The single-dose gene therapy was approved for certain patients with haemophilia B in the US and Canada earlier this year, marketed as BEQVEZ. The post Pfizer receives EU haemophilia B gene therapy approval appeared first on European Pharmaceutical Review ..read more

In this article, Roger Palframan, Head of US Research at UCB, delves into the potential of gene therapy and which modalities have the most promise, what the industry should prioritise to advance the field, as well as what is needed to develop the workforce. The post The route to enhanced gene therapies appeared first on European Pharmaceutical Review ..read more

The agreement relates to an innovative therapeutic for the most common paediatric brain cancer, where outside the US, there is no approved targeted treatment for certain patients. The post Ipsen agrees new oncology licensing deal appeared first on European Pharmaceutical Review ..read more

BeiGene has opened its flagship US manufacturing facility in Hopewell, New Jersey. The 42-acre facility provides flexibility to scale production of novel cancer treatments. The company highlighted that its oncology pipeline addresses “80 percent of the world’s cancers”. “Addition of our facility at the Princeton West Innovation Campus adds manufacturing and clinical development capabilities…to advance quality medicines faster for patients,” commented John Oyler, Co-Founder, Chairman and CEO of BeiGene. Investing for the future [BeiGene]… has invested $800 million over three years to expand i ..read more

A collaborative study involving several pharmaceutical companies has proposed reconsideration of employing naturally occurring endotoxins (NOEs) in endotoxin recovery studies. Following up on their initial research, in this part 2 of their study, the research team evaluated naturally occurring endotoxins prepared in high and low nutrient conditions in two common monoclonal antibody (mAb) buffer formulations. Furthermore, a panel of gram-negative bacterial isolates recovered at the executing sites was used to prepare analytes in both high and low nutrient conditions. The NOEs were spiked into ..read more

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the first generic raltegravir medicines for adult and paediatric patients with HIV who weigh at least 40kg. Authorisation of the antiviral medicine has been granted to Lupin Healthcare (UK) Limited and Zentiva Pharma UK Limited. Raltegravir generics – MHRA’s decision MHRA stated that overall, when combined with other medicines, the integrase inhibitor raltegravir may minimise the quantity of HIV in the patient’s blood. The active ingredient raltegravir is prescribed as a 600mg film‑coated tablet. The treatment must ..read more

The great benefit of the recent EU Annex 1 update, is that it enforced the concepts for contamination control and the responsibility for its cross-functional implementation.1 However, this necessitates correct use and application of key terminology such as aseptic and sterile. Aseptic indicates a high probability that the process is free from contamination. The term aseptic is neither absolute nor precise, and it is not accurate to use the term to describe entire rooms, areas or facilities. Aseptic is best applied to smaller, discrete techniques, behaviours and/or processes, eg, aseptic manuf ..read more

Nathalie Moll, Director General, the European Federation of Pharmaceutical Industries and Associations (EFPIA), has commended inclusion of a “dedicated life sciences strategy” in the Political Guidelines for the Next European Commission 2024-2029. The proposed guidelines were presented to the European Parliament by President-elect of the European Commission (2024-2029), Ursula von der Leyen. Key areas included in the Political Guidelines Increasing competitiveness Harnessing innovation–covering digital, collaboration, strategy and more—was conveyed as a vital component for improving European ..read more

This report delves into the latest advances and developments impacting pharmaceutical drug formulators today. Inside, articles explore current vast expansion of the formulation including patient centricity, excipients, safety, quality and regulatory considerations. Stay up to date with the latest developments in drug formulation including articles on: The trends and challenges for OSD and patient centric formulations Cell and gene therapy formulation including the prominent issues and opportunities for viral vector gene therapy Formulation design and manufacturing considerations and enablin ..read more

A report produced by the Centre for Process Innovation (CPI), alongside CDMO FUJIFILM Diosynth Biotechnologies, has acknowledged “significant” gaps in the UK skills and workforce for RNA therapeutics.  The future workforce could require “at least 150 future capabilities to meet RNA vaccine and treatment demand”, according to the report.  To support the manufacturing of RNA medicines, these capabilities include development of new equipment and reagents to increase efficiencies, the report stated. It also identified the need to enhance technical and digital ca ..read more