Written by: Adriano Leuzzi – Head of Process Development; Angelo Raggioli – Head of Technology Development, ReiThera. The field of gene therapy is witnessing unprecedented growth, offering promising avenues for treating a myriad of diseases, ranging from rare genetic disorders to complex conditions like cancer. With approximately 700 gene therapy trials underway targeting over 180 diseases, the therapeutic landscape continues to expand, encompassing metabolic disorders, neurological ailments and cardiovascular diseases. Central to the success of gene therapy is the development of viral vectors such as adeno-associated virus (AAV) vectors, which serve as indispensable vehicles for delivering therapeutic genes into target cells.…

iOnctura have announced that it has closed an €80 million Series B financing. The funding round was led by new investor Syncona Limited with participation by the EIC Fund, the venture arm of the European Innovation Council (EIC), as well as existing investors M Ventures, Inkef Capital, VI Partners, Schroders Capital and 3B Future Health Fund. iOnctura is developing a portfolio of precision oral small molecules that target cancers in novel ways. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. The Company has progressed two therapeutic candidates into mid-stage clinical development. Lead asset…

Johnson & Johnson Innovative Medicine have announced its strengthened commitment in Italy, with a projected investment of €580 million over the next five years, of which €125 million will support an increase in production capacity and build capabilities for the future. The investment announcement is part of a strategic plan that has included a 9.2 per cent investment growth each year between 2019-2023 in Italy, which is three times greater than the pharmaceutical sector average, according to a new study by The European House – Ambrosetti. Additionally, this investment has translated to a 15 percent increase in employment in Italy over…

Merck have announced an investment of €62 million at its Darmstadt headquarters in a new quality control building for its Life Science business. The facility will bring together approximately 135 employees across several departments into one collaborative state-of-the-art space. The nearly 10,000 square meter building is scheduled for completion by mid-2025. The new building is part of an investment program at the Darmstadt site: Merck will invest a total of around €1.5 billion here by 2025. “Quality plays an essential role in our purpose to impact life and health with science. The quality, compliance and business support are fundamental to our…

We caught up with Purolite’s Felix Solamo to look back on Bio International 2024 and what it meant for the Company.  EPM: What new products or innovations did your company showcase at BIO 2024? Felix Solamo: At BIO 2024, Purolite announced a major product innovation in affinity chromatography. Our new protein A resin, DurA Cycle A50, promises to address key challenges facing the biopharmaceutical industry. Our new offering represents the culmination of extensive research and development, and collaboration with top experts in the field, and we were delighted with the significant impact it has made at the show. BIO International…

Written by: Niamh Bissett, Director, Operations, PMO, West Pharmaceutical Services. While it officially applies to the manufacture of sterile medicinal products in the European Union, the revised EU Good Manufacturing Practice (GMP) Annex 1 effectively reset the benchmark for quality standards across the globe when it came into force on 25 August 2023. At this point, entire supply chains entered a new era defined by a raft of updated rules, all of which are ultimately focused on enhancing levels of public health protection. Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a…

Written by: Dr Maxim Polyakov, Senior Vice President, Business Intelligence and Research at M3. Pharmaceutical products play in a highly competitive field. Understanding the HCP target audience through market research is vital to ensure pharma companies are marketing their products effectively. The need for robust research is becoming more urgent as companies face increasing performance pressures, while continuing to scrutinise research budgets. When pharmaceutical marketing teams design their digital marketing approaches, it can be all too tempting to jump straight into the planning stage and start putting tactics to paper. However, creating an approach without audience insight carries with it a risk…

Written by: Justin Wilson, partner and pharmaceuticals & gene therapy sector specialist at European intellectual property law firm, Withers & Rogers. Investing in the development of cell and gene therapies (CGTs) for use in the treatment of rare diseases is not for the faint-hearted. As well as being a costly exercise, conducting clinical trials, securing regulatory approvals and lining up contract manufacturers to make new CGTs can take many years. Conducting clinical trials for new CGTs can also be complex and challenging as many are targeted at the treatment of people with rare conditions, which can make it difficult to recruit sufficient…

Cherwell has introduced a new Redipor Plastic Bottle prepared media range in response to a request from a large pharmaceutical company for support in meeting its sustainability targets. The new terminally sterilised plastic bottled media products have been developed and launched by Cherwell to offer a more environmentally friendly and cost-effective alternative to glass bottled media for use in sterile pharmaceutical manufacturing. Recycling plastic requires much less time and energy compared to glass. Glass requires around 900°C of heat to melt and recycle, whereas plastic has a lower temperature requirement of approximately 200°C. This ‘carbon expense’ of glass is a key reason for adopting…

Written by: Dr Sylvain Lacomble, Vice President Europe Middle East & Africa, Terumo Blood and Cell Technologies.  Blood and its components are essential medicines, utilised for a wide range of clinical indications including trauma care, major surgeries, treatment of chronic diseases like sickle cell anaemia or haemophilia, cancer therapies and managing severe anaemia or blood disorders. This breadth of applications is unparalleled by most pharmaceuticals, which typically target specific diseases or conditions. While drugs like antibiotics or pain relievers are crucial for treating infections and managing pain, they do not match the extensive variety of medical needs that blood addresses, making…

