Johnson & Johnson intends to file for US Emergency Use Authorization (EUA) for its COVID-19 vaccine in early February, having reported the vaccine is 66% effective at preventing moderate to severe COVID-19.
The European Medicines Agency (EMA) today advised that AstraZeneca’s COVID-19 vaccine can be given conditional marketing authorization (CMA) in the EU to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
The EU Commission has published a redacted version of the contract it signed with AstraZeneca on COVID-19 vaccine delivery in August last year, in a bid to show that the pharma giant is backtracking on its commitments.
The Commission has today put in place a measure that requires companies it has secured COVID-19 vaccine deals with to notify the authorities in member states about any intention to export vaccines produced in the EU.
Novavax’s COVID-19 vaccine showed 89.3% efficacy in its Phase 3 UK trial: including against the UK variant. Meanwhile a Phase 2b trial suggests 60% efficacy against the South African variant. “Our vaccine is the first to demonstrate significant clinical...
German officials are not recommending the use of the AstraZeneca-Oxford University COVID-19 vaccine on people aged over 65, according to a report in the Financial Times.
Belgian health authorities announced today that they visited Novasep’s plant in that country to determine if expected delays in the deliveries of AstraZeneca’s COVID-19 vaccine to the EU are related to production issues at that site.
US President Biden’s team is using the US Defense Production Act (DPA) to launch a full scale “wartime effort” to address the supply chain shortages inherited from the Trump administration.
French company, Sanofi, says it will support the manufacturing and supply of BioNTech’s COVID-19 vaccine, which is being co-developed with Pfizer, in a pledge to increase vaccine accessibility.
Advice published by the World Health Organization today says the two doses of the Moderna vaccine should be administered 28 days apart; but this interval can be extended up to 42 days if necessary.
AstraZeneca along with its scientific partners at the University of Oxford have rejected German media reports that their vaccine against COVID-19 has low efficacy in people aged over 65.
EU health commissioner, Stella Kyriakides, last night again expressed dissatisfaction with the responses the EU executive has received from AstraZeneca over the company's announcement there would be significant shortfalls in the supply of its COVID-19...
An in vitro study shows Moderna's existing mRNA COVID-19 vaccine provides protection against strains that have emerged from South Africa and the UK. But it does suggest reduced protection against the South Africa strain, and so the company is also...
Merck is shutting down the programs linked to its two COVID-19 vaccine candidates following early trial data indicating that they failed to generate immune responses comparable to a natural infection or existing vaccines.
The British Medical Association (BMA), the trade union and professional body for doctors in the UK, is calling for the delay between Pfizer/BioNTech COVID-19 vaccine doses to be reduced from 12 weeks to six weeks.
Australia’s Therapeutics Goods Administration (TGA) has provisionally approved the Pfizer/BioNTech COVID-19 vaccine: making it the first available in the country.
The World Health Organization’s Global Advisory Committee on Vaccine Safety says it has not seen any unexpected or untoward increase in fatalities in frail and elderly individuals who have received the Pfizer/BioNTech vaccine.
GSK has sold its GCLP-certified clinical bioanalytical laboratory located in Marburg, Germany to Canadian clinical research organization (CRO), Nexelis.
The team behind the Oxford-AstraZeneca COVID-19 vaccine says it is carefully assessing the impact of new variants from the UK, South Africa and Brazil on vaccine immunity.
VBI Vaccines is due to start a Phase 1/2 study of a coronavirus vaccine candidate in Q1 2021, after a preclinical hamster challenge study demonstrated ‘robust immunogenicity and efficacy’.
Pfizer and BioNTech have re-iterated that their COVID-19 vaccine appears to be effective against the UK strain, with the publication of new data today.
We take a look at some of the COVID-19 vaccine candidates moving through Phase 1 and 2 clinical trials - and how they could offer a point of difference to authorized vaccines.
The European Commission has set out steps to ramp up production of COVID-19 vaccines; tackle issues in the supply chain; and boost vaccination campaigns.
Loxo Oncology at Lilly, an R&D division of Eli Lilly and Co, and Merus, a Dutch clinical-stage oncology company, today announced a partnership to research and develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies.
New York based, Neurogene, has announced a research collaboration with the University of Edinburgh for the development of a multiple-platform approach to diseases not addressable by conventional gene therapy.
Thermo Fisher Scientific will acquire San Diego molecular diagnostics company Mesa Biotech for approximately $450m in cash, with up to an additional $100m upon completion of certain milestones.
California information technology and services company Syntegra and the National Institutes of Health (NIH) have signed a partnership to 'democratize access to the largest set of COVID-19 patient records': with the use of Syntegra's synthetic...
At the end of December, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated its advice on the Pfizer/BioNTech vaccine: saying that those with unrelated allergies could receive it. But this announcement did not receive as...
Previously Rexgenero Ltd, a UK-based company developing cell therapies to treat serious diseases such as cancer and CLTI, the launch of Ixaka Ltd follows the integration of its nanoparticle gene therapy business in France and a shareholder restructuring....
The growing global pipeline of cell and gene therapy projects has prompted Thermo Fisher Scientific to invest again, with it announcing today that it had bought Henogen, Novasep’s viral vector manufacturing business based in Belgium, for about US$879.72m...
Samsung Biologics is aiming to become ‘a full-service biopharmaceutical company’: creating a greater global footprint for its CDMO business, continuing to advance its biosimilars business, and laying the groundwork for novel drug development.
Therapies for cancer, autoimmune diseases, inflammatory diseases and other drug markets are all siloed, despite new research emerging that shows potential connections between them. In order to create more effective therapeutics, we need to pull from research...
UK biotech, OXGENE, says its SLIM platform for discovery of antibodies against membrane proteins in their native configuration in mammalian cells could support CAR-T therapeutics.
The European Commission had held discussions with French pharma company, Valneva, with a view to securing up to 60 million doses of its inactivated virus COVID-19 vaccine, VLA2001.
Moderna announced today that it is expanding its pipeline of innovative vaccines with three new development programs based on the 'clinical success' of its infectious disease vaccine portfolio to date.
Sanofi will acquire Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibodies. The acquisition will give it global rights to KY1005, which has the potential to treat a range of immune-mediated diseases and inflammatory...
New evidence suggests that the Pfizer-BioNTech Covid-19 vaccine might protect against a mutation found in two contagious variants of the coronavirus circulating in the UK and in South Africa.
The EU Commission has obtained 300 million more doses of the Pfizer-BioNTech COVID-19 vaccine, doubling the amount currently available to EU-27 countries.
Pharmaceutical giant Bayer will support development of CureVac’s mRNA COVID-19 vaccine candidate across numerous areas: helping facilitate the global supply of several hundred million doses.
The World Health Organization’s vaccine advisory group recommends the two doses of the Pfizer/BioNTech vaccine should be delivered 21 to 28 days apart: although it adds that the maximum time period between doses could be up to six weeks in some situations.
Tokyo headquartered, Fujifilm Corporation, has announced a new US$2bn (£1.4bn/€1.5bn) investment to establish a new large-scale biopharma site in the US.
