Pfizer and BioNTech have begun evaluating the safety and immunogenicity of a third dose of their mRNA vaccine, to understand the effect of a booster on immunity against current and emerging virus variants.
The FDA has outlined its analysis of Johnson & Johnson's single-shot COVID-19 vaccine, ahead of a meeting of the Vaccines and Related Biological Products Advisory Committee Meeting to assess the candidate's application for Emergency Use...
Moderna has announced new capital investments to increase COVID-19 vaccine manufacturing capacity: targeting global capacity of 1.4 billion doses in 2022.
Moderna’s variant-specific vaccine – designed to tackle the South Africa variant – has been shipped to the US National Institutes of Health (NIH) for a Phase 1 clinical trial.
Locus Biosciences says the results of its early stage clinical trial for CRISPR-enhanced bacteriophage therapy shows its precision medicine asset is safe and well tolerated.
A program at the University Hospital of Tübingen is the first in Germany to use whole genome sequencing (WGS) to improve the diagnosis of rare diseases and hereditary cancers.
Human B cells continue to work against SARS-CoV-2 months after infection, but derived antibodies do not recognize mutant variants from Brazil and South Africa, finds new research published in Science Immunology.
Clover Biopharmaceuticals today announced that it has raised US$230m in Series C financing, bringing to over US$400m the funds it has generated in the past 12 months.
The US Food and Drug Administration (FDA) has issued guidance for companies developing vaccines, diagnostics and therapeutics against new variants of SARS-CoV-2.
Sanofi and GSK have initiated a new Phase 2 study for their COVID-19 vaccine candidate; with a Phase 3 study set to follow in Q2 and potential rollout of the vaccine in Q4.
Sanofi’s vaccine manufacturing plant in Marcy l’Etoile, France, will formulate and fill vials of Janssen’s COVID-19 vaccine: producing around 12 million doses a month to help address global supply demands.
Real-world data from England shows that the Pfizer/BioNTech vaccine offers 'clear protection from first dose' and may help interrupt transmission; while Scottish data shows the first doses of vaccines led to a substantial fall in hospital admissions....
AstraZeneca is voluntarily withdrawing the use of its cancer drug, Imfinzi, to treat advanced bladder cancer in the US after it did not meet post-approval requirements.
Pfizer and BioNTech have submitted new stability data to the US Food and Drug Administration (FDA), showing that their vaccine can be stored at standard freezer temperatures for two weeks.
Pfizer and BioNTech have dosed the first participants in a Phase 2/3 study for their COVID-19 vaccine in pregnant women; and plan to trial the vaccine in children later this year.
Celltrion’s adalimumab biosimilar, Yuflyma (CT-P17) has been approved by the European Commission for the treatment of multiple chronic inflammatory diseases, including rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis.
The UK government has announced the launch of the Advanced Research and Invention Agency (ARIA), an initiative to fund “high-risk, high-reward” scientific research in the hope of achieving “groundbreaking” discoveries.
In 2020, GSK and Vir Biotechnology partnered to research and develop therapies for coronaviruses. This agreement has now been extended to include new therapies for influenza and other respiratory viruses, with GSK investing $345m in the extended partnership.
Quotient Sciences, a drug development and manufacturing accelerator with facilities in the UK and the US, has acquired Arcinova, a UK-based multiservice contract development and manufacturing organization (CDMO).
Avacta says data from ongoing clinical studies in Europe and the UK show excellent performance of its SARS-CoV-2 rapid antigen test in identifying patients with an infectious viral load and no false positive results.
South Africa has started administering the Janssen COVID-19 vaccine to health workers this week after the first doses arrived in the country. Meanwhile, J&J has submitted an application for Conditional Marketing Authorisation in the EU, following...
Massachusetts-based clinical research organization (CRO), Charles River Laboratories, is to acquire Cognate BioServices, a cell and gene therapy contract development and manufacturing organization (CDMO) for around US$875m in cash.
AstraZeneca’s COVID-19 vaccine has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO): meaning the vaccine can be rolled out globally through COVAX.
Researchers at the European Molecular Biology Laboratory (EMBL) have identified sequences in human proteins that might be used by SARS-CoV-2 to infect cells.
Texas headquartered Molecular Templates (MTEM) has entered into a worldwide strategic research collaboration with Bristol Myers Squibb (BMS) to discover and develop multiple novel therapies designed for specific oncology targets.
Scotland’s University of Glasgow has entered into a research collaboration with pharma group, Eli Lilly, to develop the next generation of drug targets for immunological diseases.
From new research offering promise for children's cancer to FDA registrations, we track the progress made in the past few weeks in terms of advancing CAR T-cell therapy in a number of markets.
CureVac has initiated a rolling review with the European Medicines Agency (EMA), working towards authorization for its mRNA COVID-19 vaccine in the European Union.
AbbVie and Caribou Biosciences have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR)-T cell therapeutics.
Global CDMO, Rentschler Biopharma, has announced today that it will build its ATMP capacity in the UK at the Cell and Gene Therapy (CGT) Catapult facility in Stevenage.
While some jurisdictions have limited the use of the Oxford University / AstraZeneca COVID-19 vaccine, the WHO says it can be used even where variants are known to be in circulation and with people aged 65+.
Announcing its financial results for 2020, AstraZeneca has said that it could take between six and nine months to develop shots that are effective against new variants of COVID-19.
AstraZeneca and IDT Biologika are exploring options to accelerate output of finished COVID-19 Vaccine AstraZeneca in the second quarter of 2021 in order to help support Europe’s immediate vaccination needs during the pandemic.
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.
UK catalyst organization, CPI, has announced the launch of a project that aims to revolutionize the manufacture of oligonucleotides, through a collaboration involving, among others, AstraZeneca, Exactmer, and Novartis.
Health officials in Azerbaijan have granted approval for a clinical trial to take place in that country combining Russia’s Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older.
Johns Hopkins Medicine researchers have studied the reaction of nearly 200 solid organ transplant recipients to their first COVID-19 vaccine shot. The findings, they say, suggest that the Moderna and Pfizer/BioNTech mRNA vaccines can be safely given to...
By Mike Pears and Joel Beevers, Patent Attorneys at Potter Clarkson
January 1, 2021 marked the UK’s official separation from the EU and with that has come a raft of changes to how the nation will now do business with the rest of the world.
EU pharma industry representatives have expressed concern that the recently enacted EU export transparency mechanism could risk production delays or jeopardize the supply of COVID-19 vaccines in Europe.
CureVac aims to bring together expertise from both its own company and other stakeholders to provide ‘broader and faster protection against current and future viral threats’: through collaborations with the UK Government, Bayer and GSK.
J&J pledges to start shipping doses of its COVID-19 vaccine in the US as soon as Emergency Use Authorization (EUA) is received from the Food and Drug Administration, while it plans to apply for Conditional Marketing Authorization in the EU in the...
