An industry study from the producer of CPhI North America shows the pandemic and other factors are contributing to a very dynamic pharmaceutical market.
A holistic approach to decentralized clinical trials that combines intentional design, stakeholder collaborations, and user-friendly technology is what’s needed to execute global clinical trials more efficiently, argues an expert.
WHO is recommending the use of interleukin-6 (IL)-6 receptor blockers in patients with severe and critical COVID-19, adding them to its list of treatments for the virus.
The committee for human medicines (CHMP) of the European Medicines Agency (EMA) has approved a scale-up of the active substance manufacturing process at a Janssen Biologics BV site in the Netherlands.
The University of Oxford in partnership with AstraZeneca began vaccinations yesterday for a new phase in human trials to test a COVID-19 vaccine ‘AZD2816’ in volunteers against the Beta [South African] variant.
Augmenta Bioworks and TFF Pharmaceuticals Inc have selected their first lead monoclonal antibody (mAb) for clinical development against COVID-19 as part of their collaborative alliance.
A judgement has been issued in the legal dispute between the European Commission and AstraZeneca over a shortfall of delivery of the company’s COVID-19 vaccine doses to the EU-27.
Decentralized trials and remote monitoring, long discussed, but never really taking off until COVID-19 disrupted studies last year, will be under the spotlight at the DIA 2021 Annual Meeting at the end of this month.
New analysis by PHE shows for the first time that two doses of the COVID-19 vaccines produced by Pfizer and AstraZeneca offer are highly effective against hospitalization from the Delta variant.
The G7 wants to see a 100-day response to future pandemics, including vaccines ready for deployment at scale in this time. ‘The three best weapons we have are diagnostics, therapeutics and vaccines’ says a report from the summit.
Thanks in part to swift COVID-19 response and relatively low infection rates, more sites and sponsors are looking at the region to locate their studies.
The virtual clinical development firm’s analysis of patient profiles reflects obesity is the most significant indicator for severity in those under 40.
The online pharma event will address the COVID-19 pandemic’s impact on the industry (and vice versa) and innovation in the face of formidable challenges.
A robust research and innovation ecosystem makes Italy an attractive life sciences hotspot, according to a post from an Italian trade delegation at Bio Digital 2021.
Canadian biotechnology company, Medicago, announced positive interim Phase 2 results this week for its plant-derived COVID-19 vaccine, which has been tested in combination with GSK’s pandemic adjuvant.
The European Commission today announced that it has reserved an additional 1.8 billion doses of the coronavirus vaccine developed by Pfizer-BioNTech, on behalf of all 27 EU countries, from the end of 2021 to 2023.
Sanofi and GSK announced today that their COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase 2 trial.
Ontario-based, Nicoya Lifesciences, is in the process of completing a prototype of a low-cost, single-use device that tests for active SARS-CoV-2 infection, variants and, eventually, other viruses. The novel test is called Atlas.
A new report published by Meticulous Research shows the continuous bioprocessing market is expected to grow at a CAGR of 22.9% from 2020 to 2027 to reach US$197.8m by the end of the period.
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...
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.
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.
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 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.
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.
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.
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.
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 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.
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.
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.
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.
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.
South Africa is halting the use of the Oxford University-AstraZeneca COVID-19 vaccine in its vaccination campaign following the release of trial data showing the jab offered limited protection against mild to moderate infection caused by the country’s...
UK based pharma group, GlaxoSmithKline, and German biotech, CureVac, have struck a €150m (US$180m) deal to jointly develop next generation mRNA vaccines for COVID-19; the goal is to address multi-variants with one vaccine.
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 pharma giant had announced last week that it could deliver only 25% of the doses originally promised to the EU-27 for Q1 2021 due to production issues at one of its European factories. But it has now agreed to send 9m additional doses and will start...
