Breast Cancer

© GettyImages/Pheelings Media

FDA rebuff for Keytruda in breast cancer indication

By Jane Byrne

A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the company’s application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.

© GettyImages/ChooChin

UK market sees additional Herceptin biosimilar

By Jane Byrne

Accord Healthcare has announced the launch of a Herceptin biosimilar in the UK. Zercepac is the first monoclonal antibody (mAb) and fourth biosimilar launched by the company in Europe.

(Image: Getty/Shidlovski)

Genentech taps Halozyme’s tech in Herceptin Hylecta

By Maggie Lynch

Genentech receives US FDA approval on Herceptin Hylecta, a subcutaneous co-formulation using Halozyme’s recombinant Enhanze technology, for the treatment of HER2-positive metastatic breast cancer.

INN debate: IFPMA pushes for biosimilar label changes

Dispatches from DIA Euromeeting

INN debate: IFPMA pushes for biosimilar label changes

By Fiona BARRY

IFPMA will advocate for all biologics to have a qualifier added to their names at the WHO’s INN Consultation on April 8, the biologics giant Amgen has told BioPharma-Reporter.com.

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