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 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.
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.
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.
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 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.
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...
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...
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.
The EU Commission has granted a conditional marketing authorization for the COVID-19 vaccine developed by US biotech, Moderna, the second COVID-19 vaccine authorized in the EU.
AstraZeneca officially announced today the Serum Institute of India had obtained emergency use authorization in India for its COVID-19 vaccine. It also confirmed the vaccine has been granted emergency use authorization in Argentina, Dominican Republic,...
A US advisory panel has recommended the next two US priority population groups to receive the COVID-19 vaccine should be those 75 and older and essential workers.
It is known and expected that viruses constantly change through mutation leading to the emergence of new variants, but preliminary analysis in the UK suggests the new SARS-CoV-2 variant is significantly more transmissible than previous ones.
The US Food and Drug Administration (FDA) has authorized emergency use of Moderna’s vaccine against COVID-19, mRNA-1273, in individuals who are 18 years of age or older.
The first patient has been enrolled in the randomized Phase 3 SILVAR study to evaluate the efficacy and safety of siltuximab in patients with COVID-19 previously treated with corticosteroids, or another respiratory virus infection associated with serious...
The US Food and Drug Administration (FDA), in a review of Moderna’s COVID-19 vaccine candidate, found no safety concerns that would preclude the granting of emergency use authorization (EUA) for the vaccine in the US during the pandemic.
The European Medicines Agency has brought forward a key meeting to assess the Pfizer/BioNTech COVID-19 vaccine: with its committee now convening a week earlier than scheduled.
CureVac has announced today the enrollment of the first participant in the pivotal Phase 2b/3 study of its messenger ribonucleic acid (mRNA) vaccine candidate, CVnCoV, against COVID-19.
Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.
The FDA is set to make a decision on Emergency Use Authorization (EUA) in the coming days for the mRNA COVID-19 vaccine candidate, BNT162b2, from drug makers, Pfizer and BioNTech.
The US Food and Drug Administration (FDA) said there are ‘no specific safety concerns that would preclude issuance of an EUA’ for the investigational COVID-19 vaccine (BNT162b2) from US pharma giant, Pfizer, and its German partner BioNTech.
UnitedHealth Group is partnering with Eli Lilly and Co to test the efficacy of the Indianapolis-based pharma giant’s COVID-19 monoclonal antibody treatment, bamlanivimab, with patients at the highest risk of adverse outcomes.
The Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary authorization for emergency use for Pfizer and BioNTech's mRNA vaccine (BNT162b2), against COVID-19.
Moderna has announced it will submit an Emergency Use Authorization request to the US FDA today for its COVID-19 vaccine candidate. It has also released the Phase 3 primary efficacy analysis, showing 94.1% efficacy.
Up to 10% of vaccines can be reportedly lost in transit due to breakage or fluctuations in sub-zero temperatures required for preservation, but a manufacturer of data-driven temperature-controlled smart containers says it can cut that rate to just 0.1%.
Biopharma company, CureVac, and Wacker Chemie have signed a contract for the manufacturing of CureVac’s mRNA-based COVID-19 vaccine candidate - CVnCoV.
Merck will acquire Oncolmmune for an upfront payment of $425m: pledging to accelerate the development of CD24Fc, a candidate for the treatment of patients with severe and critical COVID-19.
Regeneron’s casirivimab and imdevimab antibody cocktail (formerly known as REGN-COV2 or REGEN-COV2), has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
AstraZeneca says interim analysis of clinical trials in the UK and Brazil of its candidate COVID-19 vaccine being developed in partnership with the University of Oxford - AZD1222 - showed the vaccine was highly effective in preventing COVID-19, the primary...
How prepared is the existing global cold chain, and especially refrigerated transport, to cope with the full temperature ranges required for the multiple COVID-19 vaccine candidates? A cold chain expert responds.
The COVID-19 pandemic is expected to continue to impose enormous burdens on societies and economies globally. While governments are now getting ready to ensure large-scale distribution of a vaccine, concern about vaccine hesitancy is growing worldwide....
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Lucira COVID-19 All-In-One Test Kit: the first COVID-19 diagnostic test for self-testing at home.
Biotech funding kicked back into higher gear in October, pushing toward the summer monthly record highs with $10.5B raised, writes analyst firm, Jefferies
Johnson & Johnson has launched a second global Phase 3 trial for its Janssen COVID-19 vaccine candidate: this time exploring a 2-dose regimen (its existing Phase 3 trial is for a 1-dose regimen).
As vaccine development for COVID-19 continues to be successful in terms of clinical data, the next step in getting the vaccines to people is storage and distribution.
The clear evidence of increased risk of COVID-19 infection amongst ethnic minority groups, people from Black and Asian backgrounds, is of urgent public health importance, according to the authors of a paper published today by The Lancet.
COVID-19 is like a big oak tree casting shade on all other biopharma industry developments. Vaccine-related articles dominate the most popular story rankings. With Pfizer and BioNTech now out in front in the coronavirus vaccine race, we track the related...