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Coronavirus vaccine may have allergy warning in US, says expert

pharmaphorum

The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone to serious allergic reactions. Both recovered after appropriate treatment. Both are recovering well.”.

Vaccines 103
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The supply chain innovations behind the world’s largest vaccine programme

Pharmaceutical Technology

To develop a vaccine and then get as many people vaccinated as quickly as possible. Advanced monitoring and analysis technology has enabled more than 13 billion COVID-19 vaccinations to be distributed worldwide to date. Before the COVID-19 pandemic, 25-50% of vaccines were wasted due to cold chain issues.

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A Reuters Pharma conversation with EY: smart reviewing and payment outcomes

pharmaphorum

Harking back to the Reuters Pharma 2022 event, held at the Nice Acropolis convention centre on France’s South Coast back in October, pharmaphorum had a chance to drop by the booth of EY and discuss not only its consulting operations, but the company’s Smart Reviewer, and their own assessment of the industry event itself.

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3 ways pharma marketers can draw inspiration from digitally-native brands

pharmaphorum

The external part of this is ensuring agility around adapting customer messages to meet the market needs with ‘quick-turn’ content updates that react to the events of today and tomorrow.”. As part of this, a number of big pharma companies are also racing to develop a safe and effective vaccine for the coronavirus.

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FDA’s New RWE Guidance Provides Recommendations for Sponsors Conducting Non-Interventional Real-World Studies and Describes the Potential to Use RWE for Initial Approvals in One Limited Circumstance

The FDA Law Blog

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

FDA 108
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Discover, Delve, and Develop: Expert Workshops at the 2023 ISPE Annual Meeting & Expo

ISPE

to help facilitate participants in developing a CCS using a case study and supporting documentation from an existing cGMP facility. In a collaborative work environment, they will evaluate facility documentation and draw conclusions to be shared with the workshop team and other participants.

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Monetizing At-Home COVID Tests

DiversifyRx

’ You want to ensure that you document the attestation every time you dispense the at-home COVID tests for a patient. People don’t want to needlessly isolate themselves and miss work and life events. Do not just autofill all these at-home tests and ship them out if the patients do not want them.