The US Food and Drug Administration (FDA) is deliberating whether to allow AstraZeneca to resume its recently begun Phase 3 US clinical trial of the adenovirus-based Covid-19 vaccine it is developing for Oxford University. An adverse event last week caused the – meanwhile resumed – UK study to be paused,
So far, the pharmaceutical industry — including CMOs/CDMOs — has responded well to the outbreak of the Covid-19 pandemic.
According to its latest Chemical Quarterly Report, which CEFIC, the European Chemical Industry Council, published on Sept. 10, chemical output in the EU27 dropped by 5.2% from January to June 2020 compared to the previous year’s level (January to June 2019), following the Covid-19 outbreak in Europe.
AstraZeneca has resumed Phase 2/3 clinical trials with Oxford University’s Covid-19 vaccine candidate in the UK, days after halting the tests due to an “adverse neurological event” that CEO Pascal Soriot said occurred in the UK trial and involved an inflammatory spinal cord disorder.
AstraZeneca has temporarily paused Phase 2/3 global clinical trials of the adenovirus-viral vector-based Covid-19 candidate it is developing for Oxford University. The Anglo-Swedish drugmaker initially cited “a serious suspected adverse reaction” in a participant without revealing details.
With some potential Covid-19 vaccine makers suggesting they could have a candidate ready for approval and maybe even deployment this autumn, concerns are arising that a doubting public could shun inoculation.
The US Food and Drug Administration (FDA) has come under fire again as the federal health agency issued its third Emergency Use Authorization (EUA) for a Covid-19 treatment since the beginning of the pandemic. This extended the authorization for Gilead’s remdesivir, which it markets as Veklury.
After months of uncertainty and anxious glances across the water as potential Covid-19 vaccine manufacturers made deal after deal with other political blocs, the EU over the past four weeks has made rapid strides toward securing supplies for its 27 member states.
On the day after president Donald Trump’s announcement that the Food and Drug Administration (FDA) had granted his request for an Emergency Application (EUA) to treat Covid-19 patients with blood plasma drawn from convalescents, the US pharma and biotech communities as well as the social media universe were heatedly debating its implications.
Against the advice of some of the nation’s senior infectious disease experts, the US Food and Drug Administration (FDA) has granted president Donald Trump’s request for an Emergency Use Authorization (EUA) to allow blood plasma from convalescent Covid-19 patients to be used to treat others suffering from the same coronavirus-induced disease.
As the US death toll from Covid-19 creeps past the 170,000 mark, with a proven vaccine still months away, US president Donald Trump has begun promoting yet another miracle cure for the novel coronavirus. In this case, the focus is on oleandrin, an extract from the oleander plant.
UK chemical exports in the second quarter of this year have steadied but uncertainty looms for the rest of 2020 with risks from both Covid-19 and Brexit, said the Chemical Industries Association (CIA).
The European Commission has signed a €63 million contract with Gilead Sciences to deliver batches of Veklury, Gilead’s name for the antiviral remdesivir, to the EU’s 27 member states as well as the UK, starting in early August.
European officials recently began talking to companies developing Covid-19 vaccines about supplying the EU’s 27 member states, in hope that none would fall behind bigger markets such as the US, which began making exclusive deals early on. Now Reuters suggests the talks may have hit a snag.
The strongest and richest form of human communication is face-to-face. Until the COVID-19 pandemic occurred, most people took this form of communication for granted.
The UK will not participate in a plan to distribute a potential coronavirus vaccine to Europe’s most vulnerable citizens first. Tim Barrow, the UK’s ambassador to the EU, said in a letter to the European Commission the British government would not join the effort because as a non- EU member it would have no decision-making power in negotiations about purchases.
Germany’s BioNTech is confident it will be ready to seek regulatory approval for its mRNA-based Covid-19 vaccine by the end of this year, its co-founder and chief executive Ugur Sahin said in an interview with the Wall Street Journal (WSJ).
The European Investment Bank (EIB) has granted German biotech CureVac a €75 million loan to support its ongoing development of vaccines against infectious diseases, including its Covid-19 candidate CVnCoV.
As the global coronavirus pandemic shows no signs of abating, the US “America first” approach to preventing and treating Covid-19 has again provoked worldwide concern.
Sanofi Pasteur, the vaccines global business unit of French drugmaker Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, are formally expanding their existing 2018 collaboration and license agreement to develop mRNA vaccines for infectious diseases.
As part of a plan to establish a network of manufacturing partners to help boost capacity ahead of a potential FDA approval of a Covid-19 vaccine, US healthcare giant Johnson & Johnson (J&J) recently signed agreements with two US companies.
Sanofi has urged the EU to create an equivalent of the US government’s Biomedical Advanced Research and Development Authority (BARDA) to coordinate research into a Covid-19 vaccine, or face being left behind.
Paul-Ehrlich-Institut (PEI), Germany’s federal institute for vaccines and biomedicines, has given the go-ahead for Germany’s first clinical trial of a vaccine candidate to prevent COVID-19.
Like most industries, the global chemical industry is currently strongly affected by the outbreak of Covid-19.
