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BMS: Delayed new drug to avoid paying billions?

World of DTC Marketing

billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019. Food and Drug Administration approval for the non-Hodgkin lymphoma drug by a Dec. The post BMS: Delayed new drug to avoid paying billions?

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Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. What are the top three challenges associated with gene therapy manufacturing? How are new technologies speeding up impacting gene therapy manufacturing?

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Switzerland and US sign drug inspection agreement

European Pharmaceutical Review

A Mutual Recognition Agreement (MRA) relating to pharmaceutical Good Manufacturing Practice (GMP) has been signed between Switzerland and the US. Good Manufacturing Practice for pharmaceutical drugs. The post Switzerland and US sign drug inspection agreement appeared first on European Pharmaceutical Review.

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How did pharma develop a vaccine so quickly?

World of DTC Marketing

Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control. For the COVID-19 vaccine, the Food and Drug Administration (FDA) set up rigorous standards for vaccine developers to meet.

Pharma 307
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Amgen opens its most advanced manufacturing facility to date

European Pharmaceutical Review

It is the company ’s most advanced manufacturing facility to date. Additionally, in partnership with Columbus State Community College, Amgen declared that it hosting an 18-month manufacturing apprenticeship at the new facility. Amgen has opened a new biomanufacturing plant in Central Ohio, US.

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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift.

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FDA approves new cell therapy manufacturing plant

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. The site is a “critical component” of BMS’ expanding global cell therapy manufacturing footprint, the company said. “The