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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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As resistant tuberculosis rises, GSK says trial backs novel antibiotic

pharmaphorum

Cases of drug-resistant TB (DR-TB) rose 3% in 2021 over the previous year, the first increase since record-keeping started in 2004, according to the WHO report, which called for countries to move quickly to restore access to essential services to treat the disease, as well as greater investment in new vaccines and therapeutics.

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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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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

The 4 letters issued this calendar year: Involved 3 Untitled Letters and 1 Warning Letter – a profile not out of proportion given that about 33 percent of letters issued since 2004 have been Warning Letters. The characterization of investigative data resulted in a violation related to promotion of an unapproved compound.

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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

During 2023, there were five revisions to the European Medicines Agency ’s (EMA’s) Questions and Answers (Q&As) 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. 2004; 29: 100298. J Pharm Sci.