Japan's Astellas Pharma has filed with Japan's Pharmaceutical and Medical Devices Agency for approval of PCSK9 inhibitor evolocumab for high cholesterol under the Amgen Astellas BioPharma joint venture.
The FDA offers incentives for developing products that target life-threatening infections, and Astellas just became the latest drugmaker to take advantage.
Japanese pharma giant Astellas won FDA approval for an antifungal treatment targeting two rare but dangerous infections, the latest drugmaker to take advantage of new incentives for anti-infective products.
Astellas Pharma is getting a piece of the vaccine pie. The Japanese company is joining forces with U.S.-based Immunomic Therapeutics to develop the latter's vaccine to treat allergies caused by Japanese red cedar.
Japanese pharma giant Astellas is the latest drugmaker to make its clinical trial data available to outside researchers, increasing its R&D transparency but stopping short of some industry trailblazers.
Astellas tweaked its plans for Tuesday, the day a trial was set to start over an alleged scheme to delay generics of immune-suppressant drug Prograf. Instead of heading to court, the Japanese pharma agreed to settle a handful of lawsuits, it announced.
The world of gene therapy--in which single-dose treatments correct debilitating defects--enjoyed something of a renaissance in 2014. Strong clinical results from leaders in the once-maligned field spurred renewed optimism, helping a new generation of startups secure millions in venture financing to develop their next-generation approaches to the field.
In the coming year, you can expect to see a lot more work being done on Asian deals, particularly for China. Through the course of this past year there have been growing signs of this global evolution.
Astellas has capped a string of new drug development deals by upping the ante on its pact with South San Francisco-based Cytokinetics. After handing over a $40 million upfront fee for their original 2013 deal, Astellas has come back with $75 million more in near-term financing and more than $600 million in milestones on the table.
After ringing up a key U.S. approval in September to threaten Johnson & Johnson's Zytiga, Astellas' Xtandi now has what it needs to ramp up its market-share battle in the EU, too.