The RxView Blog

Real world data, analytics, and insights for healthcare decision makers

Advera Health Analytics, Inc.

Analysis of a FDA Safety Signal: DPP-4's and Rhabdomyolysis

By Jim Davis on December 1, 2017

Recently the FDA published the Q2 2017 version of Potential Signals of Serious Risks / New Safety Information as identified by the FDA Adverse Event Reporting System (FAERS).

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Topics: FAERS, Clinical Evidence, Evidex, Drug / Indication Information

ICER Underestimates Adverse Event Rates and Costs for Multiple Sclerosis Medications

By Jim Davis on March 10, 2017

 

On March 6th ICER released their final Evidence Report on Multiple Sclerosis medications. The conclusion was that every MS medication, except for Lemtrada, do not provide enough value to justify their prices. As with every ICER report that is released, the pharmaceutical manufacturers refute the findings and tout their R&D expenses and the very real burden of bringing life saving drugs to markets.

I’m not looking to start a debate on the merits of either ICER’s or the manufacturers’ arguments in this post. Taking my position on the fence, I can say that I believe ICER provides a valuable, independent view into value, but at the same time pharmaceutical companies should expect to be able to be reasonably compensated for their efforts.

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Topics: Drug / Indication Information

Using FAERS Data and Clinical Evidence to Compare HER2+ Antagonists

By Andrea Demakas on February 9, 2017

Recently, Advera Health released a comparative safety report of the HER2+ Antagonists. In this drug review, we analyzed FDA Adverse Event Reporting System (FAERS) and clinical trial data to better understand how the drugs in this class stacked up.

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Topics: FAERS, Clinical Evidence, Drug / Indication Information

Working Toward a Cure: The Foundation for Sarcoidosis Research

By Jim Davis on January 5, 2017

In November 2016, I was honored to be asked to join the Board of Directors of the Foundation for Sarcoidosis Research (FSR). The foundation began in 1999 as a grassroots organization, and now has expanded their efforts and impact to become the leader in supporting sarcoidosis research. I'm looking forward to using my experiences both as a sarcoidosis patient and in drug safety to contribute to the mission. Please visit www.stopsarcoidosis.org for more information. 

I originally wrote the post below for the FSR blog. The original can be seen here

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Topics: Drug Safety, Drug / Indication Information

Chronic Underreporting of Clinical Trials

By Brian Overstreet on July 8, 2016


Well, now we’re getting somewhere!

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Topics: Drug / Indication Information

How to Make Sense of the ADA Conference Data Deluge

By Jim Davis on June 16, 2016

Every June, on the heels of the ASCO annual conference, comes the American Diabetes Association (ADA) annual conference, with a data deluge that is difficult for even the most diligent industry watchers to keep up with. At time of writing, it is only midday on Tuesday and there are already huge headlines from the conference.

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Topics: Clinical Evidence, Evidex, Drug / Indication Information

3 Reasons a Clinical Evidence Database for Multiple Sclerosis is Important

By Jim Davis on May 20, 2016


Oftentimes it’s hard for me to see the forest through the trees. Being responsible for the commercial outcome of what we are working to accomplish at Advera Health with an incredibly talented, albeit small, team can be daunting at best.  At worst it is completely insanely chaotic. Ensuring sales forecasts are accurate for board and investor meetings, directing the marketing strategy for product launches like this week’s announcement of our multiple sclerosis coverage, and working out the details of big partnerships like the one we will soon be announcing with a large, national group purchasing organization (GPO) requires a lot of attention to detail, acutely managed with a long to-do list.

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Topics: Clinical Evidence, Evidex, Drug / Indication Information

The Comparative Safety of Multiple Sclerosis Medications – A 2016 Update

By Andrea Demakas on May 6, 2016

If you subscribe to our monthly RxView Newsletter, then you probably saw the announcement that later in May, annotated data from curated clinical trial results for Multiple Sclerosis (MS) medications will be available in Evidex. Our coverage will include all approved drugs, as well as those in phase II development and above.

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Topics: Drug / Indication Information

Show Me The Evidence!!!

By Brian Overstreet on April 29, 2016


The Associated Press had an interesting article last week titled “Why So Few Patients Get the New Cholesterol Busters.”  In it, the author examines why the launches of the new PCSK9s (Praulent and Repatha) have been so slow and financially lack-luster.

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Topics: Drug / Indication Information

FDA’s Early Warning System is Broken

By Brian Overstreet on April 7, 2016


One of our company-wide New Year’s resolutions in 2016 was to stop using our blog as a forum to lambast FDA.  It was getting boring, tiresome, and repetitive. While we know these blogs are well read within FDA, we also know that nothing we write here is actually going to move the needle on issues of drug safety in Silver Springs, MD. 

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Topics: Drug / Indication Information

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