The FDA has given accelerated approval for QALSODY™ (tofersen) to treat SOD1-ALS, marking a significant scientific advancement as it is the first treatment to target a genetic cause of ALS.
Biogen Inc. (Nasdaq – BIIB) has announced that the U.S. Food and Drug Administration (FDA) has approved QALSODY™ (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a specific genetic mutation. This approval is based on a reduction in plasma neurofilament light chain (NFL) observed in patients […]
FDA Approval of RNAimmune’s Investigational New Drug Application for the RV-1730 COVID-19 Booster Vaccine Phase I Trial
The United States Food & Drug Administration (FDA) has given the go-ahead for the company’s Investigational New Drug (IND) application of a Phase I clinical trial for RV-1730, a SARS-CoV-2 vaccine booster candidate. RNAimmune is a biopharmaceutical company that specialises in the discovery and development of mRNA-based therapeutics and vaccines. It is a non-wholly owned […]
Kiromic Biopharma Has Received Authorization from The FDA To Commence A Phase 1 Clinical Trial to Evaluate Deltacel In the Treatment of Non-Small Cell Lung Cancer
In order to create cell therapies with a focus on immuno-oncology, Kiromic Bio Pharma, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application to launch a Phase 1 clinical trial to assess Deltacel. The company’s allogeneic, non-engineered, over-the-counter Gamma Delta T-cell (GDT) therapy is called […]
BioNTech Announces Strategic Partnership with UK Government to Provide up to 10,000 Patients with Personalized mRNA Cancer Immunotherapies by 2030
Excerpt The multi-year partnership focuses on three strategic pillars: the development of vaccines for infectious diseases, the expansion of BioNTech’s presence in the UK, and cancer immunotherapies. In the UK, BioNTech plans to create and implement randomised clinical trials with the potential for registration of the Company’s tailored mRNA cancer immunotherapies. First patient to be […]
Respiratory syncytial virus (rsv) vaccine mrna-1345 by moderna has reached primary efficacy endpoints in phase 3 trial in older adults
Excerpt mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults mRNA-1345 was generally well-tolerated, and the DSMB found no safety issues Based on these findings, Moderna plans to request regulatory approval for mRNA-1345 Article Summary mRNA-1345, an investigational mRNA vaccine that targets […]
Marburg vaccine shows promising results in first-in-human study
Excerpt The Marburg virus (MARV) experimental vaccine was safe and elicited an immunological response in a small, first-in-human clinical trial, according to a recently published paper in The Lancet. Researchers at the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health, created the vaccine, which could someday be […]
Pfizer and BioNTech Initiate Phase 1/2 Study of First mRNA-based Shingles Vaccine Program
Excerpt Up to 900 healthy American volunteers aged 50 to 69 will participate in the phase 1/2 trial Pfizer and BioNTech plan to use mRNA technology to meet the demand for highly effective, well tolerated, and efficiently produced shingles vaccines as the world’s population age Without immunisation, shingles, a painful, localised rash brought on by […]
Bridging Supply Chain Gaps in Clinical Trial Logistics for mRNA Vaccines
Article Summary: The rapid spread of the original virus strain and its subsequent variants across the globe highlighted the importance of vaccine technologies which were capable of swift deployment for human trials with efficacy and safety remaining top priorities. Challenges in the mRNA vaccine supply chain As mRNA vaccines take centre stage, the challenges […]
Major AUD$280 million investment to deliver mRNA 2.0
Excerpt Sanofi, one of the world’s largest vaccine innovators, has partnered with the Queensland Government to inject AUD$280 million into next generation mRNA vaccine research in Queensland. Article Summary Sanofi and Queensland Premier Annastacia Palaszczuk today announced the creation of the Translational Science Hub, which will connect top researchers in Queensland with those at the […]
Phase 2 trial of ChulaCov19 BNA159 mRNA Vaccine to start in Australia
Excerpt ChulaCov19 mRNA vaccine was found safe and immunogenic for primary immunization in clinical trials in Thailand. The Australian trial will evaluate the safety and immunogenicity of a booster dose of ChulaCov19 BNA159 mRNA vaccine in healthy volunteers. The collaborators of the trial are Chulalongkorn University, BioNet and Technovalia. Article Summary The phase 2 trial […]
Vaxxas raises US$23 million (A$34 million) to develop needle-free vaccines, including a COVID-19 vaccine candidate of the next generation
Excerpt Vaxxas will advance numerous vaccination programmes in the clinic and build up manufacturing resources for commercial production. More than US$67 million (A$100 million) in non-dilutive financial support has been provided and pledged via contracts with US and Australian government agencies, industry partners, and international health organisations. Equity investment is being used to leverage this […]
First foreign COVID vaccines head to China from Germany
Excerpt The vaccines are on the way from China Berlin encourages increased usage, German citizens are encouraged to get vaccinated Batches of vaccines to release after Scholz visit to China There is increased spike in infections hence this batch was introduced Article Summary Berlin sent its first batch of BioNTech (22UAy.DE) COVID-19 vaccines […]
