Novartis has acquired Vedere Bio, giving the company a new platform for AAV-based delivery of gene therapies and an optogenetics program for the treatment and prevention of vision loss and blindness.
To support COVID-19 global preparedness, Stirling Ultracold is engaging directly with several pharmaceutical companies currently involved in COVID-19 vaccine development, with the idea of building a fleet of ULT freezers capable of storing their approved...
A lot of new companies have been entering the diagnostics field this year to address the challenges of the COVID-19 pandemic. Cytiva, as a diagnostic component provider, has been investing in new and existing sites and services to support that surge in...
Thermo Fisher Scientific is seeing “very, very significant demand” for its cold storage range as the race to get COVID-19 vaccines to market enters its closing stages.
Novavax’s Phase 3 COVID-19 vaccine trial in the UK has been expanded to 15,000 participants; while a 30,000 strong Phase 3 clinical trial is due to start in the US and Mexico next month.
Bayer will broaden its innovation base in cell and gene therapy with the acquisition of Asklepios BioPharmaceutical (AskBio): a US biotech working in gene therapies across different therapeutic areas.
Johnson & Johnson says it is preparing to resume recruitment in its Phase 3 Janssen COVID-19 vaccine trial in the US: after the trial was paused because of an unexplained illness earlier this month.
A new mathematical modeling study by Ashish Goyal and colleagues, informed by data collected from 25 patients hospitalized with COVID-19 in four different countries, offers some important new insights into the optimal timing of four different antiviral...
Moderna has flagged the diversity of the US-based Phase 3 trial of its COVID-19 vaccine candidate, mRNA-1273, for which enrollment, now at 30,000, has completed.
The use of CRISPR, the genetic scissors that allow scientists to edit the instruction manual of life, DNA, has drawn massive global attention over the last several years.
Scientists have used gene therapy and a newly developed light-sensing protein to restore sight in mice: with the technology to start clinical trials in the US later this year.
Current COVID-19 vaccine Phase 3 trials are not designed to show whether they will save lives or reduce transmission: with trials instead based on events with mild symptoms, according to a feature published in The BMJ.
The National Institute for Biological Standards and Control (NIBSC) in the UK, and Q2 Solutions in the US, have joined CEPI’s COVID-19 vaccine assessment network.
The UK is set to begin COVID-19 human challenge trials in January: aiming to increase understanding of coronavirus and speed up development of vaccine candidates.
Ori Biotech Ltd (Ori), a London and New Jersey based innovator in the cell and gene therapy (CGT) manufacturing sphere, last week announced the successful close of a US$30m Series A financing round, bringing the company’s total funding to date to US$41m.
UNICEF, the world’s largest single buyer of vaccines, is laying the groundwork for quick and efficient delivery of COVID-19 vaccines by purchasing and distributing more than half a billion single-dose syringes and other critical equipment in countries...
US company, Dyno Therapeutics, has inked a deal with Roche to develop next-generation AAV gene therapy vectors for central nervous system (CNS) diseases and liver-directed therapies.
Edesa Biotech, Inc. has received clearance from the U.S. Food and Drug Administration (FDA) to begin the Phase 2 portion of its Phase 2/3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients.
Pfizer’s CEO says the company will apply for Emergency Use Authorisation (EUA) for its COVID-19 vaccine candidate ‘soon after’ a safety milestone is reached in the third week of November.
The U.S. Food and Drug Administration (FDA) has approved Regeneron’s Inmazeb for treatment of Ebola. The antibody cocktail was developed using the same ‘rapid response’ technologies as Regeneron’s investigational COVID-19 antibody combination.
Potential vaccines for COVID-19 should not be affected by changes in SARS-CoV-2 seen to date, nor are they likely to need to be redeveloped seasonally, according to Australian scientists.
Enrollment is temporarily on hold in the ACTIV-3 clinical trial, which is evaluating Lilly's investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients. The pause was recommended by the study's...
Roche plans to launch its high-volume Elecsys SARS-CoV-2 Antigen test at the end of 2020 in markets accepting the CE mark; while the company will file for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).
Johnson & Johnson has paused dosing in all its COVID-19 vaccine candidate clinical trials – including its Phase 3 trial – due to an unexplained illness in a study participant.
The progress in the race for a COVID-19 vaccine to date has been nothing short of phenomenal. But what can the industry learn from these achievements to inform vaccine development in the future?
The US Department of Defense (DoD) and BARDA have expanded a partnership with AstraZeneca (AZ) to develop and manufacture its long-acting antibody (LAAB) combination, AZD7442, that may help treat or prevent infection with SARS-CoV-2.
Regeneron has submitted a request for Emergency Use Authorization (EUA) for its REGN-COV2 investigational antibody combination for COVID-19: which was given to US President Donald Trump last week.
A contract between the EU and Janssen Pharmaceutica NV will see Janssen supply 200 million doses of a COVID-19 vaccine, with the potential for an additional 200 million doses.
Locus Biosciences has signed a contract with BARDA to co-fund development of LBP-EC01, a CRISPR Cas3-enhanced bacteriophage (crPhage) that targets E. coli bacteria causing recurrent urinary tract infections (UTIs).
On Tuesday the FDA released its guidance on Emergency Use Authorization for COVID-19 vaccines: a move welcomed by the industry as a ‘tried and true tradition of releasing guidance in a public and transparent way’.
Fujifilm is boosting its gene therapy offering, taking the first steps to expand its viral vector contract development and manufacturing organization (CDMO) services to Europe, at the site of Fujifilm Diosynth Biotechnologies (FDB) in the North East of...
The UK’s Vaccines Manufacturing & Innovation Centre (VMIC) announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the second of two GMP COVID-19 vaccine manufacturing suites located at Oxford Biomedica's...
Vaxxas has received a $22m US Government award to conduct a Phase 1 clinical study for its novel skin-patch vaccination platform. While the trial will use a pandemic influenza vaccine, Vaxxas is also investigating opportunities to use the technology against...
Contract development and manufacturing organization (CDMO), Cobra Biologics, has been selected to manufacture plasmids for a Phase I clinical trial of a COVID-19 vaccine being developed by UK company, Scancell.
Emerging biotech, NanoSyrinx, has announced the closing of a pre-seed financing round to continue developing its ‘nanosyringes’, a selective non-viral peptide and protein delivery system.
German life science company Sartorius will merge Slovenian purification specialist BIA Separations with Sartorius Stedim Biotech, in a deal worth €360m ($423m).
The release of the FDA guidance on emergency use authorization (EUA) for vaccines to prevent the spread of COVID-19 would provide regulatory clarity to scientists and strengthen public confidence in any vaccine authorized by the US regulator, says the...
Two leading clinical research organizations (CROs) say they have identified neutralizing antibodies with great potential for monoclonal antibody treatment.
