Tags : patients

Regulatory

Exelixis Reports the US FDA’s Acceptance of IND for XB002

Shots: The US FDA has accepted IND to assess the safety, tolerability, PK, and preliminary antitumor activity of XB002 in patients with advanced solid tumors. The P-I trial is expected to initiate in Q2’21 The preclinical data demonstrated that XB002 binds to tissue factors without affecting the coagulation cascade, in contrast with prior therapies in […]Read More

Biotech

Ultragenyx Collaborates with n-Lorem Foundation to Advance Personalized Medicines Treatment

Shots: The companies collaborated to develop the personalized medicines for patients with ultra-rare diseases. The collaboration involves additional resources, financial contribution, and experience from both the company The alliance strengthens n-Lorem’s mission to bring immediate hope and rapid treatment to ultra-rare disease patients in need n-Lorem Foundation provides a free and lifetime supply of ASO […]Read More

Regulatory

Ipsen’s Cabometyx + Opdivo Receive EC’s Approval as a 1L

Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Cabometyx + Opdivo vs sunitinib in 651 patients with previously untreated advanced/m-RCC The results demonstrated significant improvement across all efficacy EPs. The trial met its 1EPs i.e. showed doubled mPFS (16.6 vs 8.3mos.); ORR (55.7% vs. 27.1%); CR (8.0% vs 4.6%); OS (40% […]Read More