Novartis says FDA gives accelerated approval for kidney-disease treatment | MarketWatch
Excerpt from MarketWatch: “Novartis said it received accelerated approval from the U.S. Food and Drug Administration for a treatment to bring down elevated levels of protein in the urine of adults who have a rare kidney disease. The approval follows a Phase 3 study in which the treatment, Fabhalta, achieved a 44% reduction in this elevated protein level, called proteinuria, at nine months relative to baseline in patients with primary immunoglobulin A nephropathy, or IgAN. This reduction in protein compared with a 9% drop in the placebo arm, the Swiss pharmaceutical company said Wednesday.” Read more.
How This $4.3 Billion Pharma Company Is Helping Underserved Patients in Neuro | Forbes
Excerpt from Forbes: “For over 30 years, Richard Pops has been the CEO of Alkermes, a company steadfastly focused on neuroscience—a notoriously challenging therapeutic area with highly stigmatized patient populations. When Pops joined Alkermes in 1991, it was a privately held company with only 25 employees. 32 years later, the company has more than 2,000 employees and is valued at nearly $4.3 billion.” Read more.
FDA approves new immunotherapy drug for endometrial cancer patients | Fox News
Excerpt from Fox News: “The U.S. Food and Drug Administration (FDA) has approved a new drug for certain adult patients with endometrial cancer. Jemperli (dostarlimab-gxly) — made by British pharmaceutical company GSK — is intended for people with primary advanced or recurrent forms of the cancer, according to the FDA’s Aug. 1 announcement. It is an immunotherapy-based drug, which means it leverages the body’s immune system to attack cancer cells.ny GSK — is intended for people with primary advanced or recurrent forms of the cancer, according to the FDA’s Aug. 1 announcement.” Read more.
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