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EMA human medicines committee meeting highlights, June 2021
Drugs recommended for approval by the European Medicines Agency’s human medicines committee included a gene therapy and two generics, among five others.
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Therapeutics
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Supply of biosimilars and generics with Adrian van den Hoven, Medicines for Europe
In this interview, Adrian van den Hoven, Director General of Medicines for Europe, discusses all things supply of generic and biosimilar medicines for the continent. Also, in a bonus video, Adrian discusses challenges disrupting access to biosimilars and generics in Europe.
![The GlaxoSmithKline headquarters building in Brentford, west London, June 2018 [Credit: Willy Barton / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/GSK-3-300x278.jpg)
![The GlaxoSmithKline headquarters building in Brentford, west London, June 2018 [Credit: Willy Barton / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/GSK-3-e1624534468322.jpg)
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GSK to focus on vaccines and specialty medicines in next decade
In an investor update, GlaxoSmithKline (GSK) revealed its plan to promote growth and performance over next ten years.
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UK and Europe approve Adtralza for treating atopic dermatitis
EU and UK regulators have approved Adtralza (tralokinumab), a monoclonal antibody, for treating moderate-to-severe atopic dermatitis in adult patients.
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EU approves Koselugo for treatment of neurofibromatosis and plexiform neurofibromas
The European approval of Koselugo was based on its ability to reduce inoperable plexiform neurofibromas in paediatric patients with neurofibromatosis type 1.
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Real-world evidence confirms Veklury® reduces COVID-19 mortality
New real-world analyses demonstrate Veklury® (remdesivir) reduces mortality and increases likelihood of discharge in hospitalised COVID-19 patients.
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Collaboration to develop ultra-long acting medicines for HIV
ViiV Healthcare is licencing Halozyme’s Enhanze® drug delivery technology to help develop ultra-long acting versions of its long-acting HIV pipeline products.
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France’s temporary authorisation (ATU) programme: reform implications
The new ATU programme may support more efficient use of healthcare spending but could it mean fewer patients receive early access to treatments? Here, experts from Charles River Associates discuss the new ATU programme reforms and how they could impact pharma.
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Zolgensma® meaningfully improves spinal muscular atrophy in patients
Asymptomatic and symptomatic children treated with Zolgensma® (onasemnogene abeparvovec) gene therapy achieved motor milestones never observed in the natural history of spinal muscular atrophy.
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Collaboration to develop novel polymer-based drug delivery system for mRNA
Evonik and Stanford University will collaborate over three years to advance an innovative polymer-based drug delivery system that could further the use of mRNA therapeutics.
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Funding to support trial of ketamine in patients with bipolar depression
The Canadian Government is funding studies to establish ketamine as a safe and effective treatment for patients with bipolar depression.
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Collaboration to develop an automated CAR T-cell manufacturing system for clinics
German oncology clinics are working with Optima Pharma to create an automated manufacturing unit for decentralised production of CAR T-cell therapies in treatment centres.
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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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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.
