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Thursday, Aug 1 2019

Full Issue

Price-Fixing Investigation: Patients Say They Couldn't Afford Crucial Psychiatric Drug After Generic Companies Hiked Cost

Patients say a month's supply of a drug called clomipramine suddenly jumped from $16 to $348. Taro Pharmaceuticals Industries Ltd., Mylan Pharmaceuticals Inc. and Novartis AG's generics arm, Sandoz, are facing a court challenge over accusations that they conspired to raise the drug's price in unison. The allegation is part of a sweeping lawsuit that names 20 generic drugmakers and subsidiaries in all. In other pharmaceutical news: fish-oil drugs, chemo-free medication, and insulin.

In May, attorneys general in more than 40 states accused three pharmaceutical companies that make clomipramine Taro Pharmaceuticals Industries Ltd., Mylan Pharmaceuticals Inc. and Novartis AG's generics arm, Sandoz of conspiring to raise the drugs price in concert. The allegation is part of a sweeping lawsuit that names 20 generic drugmakers and subsidiaries in all, as well as 15 current and former industry executives. It says they communicated with one another to fix prices and divvy up customers for more than 100 drugs, treating a range of maladies from HIV to high blood pressure to fungal infections. (Elgin, 7/31)

With a key approval decision less than two months away, Amarin said Wednesday that the Food and Drug Administration is unlikely to convene an advisory committee meeting to review data on an expanded use of its heart drug Vascepa. Amarins statement, offered as an update with its second-quarter earnings announcement, was meant to quell any residual investor concerns about the FDAs ongoing review of Vascepa with a decision deadline of Sept. 28.No FDA advisory committee meeting is good news for the Vascepa review.(Feuerstein, 7/31)

When used together, two drugs that treat the most common leukemia in adults significantly increase survival and lower the risk that the disease will worsen, according to a new study. The interim analysis of a clinical trial for chronic lymphocytic leukemia, published Wednesday in the New England Journal of Medicine, found that the drugs -- ibrutinib and rituximab -- fared better than a combination chemoimmunotherapy that's known to be effective against the cancer. (Nedelman, 7/31)

A bipartisan group of lawmakers announced Monday the beginnings of a plan to help supply emergency insulin to Minnesotans who cannot afford the rising cost of the drug. Insulin prices have tripled over the last 10 years, according to the governor's office. (John, Hallberg and Shiely, 7/31)

And the fight over CRISPR technology continues

The Broad Institute of MIT and Harvard lied about who invented the use of CRISPR genome editing in animal cells, and its lead CRISPR scientist Feng Zhang made statements to the patent office that he knew were untrue, attorneys for the University of California and its partners claim in legal documents filed Tuesday night with the U.S. Patent and Trademark Office. In strikingly tough language, the lawyers accused the Broad of trying to deceive the Office in order to win patents on the revolutionary technology, claimed another Broad scientist made a materially false declaration about when Zhangs lab got CRISPR to work, and argued that Zhang didnt know what molecules the genome editor needed until he read a rivals key paper all of which makes Zhangs work unpatentable. (Begley, 7/31)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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