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Wednesday, Feb 10 2021

Full Issue

'Skinny Labeling' Case To Be Reheard

The term refers to an effort by a generic company to seek regulatory approval to market its medicine for a specific use, but not other patented uses. An October ruling in a patent case prompted hand-wringing that many Americans might be deprived of access to generic drugs, Stat reported. But Tuesday, the ruling was vacated, with new arguments scheduled for Feb. 23.

In a surprising move, a federal appeals court panel may revisit a controversial decision that has raised concerns about the ability of generic drug makers to supply Americans with lower-cost alternatives to pricey brand-name medicines. (Silverman, 2/9)

In other pharmaceutical industry news 鈥

KalVista Pharmaceuticals said Tuesday that its oral, on-demand treatment for the swelling 鈥渁ttacks鈥 commonly experienced by patients with a genetic condition called hereditary angioedema achieved the goals of a mid-stage clinical trial. (Feuerstein, 2/9)

On Monday, Editas Medicines announced that veteran biopharma executive James 鈥淛im鈥 Mullen was expanding his role with the gene-editing biotech, taking over as the new CEO while continuing as the company鈥檚 chairman 鈥 a role he鈥檚 held since March 2018. Mullen replaces Cynthia Collins, who became Editas鈥 CEO in August 2019. (Feuerstein, 2/9)

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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