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United Therapeutics

Latest Headlines

Latest Headlines

In surprise reversal the FDA approves United's oral PAH drug Orenitram

Christmas has arrived early for United Therapeutics. The biotech took most analysts completely by surprise with the news that the FDA had stamped an approval on Orenitram (treprostinil, or oral Remodulin) after twice snubbing its application for the pulmonary arterial hypertension drug.

The feds zero in on United Therapeutics' marketing practices

The Department of Health and Human Services has just added United Therapeutics to the growing list of companies under scrutiny for their marketing practices, calling into question three of its pulmonary arterial hypertension drugs--the only three products it sells.

Strike two: FDA hands United Therapeutics another snub on oral Remodulin

United Therapeutics is going to have to revise its timeline on an oral successor to its bestselling Remodulin one more time. The FDA has handed United its second CRL in a matter of months, once again batting down its hopes of launching a new drug into an increasingly crowded market.

FDA readies final decisions on four big biotech drugs

The budget cuts required by sequestration may have added a big question mark to every FDA deadline on the schedule, but there are four big developers holding their breath right now in anticipation of a formal marketing decision on their experimental drugs.

Analysts track a spike in mid-cap biotechs' R&D spend

Analysts at GlobalData took a quarterly snapshot of the R&D expenses for a big batch of mid-cap biotechs and concluded that rising research costs were eroding corporate profitability. And they pinned the blame squarely on the pricey hunt for new cancer drugs.

FDA smacks down United Therapeutics' oral hypertension drug

United Therapeutics suffered a setback in its pursuit of commercializing an oral therapy for pulmonary arterial hypertension (PAH) yesterday, as the FDA rejected the company's new drug application with a dreaded complete response letter.

United snags Glaxo buildings as it completes expansion

Even as it completes an expansion in North Carolina, United Therapeutics is picking up for future use three buildings and a large parcel of land left idle by GlaxoSmithKline.

United Therapeutics wins $45M deal for oral antiviral

One of the biggest challenges in antiviral development is beating back the attacks mounted by a mutating virus. Now a research arm of United Therapeutics in Silver Spring, MD has won an NIH contract

United vows to file NDA on PAH drug after it flunks Ph3

United Therapeutics' late-stage oral drug for pulmonary arterial hypertension flunked a Phase III study, failing to add any significant improvement in walking distance after 16 weeks of therapy. But

For sale: Giant drug research hub

Looking for a sprawling research base for your R&D efforts? Consider Discovery Park, Pfizer's old R&D center in the UK which has been redubbed as CB Ellis looks for new tenants to fill the