Pfizer and BioNTech’s COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses in adolescents aged 12-15 years old, according to results from a Phase 3 trial released this week. “We plan to submit these data to the FDA as a proposed amendment...
Pfizer and BioNTech expect to expand COVID-19 vaccine manufacturing capacity to up to 2.5 billion doses by the end of 2021, thanks to the optimization of production processes and the recent initiation of production in Marburg, Germany.
A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the company’s application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.
COVID-19 mRNA vaccines are ‘highly effective’ in producing antibodies against SARS-CoV-2 in pregnant and lactating women; and also confer protective immunity to newborns, according to a new study.
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 EU has approved new storage conditions for Pfizer/BioNTech’s vaccine: allowing the ultra-cold storage vaccine to now be kept at standard pharmaceutical freezer temperatures for a total of two weeks.
Novartis has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents.
J&J will supply the African Vaccine Acquisition Trust (AVAT) with up to 220 million doses of its single-shot vaccine, with the potential to increase the order to a total of 400 million.
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.
Cytiva has opened a new diagnostics design lab in Tonglu, its manufacturing site close to Shanghai in East China, where it has been making filtration products for many years.
A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.
As tensions over COVID-19 vaccine supplies in Europe continue, AstraZeneca clarifies that a set of doses at its Anagni plant in Italy are destined for the EU and COVAX.
AstraZeneca has released the primary analysis from its COVID-19 vaccine US Phase 3 trial, showing 76% efficacy for the vaccine against symptomatic COVID-19. The company highlights that this backs efficacy data from Monday's interim analysis, responding...
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.
US company, KIYATEC, says a new study has shown that its immune-modified ex vivo platform can measure treatment response through direct interaction between a patient's cancer and infiltrating immune cells, and immuno-oncology agents.
The pharma company and the CDC are recommending that adults continue routine vaccination during the COVID-19 pandemic to reduce future vaccine-preventable disease (VPD) outbreaks and overall strain on the healthcare system.
Thermo Fisher Scientific has announced a new, first-of-its-kind human plasma-like cell culture medium that more closely resembles the natural cellular environment found in the human body to provide researchers with a realistic view of cell growth.
The US National Institute of Allergy and Infectious Diseases (NIAID) says it is concerned that AstraZeneca 'may have included outdated information’ when releasing initial data from its COVID-19 vaccine clinical trial.
Preclinical data shows that CureVac’s COVID-19 vaccine protects against challenge infections with the B.1.351 ‘South Africa’ variant in a transgenic mouse model.
Australia’s Therapeutic Goods Administration (TGA) has approved manufacture of the AstraZeneca COVID-19 vaccine by CSL – Seqirus: reducing the country's dependence on limited supply from abroad and allowing a wider vaccination campaign to begin....
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...