UPS Healthcare has announced an expansion of its European hub facility in Roermond, the Netherlands by 21,860 sqm, adding in-demand freezer farm capacity, a crucial link in a strong and reliable supply chain for a growing number of complex biopharma products. The expansion means the campus now has over 200 ultra-low temperature (ULT) freezers which can store products at -80°C. The upgrades also included the addition of approximately 3,200 pallet positions for storage at 2°C to 8°C. The facility’s expansion meets the needs of a booming and innovating market, which requires advanced, temperature-controlled logistics. The global market for biologic therapeutic…

Big pharma behemoths Johnson & Johnson has agreed a payment of $700 million to settle allegations that the Company mislead its customers about the safety of its talc-based products.  This follows an investigation by no less than 42 U.S. States and Washington DC, although Johnson & Johnson did not admit wrongdoing, despite withdrawing the product from the North American market back in 2020.  Johnson & Johnson announced a settlement in principle in January after having to face thousands of lawsuits over talcum powder containing traces of asbestos blamed for causing ovarian cancer, many of these are still ongoing.  Following the 2020 North…

The European Commission’s Health Emergency Preparedness and Response Authority (HERA) as part of its mandate on preparedness, has signed on behalf of participating Member States, a joint procurement framework contract for the supply of up to 665,000 pre-pandemic vaccine doses of the up-to-date Zoonotic Influenza Vaccine Seqirus, as well as an option for a further 40 million doses over the duration of the contract. Thanks to this contract the participating Member States will have access to medical countermeasures to prevent avian flu. The vaccine is intended for those most exposed to potential transfers of avian influenza from birds or animals, such as poultry farm workers…

Laboratory equipment supplier Scientific Laboratory Supplies (SLS) has opened the new SLS National Distribution Centre (NDC) at the Fairham Business Park, Nottingham, as it looks to kickstart its next phase of growth.  The move comes after a sustained period of growth, which saw SLS become the leading independent laboratory equipment distributor in the UK and Ireland. The NDC has 40,000 m3 floor area, which is more than 2.5x the size of its previous Wilford facility just three miles away. The benefit will be passed directly to customers, as SLS will have even greater capacity to meet its service requirements and further improve…

Sage Therapeutics announced topline results from the Phase 2 SURVEYOR Study. The study met its primary endpoint demonstrating a statistically significant difference as measured by the HD-Cognitive Assessment Battery (HD-CAB) composite score at baseline between healthy participants and participants with Huntington’s Disease (HD) prior to any treatment with dalzanemdor (SAGE-718) or placebo. “Huntington’s Disease is a rare, genetic, neurodegenerative condition that greatly impacts the ability of individuals to function independently. While symptoms of cognitive impairment can precede motor symptoms by up to 15 years, it is a historically underrecognised aspect of HD and there are no approved treatments for cognitive impairment…

England’s top doctor has backed calls from NHS Blood and Transplant (NHSBT) for O Positive and O Negative blood donors to urgently book appointments to donate in one of the 25 town and city centre NHS Blood Donor Centres in England, to boost stocks of O type blood following the cyber incident in London. It comes as the NHS reveals this week – National Blood Week – that three blood donations are needed every minute in hospitals to deal with emergencies, childbirth and routine treatments as it calls on more people to become lifesaving donors. There are around 13,000 appointments available nationally this…

Last week, AstraZeneca announced the successful completion of the acquisition of Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates (RCs). The acquisition marks a major step forward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients by replacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments. This acquisition complements AstraZeneca’s leading oncology portfolio with the addition of the Fusion pipeline of RCs, including their most advanced programme, FPI-2265, a potential new treatment for patients with metastatic castration-resistant prostate cancer (mCRPC), and brings new expertise and pioneering R&D, manufacturing and supply chain capabilities…

Cycle Pharmaceuticals a rapidly growing pharmaceutical company focused on treatments for the underserved rare disease patient community, have confirmed that it made a proposal to the Board of Directors of Vanda Pharmaceuticals, Inc on May 24, 2024 to acquire 100% of Vanda’s issued and outstanding shares for a cash consideration of $8.00 per Vanda share, representing a total cash consideration of $466 million. Cycle’s proposal represents: Immediate and certain cash value for all Vanda shareholders; A 98% premium above Vanda’s closing share price on April 16, 2024, the day prior to the public disclosure of the initial offer by Future…

Syngene International have announced the launch of its new protein production platform. The platform, using a cell line and transposon-based technology in-licensed from Swiss biotech services company, ExcellGene, coupled with Syngene’s clone selection and development processes, promises significant improvement in efficiency and precision. The new platform accelerates enhanced protein production, enabling quicker preclinical and clinical development as well as product launches, thereby reducing time to market.  “By combining the cell line and transposon-based platform from ExcellGene with our proprietary processes, we are pushing the boundaries in cell line development. This innovative approach will not only accelerate development timelines but also enhance…