AstraZeneca’s rare disease arm Alexion agreed to resolve all patent disputes with Chugai Pharmaceutical regarding the prescription drug Ultomiris (ravulizumab) by signing a settlement agreement that will involve a one-time payment of $775 million. 

The U.S. Food and Drug Administration greenlit Aadi Bioscience’s Fyarro for treating a rare and aggressive form of cancer that disproportionately affects women.

The U.S. Food and Drug Administration approved Enzyvant Sciences’s Rethymic (allogeneic processed thymus tissue-agdc) for children with congenital athymia. 

FDA

After discussions with the U.S. Food and Drug Administration, Paris-based Ipsen withdrew the company’s New Drug Application (NDA) for palovarotene.

The U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’ Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in children and adults.

The U.S. Food and Drug Administration’s PDUFA dates for the last week of November 2020 include a review of Liquidia Technologies’ NDA for LIQ861 for the treatment of pulmonary arterial hypertension (PAH).

Alnylam Pharmaceuticals presented complete results from the company’s ILLUMINATE-B Phase III study in children under 6 years with primary hyperoxaluria type 1 (PH1), a rare disorder affecting the kidneys.

Cambridge, Massachusetts-based Alnylam Pharmaceuticals released positive Phase III data from the ILLUMINATE-A clinical trial of lumasiran in the treatment of primary hyperoxaluria type 1 (PH1).

The U.S. Food and Drug Administration approved Alexion Pharmaceuticals Inc.’s Ultomiris for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy for adult and pediatric patients.

Akcea Therapeutics Inc. and Ionis Pharmaceuticals Inc. announced that Waylivra received conditional marketing authorization from the European Commission as the only therapy for FCS.