CureVac is expanding its late-stage clinical trials for its COVID-19 vaccine candidate; while confirming it is on schedule to apply for formal market authorization in the EU in Q2 2021.
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.
The European Medicine Agency (EMA) says its safety committee has ruled that COVID-19 Vaccine AstraZeneca is safe and effective, and the benefits of its use outweigh any possible risks.
Pfizer is selling a biologics manufacturing unit in the eastern city of Hangzhou to WuXi Biologics, despite the US pharma giant having ploughed US$350m into the site in 2016 to develop biosimilars.
Axol Biosciences, a UK provider of human induced pluripotent stem cells (iPSC) derived cells, media, and characterization services, has merged with Scotland based, Censo Biotechnologies, a cell biology CRO with expertise in iPSC-related technologies.
Seekyo, a startup biotechnology company specializing in the development of ‘smart chemotherapy’ drugs that limit harmful side effects, has raised in excess of €650,000 (US$775K) in bridge funding.
Autolus Therapeutics is seeking a partner for clinical development of an ACE2 fusion soluble receptor decoy designed to work against SARS-CoV-2 and its variants.
Precigen claims breakthroughs in CAR T cell therapy manufacturing that will eventually allow cancer centers to enable treatments earlier and at a lower cost.
Biogen has estimated 10 million patients in the US are suitable for treatment with its Alzheimer’s disease candidate aducanumab, setting it up to generate blockbuster sales if it wins approval.
Governments want to 'build up a vaccine and biologics infrastructure locally' to insulate themselves from the sorts of supply disruptions seen in the COVID-19 pandemic, according to Merck KGaA CEO Stefan Oschmann.
US biotech, Moderna, reports today that the first participants have been dosed in its Phase 2/3 clinical trial investigating the efficacy of its COVID-19 vaccine in children ages 6 months to less than 12 years.
Cell and Gene Therapy Catapult (CGT Catapult) says that GSK will leverage its Stevenage facility to perform GMP cell processing and accelerate its cell and gene therapy pipeline for clinical trials.
As more countries temporarily pause the use of the COVID-19 Vaccine AstraZeneca in their vaccination programs, the company stressed the safety of the jab, based on scientific evidence.
The Coalition for Epidemic Preparedness Innovations (CEPI) has set out a $3.5bn plan to ‘dramatically reduce or even eliminate the future risk of pandemics’. Its ambitions are for an ‘all-in-one’ vaccine against SARS, MERS-CoV and SARS-CoV-2 coronaviruses;...
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.
Affibody and Inmagene Biopharmaceuticals report that the US FDA has cleared the interleukin-17 (IL-17) blocker, izokibep, to proceed to phase 2 clinical development in non-infectious intermediate, posterior, and pan-uveitis.
Novartis reported today that a clinical trial of the drug, known as canakinumab, when combined with chemotherapy agent, docetaxel, failed to extend the lives of patients with advanced or metastatic non-small cell lung cancer compared to just chemotherapy...
A global economic recovery is in sight but a faster and more effective vaccination rollout across the world is critical, while respecting necessary health and social distancing measures, according to the OECD’s latest Interim Economic Outlook.
A laboratory study published in the New England Journal of Medicine shows the Pfizer/BioNTech COVID-19 vaccine was able to neutralize the emerging Brazil coronavirus strain.
Baxter BioPharma Solutions will provide fill/finish sterile manufacturing services and supply packaging for approximately 60-90 million doses of Moderna’s COVID-19 vaccine this year.
A coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland has set out guidance for how variant-specific versions of authorized vaccines will be regulated: saying they will not need brand new approval or lengthy clinical...
Valneva and Pfizer have initiated a Phase 2 study for their Lyme disease vaccine candidate: which is the only active Lyme disease vaccine in clinical development today.
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.
China's Pharmaron has entered into a definitive agreement to acquire the Allergan Biologics Limited (ABL) site in Liverpool, UK, for US$118.7m in cash from AbbVie.
Convergence towards common global standards for clinical trial application (CTA) rules, along with unilateral and mutual recognition of CTA approvals are some suggestions made by industry insiders in a new paper to enable robust and timely development...
The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.
Merck’s US facilities will help manufacture Johnson & Johnson’s COVID-19 vaccine: which a $268.8m injection from the US government helping it adapt existing facilities for COVID-19 vaccines and medicines.
The 2020 Pfizer/BioNTech COVID-19 vaccine trial recruited more than 44,000 participants and reached submission for emergency authorization in 248 days: showing unprecedented speed and agility in the context of a global pandemic. So what have been the...
The European Medicines Agency (EMA) has published guidance outlining the regulatory requirements for manufacturers planning to modify their COVID-19 vaccines against SARS-CoV-2 variants.
WuXi AppTec has completed its acquisition of Oxgene, a UK contract research and development organization that designs and develops scalable gene therapy technologies.
This week France has raised the age limit for the AstraZeneca COVID-19 vaccine; but Canada, conversely, has put a 65-year-old limit into its recommendations.
The Pfizer/BioNTech COVID-19 vaccine – which requires ultra-cold storage – will now be allowed to be transported and stored at standard freezer temperatures for up to two weeks in the US.
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...
