Pfizer has upped its 2021 sales forecast for its mRNA COVID-19 vaccine to $26bn: as well as reporting strong Q1 results for the business overall this morning.
Meissner Filtration Products has just been awarded a US$13.4m contract from the US government agency, BARDA, to boost its production capability for components critical to vaccines and therapies linked to the COVID-19 response.
Moderna has announced a set of additional investments to allow it to increase global supply of its COVID-19 vaccine. ‘We believe there will continue to be significant need for our vaccine into 2022 and 2023’, says the company.
As COVID-19 response initiatives and vaccine rollouts begin to bring the pandemic under control, we consider what changes to clinical trials will be made permanent.
Medicago has started a rolling submission with Health Canada for its plant-derived adjuvanted COVID-19 vaccine candidate: championing a unique and versatile platform that can also be scaled up easily.
The European Commission has decided to bring legal proceedings against AstraZeneca, it confirmed today. But AstraZeneca says the litigation is without merit, adding it will ‘strongly defend itself’ in court.
Roche witnessed a slight decrease in Q1 2021 pharmaceutical sales – a drop of 9% compared to the first three months of 2020 - as it faced continued biosimilars competition; the COVID-19 pandemic also played a role.
The European Medicines Agency’s safety committee (PRAC) says a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen: but says the benefit-risk analysis for the vaccine remains...
The European Union has exercised its option, under a previous agreement, to order 100 million additional doses of the Pfizer/BioNTech COVID-19 vaccine, Comirnaty.
Emergent BioSolutions, a contract development and manufacturing organization (CDMO), has agreed with the US FDA not to manufacture any new COVID-19 vaccine materials at its Bayview facility in Baltimore, Maryland, while the regulator investigates the...
Efficiency in the biopharmaceutical space has never been more top-of-mind. The COVID-19 pandemic brought an unprecedented urgency to R&D and the key players delivered: Several groups produced a vaccine in record time. To maintain and improve on this...
The UK’s Joint Committee on Vaccination and Immunisation (JCVI) says that pregnant women should be offered either the Pfizer/BioNTech or Moderna COVID-19 vaccines.
US pharma group, Lilly, has requested the US FDA revoke the Emergency Use Authorization (EUA) for bamlanivimab 700 mg alone due to the evolving variant landscape in the US.
Moderna will take mRNA flu and HIV vaccines into Phase 1 trials this year, as well as beginning a pivotal Phase 3 study for its cytomegalovirus (CMV) vaccine candidate.
A UK study, which has been trialing the combination of Oxford-AstraZeneca and Pfizer vaccine doses, is now extending the program to include Moderna and Novavax vaccines.
The EU has entered into negotiations with Pfizer/BioNTech for a third COVID-19 vaccine contract: which would see delivery of 1.8 billion doses of the vaccine between 2021-2023.
REGEN-COV (casirivimab with imdevimab) has been shown to reduce the risk of symptomatic SARS-CoV-2 infections by 81%, in a Phase 3 study among household contacts of infected individuals.
The European Medicines Agency (EMA) is evaluating a possible link between blood clots and Johnson & Johnson’s COVID-19 vaccine, while also reviewing reports of a bleeding condition in some individuals who received AstraZeneca’s COVID-19 shot.
Moderna today highlighted the publication of antibody persistence data out to six months following the second dose of its COVID-19 vaccine in The New England Journal of Medicine.
The European Medicines Agency’s safety committee, PRAC, has concluded there is a possible link between the use of AstraZeneca’s COVID-19 vaccine and rare side effects of unusual blood clots and low blood platelets in individuals who received the shot.
Emergent BioSolutions Inc yesterday reported that is on target in terms of all its commitments for COVID-19 vaccine production; it also reaffirmed its financial guidance, after a production issue at its Baltimore plant last week saw a massive batch of...
Media reports claim the UK regulator is set to ban the use of COVID-19 Vaccine AstraZeneca in individuals below the age of 30 over blood clot risk concerns.
GSK will help manufacture up to 60 million doses of Novavax’s COVID-19 vaccine from its facility at Barnard Castle in the UK, with doses to be distributed in the country.
The European Medicines Agency (EMA) has approved BioNTech’s Marburg site for COVID-19 vaccine production; which will become one of the largest mRNA vaccine manufacturing sites in Europe and the world. Elsewhere, additional sites are also set to produce...
The European Medicines Agency (EMA) concludes that Celltrion’s monoclonal antibody, regdanvimab, can be used in COVID-19 patients not requiring oxygen and at high risk of progressing to severe disease.
The EU Commission has adapted its export authorization mechanism for COVID-19 vaccines, shoring up its ability to prevent shipments going to countries with advanced immunization rates and good access to vaccines.
The RDIF, Russia’s sovereign wealth fund, and India based, Virchow Biotech Private Limited, have today announced a partnership to produce and supply a minimum of 200 million doses of the Russia developed Sputnik V vaccine against COVID-19.
The Oxford-AstraZeneca vaccine was 79% effective in preventing symptomatic COVID-19, according to the findings of the Phase 3 study in the US, Chile and Peru, says AstraZeneca.
Researchers have highlighted nutrition as a possible factor influencing the effectiveness of the COVID-19 vaccine, as recent news establishes a link between vitamin D levels and an adequate immune response.
Denmark has halted its vaccination campaign with COVID-19 Vaccine AstraZeneca, as a precautionary measure while a full probe is ongoing into reports of blood clots in people who received the vaccine, including one case in that country, where a person...
GSK and its partner, Vir Biotechnology, report that their jointly developed monoclonal antibody, VIR-7831, reduces hospitalization and risk of death in early treatment of adults with COVID-19.
Researchers from Cleveland Clinic's Global Center for Pathogen Research & Human Health, who have developed the nanotechnology based vaccine, say it has shown strong efficacy in preclinical disease models.
The European Medicines Agency (EMA) has started a rolling review of Sputnik V, a COVID-19 vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology.
Collaboration is not an unknown in the domain of pharmaceutical development, but it is rare enough. The demands of the COVID-19 pandemic, however, have seen competitors switch to become manufacturing allies.
Three COVID-19 vaccine manufacturing sites are set to start production in France in the coming weeks: while the French government is seeking to boost further production with a €300m ($363m) initiative announced on Monday.
BioNTech announced this morning it has started the production of mRNA at its new facility in Marburg, Germany: which will become one of the largest mRNA manufacturing sites in Europe.
Rows about vaccine supply and threats of export blocks don’t do anything to bring us closer to ending the COVID-19 pandemic, say campaigners pushing for vaccine equity on a global level.
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.
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...
Australia’s Therapeutics Goods Administration (TGA) has provisionally approved the Pfizer/BioNTech COVID-19 vaccine: making it the first available in the country.
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...
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.
