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Chinese patent reforms to bolster pharma innovation
Market research suggests the new drug patent reforms in China, in addition to other regulatory changes, will incentivise innovative pharma research.
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Therapeutics
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Targeted drug delivery enabled by genetically engineered nanoparticles
In a pre-clinical study, researchers were able to genetically engineer cell membrane-coated nanoparticles to deliver dexamethasone directly to the inflamed lungs of mice.
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COVID-19 antibody therapeutics – where are they now?
In this article, EPR’s Hannah Balfour explores the current usage of monoclonal antibody therapies for COVID-19, with commentary from Professor Adrian Streinu-Cercel of the Carol Davila University of Medicine and Pharmacy.
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Realising the therapeutic potential of MDMA
Psychedelic drugs are gaining popularity in the pharmaceutical R&D sector because of their apparent benefits for people suffering with neuropsychiatric disorders - and those which are resistant to existing therapies in particular. In this article, Imperial College London’s Professor David Nutt discusses the evidence underlying the development of psychedelic therapies…
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Antibody cocktail improves survival in seronegative hospitalised COVID-19 patients
Phase III data shows REGEN-COV™ (casirivimab and imdevimab) reduced risk of death by 20 percent in hospitalised COVID-19 patients lacking an immune response to SARS-CoV-2.
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CAR T therapy achieves high remission rate in acute lymphoblastic leukaemia trial
Trial data shows 71 percent of adult B cell acute lymphoblastic leukaemia patients receiving Tecartus® autologous anti-CD19-transduced CD3+ cell infusion achieved complete remission.
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beti-cel gene therapy demonstrates durable efficacy in beta thalassaemia patients
The betibeglogene autotemcel (beti-cel) gene therapy caused paediatric and adult beta thalassaemia patients to achieve transfusion independence lasting over two years.
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Navigating pharmacovigilance complexity in the US and EU: notes for biotechs
Pharmacovigilance obligations present significant challenges for biotechs. Small companies face the same rigor as large pharma - and it does not help that there is divergence between the requirements of the FDA, the EU and its member states. Here, seasoned pharmacovigilance experts and non-executive advisors to Arriello, Eric Caugant in…
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New consortium to develop PAT for cell and gene therapies
The Cell and Gene Therapy Catapult’s new consortium aims to accelerate therapeutic development by developing process analytical technologies (PAT) for cell and gene therapy manufacturing.
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Health Canada to modernise its clinical trial regulations
Health Canada has proposed a single regulatory framework for clinical trials for all health products that will support innovation and streamline drug and medical device development.
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Pharmacovigilance Risk Assessment Committee meeting highlights, June 2021
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
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COVID-19 antibody therapies safe and effective for transplant patients
Monoclonal antibody therapies found to reduce progression to severe disease, risk of hospitalisation and death in transplant recipients with mild to moderate COVID-19.
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DFE pharma joins UK’s leading initiative for innovation in drug manufacturing
DFE Pharma is the latest member of the UK’s Medicines Manufacturing Innovation Centre and will work on Grand Challenge 1: improving the manufacture of oral solid dosage medicines.
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Waiving COVID-19 vaccine intellectual property rights
South Africa and India’s request that the World Trade Organization waive intellectually property rights for COVID-19 vaccines, treatments, diagnostics and technology has garnered extensive media coverage, particularly since the US decision to support the proposal. In a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss the IP…
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Experts call for improved oversight to combat rise of unproven stem cell therapies
Stem cell therapy authorities urge the WHO to create an advisory committee for regenerative medicine and work to combat the rising use of unproven stem cell therapies worldwide.
