23 December 2019
GlobalData’s Likelihood of Approval (LoA) tool in the Drugs database considers the case for pipeline recombinant peptide drugs.
7 January 2019
On December 19, Spectrum Pharmaceuticals’ shares tumbled 31% following the FDA decision to decline the company’s request of a breakthrough therapy designation (BTD) for its clinical candidate EGFR tyrosine kinase...
4 January 2019
On December 17, China’s National Medical Products Authority (NMPA) conditionally approved the listing of the first locally developed programmed cell death-1 (PD-1) checkpoint inhibitor, Tuoyi (toripalimab) monoclonal antibody injection for...
17 December 2018
On December 7 Roche announced the FDA approval of its triplet of programmed death-ligand 1 (PD-L1) inhibitor Tecentriq (atezolizumab) + vascular endothelial growth factor (VEGF) inhibitor Avastin (bevacizumab) + chemotherapy...
18 September 2018
Recently medicinal cannabis has been at the forefront of media attention in the UK, and in July 2018 the UK home secretary announced that specialist doctors can legally prescribe cannabis-based...
11 September 2018
The American Society of Blood and Marrow Transplantation (ASBMT) is in the process of developing a toxicity rating system for CAR-T therapies, a new type of cancer therapeutic approach, for...
26 June 2018
A longstanding aim of the cancer research community has been to increase the body’s ability to respond to cancerous cells.
22 May 2018
Complete response letters (CRLs) were issued by the FDA recently for two biosimilar versions of Roche’s Rituxan—first to Celltrion and Teva on April 9 for Truxima and then to the...
21 May 2018
Aspirin is still the standard of care (SoC) in the US for patients with non-cardioembolic acute ischemic stroke (AIS) and transient ischemic attack (TIA) to reduce the risk of recurrence....
8 May 2018
Back in 2010, the FDA implemented the Biologics Price Competition and Innovation Act (BPCIA) as part of the Affordable Care Act (ACA), which created an abbreviated pathway for biosimilar drug...