People who have been infected with SARS-CoV-2 retain immune memory to protect against reinfection for 'at least eight months', according to Australian scientists. "This research is the strongest evidence for the likelihood that vaccines...
More than 360,000 people have signed up to the UK’s registry of people interested in participating in vaccine trials: the world’s first database of its kind. The UK is also exploring other measures – such as human challenge trials - to boost clinical...
BioNTech's CEO says it is highly likely that the Pfizer/BioNTech vaccine will be able to deal with the new variant that has emerged in the UK. And a new vaccine could be developed within six weeks if needed.
Valneva has started a Phase 1/2 trial of its COVID-19 vaccine: eying up potential regulatory approval in the fourth quarter of 2021. It champions a ‘tried and tested’ approach with its inactivated candidate.
The US has started COVID-19 vaccinations this morning: after the Pfizer/BioNTech vaccine was granted Emergency Use Authorization (EUA) by the FDA on Friday.
US headquartered company, Orgenesis, and South Korea-based, Cure Therapeutics, have signed a JV deal to advance the development, regulatory approval, and commercialization of point of care production for both companies’ cell and gene therapies and immunotherapies....
Rani Therapeutics, a clinical-stage biopharma company and developer of the RaniPill robotic pill, today announced that it has raised US$69m in a Series E financing round, bringing total funding to date to US$211.
AstraZeneca and the University of Oxford's COVID-19 vaccine candidate threw up a surprise last month when a lower initial dose of the two-dose vaccine showed higher efficacy. More detailed results from this interim analysis, now peer-reviewed and...
Three studies, which are being presented during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, report promising results in the use of cutting-edge genome editing and cellular therapies for hard-to-treat blood disorders and...
Janssen Pharmaceuticals, Inc. has acquired the rights to Hemera Biosciences’ investigational gene therapy HMR59: which has been designed to help preserve vision in patients with severe age-related macular degeneration (AMD).
Erbi Biosystems recently raised US$3.8m in a round led by Jaguar Biotech; the funds will allow the company to expand its platform of microfluidic bioprocess and bioreactor equipment, which is said to enable ultra-high cell density and continuous processing.
A neuroprotective drug which is already in development may be particularly effective for MND patients carrying a newly discovered genetic risk factor, helping to halt progression or even prevent the onset of the devastating degenerative disease.
US based scientists have hit upon a method to efficiently identify potential biological mechanisms underlying autism spectrum disorder (ASD); the Harvard and MIT based researchers say the approach is an important first step toward developing treatments...
From operational uncertainty and outdated manual processes to new cell lines and a potential shift towards allogeneic cell therapy, CRB’s new report - Horizons: Cell and Gene Therapy - finds the biopharma industry at the critical intersection of obstacle...
Moderna has announced it will submit an Emergency Use Authorization request to the US FDA today for its COVID-19 vaccine candidate. It has also released the Phase 3 primary efficacy analysis, showing 94.1% efficacy.
BioNTech and InstaDeep are creating a joint AI innovation lab in Europe to develop novel immunotherapies. “We see a significant opportunity at the intersection of AI and immunology by computational design of new precision immunotherapies,” says BioNTech....
BioInvent, a Swedish biotech focused on the discovery and development of immuno-regulatory antibodies for oncology, reports that it has been contracted as manufacturer of Cantargia’s antibody CAN10.
GlaxoSmithKline has started dosing patients in a Phase 3 clinical program investigating the safety and efficacy of its Respiratory Syncytial Virus (RSV) candidate vaccine for maternal immunisation.
Biopharma company, CureVac, and Wacker Chemie have signed a contract for the manufacturing of CureVac’s mRNA-based COVID-19 vaccine candidate - CVnCoV.
Merck will acquire Oncolmmune for an upfront payment of $425m: pledging to accelerate the development of CD24Fc, a candidate for the treatment of patients with severe and critical COVID-19.
Regeneron’s casirivimab and imdevimab antibody cocktail (formerly known as REGN-COV2 or REGEN-COV2), has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
Eli Lilly and Company's neutralizing antibody bamlanivimab (LY-CoV555) has received interim authorization from Health Canada as a treatment for COVID-19.
Sanofi’s MenQuadfi becomes the first quadrivalent meningococcal conjugate vaccine available in Europe in a fully liquid presentation, avoiding the need for vaccine reconstitution.
AstraZeneca says interim analysis of clinical trials in the UK and Brazil of its candidate COVID-19 vaccine being developed in partnership with the University of Oxford - AZD1222 - showed the vaccine was highly effective in preventing COVID-19, the primary...
The European Commission has granted a marketing authorization for Sanofi’s Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine: representing the first and only recombinant influenza vaccine approved in the European Union.
It’s been a big week for mRNA-based COVID-19 vaccines: with both Pfizer/BioNTech and Moderna reporting impressive efficacy for their COVID-19 vaccine candidates. Here's five key takeaways from this week's developments.
Pfizer has revised the efficacy figures for its COVID-19 vaccine candidate – now stating the vaccine is 95% effective – with its Phase 3 study meeting all primary efficacy endpoints.
Moderna’s mRNA COVID-19 vaccine candidate has reported vaccine efficacy of 94.5% in the first Phase 3 interim analysis, released this morning. "This is a pivotal moment," says Moderna's CEO.
Johnson & Johnson has launched a second global Phase 3 trial for its Janssen COVID-19 vaccine candidate: this time exploring a 2-dose regimen (its existing Phase 3 trial is for a 1-dose regimen).
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines in preparation for the first three vaccines likely to be launched in Europe.
Sinovac’s Phase 3 COVID-19 vaccine trial has been put on hold in Brazil after a serious adverse event. But in a statement this morning, the company says the event is not related to the vaccine.
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Novavax’s COVID-19 vaccine. Novavax plans to start Phase 3 trials for the candidate in the US and Mexico by the end of the month.
Pfizer says its COVID-19 vaccine candidate is more than 90% effective in preventing COVID-19, releasing interim analysis from its Phase 3 study this morning. “Today is a great day for science and humanity,” says the company’s CEO.
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a text on analytical strategy options for the control of COVID-19 recombinant viral vectored vaccines.
Sanofi is eying up the European biopharmaceutical company’s proprietary next generation natural killer (K-NK) cell platform and pipeline of cell-based cancer immune-therapeutics and infectious disease therapies.
