Tag:
United Therapeutics
Latest Headlines
Latest Headlines
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
Plant design emphasizes green
United Therapeutics has pulled out all the green stops in its recently completed facility in Research Triangle Park, NC. The hub-and-spoke building houses manufacturing at the core with R&D and
FDA still mum on Onglyza, United wins fourth approval
AstraZeneca is waiting this morning for word of the FDA's decision on its new, and closely watched, diabetes drug Onglyza. The agency was scheduled to deliver a verdict yesterday, but AstraZeneca
