarker Predicts High Risk – Helps Manage Costs

eMAX Health Systems, LLC recently released the results of new research looking at the health care costs of asthma patients. Patients with elevated peripheral blood eosinophil counts, a key biomarker for severe asthma, show almost 200% higher health care cost than those without ($28,000/yr vs […]

more info 02/07/2017View Related Articles
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AMCP Praises FDA Draft Guidance on Communications

The Academy of Managed Care Pharmacy (AMCP) recently released its comments on the Food and Drug Administration (FDA)'s recently released new draft guidance  in clarifying how biopharmaceutical companies and population health decision makers can share clinical and economic information. Read more […]

more info 01/23/2017View Related Articles
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5 Major 21st Century Cures Provisions for Biopharma

Now that the 21st Century Cures Bill has been signed into law, there is a lot of work to do! Where do we start? How will the new administration affect the implementation plan? This article outlines five major provisions that biopharma, combination product, and advanced therapy companies will need to […]

more info 12/22/2016View Related Articles
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Take a Virtual Look Inside Biotech Manufacturing

Ever wonder what the inside of a biologic medicines manufacturing facility looks like? Take this virtual tour for a rare look at the highly unique manufacturing facility at Amgen. Step by step, the video takes you through the whole process of product development, all the way to packaging and […]

more info 12/20/2016View Related Articles
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What “Beyond-the Pill” Services Do Biologic Companies Need to Deliver?

This expert FirstWord report, Benchmarking Biologic Innovator Value-Added-Services, establishes which Value-added services (VAS) are appropriate, identifies the challenges specific to biologics, designs winning programs and gains competitive advantages. Available for purchase here. (Source: […]

more info 11/27/2016View Related Articles
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Benchmarking Biologic Innovator Value-Added-Services

What are the “beyond-the-pill” services that biologic companies need to deliver to ensure improved patient compliance and outcomes? Patient, payer and clinical expectations of biologic drugs are high and developers must go the extra mile to support all stakeholders and see patient outcomes improve. […]

more info 11/16/2016View Related Articles
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Why are the New PCSK9 Inhibitors Failing?

Sales of drugs that use a novel mechanism to reduce cholesterol levels have remained flat amid prescriber and payer skepticism, despite high spending on promotional campaigns by the drugs' makers. Read more here. (Source: Damian Garde, STAT, 10/28/16) […]

more info 10/31/2016View Related Articles
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Biomarkers – Full of Opportunities and Challenges

During the Academy of Managed Care Pharmacy (AMCP) Nexus 2016, Diana Brixner co-presented a session titled, "Biomarkers and Treatment Decision-Making: Focus on Rheumatoid Arthritis." Learn more here. (Source: Aubrey Westgate, Managed Healthcare Executive, 10/5/16) […]

more info 10/17/2016View Related Articles
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Is EpiPen Pricing Threatening to Impede Innovation?

Mylan's EpiPen has been the most recent of a series of pharmaceutical pricing increases to invoke a strong public reaction. How will all of the push against rising pharmaceutical prices affect R&D-focused companies' ability to provide innovative, life-changing new therapies to patients? Read […]

more info 09/18/2016View Related Articles
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NICE Explores Charging Technology Appraisal Fees

The National Institute for Health and Care Excellence (NICE) has recently proposed an idea of charging the pharmaceutical industry and medical device industry for Technology Appraisals (TAs). Find out more here. (Source: leela Barham, PharmExec.com, 9/7/16) […]

more info 09/12/2016View Related Articles
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3 Key Concepts of the New PhRMA and BIO Principles

Patients, caregivers, health care professionals and insurers are demanding more information about safety, effectiveness and value of treatments, however, the regulatory framework governing this information needs to be modernized to reflect the rapidly evolving science and increased pace of the […]

more info 07/29/2016View Related Articles
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AMCP Recommendations for HCEI Sharing

The Academy of Managed Care Pharmacy (AMCP) recently released recommendations allowing biopharmaceutical companies to share health care economic information (HCEI) more easily. Learn more here. (Source: PR Newswire, 6/24/16) […]

more info 06/27/2016View Related Articles
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Which Therapeutic Areas are Targets for Outcomes-Based Contracts?

A recently released Avalere analysis shows the majority of health plans are interested in forming outcomes-based contracts with biopharmaceutical manufacturers, tying product reimbursement to patient outcomes. Which drugs will be targeted first? See more here. (Source: Rujul Desai, Avalere, 6/16/16) […]

more info 06/21/2016View Related Articles
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How are Fitbits and Tweets Helping Drugmakers?

