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Moderna unveils $500m plan for African vaccine facility

pharmaphorum

Moderna has said it plans to invest $500 million in a new facility for manufacturing mRNA vaccines in Africa, and has kicked off a search to find a suitable country and location. of Africans have been fully vaccinated against COVID-19, and just 15 African nations have met the agency’s objective of 10% coverage.

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

pharmaphorum

Ocugen is the first company to be affected by the FDA’s recent decision to raise the bar on emergency use authorisations for COVID-19 medicines, and will have to file for full approval of its vaccine candidate. The Russian Sputnik V vaccine was approved for use in India in April. That includes the more transmissible B.1.617.2

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Should we be worried about pharma’s supply chain?

World of DTC Marketing

A blood-thinning agent, heparin, had been adulterated due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material. Can patients really be confident in pharma supply chains? Why would a pharma company take risks like these?

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Can technology help diversify clinical trials?

pharmaphorum

There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials. Underrepresentation is multifactorial, so concerted efforts from life science companies are required to address inequitable healthcare. What comes next? About the interviewees.

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European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

The commission is looking to put more pressure on pharma companies to report such shortages, and to offer a drug’s marketing authorisation to another company before withdrawing it from the market. This looks like it may change shape in the future for the region, if the proposal put forward by the commission is adopted.

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Why are clinical trials struggling with diversity?

pharmaphorum

While many pharma companies are actively working on initiatives to improve diversity in clinical trials, we still have a long way to go. A risk-benefit approach underpins the decision-making process to evaluate human drugs, drug/device combinations and advanced therapy medicinal products for licensing of human medicines.

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Why project management holds the key to efficient drug development

Drug Discovery World

One indirect effect of the Covid pandemic – and the successful development of numerous vaccines at unprecedented speed – has been a greater-than-ever demand for new, effective medicines to be developed more quickly and efficiently, without compromising on safety. Why sponsors use external consultants.