Senhwa gets FDA orphan drug designation

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

Senhwa Biosciences Inc. of Taipei and San Diego received the orphan drug designation to CX-4945 for the treatment of cholangiocarcinoma.

CX-4945 is a novel small molecule drug that inhibits protein kinase CK2, the company said.

Orphan drug designation is granted by the FDA to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. In the US, orphan drug status carries with it seven years of marketing exclusivity following FDA approval.

Under the agreement, Phylogica will receive a milestone payment of $2 million. Phylogica is eligible to receive research, development, and commercialization milestone payments totaling up to $142 million.

YOU MAY BE INTERESTED IN

The Trump administration did exactly what it said it would do to disorient anyone involved in making policy or touched by it. The president and his crew have “flooded the zone”—the term and the image are theirs, as is the strategy of dropping a flurry of executive orders and memoranda that shake the foundations of the American system of government, raising questions of legality and constitutionality, and, above all, making it a challenge for anyone to see the entire picture and think strategically.
In two raucous back-to-back hearings on Jan. 29 and Jan. 30, anti-vaccine crusader Robert F. Kennedy Jr. was grilled by members of the United States Senate Finance Committee and the Health, Education, Labor, and Pensions Committee as the Trump administration seeks his confirmation as secretary of the Department of Health and Human Services. 
Over the past century, groundbreaking cancer research in the U.S. has led to life-saving medical advances that benefit patients worldwide. Scientists often devote their lives to making discoveries, putting their scientific endeavors ahead of status, income, or lifestyle. Investigators work tirelessly, often seven days a week, to solve complex medical problems. These efforts often lead to game-changing outcomes that help us understand difficult medical challenges, advance technologies and develop new therapies. 

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login