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European Pharmaceutical Review Issue 5 2023
EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.
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MSD
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Key developments in pharmaceutical manufacturing – September 2023
This article outlines the recent progress of several major new manufacturing facilities that will be central in supporting the production of innovative therapies in Europe.
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MSD medicine accepted for use in Scotland
Scotland is the first European country to accept the HIF-2α inhibitor WELIREG® (belzutifan) for eligible adults with von Hippel-Lindau (VHL) disease.
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MSD Ireland’s €1b facility investment achieves new milestone
Opening of a new facility in Dunboyne, Co. Meath and expansion of MSD’s first vaccines operation outside of the US enables MSD Ireland to help address the demand for vaccines and medicines worldwide.
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MHRA approves prostate cancer combination therapy
The first PARP inhibitor to show clinical benefit with a new hormonal agent in first-line metastatic castration-resistant prostate cancer has been granted UK approval.
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MSD and Nectin to collaborate on clinical trial for KEYTRUDA® combination
MSD/Merck and Nectin Therapeutics have agreed to collaborate on a clinical trial for KEYTRUDA® in combination with monoclonal antibody NTX1088.
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Lynparza combination approved in EU for advanced prostate cancer
Patients in the EU with an advanced prostate cancer will benefit from a newly approved Lynparza-based treatment combination for the first time.
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Lynparza® significantly reduces risk of death in early breast cancer patients
Lynparza® (olaparib) is the first PARP inhibitor to demonstrate overall survival benefit in early breast cancer, according to new data.
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Keytruda® promising in adjuvant treatment of lung cancer
MSD/Merck reveals Keytruda® (pembrolizumab) significantly improved disease-free survival in adjuvant treatment of non-small cell lung cancer (NSCLC) patients.
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Energize initiative to boost renewable energy access for pharma suppliers
The Energize programme will allow 10 big pharma companies to engage with renewable energy suppliers and address their greenhouse gas emissions.
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Developing and delivering live biotherapeutic products
The microbial content of the gut has a well established role in health and disease. In this article, European Pharmaceutical Review’s Hannah Balfour explores the development and formulation of live biotherapeutic products (LBPs), an emerging treatment modality that seeks to capitalise on the interaction between the microbiota and host in…
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Lynparza® with abiraterone delays prostate cancer progression
Lynparza with abiraterone is the first PARP inhibitor to demonstrate clinical benefit in combination with a hormonal agent in this setting.
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Lynparza crosses superiority boundary for invasive disease-free survival at interim analysis
The OlympiA trial will conduct its primary analysis early, after the Independent Data Monitoring Committee found it met its primary endpoint in BRCA mutated early breast cancer patients.
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Gavi to make 500,000 doses of Ebola vaccine available for outbreak response
The global stockpile will provide developing countries responding to Ebola outbreaks with doses of the approved single-dose Ebola vaccine, rVSV∆G-ZEBOV-GP, live, free of charge.
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UK Prime Minister visits the UK Vaccines Manufacturing and Innovation Centre (VMIC)
Prime Minister Boris Johnson visited the construction site of the VMIC and met scientists and engineers at the forefront of the UK’s COVID-19 response.
