‘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.
Stat:
To Delight Of Generic Drug Makers, Court Tosses 'Skinny Labeling' Decision
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 —
Stat:
KalVista Pill Halts Swelling Attacks Caused By Rare Disease, Study Shows
KalVista Pharmaceuticals said Tuesday that its oral, on-demand treatment for the swelling “attacks” commonly experienced by patients with a genetic condition called hereditary angioedema achieved the goals of a mid-stage clinical trial. (Feuerstein, 2/9)
Stat:
Q&A: James 'Jim' Mullen On Why He Took The Job As Editas CEO
On Monday, Editas Medicines announced that veteran biopharma executive James “Jim” Mullen was expanding his role with the gene-editing biotech, taking over as the new CEO while continuing as the company’s chairman — a role he’s held since March 2018. Mullen replaces Cynthia Collins, who became Editas’ CEO in August 2019. (Feuerstein, 2/9)