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Twice yearly HIV treatment approved in Europe
Gilead’s Sunlenca® (Lenacapavir) was authorised by the European Commission for people with multi-drug-resistant HIV who have very limited treatment choices.
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Therapeutics
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The EU HTA regulation: a new frontier for access to innovative technologies
A new health technology regulation is due to be applied to help EU countries determine the effectiveness of novel technologies and decide on pricing and reimbursement by health insurers or health systems. Here, Professor Vincenzo Salvatore and Giuseppe Ragucci from BonelliErede reflect on what this means for the UK and…
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Actualising the power of antibody-drug conjugates as cancer therapeutics
Antibody-drug conjugates (ADCs) are designed to be highly-targeted therapies with the potential to maximise the potency of a treatment while reducing unwanted side effects on healthy tissues. Some 20 years after the first ADC product approval, Dominik Schumacher and Jonas Helma-Smets of Tubulis GmbH discuss how improved and optimised technologies…
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European Pharmaceutical Review Issue 4 2022
In EPR Issue 4, experts discuss implementing a global strategy to improve the sustainability of endotoxin testing, how to accelerate timelines for manufacture of multi-specific antibodies and the potential of oncolytic viruses as a therapy for glioblastoma. Also featured: progress towards smart vaccine manufacturing, an update on edible anticounterfeiting technology,…
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Trends in biopharma contract manufacturing 2022
As biopharmaceuticals become an increasingly important part of the drug development pipeline and market, EPR discusses key trends in the outsourcing of their manufacturing.
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Pharma contract manufacturing market to grow to $130bn by 2026
Growth in the global pharmaceutical contract manufacturing market will be driven by rising consumption of medicines and increasing commercialisation of generic and innovative therapies, among other factors.
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FDA approves Zynteglo gene therapy for beta-thalassemia patients
bluebird bio’s Zynteglo (betibeglogene autotemcel), a one-time treatment for transfusion-dependent beta-thalassemia, will roll out with a $2.8mn price tag per dose.
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Merck to support development of Orna’s circular RNA (oRNA) therapies
Under a collaboration agreement Merck will pay Orna $150 million to support the progress of multiple oRNA vaccine and therapeutic programmes.
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Formulation development outsourcing market to be worth over $60bn by 2030
Market research suggests the global formulation development outsourcing market will significantly expand in coming years, owing to disease burden and R&D expenditure.
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Tackling the silent pandemic: AMR Industry Alliance sets the Standard
Here AMR Industry Alliance representatives Melissa Gong Mitchell and Steve Brooks discuss how the Alliance is mobilising the life sciences sector in combatting antimicrobial resistance (AMR). They present the newly established antibiotics manufacturing standard that aims to minimise pharma’s contribution to AMR in the environment, considering the critical considerations and…
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MHRA approves Pluvicto® and Locametz® for prostate cancer
The UK’s regulator approved Novartis’ radioligand therapy Pluvicto®▼ and radioactive diagnostic agent Locametz® for use in advanced prostate cancer.
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Phase III trial shows tislelizumab improves outcomes for liver cancer patients
Phase III trial results indicate BeiGene’s tislelizumab improved overall survival in patients with unresectable hepatocellular carcinoma (HCC) versus sorafenib.
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Does terminal sterilisation affect the quality of ophthalmic APIs?
EPR summarises research into the impact of gamma irradiation and ethylene oxide sterilisation treatments on European Pharmacopoeial compliance of common ophthalmic APIs.
![Close up of Amgen sign at its headquarters in Thousand Oaks, California, USA [Credit: JHVEPhoto/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/amgen-2-e1660136652889-300x278.jpg)
![Close up of Amgen sign at its headquarters in Thousand Oaks, California, USA [Credit: JHVEPhoto/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/amgen-2-e1660136652889.jpg)
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Amgen to acquire ChemoCentryx for $3.7bn
The nearly $4bn ChemoCentryx acquisition will expand Amgen’s inflammation and nephrology portfolio and pipeline.
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ADC shrinks brain metastases in HER2+ breast cancer patients
Phase II results show a high intracranial response rate in breast cancer patients with active brain metastases treated with trastzumab deruxtecan (T-Dxd), an antibody-drug conjugate (ADC).
