The German Patent System has been a very patentee-friendly system, in particular for smaller patentees. Enforcement of patents has been relatively easy, affordable and fast.
Following assemingly good results in a Phase III study AstraZeneca goes for Emergency Use Approval in the US.
On Tuesday, Emer Cooke had already hinted at it. Now the EMA’s PRAC committee confirmed: the benefits of AZ1222 by far outweigh the risks of the COVID-19 vaccine.
Reagents?- Three fast-spreading new variants of SARS-CoV-2 virus have emerged in recent months: the U.K. variant B.1.1.7, the Brazil variant P.1, and the South Africa variant B.1.351.
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.
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.
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.
With many complex factors affecting a therapeutic candidates 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 thats delivered within your target timeline?
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.
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.