CIR-101 binding to the receptor binding site of the viral spike protein. © CORAT Therapeutics

German CORAT Therapeutics GmbH got the greenlight for Phase Ib/II testing of COR-101, an antibody that reduced virus load in the lung by more than 99 % within three days.

Picture: Premier Research

Study start-up is a chaotic time. There are lots of moving parts. Lots of decisions to make and processes to establish. Lots of room for error. Mistakes can quickly derail a trial – and delays are endemic. That all represents a potential waste of time and resources – just at a moment when speed is of the essence. In many cases, the problem comes down to spreadsheets.

Picture: Yumab

First emergency approvals of vaccines and antibody drugs in less than a year are great achievements of modern biotechnology in our battle against the COVID-19 pandemic, but we still have no efficient therapeutics to cure severe COVID-19. Millions of lives remain at risk until we control the pandemic, and what if we will never reach herd immunity? Waiting for others to do the job cannot be the strategy, as well as betting only on vaccines.

Picture: Cytiva

With many complex factors affecting a therapeutic candidate’s chances of approval, partnering with a qualified service provider can be the most effective way to produce material for clinical trials. Outsourcing allows you to delay critical capacity decisions until the fate of your molecule is more certain but, how do you ensure this approach results in a successful process that’s delivered within your target timeline?

Picture: Pharming Securities

European biotechs have been longly undervalued. In the wake of the COVID-19 pandemic, some of them took off. They will have to prove their value in a post-COVID era. However, Europe is there.

Thanks to a grant by Germany's €45m funding programme for clinical COVID-19 therapeutics set up in January 2021, CORAT Therapeutics got money to start their Phase I/II programme with COR-101. In May the funding programme will be upgraded by €300m - a model for the EU? © NIAID

The B.1.1.7 variant of SARS-CoV-2, which was first identified in the UK, may be associated with an increased risk of death, a Nature study suggests.

© Roche AG

Roche to acquire GenMark Diagnostics, Inc., to access platform to test for broad range of pathogens with one patient sample.

While AZD1222 is under fire in Europe, the Indian version of the jab is saving lives in Ghana, and other low income coutries supplied by the COVAX facility. © By Agência Brasília - flickr.com/photos/64586261@N02/50870507747/

While media reports suggest AstraZeneca’s COVID-19 jab might have caused blot clots, the EMA didn’t confirm a causal relationship.

© NIAID

Swiss Roche AG has missed the primary endpoint in the REMDACTA trial in patients with severe COVID-19 pneumonia. 

Picture: AVMI/Merck

Africa produces less than 1% of the human vaccines it uses. To effectively respond in time of outbreaks and pandemics, Africa must expand its vaccine development and production capabilities to cater for its growing population. Successfully establishing such an industry at scale is a multifaceted endeavour to create an enabling environment. This article highlights key factors and considerations for establishing local vaccine manufacturing.