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Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

Ocugen is currently enrolling patients in the Phase I/II ArMaDa clinical trial to assess the safety and efficacy of OCU410 for GA secondary to dAMD. The ArMaDa clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases.

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Effective data quality governance: challenging five common myths

European Pharmaceutical Review

Yet, without the assumption of high trust in the data with strong data governance, the risks can become intolerably high as companies’ dependency on the flow of good data broadens. SG: Another preconception is that data quality governance is an IT / data management concern first and foremost. So, what’s the best way forward?

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Pfizer, BioNTech enter $3.2bn deal with US government for Covid-19 shots

Pharmaceutical Technology

Pfizer and BioNTech have entered a new vaccine supply agreement worth $3.2bn with the US government to supply further doses of their Covid-19 vaccine. As per the agreement, the government will procure 105 million 3µg, 10 µg and 30 µg doses of the vaccine.

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Eli Lilly reveals plans for new high-tech parenteral manufacturing site

European Pharmaceutical Review

billion parenteral (injectable) manufacturing site in Alzey, Rhineland-Palatinate, Germany. This includes automation and high-speed manufacturing lines. With the planned additional manufacturing facility in Alzey, the company will operate a total of six manufacturing sites in Europe.

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AMR certification: recognising responsibly in antibiotic manufacture

European Pharmaceutical Review

On 6 June 2023, the British Standards Institute (BSI) launched its Minimized Risk of Antimicrobial Resistance (AMR) certification for antibiotic manufacturing. According to the information sharing platform AMR Insights , AMR is considered one of the biggest global threats to health and food safety.

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Covid vaccine profits and the strain on supply channels

World of DTC Marketing

At the time, pharmaceutical giant Pfizer and its partner BioNTech—which now have the other US-authorized COVID-19 vaccine—had inked a deal with the US government to supply doses at $19.50 Also, Johnson & Johnson had a deal to supply the US government with doses of its vaccine—still in the works—at a rate of $10 per dose.

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The internet enables misinformation on COVID

World of DTC Marketing

In some instances, vaccine-hesitant activists are manufacturing stories of deaths related to the vaccine that never happened. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. The government allowed the drugmakers to mass-produce the vaccine while still conducting clinical trials.