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.
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.
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.
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.
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.
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?
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.
Two leading clinical research organizations (CROs) say they have identified neutralizing antibodies with great potential for monoclonal antibody treatment.
Oslo headquartered, Vaccibody, a pioneer in the neoantigen cancer vaccine space, has entered into an exclusive worldwide license and collaboration agreement with Genentech.
The Serum Institute of India will receive six 4,000L CSR bioreactors from ABEC to help it scale up manufacture of Novavax’s COVID-19 vaccine candidate.
Ena Respiratory’s preventative nasal spray treatment could reach human trials within four months, following results from an animal study released today which showed the spray reduced COVID-19 replication by up to 96%.
Johnson & Johnson has launched its pivotal global Phase 3 trial for its COVID-19 vaccine candidate: anticipating the first batches of its vaccine will be available for emergency use authorization in early 2021.
Catalent recently announced that it is investing US$130m in an expansion project at its viral vector manufacturing facility located in Harmans, Maryland, with five new manufacturing suites set to respond to a growing customer pipeline and market demand.
Viral vector production capacity has become increasingly constrained in recent years due to increases in the therapies in development, the dosages given and the patient populations targeted. COVID-19 is exacerbating the situation.
Recognizing the industry-wide need to improve adeno-associated virus (AAV) vector manufacturing, Applied Genetic Technologies Corporation (AGTC) has adopted changes intended to increase yield and purity.
Naturally occurring viral vectors of human liver origin may be more effective than vectors grown in cultured lab conditions for liver gene therapy, according to a study published in Science Translational Medicine this month.
Californian biotech Siolta Therapeutics has raised $30m in a series B investment round: with the financing to fund the clinical development of novel microbiome-based medicines.
BioNTech will acquire Novartis’ GMP certified manufacturing facility in Marburg, Germany: with the site set to become one of the largest mRNA manufacturing plants in Europe.
Thermo Fisher Scientific has opened a new bioprocessing collaboration center (BCC) adjacent to its biologics manufacturing facility in St Louis, Missouri.
Merck and Seattle Genetics have announced two strategic oncology collaborations: one to develop Seattle Genetics’ antibody-drug conjugate ladiratuzumab vedotin worldwide; and another to accelerate the global reach of Tukysa (tucatinib).
Cytiva is to invest US$500m over the next five years to raise manufacturing capacity, hiring nearly 1,000 personnel in Austria, China, Singapore, Sweden, and the US, and bringing on new manufacturing lines, 24/7 shift patterns, and increased automation.
AstraZeneca has resumed UK clinical trials for its Oxford coronavirus vaccine, having paused all trials last week for a safety review. Other late-stage global trials, however, remain on hold while AstraZeneca waits for regulators in each market.
An FDA regulatory request to Sarepta could delay the timeline for approval of its Duchenne muscular dystrophy (DMD) gene therapy if it results in a deferral of the start of a planned Phase 3 study for SRP-9001.
Venom from honeybees has been found to rapidly destroy triple-negative breast cancer and HER2-enriched breast cancer cells – with minimal effect on healthy cells, according to a study published this month.
The Australian Government has made a $1.7bn AUD ($1.24bn USD) supply and production agreement for COVID-19 vaccines: with the first doses set to come from AstraZeneca’s vaccine in January 2021.
Swiss giant Nestlé is to acquire Aimmune Therapeutics, a biopharmaceutical company developing and commercializing treatments for food allergies. Aimmune’s Palforzia is the world’s first approved treatment for peanut allergy.
