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European Commission revokes marketing authorisation for Novartis’ crizanlizumab

European Pharmaceutical Review

Novartis said the decision to revoke the authorisation was based on a review of crizanlizumab under Article 20 of Regulation (EC) No 726/2004. Crizanlizumab is approved for use by the United States Food and Drug Administration (FDA). EMA required the STAND study as part of the marketing authorisation.

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API nitrosamines: method sensitivity issues

European Pharmaceutical Review

For instance, Lhasa initiated a Nitrites in Excipients database to facilitate risk assessment of drug products, which was recently published. This data provides invaluable insight into the likelihood of nitrites in a drug product formulation. European Directorate for the Quality of Medicines & HealthCare. 25 June 2020.

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Cancer: Progress but a long way to go

World of DTC Marketing

In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease.

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Realising milestones with gene therapy for SMA

European Pharmaceutical Review

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. percent of Europe’s annual healthcare spend. This is often called an ‘SMN-based’ or ‘SMN-enhancing’ approach. Stakeholder education is critical to achieving this.

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Reality Bites: Disappointment in the R&D Sector

Pharmaceutical Technology

As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. Even so, current figures show firms’ biggest portion of spend is still on marketing and administration at 33.1%,

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Russia’s focus on domestic pharma production could shield it from sanctions’ effects

Pharmaceutical Technology

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

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Uri Goren

Cadensee

02:25 Uri Goren talks about his road to become a trailblazer and advocate for patient-centric healthcare. 52:21 Uri's opinion about the main problem that needs to be solved for the healthcare market with technology. When he was going through his cancer, he died in 2004. Interview Transcription (mild edits).