The Cancer Letter

Inside information on cancer research and drug development

Drugs & Targets

Senhwa gets FDA orphan drug designation

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print
BYLINE
IN THIS ISSUE
DOWNLOAD PDFTABLE OF CONTENTS

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.

Table of Contents

YOU MAY BE INTERESTED IN

Black History MonthConversation with The Cancer Letter

Shearwood McClelland III: “When you stand for something, you’re always going to be attacked.”

Shearwood McClelland III’s grandfather was a ditchdigger who dreamed that his six Black daughters would become doctors. McClelland’s mother did not disappoint—she became the first Black woman board-certified in maternal fetal medicine in the history of the United States.  Now, McClelland is the chief medical officer of Cancer Health Equity at the University of Oklahoma...

By Jacquelyn Cobb
Guest Editorial

Biomarker-driven innovation: What the FDA’s evolving strategy means for oncology

As oncology enters a new era of precision medicine, the Food and Drug Administration’s evolving biomarker strategy aims to ensure that life-saving therapies are tailored to individual patient needs, fostering safer and more effective treatments.  Historically, therapies were approved with broad indications based on overall efficacy, even when outcomes for biomarker-positive and -negative patients were...

By Harpreet Singh
Sponsored

Advancing pediatric oncology and survivorship: A research vision at City of Hope

In the evolving landscape of pediatric oncology, survivorship research has become an essential component of our mission to improve long-term patient outcomes. At City of Hope, we are focused on not only curing childhood cancers but also ensuring that survivors live the healthiest lives possible. A significant part of my research has been dedicated to mitigating the long-term toxicities of cancer therapy—particularly cardiovascular complications that can arise decades after treatment.
By Saro Armenian
Table of Contents

Never miss an issue!

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

Login

Site license subscribers:
Log in with your IP | Register a sponsored account