logo
Plus   Neg
Share
Email

MorphoSys And Incyte : Health Canada Accepts NDS For Anti-CD19 Antibody Tafasitamab

MorphoSys AG (MOR) and Incyte (INCY) said that Health Canada has accepted the New Drug Submission or NDS for tafasitamab, an anti-CD19 antibody.

The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma or DLBCL, including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant or ASCT.

Incyte has exclusive commercialization rights for tafasitamab outside of the United States and, if approved, Incyte will hold the marketing authorization for tafasitamab in Canada.

MorphoSys noted that the NDS marks the second marketing application that Incyte Biosciences Canada has made to Health Canada since establishing operations in Canada in April 2020.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Nestle Prepared Foods, part of Swiss food and beverage giant Nestle SA, has recalled around 762,615 pounds of not-ready-to-eat or NRTE pepperoni hot pockets as it might be contaminated with extraneous materials including glass and hard plastic, the U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS said. Lake Champlain Chocolates or LCC has recalled select LCC milk chocolate products citing the possible presence of foreign objects, mainly brittle plastic pieces, according to the U.S. Food and Drug Administration. The affected products include Hazelnut Five Star Bar; Fruit & Nut Five Star Bar; Almond Five Star Bar; Granola Five Star Bar... A public health alert has been issued for ready-to-eat or RTE beef jerky products by the U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS. The warning is given due to misbranding and the presence of undeclared anchovies, a known allergen. A recall was not requested because the products are not currently available for sale to consumers.
Follow RTT