A project initiated by the European Medicines Agency in 2022 to collect data on healthcare, disease prevalence, and the use of medicinal products, is entering its second year with plans to quadruple the number of studies. The project looks at real-world data, or data on a patient’s health from sources other than clinical trials, and real-world evidence, which is the analysis of this data.
The Food and Drugs Authority (FDA) of Ghana has approved a vaccine developed by the University of Oxford, UK, to prevent malaria – the first regulatory clearance for the product globally. The vaccine, R21/Matrix-M, is a subunit vaccine made up of a protein secreted by the malaria parasite and fused to a fragment of the hepatitis B virus. It is delivered alongside a plant-based adjuvant that enhances a person’s immune response. The adjuvant was developed by Novavax Inc of the US. The vaccine is being manufactured and scaled up by the Serum Institute of India PvT Ltd.
Switzerland-based Alentis Therapeutics AG has completed a Series C financing of $105 million to support the development of antibody therapeutics to treat cancer and fibrosis, rounding out the next stage in its anti claudin-1 development programme. Claudins are a group of membrane proteins that are essential for cell growth and differentiation. One of these proteins, claudin-1, is a target of considerable interest in the scientific community.
Novo Nordisk A/S is to collaborate with the Canadian biotech company Aspect Biosystems Ltd to use bioprinting technology to advance its work in cell therapies for diabetes and obesity. Novo is a leading producer of insulins and more recently glucagon-like peptide 1 medicines for the treatment of diabetes. It has also been building a presence in regenerative medicine.
The economic environment may be difficult, but there’s still plenty of money looking for good science, according to a panel of venture capitalists offering advice to start-ups at the Terrapinn Advanced Therapies Congress in London on 14 and 15 March. The conference came shortly after the collapse of Silicon Valley Bank, and all three VCs called on standard banks to become more start-up friendly, and advised start-ups to diversify their funds across a number of banks, wherever possible.
Bicycle Therapeutics Plc has entered a strategic collaboration with Novartis to pair its peptide technology with Novartis’ experience in radiopharmaceutical development to design new therapies for cancer. The agreement was announced on 28 March and will include a $50 million upfront payment to Bicycle and milestone commitments of up to $1.7 billion. Bicycle’s molecules are synthetic peptides held in place with small molecule scaffolds to form two loops that stabilise the structure. This creates a small binding site for its therapies which are said to achieve very specific targeting.
Galapagos NV has consolidated its drug discovery activities under a new agreement with the French contract research organisation (CRO) NovAliX SAS enabling it to focus on fewer therapeutic areas. Announced on 30 March, the agreement will see NovAliX acquire Galapagos’ research and discovery assets in Romainville, France. Employees of Galapagos at the same site will also transfer to the CRO.
The Austrian biotech company Proxygen GmbH has executed a new collaboration with a large pharma company to identify and develop compounds that can promote the degradation of disease-causing proteins. Known as molecular glue degrader therapies, these small molecule drugs accomplish their task by stabilising protein to protein interactions in the cell, enabling ubiquitin ligases to mark faulty or misfolded proteins for degradation.
Evotec SE rebounded in the fourth quarter of 2022 producing a 29% gain in revenue for the strongest quarter in the company’s history. Revenue for the quarter was €240.7 million, making the total for the year €751.4 million, up by 22% compared with 2021. The company’s service business, which ranges from drug discovery to manufacturing and clinical development, remained strong. In 2022, the company was involved in more than 800 alliances and recorded a repeat business of 92%.
Pharming Group NV has won US regulatory approval for Joenja (leniolisib), a small molecule drug in-licensed from Novartis for the treatment of a rare genetic disorder that impairs the immune system. The disorder is activated phosphoinositide 3-kinase delta syndrome (APDS) which is estimated to affect one to two people per million and can lead to infections in the ears, sinuses and the upper and lower respiratory tracts. Infections usually begin in infancy. Patients with the disease are also susceptible to blood cell cancers like lymphoma, according to the Food and Drug Administration.