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RFK Jr looks to alter rare disease regulation by fast-tracking drug approvals

Pharmaceutical Technology

The approval process for cell and gene therapy candidates is tricky, however, given their high-cost and oft-debated benefit-risk ratio. RFK Jr did not question their importance, and acknowledged panellists’ calls for faster regulatory processes. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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SpliceBio secures $135m for gene therapy development

Pharmaceutical Technology

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. In 2023, SpliceBio signed a licensing agreement with Spark Therapeutics, allowing the latter to use its protein splicing platform and develop a gene therapy for an undisclosed inherited renal disease.

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How early planning leads to successful market access and drug launch in Europe

Pharmaceutical Technology

Launching a new drug can be a risky business, with regulatory approval no guarantee that private, commercial, and government-funded insurers will reimburse it. Meanwhile, in Germany, the AMNOG process is conducted twelve months after the drug is launched, thus giving freedom to the company to set the drug’s price during this period.

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Ethris and Thermo Fisher partner on mRNA solutions

Pharmaceutical Technology

These platforms are designed for safe drug production while allowing scaleable manufacturing processes. mRNA vaccine coverage on Pharmaceutical Technology (or Clinical Trials Arena) is supported by Trilink. The trial data indicated dose-dependent protein production at the site without systemic bioavailability. “By

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Sarepta and Roche halt DMD gene therapy’s use after second death  

Pharmaceutical Technology

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Give your business an edge with our leading industry insights.

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Moderna’s mRNA RSV vaccine wins expanded FDA approval for younger adults

Pharmaceutical Technology

mRNA vaccine coverage on Pharmaceutical Technology (or Clinical Trials Arena) is supported by Trilink. GSK also has an FDA-approved vaccine in the form of Arexvy, though its label only covers those at risk in individuals aged between 50 through 59 years , along with the standard indication of ages 60 and over.

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RFK Jr axes vaccine advisory committee members

Pharmaceutical Technology

Disrupting ACIP’s work introduces dangerous uncertainty about which vaccines will continue to be covered and whether families will have to pay out of pocket for routine immunisations,” the non-profit said. Give your business an edge with our leading industry insights.