LONDON – The COVAX initiative, set up in a bid to ensure equitable distribution of COVID-19 vaccines, is poised for a global rollout starting in Q1 2021, after sealing agreements to access 2 billion doses of a number of different products. That puts the world on a clear pathway to ending the acute phase of the pandemic, by protecting the most vulnerable people around the world, according to GAVI, the vaccines alliance, which is spearheading COVAX.
DUBLIN – Bowing to public and political pressure, the EMA has brought forward its review of BNT-162b2, the mRNA-based COVID-19 vaccine jointly developed by Pfizer Inc. and Biontech SE, to Dec. 21, more than a week ahead of its originally scheduled date of Dec. 29.
DUBLIN – The European Medicines Agency’s human medicines committee, the CHMP, all but closed out the year by issuing positive opinions on eight marketing authorization applications during its December meeting. Its work for 2020 is not quite yet done, however. It has scheduled an extraordinary meeting for Dec. 29 to review an application from Pfizer Inc. and Biontech AG for their mRNA COVID-19 vaccine BNT162b2.
LONDON – A study of genetic variants in patients with life-threatening COVID-19 has shed light on the mechanisms that underpin severe disease, uncovered new drug targets and pointed to approved drugs, including JAK inhibitors and phosphodiesterase type 4 inhibitors, as therapies that could aid recovery.
LONDON – Retinai Medicine AG reported a three-year master agreement with Novartis AG to apply its artificial intelligence (AI) tools in ophthalmology clinical trials. The first project will look at how machine learning can be used to speed up and improve the interpretation of optical coherence tomography (OCT) images of patients with neovascular age-related macular degeneration (AMD).
LONDON – The first 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine are due to arrive in the U.K. over the next few days, after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration now expected to start on Monday, Dec. 7.
LONDON – The 10 weeks of laboratory time lost during the first U.K. COVID-19 lockdown will translate to a 17-month delay in oncology drug discovery and development projects, according to the Institute of Cancer Research (ICR) in London.
Moderna Inc., late on Nov. 30, said it has asked the FDA to bless emergency use of its COVID-19 vaccine mRNA-1273 after phase III data confirmed it to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. The Cambridge, Mass.-based company said efficacy was "consistent across age, race and ethnicity and gender demographics."
Moderna Inc. and Covaxx Inc. are readying for delivery more than 220 million doses of their respective COVID-19 vaccines to Europe and emerging countries in newly cut deals. Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December. The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.
DUBLIN – Synox Therapeutics Ltd., a spin-out from Celleron Therapeutics Ltd., has raised €37 million (US$43.7 million) in a series A round to conduct a pivotal trial of emactuzumab, an antibody its parent company in-licensed from Roche Holding AG in August.
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