Pharmaceutical and biotechnology companies are increasingly interested in how patient-reported information can be used to get their products to market faster and assess how they perform in the real world. Login to read more. (Source: Beth Kutscher, Modern Healthcare, 6/8/16) […]

more info 06/14/2016View Related Articles
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New Report: The Competitive Biopharmaceutical Market Controls Costs

A new report from IMS Institute for Healthcare Informatics claims the competitive biopharmaceutical market is working when it comes to controlling costs. Read more here. (Source: Holly Campbell, PhRMA, 4/14/16) […]

more info 04/19/2016View Related Articles
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FDA Working with Payers at Device Pre-submission Meetings

The US Food and Drug Administration (FDA) is calling on payers to participate in medical device pre-submission meetings. Find out why here. (Source: Michael Mezher, RAPS, 2/23/16) […]

more info 03/03/2016View Related Articles
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2015 Year in Review for New Medicine Approvals

Last year was an exceptional year for FDA drug approvals with a record 45 new medicines. Read more here. (Source: Holly Campbell, PhRMA, 1/11/16) […]

more info 01/13/2016View Related Articles
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Purchasing Medical Innovation: The Implications for the Medical Device Industry

This post, on tHEORetically Speaking, recaps the main points of Chapter 7 in James Robinson's book, 'Purchasing Medical Innovation: The Right Technology, for the Right Patient, at the Right Price', which reviews the implications for the medical device industry. Read here. (Source: Cara Scheibling, […]

more info 01/06/2016View Related Articles
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What Marketing, Scientists, and the C-Suite Need to Know About HEOR

Audioconference with slides presented live by Dr. Patti Peeples, CEO of HealthEconomics.Com will air live on November 19, 2015. This presentation is designed to provide marketers, clinical scientists, C-suite executives and others with a solid understanding of how value is demonstrated in […]

more info 11/16/2015View Related Articles
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Don’t Miss Xcenda at ISPOR This Week

Join Xcenda's Global HEOR consultants in Milan, Italy as they demonstrate their global perspective, as well as findings from the latest evidence-based research at ISPOR's 18th Annual European Congress from November 7-11, 2015. Stop by and see the Xcenda team at booths #610, 611, 706, 707. View a […]

more info 11/09/2015View Related Articles
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Check Out the New Issue of the Evidence Forum

The recent issue of the Evidence Forum includes a special interview: Establishing Health Technology Assessment in Russia: An Interview with Vitaly Omelyanovskiy. You can access this issue here, as well as archived issues. (Source: Evidera, October 2015) […]

more info 11/06/2015View Related Articles
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Drug Pricing Fears Cause Biotech Stocks to Plummet

Despite attempts to calm investors' nerves, the biotech industry has seen continued aggressive selling of stocks among non-stop headlines and political debate. Fears that the next president or Congress will push through legislation to rein in drug prices remains key to the sell off. Read more here. […]

more info 10/15/2015View Related Articles
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How Much Would You Pay for a Cure? How about a Not Quite Cure?

Sam Isaly, manager of the Worldwide Healthcare Trust, responds to political pressure to manage the cost of pharmaceuticals in the United States. What does this all mean for products such as biosimilars and Gene therapy? Will all the political talk bring about any real change?Read more here. (Source: […]

more info 10/15/2015View Related Articles
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Pharma Disappointed with Trade Deal’s Limited Protections

The Pharmaceutical industry is left disappointed after trade officials recently agreed to shrink the length of time that pharmaceutical companies can receive monopoly rights for certain drugs. Read more here. (Source: Sarah Ferris, The Hill, 10/5/15) […]

more info 10/06/2015View Related Articles
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What Does Broader Access to CMS Data Mean for Patients?

The Centers for Medicare and Medicaid Services (CMS) recently made an announcement allowing innovators and entrepreneurs to analyze and utilize datasets maintained by the federal agency. Find out more here. (Source: NPC, 9/10/15) […]

more info 10/01/2015View Related Articles
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How Far Has Martin Shkreli Crossed the Line?

Martin Shkreli, CEO Turing Pharmaceuticals, is taking some heat for his 4,000% price increase on a 50 year old life saving drug. Even the Pharmaceutical Research and Manufacturers of America group (PhRMA) has turned its back on him. Read more here. (Source: Ariana Eunjung Cha, The Washington Post, […]

more info 09/28/2015View Related Articles
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Are Actual Drug Costs Really Skyrocketing?

The actual cost of a drug can be very different than the list price after rebates and discounts, so when everyone is talking about skyrocketing drug cost are they talking about the list price or the actual price paid? See what SSR Health has to say about second quarter spending here. (Source: Holly […]

more info 09/17/2015View Related Articles
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Asia Sees Growth in Medical Writing Due to Outsourcing

Overall growth in outsourcing in clinical research organizations (CROs) has led to the development of medical writing hubs in China, Japan and India. Take a closer look at this emerging profession in each of these locations, here. (Source: Dr Julia Cooper, PAREXEL) […]

more info 08/27/2015View Related Articles
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