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STAT+: ‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices

STAT

Not long after the patent was awarded, the company leveraged federally funded research and began investigating different forms of the compound, called Revlimid.

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Health Innovators: Owlstone Medical’s Billy Boyle on breath biopsy technology

pharmaphorum

Owlstone is developing a breath-based analyser that captures Volatile Organic Compounds (VOCs) in breath non-invasively, and analyses them with high sensitivity. After studying engineering at Cambridge University, Boyle founded Owlstone Inc in 2004 with a focus on sensor technology for military and industrial applications.

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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2004.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

4,6 Traditional Herbal Registration The Traditional Herbal Medicines Directive (Directive 2004/24/EC) is implemented in the UK by the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 and came into force on 30 April 2011. 13 Currently, over 350 herbal remedies have been granted a THR licence. 2012/1916).

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PROTACs show promise for cancer treatment

Pharmaceutical Technology

According to the GlobalData deals database, the National Cancer Institute (NCI) in the US has issued 67 grants from 2021-2022 for PROTACs-related studies, while between 2004 and the end of 2018, the NCI issued just 45 grants for PROTACs-related studies.

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ISPE Communities of Practice Leaders – Nik Krpan

ISPE

And like money in a bank account, that experience goes into an experience account, and it starts to compound because now you're going to start to get more opportunities.”. Nik has been a member of ISPE since 2004. He is Past Chair of the Critical Utilities Community of Practice (CoP) and member of various other CoPs.

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NITROSAMINES: Where now?

European Pharmaceutical Review

Questions and Answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. Pathways for N-Nitroso Compound Formation: Secondary Amines and Beyond. EMA/409815/2020 Rev.13. Org Proc Res Dev.

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