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European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

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Scandinavia: insight into opportunities for drug discovery

Drug Discovery World

DDW Editor Reece Armstrong explores the Scandinavian drug discovery sector and speaks to key players about Sweden’s place in the market. Scandinavia represents one of the most exciting but perhaps underrepresented markets for the discovery and development of pharmaceuticals.

Science 130
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MindMed Adds Chief Development Officer with FDA Phase 2 Psilocybin Clinical Trial Experience

The Pharma Data

These statements concern, and these risks and uncertainties include, among others, MindMed’s and its collaborators’ ability to continue to conduct research and clinical programs, MindMed’s ability to manage its supply chain, product sales of products marketed by MindMed and/or its collaborators (collectively, ” Products”), (..)

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RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients

The Pharma Data

These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue (..)

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Analysis Life Sciences Thank You Ahead of a November deadline, FDA finalizes guidance on waivers, exemptions or exceptions from supply chain security requirements

Agency IQ

a wholesaler or pharmacy) would be able to see a valid chain of custody for a product. They may seek “exceptions… to the requirements relating to product identifiers if a product is packaged in a container too small or otherwise unable to accommodate a label.” The system is intended to increase transparency and safety.

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REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

The Pharma Data

These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue (..)

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Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

Samples retained for testing should be kept under similar storage conditions and within the same container-closure system in which the drug is marketed. In some cases, manufacturers have determined that specific drug products have limited stability when the original packaging is opened.

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