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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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Drug Safety
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49 percent ORR for Tagrisso plus savolitinib in lung cancer
Almost half of patients with EGFR-mutated lung cancer with high MET overexpression who had progressed on Tagrisso alone responded to treatment with the addition of savolitinib.
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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.
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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).
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How does irradiation sterilisation impact herbal medicines?
EPR discusses the findings of a recent study exploring whether microbicidal treatments using radiation cause the degradation of crude herbal medicinal components.
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Monkeypox update – August 2022
In this article, EPR’s Hannah Balfour discusses the recent multi-country monkeypox outbreak, highlighting key developments in the international response.
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LAMP assays to enable rapid and sensitive detection of BCC
Here, EPR presents a novel loop-mediated isothermal amplification (LAMP) assay developed to enable the rapid and sensitive detection of Burkholderia cepacia complex (BCC) in pharmaceutical manufacturing.
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UK recall of Clinigen’s Mexiletine hydrochloride hard capsules
A Class 1 Medicines Recall Notification has been issued for three batches of Mexiletine hydrochloride hard capsules due to potential for under- or overdosing.
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L9LS antibody safe and highly protective against malaria, finds study
Phase I human challenge study shows a single subcutaneous injection of the monoclonal antibody L9LS provides at least short-term protection against malaria.
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Litifilimab reduces skin disease activity in CLE trial
Phase II results suggest litifilimab safely and effectively reduces skin disease activity in cutaneous lupus erythematosus (CLE) patients.
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Bristol Myers Squibb aims to improve disability diversity in clinical trials
Bristol Myers Squibb is collaborating with non-profit organisation Disability Solutions on an initiative to increase diversity in clinical trials.
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Regulators commit to collaborating on RWE integration
Global regulators commit to collaborate on the integration of real-world data and real-world evidence (RWE) in regulatory decision-making.
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CHMP meeting highlights – July 2022
At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
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EU proposes new blood, tissues and cells Regulation
The draft Regulation aims to enhance the protection of donors and recipients of substances of human origin (SoHO) therapies, while facilitating supply and innovation.
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Tackling fake pharmaceuticals: an industry united against counterfeit products
The market for counterfeit pharmaceutical products remains strong, with dishonest actors proving perennially tenacious. Here, Rich Quelch offers guidance on the technologies and practices that are helping to impede fraudsters.
