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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 2018; 8(1). EMA/95098/2010.

Safety 112
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The role of outsourcing in antibody drug manufacture

European Pharmaceutical Review

Other factors were listed related to the development process of inter-organisational collaboration networks in the R&D of mAbs. Findings included: “the size and complexity of the collaborative network continuously increased as dedicated biotech firms established new partnerships with existing pharmaceutical companies”.

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The EU HTA regulation: a new frontier for access to innovative technologies

European Pharmaceutical Review

1 The regulation is the culmination of a long debate between European Union (EU) Member States and health sector stakeholders, triggered by joint actions such as European Network for Health Technology Assessment (EUnetHTA) and formalised through the European Commission (EC)’s proposal in January 2018. European Commission; 2018. Lorgelly PK.,

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Voice is Becoming the Loudest Tool in the Exam Room

PM360

The line from the 2011 Pixar “Cars” sequel (trust me, as a parent of two, I have seen it countless times) points to the practical implication for voice technology. Health systems are signing off on network-wide solutions that use AI companions to record conversations, compile EHR notes, and even order tests and prescriptions.

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Strengthening and transforming the pharmaceutical supply chain

European Pharmaceutical Review

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Going forward, it is imperative for companies to invest in constructing more resilient supply networks.

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Are timely access and robust safety mutually exclusive?

pharmaphorum

A European Federation of Pharmaceutical Industries and Associations (EFPIA) report published earlier this year, for example, compared the timelines of six regulatory agencies between 2011 and 2020. It found the EMA “lagged behind” most, with a median approval time in 2020 of more than 400 days.

Safety 91
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Top 12 Healthcare Technology Start-ups To Know

Medico Reach

Founder: Jacob Sattelmair Year of establishment: 2011 Headquarters: Boston, Massachusetts. They have developed mobile apps that are meant to: Provide patients with clinical and emotional support in crises Create a network of clinics and facilities to help patients find doctors easily.