Tags : Seattle

Insights+

PharmaShots’ Key Highlights of Second Quarter 2020

The second quarter of 2020 has ended with big approvals in pharma and biotech industry. Moving with the latest approval of Roche’s Phesgo and Enspryng & Zogenix’s Fintepla. Highlights of the quarter is COVID-19 as the development of vaccines and drugs were on peak. Celltrion evaluated Remsima (biosimilar, infliximab) against COVID-19 in the UK. The […]Read More

Insights+

Insights+: The US FDA New Drug Approvals in March and

The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products so far in 2019. However, there is a significant increase in multiple diseases while the new approvals are helping and advancing the changes to understand, diagnose, and treat the diseases Our team […]Read More

Biotech Regulatory

Seattle’s TUKYSA (tucatinib) Receives the US FDA’s Approval for Advanced

Shots: The approval is based on HER2CLIMB study assessing TUKYSA in combination with trastuzumab and capecitabine vs trastuzumab & capecitabine monothx in ratio (2:1) in 612 patients with 1L+ Anti-HER2 therapies in the metastatic setting either monothx or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1) The study resulted in 46% reduction in the risk […]Read More