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...
2020 has been an eventful year: but 2021 will also require skilful navigation. Here's some of the people who are stepping up to leading roles as we head into a new year.
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.
Ajinomoto Bio-Pharma Services and Revance Therapeutics have announced a strategic commercial manufacturing agreement for the supply of DaxibotulinumtoxinA for Injection.
The European Medicines Agency (EMA) has recommended authorization of the Pfizer/ BioNTech COVID-19 vaccine: paving the way for the first marketing authorization of a COVID-19 vaccine in Europe.
A US advisory panel has recommended the next two US priority population groups to receive the COVID-19 vaccine should be those 75 and older and essential workers.
It is known and expected that viruses constantly change through mutation leading to the emergence of new variants, but preliminary analysis in the UK suggests the new SARS-CoV-2 variant is significantly more transmissible than previous ones.
The US Food and Drug Administration (FDA) has authorized emergency use of Moderna’s vaccine against COVID-19, mRNA-1273, in individuals who are 18 years of age or older.
The first patient has been enrolled in the randomized Phase 3 SILVAR study to evaluate the efficacy and safety of siltuximab in patients with COVID-19 previously treated with corticosteroids, or another respiratory virus infection associated with serious...
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.
New Zealand now has enough COVID-19 vaccines for everyone in the country, says the government, as it announces two new supply agreements with Novavax and AstraZeneca today.
Sterling Pharma Solutions, a global contract development and manufacturing organization (CDMO), has announced a new strategic partnership with ADC Biotechnology, a UK based company specializing in antibody-drug conjugates (ADCs).
The US Food and Drug Administration (FDA), in a review of Moderna’s COVID-19 vaccine candidate, found no safety concerns that would preclude the granting of emergency use authorization (EUA) for the vaccine in the US during the pandemic.
The European Medicines Agency has brought forward a key meeting to assess the Pfizer/BioNTech COVID-19 vaccine: with its committee now convening a week earlier than scheduled.
Sanofi has made a new five-year, $25m partnership agreement with the World Health Organization (WHO) to fight Neglected Topical Diseases (NTD); and eliminate sleeping sickness by 2030.
Following the announcement yesterday by the UK’s Health Secretary Matt Hancock that a new strain of SARS-COV-2 could be responsible for faster spread of the virus in the South East of England, Shore Capital analysts give their perspective on what is known...
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....
CureVac has announced today the enrollment of the first participant in the pivotal Phase 2b/3 study of its messenger ribonucleic acid (mRNA) vaccine candidate, CVnCoV, against COVID-19.
Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.
The FDA is set to make a decision on Emergency Use Authorization (EUA) in the coming days for the mRNA COVID-19 vaccine candidate, BNT162b2, from drug makers, Pfizer and BioNTech.
UK company, Spirea, a spin-out from the University of Cambridge, which was founded to deliver the next generation of antibody drug conjugate (ADC) cancer therapeutics, has secured financing from o2h Ventures and Syndicate Room.
The UK’s MHRA says anyone with a history of anaphylaxis should not receive the Pfizer/BioNTech COVID-19 vaccine: following two reports of anaphylaxis and one report of a possible allergic reaction in the first immunizations carried out this week.
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...
As the US FDA advisory committee meets to discuss the merits and risks of Pfizer/BioNTech’s application for emergency use of their COVID-19 vaccine candidate, we talk to two US legal experts to get their perspective on vaccine distribution stateside....
The US Food and Drug Administration (FDA) said there are ‘no specific safety concerns that would preclude issuance of an EUA’ for the investigational COVID-19 vaccine (BNT162b2) from US pharma giant, Pfizer, and its German partner BioNTech.
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...
UnitedHealth Group is partnering with Eli Lilly and Co to test the efficacy of the Indianapolis-based pharma giant’s COVID-19 monoclonal antibody treatment, bamlanivimab, with patients at the highest risk of adverse outcomes.
New data shows a move towards commercialization and a 48% increase in GMP cell and gene therapy (CGT) manufacturing space in the UK this year despite the COVID-19 pandemic.
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).
ERS Genomics, which was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property co-owned by the one of the joint 2020 Nobel Prize winners for Chemistry, Dr Emmanuelle Charpentier, has granted a non-exclusive license agreement...
With the Pfizer/BioNTech COVID-19 vaccine authorized in the UK yesterday, the roll out of the first 800,000 doses will begin next week. 'We have spent months preparing for this day, so that as soon as we got the green light we would be ready to go,'...
Upstream processes were the focus of most early applications of continuous bioprocessing. That is now changing, with many biologic manufacturers evaluating downstream continuous processing and suppliers preparing their portfolios for the anticipated pivot...
Special Edition: The Future of Continuous BioProcessing
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.
Special Edition: The Future of Continuous BioProcessing
The shift away from batch downstream processing has moved closer in recent years amid progress on techniques such as antibody purification using continuous chromatography media. However, there remain barriers to clear before manufacturing facilities that...
