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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. Key areas of potential legislative change. Reducing market exclusivity. Conclusions.

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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4 As of October 2023, 62.93

Safety 113
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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact. EU competitiveness Moll said the legislation revisions should instead be used to make Europe more attractive to pharma companies.

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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

Nonetheless, some stakeholders remain concerned with this new approach given the complexity of biological medicines and the need for patients to be treated individually and have called for further discussions with regulators and all stakeholders. Directive 2001/83 (as amended). EMA Biosimilars Q&A.

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The Fastest Growing Companies in Boston Hiring For Sales

CloserIQ

Kyruus is revolutionizing healthcare with its data-driven system that makes it easier for healthcare system to match patients to appropriate providers. Cybereason’s workplace culture is known to be fast-paced and competitive, with plenty of opportunities for learning. Salsify offers competitive benefits and a flexible vacation plan.

Sales 76
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PROTAC development gains momentum, but clinical performance is poor

Pharmaceutical Technology

The first concept for a PROTAC was published in 2001, and recently these protein degraders have gained rapid momentum as a promising novel modality. By this same virtue, PROTACs are able to degrade previously undruggable targets, which provides a major competitive advantage for this modality if shown to be true.

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Achieving scale up success under economic uncertainty

European Pharmaceutical Review

Market uncertainty Rising operational costs, stiffening competition, ongoing patent expirations, evolving environmental and social governance requirements and increasing pressure on drug prices mean the industry will have to navigate thoughtfully to be successful amid this complicated mix of financial and strategic risks.