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Should we be worried about pharma’s supply chain?

World of DTC Marketing

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. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. 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. According to the latest WHO data, just 4.4%

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Can technology help diversify clinical trials?

pharmaphorum

The development of guidance to support companies who require risk assessments when working with clinical trial data on selected computerised systems is welcomed. There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials. What comes next? About the interviewees.

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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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European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

Antibiotic development According to Politico, the European Medicines Agency is investigating a chronic shortage in antibiotics across Europe, where almost every country is reporting gaps in supplies – 25 out of the 27 EU countries have reported local shortages, the agency’s Chief Medical Officer, Steffen Thirstrup, told a press briefing 6.

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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. It’s not a coincidence that we now have over 2.3

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

Advarra

Also consider quality agreements for key vendors, such as contract development and manufacturing organizations (CDMO) and CROs. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? The sponsor-initiated IND is conducted by a pharma company seeking commercial approval.