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Safety Stands Out in Arcellx Cell Therapy’s ASH Data, But Don’t Overlook Manufacturing Advantages

MedCity News

The post Safety Stands Out in Arcellx Cell Therapys ASH Data, But Dont Overlook Manufacturing Advantages appeared first on MedCity News. Arcellx is developing its CAR T-treatment under a partnership with Gilead Sciences.

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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. All vaccines go through clinical trials to test safety and effectiveness. Let’s also remember that pharma is going to make a LOT of money on these vaccines.

Pharma 307
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PhRMA lies to protect pharma profits

World of DTC Marketing

Such warnings “constitute the pharma response in literally every instance since 1906,” the first drug regulation agency was created, said Dr. Aaron Kesselheim. About 40 percent of drugs fail in preliminary Phase I studies, which assess a drug’s safety in humans and typically cost just $25 million.

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Innovation in pharma manufacturing quality systems

European Pharmaceutical Review

As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. That is because of the relative expense of emerging therapies and the pressure on pricing for continuing product lines.

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Regeneron's high-dose Eylea hit with surprise FDA rejection over manufacturing hiccups

Fierce Pharma

But the company said it has nothing to do with the drug's efficacy or safety. | In a surprise decision, the FDA issued powerhouse Eylea's high-dose version a complete response letter.

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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. Hedley Rees has written a book on pharma supply chains that is eye-opening and downright scary. We need a 21st-century approach that puts patient safety first. In other words, money over safety. Patients should be scared.

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Brazil: untapped market for big pharma manufacturing

Pharmaceutical Technology

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.