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EpiPen patent expiry opens new era for innovation

Pharmaceutical Technology

Using real-world data to support vaccine outreach and education Buy Reports Newsletters PT News EpiPen patent expiry opens new era for innovation The expiration of Viatris’s EpiPen patent in September 2025 will likely result in increased competition and lower costs in the epinephrine delivery space. In January 2025, Mylan reached a $73.5m

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Uruguay progresses towards developing its first regulatory agency

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? Since 2008, the Association of Chemistry and Pharmacy of Uruguay has played an active role in promoting a National Health Surveillance Agency, and in 2020 the government attempted to launch a similar agency but it ultimately failed.

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Who is Dr. George Tidmarsh, the new director of CDER?

PharmaVoice

Tidmarsh was the founder of Horizon Therapeutics in 2005, serving as CEO until 2008. In particular, Tidmarsh said he wants to boost efficiency in reviews and establish more consistency in communication to sponsors working in the “same disease state.”

FDA
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4mn dose shortage of GSK’s childhood rotavirus vaccine expected

European Pharmaceutical Review

According to Reuters , Kenya, Tanzania, Senegal and Cameroon have either run out of or are close to running out of vaccines to protect children against the deadly rotavirus infection following undisclosed “manufacturing challenges” at GSK. We are witnessing the largest sustained drop in childhood immunisation in a generation.

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Why pharma needs a revolution in culture

pharmaphorum

As we come up on a year and a half of the COVID-19 pandemic, with the global roll out of vaccines slowly gathering pace and big pharma riding high in the opinion charts, the biopharmaceutical sector would do well to learn lessons from the banks. Compliance systems by themselves are not enough. Of course, having rules is necessary.

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Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence

ISPE

Jaguar Gene Therapy is building a $125 million facility in RTP to manufacture adeno-associated virus (AAV)-based gene therapies, Beam Therapeutics is constructing an $83 million plant to develop precision medicines, and IQVIA, a CRO, opened an innovation lab in the park in 2021, focusing on bioanalytics, vaccines, biomarkers, and genomics.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. Published 2008. Published May 2012. Guidance for Industry.