Valneva and Pfizer report positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15: and now plan to include this population in an upcoming Phase 3 trial.
Arcturus Therapeutics Holdings Inc. has reported topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, its self-amplifying mRNA COVID-19 vaccine candidate.
Chinese companies, Biocytogen Pharmaceuticals and CtM Biotech Co Ltd, are collaborating on the development of antibody drugs against intracellular tumor-associated antigens.
Moderna’s bivalent COVID-19 booster vaccine candidate, mRNA-1273.211, demonstrated superior neutralizing titers compared to the original mRNA-1273 booster dose against all variants of concern, including Omicron, according to data released by the company...
Dyadic licensee, Epygen Biotech, has received funding from the Government of India to advance a low-cost COVID-19 vaccine through Phase 1 and 2 clinical trials in India, using Dyadic’s C1 protein production platform.
Pfizer is set to acquire Australia’s ResApp - a company developing a smartphone app to detect COVID-19 and other respiratory diseases based on the user’s cough - for $100m AUD ($74m USD).
Lonza has added new integrated capabilities in cell binding, cell separation, and bead removal to its closed, automated, and scalable platform for personalized therapy manufacturing.
After the success of mRNA with COVID-19 vaccines, a new partnership between Moderna and IAVI will seek to use the tech to target HIV/AIDS, tuberculosis, and antimicrobial-resistant enteric infections.
Pfizer will acquire ReViral, a privately-held clinical-stage company which is focused on novel antiviral therapeutics for respiratory syncytial virus (RSV), for up to $525m.
Spirulina has been converted into a biomanufacturing platform that offers a way to rapidly produce mass quantities of biologic drugs for common diseases that currently lack effective treatments, say US developers.
Curate Biosciences reports that City of Hope, one of the largest cancer research and treatment organizations in the US, has given a thumbs up to the company’s cell processing system for advanced cell separation.
The Bill & Melinda Gates Medical Research Institute is conducting a tuberculosis epidemiology study: setting the stage for a Phase 3 efficacy trial for its investigational tuberculosis vaccine.
The first patient has been dosed in the Phase 1/2 clinical trial of OCU400, a modifier gene therapy candidate for the treatment of retinitis pigmentosa (RP) resulting from mutations in the nuclear receptor subfamily 2 group E member 3 (NR2E3) and Rhodopsin...
Biogen's Phase 4 trial for Aduhelm – required by the FDA as part of last year's accelerated approval of the Alzheimer’s drug – will start screening patients in May.
While skills shortages present one of the main challenges to the biopharma industry, North Carolina believes its investments in the life science ecosystem have given it a ‘multiple decade jumpstart’ in building a successful biopharma hub for both manufacturing...
The latest results in an ongoing study are a ‘step forward’ for one of 4D Pharma’s live biotherapeutics (LBPs). The findings underscore the increasing importance of the microbiome in cancer treatment, says the chief executive.
A study that reveals new understanding of Chimeric Antigen Receptor (CAR) T cell functionality is said to underscore the critical role that cell avidity or binding plays in uncovering and optimizing CAR T cells.
Researchers at Australia’s national science agency, CSIRO, have developed a technique that protects vaccines at temperatures of up to 37 degrees Celsius: addressing the challenge of transporting vaccines to rural communities.
Biogen has announced new Phase 3 data showing that, after nearly 2.5 years of treatment, Aduhelm continued to reduce two key Alzheimer’s disease pathologies.
Sanofi and Blackstone today announced a strategic, risk-sharing collaboration under which funds managed by Blackstone Life Sciences will contribute up to €300m ($329m) to accelerate development for subcutaneous formulation and delivery of anti-CD38 antibody...
Novo Nordisk is expanding its existing collaborative research partnership in oral drug delivery technologies with the Massachusetts Institute of Technology (MIT) and Brigham and Women’s Hospital (BWH).
Stevenage Bioscience Catalyst (SBC) has launched an accelerator program for biotech start-ups focusing on data-enabled drug discovery, genomics and advanced therapies: aiming to give such companies the skills they need to get potential new drugs and therapies...
The authors of clinical data published in Nature Medicine this week said the findings indicate the use of a live biotherapeutic (LBP) with immunotherapy medicine can improve survival in patients with metastatic kidney cancer.
Alexion, AstraZeneca’s Rare Disease group, has closed an exclusive global collaboration and licence agreement with Neurimmune AG for NI006, an investigational human monoclonal antibody for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).
Releasing data from both Phase 3 and booster trials, Sanofi and GSK have announced they will submit the results as the basis for regulatory applications for their COVID-19 vaccine.
Moderna has initiated the Phase 3 portion of its pivotal respiratory syncytial virus (RSV) vaccine trial: looking towards its ultimate goal to combine the vaccine with its COVID-19 and flu boosters into a single dose booster.
PerkinElmer’s Sirion Biotech business is teaming up with the Centre for Genomic Regulation (CGR) to jointly develop new generation adeno-associated virus (AAV) vectors for type 1 and type 2 diabetes gene therapy in the pancreas.
Moderna is expanding its mRNA pipeline with three new development programs: with vaccine candidates against herpes simplex virus (HSV), varicella-zoster virus (VSV) and a new checkpoint cancer vaccine.
A number of intranasal vaccines against COVID-19 are in development: hoping to provide a point of difference against authorized vaccines but also create a springboard for wider development against other respiratory diseases.
Lipid nanoparticle systems (LNPs) as a delivery mechanism for novel drug modalities are proving effective, but there are bioanalytical challenges associated with encapsulation, says an expert.
AffaMed Therapeutics has announced that the US FDA has cleared its Investigational New Drug (IND) application for the clinical development of AM712 (ASKG712), a novel proprietary bispecific biologic molecule blocking both vascular endothelial growth factor...
IASO Biotherapeutics and Innovent Biologics have announced that the FDA has granted Orphan Drug Designation (ODD) to their fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed and/or...
Seismic Therapeutic, Inc., a biotechnology company advancing machine learning for immunology drug development, has announced its launch and $101m in Series A financing.
Fujifilm Corporation has launched a new global life sciences strategic investment fund: starting off with 7B¥ ($60m) targeting early-stage biotech companies.
Having built up its mRNA expertise with its COVID-19 vaccine, Pfizer now sets out its strategy for the future. “Going forward, we plan to continue to capitalize on the leadership we have built in both mRNA R&D and manufacturing."
Mission Bio says it is paving the way for the routine use of its technology in clinical trials on materials to support the next wave of life-saving CGT treatments.
Valneva and Pfizer have reported further positive Phase 2 data for their Lyme disease vaccine candidate, VLA15, with a Phase 3 trial set to start in Q3, 2022.
The Coalition for Epidemic Preparedness Innovations (CEPI) has launched a Call for Proposals to improve the thermostability of vaccines: with a particular interest in temperature-stable vaccine nasal sprays, microarray patches, or orally administered...
Biogen has exercised its option to participate in the development and commercialization of mosunetuzumab, an investigational T-cell engaging biospecific antibody targeting CD20 and CD3 in development for B-cell non-Hodgkin’s lymphoma and other therapeutic...
Biogen releases further details on how its Phase 4 post-marketing confirmatory study for Alzheimer’s drug, Aduhelm, will run: including increased enrolment and enhanced efforts to encourage diversity.
