Top Regulatory News Stories – Week Ending September 20, 2019

Ardelyx, Inc. announced that the U.S. Food and Drug Administration has approved IBSRELA® (tenapanor), a 50 mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

Amplyx Pharmaceuticals announced that the FDA has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company’s lead antifungal candidate, fosmanogepix (APX001), for seven indications.

Seattle Genetics and Astellas secured priority US review for armed antibody enfortumab vedotin aimed at bladder cancer

The FDA has granted breakthrough designation to Roche’s Gazyava CD20-targeting antibody in lupus nephritis, a life-threatening manifestation of systemic lupus erythematosus in the kidney.

Ocugen, Inc. announced the FDA granted the second orphan drug designation for OCU400, Ocugen’s novel gene therapy, for the treatment of CEP290 mutation associated retinal disease.

Wave Life Sciences announced that the FDA has granted Fast Track designation to suvodirsen for the treatment of Duchenne muscular dystrophy (DMD) in patients amenable to exon 51 skipping.

In other news…

Purdue Pharma filed for Chapter 11 bankruptcy protection after the drugmaker attempted to settle more than 2,000 opioid-related lawsuits last week for more than $10 billion.

Karyopharm has entered into a royalty agreement worth up to $150 million to back the launch of their multiple myeloma drug — recently approved by the FDA over the objections of a majority of the agency’s outside experts.

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