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Elizabeth Anne Wright, Head of the EU regulatory life sciences team at law firm Cooley, and associates Jessica Koffel and Edward Turtle look ahead at EU regulatory milestones for the life sciences sector in 2023. Five key areas of potential change include: clinical trials, medical devices, pharmaceutical legislation, class actions…
A potentially first-in-class PKC theta inhibitor, in development for immunology and inflammation indications, has entered first-in-human trials in the US.
Schizophrenia and bipolar I disorder patients can be offered Rykindo® as a bi-weekly long-acting risperidone injection, as a result of the FDA's approval.
Here, microbiology experts Tim Sandle, Tony Cundell and AstraZeneca’s Miriam Guest reflect on key developments in pharmaceutical microbiology during 2022.
A study from the University of Toronto is one of the first to apply machine learning to the design of polymeric long-acting injectable drug formulations.
Subin Baral, EY Global Deals Leader, Life Sciences, recounts the global M&A trends in 2022 and predicts activity for 2023 in EY’s 2023 M&A Firepower report.
Moderna has agreed on its first acquisition for $85 million, enabling it access to cell-free DNA synthesis and amplification technologies.
Operation has begun for CRDMO WuXi STA's first continuous manufacturing line for oral solids, in Wuxi city, China.
The preparation of buffer solutions is a crucial component in the downstream manufacturing process for biomolecules; however, it is also one of the most resource-heavy and intensive steps. Solving these downstream issues with new approaches is critical to achieving efficiency and commercial gains within the upstream process. Here, Andrea Johnston…
Here, Sanofi’s Arnaud Robert and Brendan O’Callaghan explore how advances in digital technology, partnerships and new ways of working are supporting manufacture and delivery of medicines for patients across the globe.
It is possible to manufacture monoclonal antibodies using traditional methods, but the challenges inherent in bispecific antibodies such as low titer, mismatched chains, unwanted fragments and higher aggregation levels require a heightened analytical focus on clonal cell selection. Here, Stuart Jamieson and Alice Harrison at Lonza discuss high-throughput analytical strategies…
Almost £1m awarded to MHRA will advance projects to innovate AI and microbiome regulation and develop synthetic clinical trial data.
Articles on high-throughput analytics for optimising bsAb clonal cell selection and a technology to overcome buffer preparation bottlenecks.
Despite tremendous innovation in the realm of pharmaceutical therapeutics, the packaging of medicines has been staid. In this article, Giana Carli Lorenzini from the Technical University of Denmark investigates the potential of patient-centred pharmaceutical packaging.
Innate Pharma will receive a €25m upfront payment from Sanofi to license its B7H3 ANKETTM platform, which is creating a new class of molecules to induce synthetic cancer immunity.
