Volume IV, Issue 24

June 12, 2017
FDA Approves First Generic Truvada in U.S.
Robert Lowes delivers news (login/complimentary subscription required) from the FDA on June 09, 2017:

The U.S. Food and Drug Administration (FDA) has approved the first generic version of emtricitabine/tenofovir disoproxil ( Truvada, Gilead Sciences) to both treat and prevent HIV infections in this country, the agency announced today.

According to Mr. Lowes:

The list price for Gilead Science's Truvada is roughly $1500 for a month's regimen of one pill per day, or about $18,000 a year, although health insurance and patient-assistance programs knock down the price considerably. Generic versions of Truvada in other countries cost as little as $70 a year, according to Mitchell Warren, executive director of AVAC, an international organization that promotes HIV prevention.
eClinicalWorks Announces New Client
Tom Sullivan reports for Healthcare IT News on June 9, 2017:

The Department of Justice just last week slammed EHR vendor eClinicalWorks with a $155 million settlement for falsely obtaining meaningful use certification but that has not stopped hospitals from picking eClinicalWorks.

Ezras Choilim, a federally qualified health center in Monroe, New York, in fact, announced on Thursday that it picked eClinicalWorks cloud-based EHR and population health services.

According to the author:

While health IT pros might be surprised that eClinicalWorks announced a customer win so soon after the DOJ settlement -- part of which mandates that eClinicalWorks transfer a client's data to a rival EHR vendor for the asking -- it's too early to tell whether customers will start moving away from eClinicalWorks or if everything involved in migrating to a new EHR will mean most customers stick with the vendor.
FDA wants opioid painkiller pulled off market
Jen Christensen, reporting for CNN on Thursday, June 8, 2017:

The US Food and Drug Administration said Thursday that drugmaker Endo Pharmaceuticals must remove its powerful opioid painkiller Opana ER from the market. The agency says this the first time it has asked that an opioid pain medication be pulled due to "the public health consequences of abuse."

"We are facing an opioid epidemic -- a public health crisis -- and we must take all necessary steps to reduce the scope of opioid misuse and abuse," FDA Commissioner Dr. Scott Gottlieb said. "We will continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse."



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