Tags : (pembrolizumab)

Biosimilars

Neuclone Discloses Two Biosimilars Referencing Opdivo (nivolumab) and Keytruda (pembrolizumab)

Shots: The company discloses two additional biosimilars in active development referencing Opdivo (nivolumab) and Keytruda (pembrolizumab). The biosimilars are in the advanced stages of pre-clinical development and are being co-developed by NeuClone and Serum Institute of India The disclosure demonstrates NeuClone’s ability to develop multiple biosimilars simultaneously through its NeuMAX platform Additionally, NeuClone and Serum […]Read More

Regulatory

Merck & Co. Reports the Resubmission of sBLA to the

Shots: The company resubmits the sBLA to the FDA for updating the dosing frequency for Keytruda, to include a 400mg dose infused over 30mis q6w, in addition to the currently approved dose of 200mg q3w Merck has filed the resubmission addressing the Complete Response Letter issued in Febr’2020 and filed sBLA across all indications of […]Read More

Pharma

Merck & Co. Reports Results of Keytruda (pembrolizumab) in P-III

Shots: The P-III KEYNOTE-177 study involves assessing of Keytruda as monothx. vs SOC CT (mFOLFOX6/ FOLFIRI, with/out bevacizumab/ cetuximab) as a 1L treatment in 308 patients with MSI-H or dMMR advanced colorectal cancer The P-III KEYNOTE-177 study resulted in meeting its one of its dual 1EPs i.e. demonstrated significant improvement in PFS. Following the DMC’s […]Read More