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Navigating Regulatory Hurdles in Drug Development

DrugBank

In 2020, the FDA halted Johnson & Johnson’s COVID-19 vaccine production at a contract manufacturing facility after discovering quality control issues. One notable success story is Moderna’s mRNA vaccine development for COVID-19, which benefited from early regulatory engagement and streamlined approval pathways.

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mRNA Tech Transfer Phase 2.0 Discussed at G20 Summit

The Pharma Data

This meant putting the fundamentals of mRNA production directly into the hands of local innovators — a dramatic departure from previous models that kept much of vaccine production within a small number of firms in high-income settings. mRNA Technology Transfer Programme Moves Into Phase 2.0, 2026–2030).

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Moderna COVID vaccine gets full approval for children

BioPharma Drive: Drug Pricing

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., Kennedy Jr.

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Soleno sales of new Prader-Willi drug rise faster than expected

BioPharma Drive: Drug Pricing

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. TechTarget, Inc.s registered office is 275 Grove St. Newton, MA 02466.

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FDA to ask Sarepta to stop shipping Duchenne gene therapy

BioPharma Drive: Drug Pricing

While the two treatments are constructed differently, they both use the same kind of engineered virus to deliver a replacement gene to the body’s muscles. You can unsubscribe at anytime. The man died of complications from acute liver failure in June. TechTarget, Inc.s registered office is 275 Grove St. Newton, MA 02466.

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Fourth IHR Emergency Meeting on 2024 Mpox Surge – Temporary Recommendations

The Pharma Data

Temporary Recommendations: Strengthened Global Coordination and National Action The revised temporary recommendations, applicable until at least 20 August 2025, target all WHO Member States experiencing mpox virus (MPXV) transmission. Differentiating between virus clades and employing genomic sequencing to inform public health decisions.

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Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

BioPharma Drive: Drug Pricing

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules Biocryst is offloading part of its business to an Italian drugmaker for $250 million upfront. .