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Dystrogen begins trial for Duchenne muscular dystrophy cell therapy
The first patient has been infused in the Phase I pilot study of DT-DEC01, a chimeric cell therapy for Duchenne muscular dystrophy.
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Therapeutics
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Microneedle patch with precise vancomycin drug dose against MRSA skin infections
Effective vancomycin concentrations can be delivered locally to methicillin-resistant Staphylococcus aureus (MRSA)-infected sites of the skin with the use of miniaturised needles. This presents opportunities for targeted delivery of medication for focal skin diseases. Here, Georgios A Sotiriou and Liv Eidsmo of the Karolinska Institutet discuss some of them.
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Nearly two years on, how are European pharma supply chains coping with COVID-19?
When the pandemic broke out in 2020, pharmaceutical supply chains showed signs of potential failure across the continent. Now, with COVID-19 cases rising once more, and an end to the problem not yet in sight, we discuss with Medicines for Europe how these supply chains are faring, almost two years…
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Event review: The Future of QA/QC for Complex Biologics
On 30 November and 1 December 2021, European Pharmaceutical Review hosted its first ever event – The Future of QA/QC for Complex Biologics Online Summit. Bringing together more than 600 attendees, 15 expert speakers and Thermo Fisher Scientific and Merck as sponsors, the summit gave industry experts the chance to…
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New developments in the pharmaceutical stress testing industry
A team of American scientists report on some recent developments in the realm of pharmaceutical stress testing, or forced degradation, practices relating to solid dosage forms, bringing some valuable clarity for drug developers.
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Critical steps when validating an assay or analytical method for cell and gene therapy products
Dr Kiren Baines, Analytics Lead at eXmoor Pharma, details some of the critical steps when validating an assay or analytical method, including key considerations for developing an experimental plan aligned with ICH guidelines.
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Ways to promote patient access as a European healthcare priority
We are experiencing a time of polarity in our healthcare systems with breakthrough treatment options developed, but access prohibited. Here, Catherine Owen, SVP of Major Markets at Bristol Myers Squibb, explains why, despite continued COVID-19 pressures, the time is ripe to rectify this situation.
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First drug for acute graft-versus-host disease prevention approved by FDA
BMS’s Orencia (abatacept) has been approved by the US FDA for prophylaxis of acute graft-versus-host disease (aGvHD) in patients aged two years plus.
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US healthcare groups publish drug supply chain recommendations
Healthcare groups including the US Pharmacopeia and American Medical Association release advice for policymakers on addressing challenges in the US supply chain.
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Application Notes Supplement 2021
Here, industry experts from bioMérieux Industry, Charles River, Shimadzu, TA Instruments, Thermo Fisher Scientific and WITec share their research, guidance and pharmaceutical knowledge.
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Manufacturing, Packaging & Logistics In-Depth Focus 2021
Articles in this in-depth focus explore how to promote patient access to breakthrough treatments across Europe and discuss some of the latest and greatest innovations in packaging.
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Formulation, Development & Delivery In-Depth Focus 2021
This in-depth focus explores recent developments in pharmaceutical stress testing and why collaboration is key in the development of cancer therapeutics.
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Bioprocessing & Bioproduction In-Depth Focus 2021
In this in-depth focus, experts discuss how a future skills shortage may impact the biopharma industry and the key considerations when validating assays and analytical methods for ATMPs.
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EMA recommends GSK’s Xevudy for the treatment of COVID-19
The EMA has recommended granting marketing authorisation for the use of Xevudy (sotrovimab) to treat COVID-19 in adults and adolescents.
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New Digital Grand Challenge announced by CPI
The Centre for Process Innovation (CPI) reveals the National Physical Laboratory, StreamNative and Wyoming will collaborate on new projects to drive digital medicines manufacturing technology.
