After fast approval of oral chemotherapy combination Lonsurf for late-line colon cancer, U.S. oncology newcomer and Otsuka Holdings subsidiary plans to launch within two weeks at a reasonable price, says CEO Eric Benn.
Taiho Pharmaceutical Co. Ltd.’s US oncology division scored its first FDA approval Sept. 22 with early clearance of the oral fixed chemotherapy combination Lonsurf (trifluridine/tipiracil) in a very narrow indication for late-line treatment of metastatic colon cancer.
Taiho Oncology’s candidate (TAS-102) was approved for metastatic colorectal cancer (mCRC) in patients who already had fluoropyrimidine-, oxaliplatin- and irinotecan-...
The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.
In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.
A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
NRx Pharma is trying to capitalize on the headlines about a new US FDA hyper-fast review program, illustrating that the lack of details in the FDA’s announcement is an opening for sponsors to try to grab some attention.
A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
