Drugs

Evusheld (formerly known as AZD7442) combines tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by convalescent patients after SARS-CoV-2 infection. The antibody combination was discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020. Evusheld gained emergency use authorization in the US for prevention of COVID-19 in December 2021​, offering an

The Pitt BioForge Biomanufacturing Center will be fully equipped with its enabling technologies, including gene editing, induced pluripotent stem cell (iPSC) and cell, vector, and protein engineering capabilities. The new facility is expected to generate more than 170 permanent full-time jobs, 900 construction jobs and 360 off-site support jobs. “This announcement supports the region’s rise

As US market awaits new launches, study shows adalimumab biosimilars effective in IBD Relatively few prospective studies have been published in relation to adalimumab biosimilars in patients with IBD, according to the authors of the study. A paper in Plos One​​​ describes how their prospective observational study – clinical monitoring – was performed at seven

The two monoclonal antibody treatments, mAb114 (Ansuvimab; Ebanga) and REGN-EB3 (Inmazeb), were selected by the WHO following systematic review and meta-analysis of randomized clinical trials, with the organization highlighting ‘clear benefits’ from the therapeutics. In 2019, Inmazeb became the first ebola virus treatment approved by the FDA. Ansuvimab / Ebanga received FDA approval in 2020.

BV-101 is a novel, exclusively designed adeno-associated virus (AAV) gene therapy vector that simultaneously addresses the metabolic dysfunction of diseased neurons as well as contributes to the clearance of the mutant huntingtin protein. It was granted orphan drug designation by the European Medicines Agency (EMA) in 2019. BrainVectis has now received the green light from ANSM (L’Agence nationale de

Novartis’ strategic review of the Sandoz business, initiated in October 2021, concluded that a 100% spin-off is in the best interest of shareholders. Joerg Reinhardt, chair of the board of directors of Novartis, said a spin-off would offer differentiated and clear investment theses for the individual businesses. Making Sandoz a standalone company will allow both

The funding round was led by V-Bio Ventures and Fund+. The other investors are Flanders Future TechFund, Thuja Capital, Ackermans & van Haaren, Mérieux Equity Partners (via OMX Europe Venture Fund), BNP Paribas Fortis Private Equity, and the KU Leuven Gemma Frisius Fund. AstriVax intends to use the seed capital to bring its first thermostable

Located at Deison Technology Park in Conroe, Texas, the official opening of its new 120,000 square-foot building is scheduled for October 7, 2022. The CDMO specializes in production of plasmid DNA and RNA products for use in vaccines, immunotherapies, gene and cell therapies, and gene editing technologies. It has supported those industries with specialized CDMO

The Chinese company said it will use the proceeds to continue its business expansion into different markets, with investment in core manufacturing infrastructures and in global commercial operations, with the goal of becoming a global end-to-end cell and gene therapy (CGT) contract development and manufacturing organization (CDMO). The current round of financing was led by

The patent was filed with the US Patent and Trademark Office (USPTO). It describes a novel way of leveraging cellular therapy to ‘teach’ the immune system to seek and destroy cancer.   In 2021, the company outlined how it was granted US patent #11,090,332 on composition of matter of survivin modified-mRNA useful for teaching the immune

A Conditional Marketing Authorization application has also been initiated with the European Medicines Agency (EMA) and is expected to be completed in the coming days. Distribution of the new vaccine will start next month, pending authorization. Bivalent vaccine The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is present in the original

The evaluation of data for Skycovion is one of several European Medicines Agency’s data reviews underway in relation to COVID-19 vaccines. As the pandemic continues to evolve, the agency said it critical that the EU has a wide array of vaccines and treatments to ensure countries can combat the pandemic effectively. The EMA’s human medicines

Developed in collaboration with GSK, CV0501 is based on CureVac’s second-generation mRNA backbone and is designed to specifically protect against the Omicron variant. It is one of two second-generation candidates now in clinical trials from the German mRNA specialist, which withdrew its first-generation COVID-19 vaccine​​ in 2021. Data from these two early-stage clinical trials will

UPS has announced plans to acquire Bomi Group, a multi-national healthcare logistics provider. The acquisition adds temperature-controlled facilities in 14 countries in Latin America and Europe. “As a leading global healthcare logistics company, Bomi enhances our portfolio of services and accelerates our journey to become the number one provider of complex healthcare logistics​,” said Kate

Auransa and Polaris Quantum Biotech first teamed up last year, bringing together Auransa’s artificial intelligence (AI) capabilities and Polaris’ quantum computing (QC) based drug design platform to tackle neglected women’s diseases. Triple-negative breast cancer remains an unmet medical need despite efforts to tackle the aggressive tumor type. Auransa and Polaris applied their capabilities to the

The partnership will focus on therapies derived from biologics — cells, blood, enzymes, tissues, genes, or genetically engineered cells — for use in medicines. It will help Mayo Clinic and third-party biotechs to advance cell therapies into clinical trials. The partners say the collaboration will help establish Rochester, Minnesota, as a center of excellence for

Founded in 2019, Orna is devoted to designing and delivering fully engineered circular RNA (oRNA) therapeutics, which have been shown to have greater stability in vivo than linear mRNA with the potential to produce larger quantities of therapeutic proteins inside the body. Newly synthesized oRNA molecules can also be more compactly packaged into custom lipid

Latch Medical was spun out of University College Dublin by its co-founders Ronan Byrne and Nicky Bertollo in 2019: pioneering a new approach to intradermal delivery. Its Pharma Latch technology offers two delivery device platforms that allow for intradermal delivery of vaccines and biologics with rapid, consistent dosing. The technology anchors securely to the skin

Trelleborg is known for supplying original equipment manufacturers and pharmaceutical companies with high-quality tubing and hose products, such as its PharmaTube platinum silicone tubing for single- and multi-use pharmaceutical applications. The company’s portfolio also includes a broad range of O-Rings, seals, bearings, and composite products. Last year the company expanded its milling and extrusion capabilities

bluebird bio’s Zynteglo gene therapy receives FDA approval After nearly 10 years of development, the therapy is the first of its kind and will offer patients an alternative to regular red blood cell transfusions and iron chelation. It also becomes the most expensive drug in the world, with a $2.8m price tag. “The FDA approval

The collaboration draws on RoosterBio’s cell and media products and process development services, coupled with AGC Biologics’ cell and gene therapy manufacturing capabilities. The two companies see ‘tremendous opportunities’ in EVs/exosomes: with projections suggesting a CAGR of 31% (2015-2030) for the market, reaching the $1bn mark by 2027. In published biomedical research, this subject area

The new Delaware campus, which will become Wuxi STA’s second facility in the US, is expected to begin operations in 2025. Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labeling, storage and distribution