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European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

Peter O’Donnell, Applied Clinical Trials’ Brussels Correspondent, summarises this as the EMA being tasked with creating a European network of patient representatives, academics, drug developers, investigators, and centres with expertise in the performance of studies in the paediatric population.

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Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®

The Pharma Data

For complete information on the safety of COMIRNATY® always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website. The information contained in this release is as of April 19, 2021. Pfizer Disclosure Notice.

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

The Pharma Data

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.

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Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

The Pharma Data

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. The Company expects that the U.S. government has agreed to provide up to $1.525 billion to purchase supply of mRNA-1273 under U.S.

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments. The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries.

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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

Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. (..)

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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. It contains the antiviral medications nirmatrelvir and ritonavir. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13 This partnership will expand the company’s immunology pipeline.

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