news
Nirsevimab first potential immunisation to protect against RSV in infants
Nirsevimab has the potential to offer RSV protection for all infants, with a single dose showing 74.5 percent efficacy in the Melody Phase III trial.
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Biologics
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Clostridioides difficile vaccine shows promise in Phase III trial
Pfizer’s investigational C. difficile vaccine was shown to reduce the duration and severity of disease, but not prevent primary C. difficile infection.
news
FDA approves Carvykti for patients with multiple myeloma
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
news
USP calls for industry input in developing mRNA quality guidelines
USP is developing mRNA quality guidelines to support the development of innovative medicines and vaccines.
news
EMA’s human medicines committee (CHMP) Feb meeting highlights
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
news
Lilly to create $700mn Institute for Genetic Medicine
Investing $700mn to establish a new site, Eli Lilly plans to fuel the development of genetic medicines through the company’s new Institute for Genetic Medicine.
news
β-thalassemia patients achieve transfusion independence with gene therapy
Over 90 percent of β-thalassemia patients treated with Betibeglogene autotemcel (beti-cel) achieved transfusion independence lasting over a year.
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Challenges in downstream purification of advanced therapies
John Liddell, Chief Technologist at the Centre for Process Innovation (CPI), writes about the challenges associated with gene therapy products, which constitute a major portion of the overall cell and gene therapy market.
podcasts
EPR Podcast Episode 9 – Future of ATMPs – Jérôme Larghero and Julien Textoris, bioMérieux
Is the future of cell and gene therapy autologous or allogeneic? Which solid tumour may receive the first cell therapy treatment? How will the use of ATMPs in cancer care change our healthcare structures in years to come? Discover all this and more in this podcast with bioMérieux.
article
Drug Delivery In-Depth Focus 2022
Articles featured in this in-depth focus discuss a technology enabling drugs to be delivered across the blood-brain barrier, the potential of targeted radionuclide therapy as a precision oncology treatment and novel bioconjugation methods to improve biologics drug delivery.
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European Pharmaceutical Review Issue 1 2022
In our latest journal, discover the innovations enabling drugs to be delivered across the blood-brain barrier, the challenges associated with downstream purification of cell and gene therapies, as well as applications of NIR spectroscopy in ingredient analysis. Also featured in this issue, explore the development and future potential of radiomolecular…
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The microbiome: unlocking the Fourth Industrial (Bio) Revolution
The impending ‘Bio Revolution’, with the microbiome at its foundation, offers ground-breaking solutions and a wealth of opportunity in data science and bioinformatics, explains Anthony Finbow of Eagle Genomics.
news
NICE recommends first treatment for children with metachromatic leukodystrophy
The one-time gene therapy treatment for rare, neurodegenerative disease metachromatic leukodystrophy (MLD) is the most expensive drug ever evaluated by NICE.
news
Could COVID-19 vaccines be swallowed?
New pre-clinical research demonstrates the potential of gastric autoinjectors to deliver mRNA in sufficient quantities for vaccination.
news
Second COVID-19 vaccine ‘Spikevax’ is approved by the FDA
The FDA has approved a second vaccine, marketed as Spikevax, shown to be 93 percent effective in preventing COVID-19.
