Tags : Against

Biotech COVID-19

Bayer Collaborates with CureVac for CVnCoV Against COVID-19

Shots: Bayer to support the development, supply and key territory operations of CureVac´s COVID-19 vaccine candidate, CVnCoV and will contribute its expertise and established infrastructure in numerous area Curevac will be the MAH for the product while Bayer will support CureVac with country operations within the EU and additional markets. Additionally, Bayer has an option […]Read More

COVID-19 Regulatory

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting

Shots: The VRBPAC voted 20-0, with one abstention that the benefits of the Moderna’s vaccine outweighed its risks for use in people aged ≥18yrs The recommendation is based on data analysis from the pivotal P-III clinical study that demonstrated 94.1% efficacy The US FDA’s committees provide non-binding recommendations. The FDA will take the VRBPAC’s recommendation […]Read More

Biosimilars

Genentech Files Complaint Against Centus Over Proposed Bevacizumab Biosimilar

Shots: Genentech filed a complaint in the Eastern District of Texas alleging that the proposed biosimilar to Avastin (bevacizumab) product infringes 10 US patents Genentech alleges that Centus and partners failed to disclose sufficient information about the proposed biosimilar to enable Genentech to do a sufficient analysis of potential patent infringements Centus has a BLA […]Read More

Clinical Trials COVID-19

Pfizer and BioNTech’s BNT162b2 Demonstrates 90% Efficacy in Preventing COVID-19

Shots: The BNT162b2 showed more than 90% efficacy in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis, conducted on Nov 8, 2020 from P-III clinical study The companies reported no serious safety concerns so far while safety and additional efficacy data continues to be collected. The company […]Read More