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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.

Pharma 255
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Norstella, Citeline merge to create $5bn pharma tech firm

pharmaphorum

Citeline provides intelligence, data and software for clinical trials, development and regulatory compliance and was formerly part of Informa was called Pharma Intelligence ahead of a rebranding earlier this year. The post Norstella, Citeline merge to create $5bn pharma tech firm appeared first on.

Pharma 101
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How one pharma “family business” places patients first

pharmaphorum

When people think about pharma, they often think about “big” pharma: large, faceless corporations. Every pharma company developing treatments for new diseases is contributing to some degree to better global health. But Giacomo Chiesi, head of Chiesi Global Rare Diseases, thinks of his 6,000-person company as a family business.

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FDA accepts BLA for Pfizer’s haemophilia B gene therapy

Pharma Leaders

Based on the safety and efficacy findings from the Phase III BENEGENE-2 study, the company made these filings. Fidanacogene elaparvovec also demonstrated to be well-tolerated, with a safety profile in line with Phase I/II data. Pfizer obtained the licence for gene therapy from Spark Therapeutics in December 2014.

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Psychedelic research: evaluating the fast-evolving regulatory roadmap

European Pharmaceutical Review

Despite the tidal wave of renewed interest in psychedelic therapies, there is still much to be learned about them, including their precise mechanisms of action, their long- and short-term safety profiles, the durability of their effect, and their adverse effects—which can be severe. Authorisation under exceptional circumstances. References.

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Morphic loses second partner as J&J exits integrin alliance

pharmaphorum

Morphic Therapeutic has lost Johnson & Johnson’s Janssen Pharma as a partner, following the termination of an alliance to develop drugs targeting integrins first agreed in 2019. In a filing with the Securities and Exchange Commission (SEC). ” It was modified again in the middle of 2021.

Safety 52
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Economist Impact: World Cancer Series – pharmaphorum in attendance, day one (part i)

pharmaphorum

The present moment within and without healthcare, biotech, and pharma is a difficult and pivotal time in history, a time in which such issues need must be addressed. The keynote address of the event entire came from Stella Kyriakides, commissioner for health and food safety at the European Commission. Her opener?