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STAT+: U.K. pharma increasingly violates voluntary industry marketing codes, and probes are taking longer

STAT

Pharmaceutical companies in the U.K. Between 2004 to 2021, the Prescription Medicines Code of Practice Authority, a self-regulatory body overseen by the Association of the British Pharmaceutical Industry, ruled on more than 1,100 cases involving nearly 160 companies where there was a breach of the industry code.

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The Issue with Reissue: PTE Edition

The FDA Law Blog

Merck applied for a patent term extension on the reissued patent, claiming the start of the regulatory review period as April 2004 and termination at the approval of the BRIDION NDA in December 2015. With this long regulatory review period, the PTO granted the statutory-maximum five-year patent term extension. The plain text of 35 U.S.C.

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

STAT

But like any pharmaceutical company with an eye toward the future, Celgene continued to seek other ways to wring profits from its development work. 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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Teva appoints Eric Hughes as head of R&D and Chief Medical Officer

European Pharmaceutical Review

Dr Eric Hughes joins Teva with experience in all phases of drug development at global pharmaceutical companies, most recently Boston-based Vertex Pharmaceuticals, which he joined last year. He will be based out of Teva’s US headquarters in Parsippany, New Jersey. .

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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. Navigating Market Authorisation in the UK for the Pharmaceutical Industry [Internet].

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How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

pharmaphorum

So, how do smaller pharmaceutical companies at the cutting edge get ready for their acquisition milestone, so they maximise their value and attractiveness? Any purchasing company would ideally like to integrate their acquisitions into their company seamlessly. She joined NSF in 2017.

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Insider’s Guide to Manufacturing, QC, and Operational Excellence

ISPE

Join our experts representing various disciplines within pharmaceutical science and manufacturing across the globe, offering professionals the opportunity to engage in industry-critical advancements and conversations.