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).
Gilead Sciences agreed to pay $97 million to resolve claims from the U.S. government that the company violated the False Claims Act.
Acceleron Pharma and Fulcrum Therapeutics enter 2020 as partners to tackle pulmonary diseases.
PhaseBio Pharmaceuticals’ antiplatelet drug PB2452 received Breakthrough Therapy designation from the U.S. FDA.
Silver Spring, Maryland-based United Therapeutics announced that the company’ esuberaprost tablet did not meet the primary endpoint in the BEAT Phase III clinical trial in patients with pulmonary arterial hypertension (PAH).
A unit of Johnson & Johnson will pay $360 million to resolve an investigation into the company’s financial support of a charity that helped Medicare patients cover out-of-pocket drug costs.
Shares of Arena Pharmaceuticals rocketed more than 28 percent after the company signed a licensing agreement with United Therapeutics for a late-stage drug candidate. The deal could be worth more than $1.2 billion for Arena.
MannKind Corp. and United Therapeutics Corp. signed a worldwide exclusive license and collaboration deal to develop and commercialize a dry powder formulation of treprostinil being studied in clinical trials to treat pulmonary arterial hypertension.
Bellerophon Therapeutics’ Phase III pulmonary arterial hypertension drug INOpulse failed to meet endpoints following a pre-specified interim analysis from a Data Monitoring Committee.
Eiger BioPharmaceuticals Inc. will stop development of a drug to treat pulmonary arterial hypertension after it failed in a mid-stage study.