Morning Briefing
Summaries of health policy coverage from major news organizations
Pharma Companies Race To Develop Rapid-Acting Anti-Depressant
Stat: Companies Developing Fast-Acting Antidepressants Grapple With Trial Design
As companies race to develop fast-acting antidepressants, they are grappling with how to design clinical trials for a type of drug that doesn’t yet exist. There’s no shortage of interest in the idea: Janssen (JNJ) is testing an esketamine nasal spray, which, when combined with an oral antidepressant, has shown promise in quickly curbing symptoms of serious depression. Allergan (AGN) is developing its own experimental rapid-acting antidepressant, rapastinel, for patients with major depression and those at high risk of suicide. Both act on the brain’s NMDA receptor, which is involved in learning and memory. (Thielking, 7/3)
In other pharmaceutical news —
Stat: AbbVie And Its Partner Ordered To Pay $448 Million Over Pay-To-Delay Case
In a big win for the Federal Trade Commission, a federal judge ordered AbbVie (ABBV) and another company to pay $448 million to consumers for violating antitrust laws and striking deals that delayed lower-cost generic versions of their AndroGel testosterone treatment from reaching the market. The Friday decision comes in response to a lawsuit the FTC filed nearly four years ago in which AbbVie was accused of filing “sham” patent litigation against potential generic rivals, and then entered into an allegedly illegal patent settlement in order to thwart competition. (Silverman, 7/2)
Stat: FDA Reprimands Mylan For Shoddy Quality Control At A Key Plant
Several weeks ago, Mylan (MYL) unexpectedly disclosed plans to lay off more than 400 employees at a West Virginia manufacturing plant because the facility needed to be “right-sized and less complex. ”Now we know why. Last Friday, the Food and Drug Administration posted a lengthy inspection report chock-full of troubling manufacturing practices that were observed during an inspection this past March and April. (Silverman, 7/2)
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