Late on Friday the FDA came through with an approval for Actelion's pulmonary arterial hypertension drug Opsumit (macitentan), its next-gen successor to the franchise drug Tracleer.
Just hours after Bayer laid out some ambitious plans to accelerate development of a new wave of cancer and cardiovascular therapies, the FDA came through with a key new approval of riociguat--to be sold as Adempas--for a devastating lung disease.
An FDA panel of outside experts has contributed a round of thumbs-up for Bayer's new drug for pulmonary arterial hypertension, to be sold as Adempas, sending the pharma giant on what appears to be another victory lap in the lead-up to a likely approval.
Bayer has a new set of upbeat results from its long-term extension study of riociguat, a major new player in a busy field of competitors angling for a share of the market for pulmonary arterial hypertension.
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.
Bayer has raced to the FDA with its application for riociguat, a promising candidate for pulmonary hypertension and a key player in the pharma giant's plans for a blockbuster year in 2013 as it sets the stage for a high-profile market battle with two big competitors.
Bayer Healthcare is on a roll, and it has no intention of easing off the gas now. Emboldened by rising sales of Xarelto, pumped by the prospects of the macular degeneration drug Eylea and optimistic about the newly approved cancer drug Stivarga, Bayer's pharma division has outlined some ambitious plans for its $4 billion annual R&D budget.
Bayer is on a roll. Just days after nabbing a speedy FDA approval of its cancer drug Stivarga (regorafenib), Bayer says it has nailed positive Phase III data on its new drug for rare cases of pulmonary arterial hypertension, which sets up an NDA that leave Bayer slugging it out with Actelion and Gilead for market share in 2014.
A published abstract ahead of a science meeting next week gave Actelion's investors a look at its late-stage data for macitentan, a key new therapy for pulmonary arterial hypertension it will depend on to replace its primary product on the market.
Gilead's $11 million gamble on a new cardiovascular drug has ended in failure. Five years after picking up cicletanine in a deal with Navitas Assets, the biotech says that it's pulling the plug on the program after it failed a mid-stage study for pulmonary arterial hypertension, according to a report by Dow Jones.