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Should we be worried about pharma’s supply chain?

World of DTC Marketing

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. We can’t continue to develop drugs the same way as we have done before.

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Moderna unveils $500m plan for African vaccine facility

pharmaphorum

The factory will be able to supply up to 500 million doses of mRNA shots a year, and cover the full spectrum of manufacturing from drug substance production through to full/finish and packaging, according to the company.

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Ocugen gets a black eye as FDA denies emergency OK for COVID jab

pharmaphorum

The Philadelphia-based company said it had taken the decision to go down the biologics license application (BLA) route for Covaxin based on FDA feedback to the EUA data package it had submitted to the agency. Bharat has also reported data suggesting the shot is effective against the beta (B.1.351) 1.351) variant.

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Can technology help diversify clinical trials?

pharmaphorum

However, if considered early in the drug development plan, compliance is by no means insurmountable and would be offset by the benefits of digital healthcare tools for patient engagement. There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials. What comes next?

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Q&A: The IND Journey Phase I – Navigating Success

Advarra

If the sponsor wants their drug approved, they need to complete all clinical studies and submit an application. Q: Please discuss the transfer of investigational new drug (IND) sponsorship from one sponsor to another and that process. The sponsor is the pharmaceutical company conducting the trial. A: No, this is not allowed.

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European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

Politico published a summary of the key propositions outlined in the draft 2 , and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded. Key proposals Approved drugs must launch in all EU countries within two years Politico described this as a measure to ensure a level playing field.

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Improving access to treatments in challenging markets

pharmaphorum

Jirair Ratevosian, executive director of global patient solutions and government affairs at Gilead Sciences, tells us how his company utilised previously developed partnerships and their knowledge of providing global access to HIV treatments to distribute Remdesivir. We went back to what we do best … we engaged our network of companies.