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FDA approves first EpiPen generic

FDA approves first EpiPen generic

By Alex Kacik  |  August 16, 2018

Teva Pharmaceutical's product is the first direct generic copy of the EpiPen, the life-saving automatic epinephrine injector that fueled a national debate on rising pharmaceutical prices.

Officials remove special rules for gene therapy experiments

Officials remove special rules for gene therapy experiments

By Associated Press  |  August 16, 2018

A special National Institutes of Health oversight panel will no longer review all gene therapy applications and will instead take on a broader advisory role, as the treatment quickly becomes an established form of medical care with no extraordinary risks.

Rebates don't correlate to drug price spikes, AHIP study says

Rebates don't correlate to drug price spikes, AHIP study says

By Susannah Luthi  |  August 16, 2018

As scrutiny tightens on drug middlemen and the significance of their role in spiking drug costs within Medicare Part D, health insurers are hitting back with data that show the most expensive drugs offer the lowest rebates.

Medicare Part B change could lead to increased hospitalizations

Medicare Part B change could lead to increased hospitalizations

By Virgil Dickson  |  August 09, 2018

The CMS' move to allow Medicare Advantage plans to require patients to try low-cost generic drugs before more expensive therapies on Part B could lead to poor health outcomes, causing an increase in ED use and inpatient admissions, providers say.

FDA gives drugmakers new ways to prove opioid disorder treatments work

FDA gives drugmakers new ways to prove opioid disorder treatments work

By Steven Ross Johnson  |  August 06, 2018

The FDA has noticeably shifted its approach to drug approval, releasing new recommendations that give drug developers a wider array of outcome measures to prove the efficacy of new medication-assisted treatments for opioid use disorder.

Opioid laws hit physicians, patients in unintended ways

Opioid laws hit physicians, patients in unintended ways

By Jay Greene  |  July 30, 2018

New Michigan laws on opioids intended to save lives have physicians complaining about unintended consequences. They say regulations have added unnecessary administrative headaches, led to a climate of fear for doctors and left patients unable to get medications when they really need them.

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