Drugs

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
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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.
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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
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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
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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,
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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
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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
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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
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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
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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
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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
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The collaboration covers R&D of ‘off-the-shelf’ cell therapies for up to five shared cancer targets along with the development of a novel allogeneic personalized cell therapy platform. The partners have not disclosed any details on indications or likely targets. The UK biotech will receive US$150m upfront, as well as US$150m over the next five years in
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September 7, 2021 Audience: Health Professional, Pharmacy September 07, 2021 — ICU Medical, Inc. is voluntarily recalling one lot (2,112 units) of Aminosyn II, 15%, An Amino Acid Injection, Sulfite Free intravenous (IV) solution to the hospital/user level due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with
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September 8, 2021 Audience: Health Professional, Pharmacy  September 08, 2021 — Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“Firvanq®”) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI)
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The multi-year agreement will see the Californian-headquartered company, founded in 2020 and described as a company seeking to build the ‘world’s most advanced biopharmaceutical manufacturing ecosystem’, produce mRNA in Canada for distribution worldwide. “Moderna’s COVID-19 vaccine has saved countless lives, and we’re excited to manufacture mRNA for this important vaccine,” ​said Rahul Singhvi, Sc.D, Chief
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The biosimilar is a recombinant humanized monoclonal IgG1 antibody that targets vascular endothelial growth factor (VEGF), a key mediator of angiogenesis in cancer, and is used in combination with other treatments, said the partners. Guangzhou, China based Bio-Thera will maintain responsibility for development and manufacturing, Sandoz will have the right to commercialize the medicine upon
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