Drugs

The South Korean CDMO began work on the site in Incheon in November 2020, with the multi-story 238,000 square-meter building set to be the world’s largest biopharmaceutical manufacturing facility of its kind with 256,000 liters total manufacturing capacity. Large scale manufacturing contracts secured This morning Samsung Biologics announced record-high semi-annual revenue, exceeding KRW 1 trillion

It means manufacturing capacity of aseptic filling machinery is expanded by over 200%. Cytiva said the machines, known as workcells, provide gloveless, robotic aseptic filling capability for final drug product into vials, syringes, and cartridges. “Robotic aseptic filling workcells reduce risk and increase flexibility in pharmaceutical manufacturing.”​ The site will serve as a Center of Excellence

The discovery leveraged sequencing data from more than 360,000 individuals in UK Biobank, and was published in Nature Communications​​. ​ The published data shows that rare mutations in the liver-expressed INHBE gene are associated with lower waist-to-hip ratio adjusted for body mass index, (WHRadjBMI), a surrogate for abdominal fat that is causally linked to type

The vaccine has been approved in Europe for prevention of smallpox since 2013, although has been used off-label against monkeypox. It is already approved for both smallpox and monkeypox in the US and Canada (where it is known as Jynneos and Imvamune respectively). The approval follows a positive opinion issued by the European Medicine Agency

Such tools will standardize the assessment of monkeypox vaccines: helping advance development as well as informing public health agencies of the best deployment strategies. The funding will go towards developing assays to test for the presence of specific antibodies — indicative of an immune response to monkeypox — following either natural infection or vaccination. It

There is currently no treatment for SOD1-ALS. If approved, tofersen, which Biogen licensed from Ionis Pharmaceuticals, Inc. under a collaborative development and license agreement, would be the first treatment to target a genetic cause of ALS. Tofersen is designed to bind to SOD1 mRNA, allowing for its degradation by RNase-H in an effort to reduce

The partnership aims to apply Avista’s single-cell adeno-associated virus (AAV) engineering (scAAVengr) platform technology in the development of intravitreal AAV capsids matching a capsid profile defined by Roche. Under the terms of the partnership, Roche has the right to evaluate and license novel capsids from Avista, and will be responsible for conducting preclinical, clinical and

The BLA submission includes all indications covered by the reference medicine Tysabri (natalizumab) for relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), active secondary progressive disease in adults, and Crohn’s Disease. Sandoz entered into a global commercialization agreement​​ on that biosimilar in 2019 with Polpharma Biologics, a company with facilities

The deal, said the MIT spin out company, is set to accelerate the development of its synthetic biology platform. Ginkgo will integrate its synbio competitor’s core automation and software tech for scaling strain engineering capacity, including its machine learning and data science tools, and can leverage its vast experience across diverse biological engineering approaches as

The South Korean vaccine developer and manufacturer is already producing Novavax’s authorized protein-based COVID-19 vaccine, Nuvaxovid (NVX-CoV2373), from its vaccine plant in Andong for the South Korean market and the EU. It also has non-exclusive rights for the product in Thailand and Vietnam. Now, Novavax is developing an Omicron-specific vaccine, which it expects to make

A new site will add 120,000L biomanufacturing capacity to WuXi Biologics’ global network by 2026. It is expected to employ 1,500 research, development and manufacturing staff when complete; adding significantly to the 10,000 people the company already employs worldwide. The company says the Singapore site will become a ‘critical part’ of its global supply chain

The IVI -  an international non-profit intergovernmental organization with a mission to discover, develop, and deliver safe, effective, and affordable vaccines – says the partnership will focus on accelerating vaccines for infectious diseases with high disease burden. Priority disease areas for the organization include chikungunya, shigella, salmonella, schistosomiasis, Group A Strep, Hepatitis E, HPV, and

Hyrimoz HCF (adalimumab-adaz), if approved, would help expand access to more patients with serious inflammatory diseases, said Keren Haruvi, president, Sandoz Inc. The sBLA includes the indications of the reference medicine, Humira, not protected by orphan exclusivity including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Market

The capital will also go towards advancing the Cambridge, Massachusetts company’s lead programs into the clinic. The financing round was led by Enavate Sciences, with additional investors including a large national managed care organization and the Gaingels, an LGBTQIA+/Allies investment syndicate supporting diversity in venture capital, along with other unnamed investors. Existing investors such as

Biogen’s Tysabri was first approved in the EU in 2006 as an intravenous formulation, while a subcutaneous formulation was approved last year. The drug made close to $2.1bn worldwide in 2021: making it one of the top-sellers for the company. Phase 3 data supports application The EMA application for natalizumab is for an intravenous (IV)

Concern access and adoption barriers could limit huge savings from Humira biosimilars in US market Much of the future of the biosimilars sector in the US depends on whether an incoming wave of Humira biosimilars will be placed on formularies as they become available, said executive director of the Biosimilars Forum, Julie Reed. Humira is

The Danish vaccine company says a ‘number of contracts of varying sizes’ have been signed, most with deliveries starting immediately, although it has not disclosed most of the countries it is supplying. The company has raised its financial guidance for 2022 on the back of new smallpox vaccine orders several times: and with orders now

Acquiring the land for KRW 462bn ($353m), Samsung Biologics gains a 357,366 square meter site that is 30% larger than the company’s current campus. Bio Campus II will support Samsung Biologics’ expansion of large-scale manufacturing capacity as well as host a multi-modal plant and an open innovation facility. Milestone in ambition to build a world-class

The new site, it said, will strengthen security of supply. The company is planning to transform the site into a 168,000 sq ft (15607.7 sq. m) biomanufacturing center consisting of multiple buildings. It is the first time Cytiva will expand beyond Sweden to manufacture chromatography resins, media that is used for purifying and analyzing biomolecules

Eden and Bora entered into a definitive agreement in May this year to enable Eden’s CDMO assets to be acquired by an entity wholly owned by Bora in a cash deal valued at no less than US$50m and up to US$65m if certain milestones are achieved after one year. In a letter to shareholders this

The company, which is focused on single-cell DNA and multi-omics analysis, is launching solid tumor assays through its Pharma Assay Development (PAD) services. These tools, it said, will help to accelerate the development of cancer therapeutics by reducing the time and cost associated with the characterization of solid tumor cells. “We have seen tremendous uptake

The partnership was first reporter on Business Insider.​ In an emailed statement to BioPharma-Reporter, the Seattle-based center confirmed the collaboration saying: “Fred Hutch is working with Amazon to explore the development of a personalized treatment for certain forms of cancer. Fred Hutch recently received permission from the US Food and Drug Administration to proceed with