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.
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 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.
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.
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.
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 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
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
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
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