Drugs

Recommendations for plain language summaries in medical journals The COVID-19 pandemic has bought the scientific community and general public far closer together than ever before. Clinical studies on vaccines and treatments have turned into mainstream headlines. People from all walks of life want to understand how vaccines work, and need to understand how vaccines are

The booster shot can be given to people at least six months after completion of the two-dose primary series in the following groups: individuals 65 years of age and older; individuals 18 through 64 years of age at high risk of severe COVID-19; and  individuals 18 through 64 years of age whose frequent institutional or

Samsung, Biogen get US green light for biosimilar to blockbuster Roche drug Developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen, Byooviz (ranibizumab-nuna) is the first biosimilar referencing blockbuster Roche drug, Lucentis; it treats macular degeneration, macular edema, and myopic choroidal neovascularization. The Roche drug was responsible for revenue of over CH

Contract development and manufacturing organization (CDMO), Naobios, announced the next phase in its partnership with, FluGen, Inc; it will work with the US vaccine developer throughout the execution of clinical trials for its investigational intranasal M2SR flu vaccine. Intranasal flu vaccine The Wisconsin, US based company’s lead candidate is a supra-seasonal, live, single-replication, intranasal flu

The acquisition gives Novartis a pre-clinical optogenetic AAV gene therapy program and Arctos’ proprietary technology introducing a distinct mechanism of action. Widening gene targets Arctos’ tech is based on the work of its scientific founders, Drs. Sonja Kleinlogel and Michiel van Wyk, with the start-up being a spin-off from the University of Bern founded in

Founded in 2016 in Arlington, Texas, Abexxa Biologics is preclinical-stage company creating the ‘next generation of precision medicines designed to revolutionize cancer treatments’. In particular, its tech targets cancer-specific proteins that are located inside the cell (rather than those expressed on the cell membrane) thus enlarging the pool of potential cancer antigen targets and potentially

Demand for its dbDNA has grown rapidly in the last year, said the UK biotech, driven by its use in mRNA, lentivirus, gene editing, DNA vaccines, AAV, and other applications. Touchlight claims its ‘doggybone’ or dbDNA synthetic vector, and its enzymatic production, enable it to make DNA at the speed, scale and purity necessary to

The Phase 2/3 trial used a two-dose regimen of 10 µg (in contrast to the 30 µg used in individuals 12+) administered 21 days apart. The antibody responses in the participants given 10 µg doses were comparable to in people 16 to 25 years of age with 30 µg doses. Pfizer CEO Albert Bourla says

The partners will look to develop and commercialize RGX-314, a gene therapy candidate for the treatment of eye diseases such as wet age-related macular degeneration (wet AMD), and diabetic retinopathy (DR). Regenxbio said it wants to leverage AbbVie’s global developmental and commercial infrastructure within eye care with its own in-house capabilities – its expertise in

The National Institutes of Health (NIH) has announced its plans to provide approximately $185m USD to fund research intended to advance understanding of the human genome. The newly launched Impact of Genomic Variation on Function (IGVF) consortium will include 30 sites in the US. The consortium was initiated and will be funded by the NIH’s

The expanded facilities will also allow the contract development and manufacturing organization (CDMO) to meet the increasing demands of the rapidly growing cell and gene therapy (CGT) market.  The outlay involved was not disclosed. AGC Biologics, which is headquartered in Seattle, Washington State, operates multiple manufacturing lines and a variety of scales at the Heidelberg, Germany facility.

Flu vaccines have been made in the same way for nearly 70 years: based on growing the flu virus in chicken eggs or mammalian cells, which is then inactivated and processed to be made into vaccines. The disadvantage of this approach is there can be much variability in the finished product – the virus can

CureVac – whose vaccine is under regulatory review with the European Medicines Agency (EMA) but has not yet been authorized – notes a ‘reduced short-term peak demand for vaccines following the first wave of pandemic vaccination efforts and corresponding changes in the demand of its first-generation COVID-19 vaccine candidate, CVnCoV’. The EU has administered 549

The two companies are expanding an existing facility jointly launched in 2018. They say newly added manufacturing lines will triple the supply capacity of single-use consumables in the Asia-Pacific region. The adoption of single-use technology is expected to increase rapidly in clinical production and in manufacturing, according to the BioPlan Annual Biomanufacturing report, which noted

The financing round was led by Bpifrance Large Venture, and it was joined by US investment firm, Leonard Green & Partners, pharma giant, Bristol-Myers Squibb (BMS), and European venture capital team, XAnge. In conjunction with the financing, independent board member Frederic Desdouits, PhD, has been appointed CEO of TreeFrog Therapeutics, while co-founder, Kevin Alessandri, PhD,

The company’s two-dose vaccine regimen for the prevention of Ebola virus disease consists of Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). The data, from two papers published in The Lancet Infectious Diseases​​​, demonstrated that the regimen generated robust antibody immune responses in adults and children (ages 1-17) with the immune responses persisting in adults for at least

The UK government and Valneva were in a €1.4bn ($1.65bn) five-year deal: to not only supply the UK with up to 190 million doses of the French company’s COVID-19 vaccine candidate once authorized; but also to boost manufacturing capacity at the company’s Livingston site in Scotland. Clinical trials are also under way with government agencies in

Called ten23 health, the new entity is focused on helping innovative biotech and pharma customers develop and commercialize injectable biopharmaceutical drugs. It is headquartered in Basel, Switzerland. “We haven’t disclosed any financials in relation to this transaction. While no set amount of capital has been committed for ten23, in a typical deal, 3i will invest

The company, best known for co-inventing the ChAdOx1 COVID-19 vaccine with the University of Oxford (now licenced to AstraZeneca), will relocate its headquarters to the site in spring 2022. Vaccitech’s new facility will take over half of the newly constructed Zeus building at the campus, which is located just out of Oxford. Accommodating a growing

Building a biotech hub: Switzerland focuses on mRNA, CGT and more The country has long been home to global heavyweights such as Roche and Novartis. And having been ranked as the world’s most innovative country for the 10th​ year in a row by the United Nations Global Innovation Index, the industry has also set its

Avantor says the acquisition will strengthen its offer across monoclonal antibodies, cell and gene therapy and mRNA: as well as supporting both therapy and vaccine manufacturing including COVID-19. Founded in 1955 and headquartered in Vernon Hills, Illinois, Masterflex has projected 2022 revenues of approximately $300m.  “The acquisition of Masterflex reflects our commitment to the biopharma industry, and

As part of a previously announced deal with Novavax, Takeda is establishing the capability to manufacture TAK-019 – known outside Japan as NVX-CoV2373 – at its facilities in Japan and aims to begin distribution early net year. Novavax is licensing and transferring manufacturing technologies to enable Takeda manufacture the vaccine antigen and it is supplying