Mitochondrial dysfunction is known to play a central role in drug-induced hepatotoxicity, and thus early detection of mitochondrial toxicity is a critical component of initial drug development efforts. While immortalised cell lines are widely used for in vitro assessment of hepatotoxicity, cryopreserved primary human hepatocytes are a preferred model for drug safety screening. Download this new […]

Mitochondrial dysfunction is known to play a central role in drug-induced hepatotoxicity, and thus early detection of mitochondrial toxicity is a critical component of initial drug development efforts. While immortalised cell lines are widely used for in vitro assessment of hepatotoxicity, cryopreserved primary human hepatocytes are a preferred model for drug safety screening. In this App […]

Biomia, the first company spun out from BioInnovation Institute’s Bio Studio programme, has secured $3 million in pre-seed financing from an international syndicate of investors. Biomia says it plans to use the investment to accelerate its development of plant-inspired natural and new-to-nature halogenated small molecule drug candidates and further build its biosynthetic manufacturing platform. Chief […]

Both GTPs and GMPs must be followed to get cell-based advanced therapies or tissue-based therapy products to market. Learn about important considerations when sourcing Leukocytes/Cellular starting materials and related ancillary products that must be factored into your programme to efficiently move through the clinical pipeline and successfully receive regulatory approval. In this webinar from BioIVT, the […]

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to 4SC’s resminostat (Kinselby) for cutaneous T-cell lymphoma (CTCL). Resminostat is an orally administered class I, IIb and IV histone deacetylase (HDAC) inhibitor that potentially offers an approach to treating different kinds of cancer. The company demonstrated that resminostat is well tolerated and can inhibit […]

The National Institute for Health and Care Excellence (NICE) has recommended Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (DLd) for untreated multiple myeloma (MM) for routine use on the NHS in England and Wales. The therapy is now recommended within an NHS setting for the treatment of adults with newly diagnosed MM where an […]

Leucid Bio has been granted clinical trial authorisation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase I/II clinical trial evaluating autologous NKG2D-targeted CAR-T cell therapy, LEU011, in patients with relapsed or refractory solid tumours. The open-label, single patient cohort ascending dose design aims to rapidly identify the maximum tolerated […]

The European Commission (EC) has granted marketing authorisation for Jazz Pharmaceuticals’ Enrylaze as part of a multi-agent regimen for acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL). The treatment is approved in adult and paediatric patients who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. Enrylaze, approved as Rylaze in the United States and […]

Umoja Biopharma has revealed data from an ongoing non-human primate (NHP) study demonstrating effective, durable, and well tolerated in vivo chimeric antigen receptor (CAR) T cell generation using the company’s VivoVec platform. The data include results from the first four NHPs treated in an ongoing study and demonstrate rapid and efficient in vivo generation of […]

Synthetic biology has shown significant potential to the drug discovery sector. Although not a new area of science, the prominence of this technology and its applications – evident during the Covid-19 pandemic – have increased of late. This has created advances in the development of new medicines and our ability to find solutions for unmet medical […]

Researchers have uncovered a link between antiviral drug molnupiravir and a pattern of mutations in the SARS-CoV-2 virus. Molnupiravir induces mutations in the virus’s genome during replication, with the aim of damaging or killing the virus. It was one of the first antivirals available on the market during the Covid-19 pandemic and was widely adopted […]

A considerable roadblock in the successful triaging of new therapeutics for liver and metabolic related diseases is the reliability and effectiveness of pre-clinical disease models. Methods employing animal models may have limited success in replicating liver diseases, primarily because of species-specific differences, furthermore, the utilisation of animal models to simulate liver disease phenotypes frequently leads […]

Enrolment in a Phase I trial of a new investigational universal influenza vaccine candidate has begun at the National Institutes of Health’s Clinical Center in Bethesda, Maryland, US. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and will evaluate the investigational vaccine for safety and […]

Download this exclusive DDW eReport to learn more about: The global market for synthetic biology: its potential and where innovative drug development is taking place Analysis of regional markets and the key players within the synthetic biology sector How advances in the synthetic biology field are impacting drug discovery – from hit finding and lead generation […]

CRISPR gene editing companies Integrated DNA Technologies (IDT) and Aldevron have inked a new global distribution agreement to expand CRISPR products for cell and gene therapy customers. IDT will stock and sell three additional research use only (RUO) and current good manufacturing practice (cGMP) CRISPR nucleases with unique performance characteristics, manufactured by Aldevron, to provide […]

AbolerIS Pharma has raised €27.3 million in a Series A financing led by Caixa Capital Risc and co-led by Sound Bioventures and Newton Biocapital. Proceeds from the financing will enable AbolerIS to accelerate the development of its lead programme in clinical trials and explore its effectiveness in additional autoimmune diseases. AbolerIS’ lead programme is a […]