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European Pharmaceutical Review Issue 2 2024
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
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Drug Development
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Benefits of 3D printing for personalised medicine formulation
A study has demonstrated how 3D printing can be used to manufacture tailored, safe, and effective treatments for patients with rare diseases via pharmaceutical compounding.
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European Commission authorises one of first ustekinumab biosimilars in Europe
This approval follows a development and commercialisation agreement made in September 2023 between Sandoz and Samsung Bioepis for the biosimilar ustekinumab.
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AbbVie JAK inhibitor shows potential in novel atopic dermatitis head-to-head trial
Patients with moderate-to-severe atopic dermatitis can strive for both little to no itch and clearer skin with AbbVie’s upadacitinib, topline Phase IIIb/IV study results suggest.
webinar
Testing of Rapid Microbiological Methods (RMMs) – Demonstrating Equivalence to Existing Methods in Alignment with USP <1223>
26 April 2024 | By Veolia Water Technologies & Solutions - Sievers Analytical Instruments
Watch this on demand webinar to hear about the latest RMM technology and how it aligns with USP testing criteria. This webinar will cover testing strategy, and data will be presented to effectively demonstrate suitability of the Soleil for its intended use and correlation to plate counts.
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Stress impact on protein particle formation for monoclonal antibody formulation
The driving factor for protein particle formation is surface mediated in protein only formulations in manufacturing, research asserts.
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Research calls for greater investment in Alzheimer’s clinical trials
Despite some challenges, for the Alzheimer’s drug development pipeline, 2024 is a “learning year”, an expert on the disease says.
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NICE recommends Novartis precision brain cancer treatment
An “innovative, life-extending treatment” for BRAF V600E mutation-positive glioma has been recommended for certain young people on the NHS.
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AAV gene therapy demonstrates positive activity in Duchenne muscular dystrophy
Initial trial results show the gene therapy enabled up to 85 percent of muscle fibres expressing microdystrophin in boys with Duchenne muscular dystrophy eight weeks post-injection.
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European Commission approves novel antibiotic
Authorisation of the antibiotic combination, which targets multidrug-resistant bacteria, could help to address the global challenge of antimicrobial resistance (AMR).
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Genentech oncology treatment granted first-of-a-kind approval
The novel approval provides a dedicated therapy option for patients with ALK-positive early-stage lung cancer.
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Enhancing competitiveness of European life sciences
EFPIA’s reflections on the recent Conclusions of the Special Meeting of the European Council assert the importance of ensuring a more resilient and competitive life sciences sector.
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Antibiotic demonstrates non-inferiority to a leading gonorrhoea treatment
Based on its novel mechanism of action, GSK’s gepotidacin could provide a new oral option for the treatment of gonorrhoea.
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Analysis of corticosteroid formulations in metered dose inhalers
The spectrophotometric-based method offers rapid and reliable analysis of formoterol and beclomethasone formulations in metered dose inhalers, according to research.
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Encouraging data for Roche multiple sclerosis injection
EU approval for Roche’s subcutaneous OCREVUS is anticipated mid-2024, depending on acceptance of regulatory submission.
