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European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

The commission is proposing the introduction of temporary emergency marketing authorisations 1. Extra foreign inspections Since July 2019, the MRA (Mutual Recognition Agreement) between the EU and the US FDA has been fully in force.

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

The Pharma Data

Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S.

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Regeneron Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

billion versus third quarter 2019 (4). billion versus third quarter 2019. billion versus third quarter 2019. Total revenues increased by 32% to $2.294 billion in the third quarter of 2020, compared to $1.744 billion in the third quarter of 2019. in the third quarter of 2019. TARRYTOWN, N.Y. , Total revenues (4). $.

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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

Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended June 30, 2020. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S.

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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

More recently – in 2019 – researchers from Germany published a sweeping review of the available literature on drug stability beyond the labeled expiration date. In some cases, manufacturers have determined that specific drug products have limited stability when the original packaging is opened.

Science 40
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CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

FDA Law Blog: Biosimilars

Penalties for “Misclassification” The Medicaid Services Investment and Accountability Act of 2019 added new penalties to the Medicaid rebate statute for knowingly misclassifying a covered outpatient drug. The most noteworthy are the following: 1. See 42 U.S.C. 1396r-8(b)(3)(C)(iii).

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Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

Securities and Exchange Commission , including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S.