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EMA recommends Idefirix (imlinfidase) is granted marketing authorisation
The European Medicines Agency (EMA) recommended Idefirix is granted conditional marketing authorisation for highly sensitised patients awaiting kidney transplant.
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CHMP recommends cystic fibrosis treatment Kaftrio is granted marketing authorisation
The European Medicines Agency's human medicines committee (CHMP) said the treatment would offer a therapeutic option for certain cystic fibrosis phenotypes that are currently untreatable.
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Comparison of health technology assessments and time to reimbursement for orphan drugs
This article delves into four health technology assessment agencies, analysing the opportunities and challenges for orphan drugs in France, Germany, England and Scotland.
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FDA approves new administration route for Phesgo to treat breast cancer
The FDA has given approval to Phesgo for injection under the skin to treat HER2-positive breast cancer, meaning it can be administered at home by a healthcare professional.
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NICE does not recommend Novartis’ siponimod for secondary progressive MS
NICE has decided to not recommend Mayzent (siponimod) for use on the NHS as a secondary progressive multiple sclerosis treatment because its clinical trial did not directly compare it to interferon beta-1b.
Whitepapers/App Notes/Posters
Application note: Ozonia Ozone Technology for ultrapure water disinfection
Learn why Ozonia MEMBREL electrolytic ozone technology is the ultimate solution for ultrapure water disinfection applications.
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Infographic: Benefits and applications of Ozone Technology
Learn the benefits of Ozonia MEMBREL electrolytic ozone technology in ultrapure water disinfection applications.
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Kymab wins UK court case against Regeneron’s patent claims
The UK Supreme Court has ruled that Regeneron's patent claim regarding genetically modified mice against Kymab are invalid.
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Five patent issues that European biosimilar developers should consider before entering the US market
As patents on originator biologic medicines begin to expire, there are growing opportunities for biosimilars to enter the market at lower prices. Joshua Whitehill, Natasha Daughtrey and Grace Truong discuss key aspects of US patent law that European developers should consider before entering the American market.
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Patents and approvals – medicines, vaccines and diagnostics for COVID-19
As companies race to develop a COVID-19 vaccine, various discussions about patents and ownerships of the vaccine have occurred, especially in light of funding from various governments. This article explores the patent and regulation issues, with a focus on patent extensions and suspensions for global good.
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Life sciences M&A activity during the global pandemic
COVID-19 has severely disrupted the lives of many people around the world. In this article, corporate partner Theo Godfrey and competition partner Russell Hoare from the life sciences team at law firm CMS Cameron McKenna Nabarro Olswang LLP consider some issues related to COVID-19 that have impacted life sciences merger…
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Whitepaper: Enabling data integrity during drug manufacturing
High data quality and integrity is critical to ensure successful manufacturing of a drug. This whitepaper discusses how utilisation of software systems such as SampleManager LIMS enables and promotes compliance with regulations for the manufacturing of a drug.
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EMA recommends authorisation for remdesivir to combat COVID-19
The EMA's human medicines committee (CHMP) has recommended a conditional marketing authorisation for Veklury (remdesivir) to treat COVID-19.
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Epidyolex (cannabidiol) reclassified as Schedule 5 in UK, relaxing control over drug
GW Pharmaceuticals's Epidyolex (cannabidiol) has been changed from a Schedule 2 drug to a Schedule 5 drug, making it exempt from virtually all controlled drug requirements.
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Enabling compliant data management with a comprehensive informatics solution
This guide to from Thermo Fisher Scientific explores how laboratory data management solutions help thier pharmaceutical and biopharmaceutical customers to address their business challenges.