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Royalty Pharma and Revolution Medicines Sign Funding Deals Worth Up to $2 Billion

The Pharma Data

securing a funding package of up to $2 billion. The synthetic royalty component involves payments to Royalty Pharma based on future net product sales of daraxonrasib, once approved and commercialized. The agreement is structured around two key financial components: a synthetic royalty agreement valued at up to $1.25

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Vamorolone

New Drug Approvals

Finally, the acetate group is cleaved under basic conditions to give crude Vamorolone, which was recrystallized from iPrOH to obtain the pure product. The product was filtered off, washed with H 2 O (3 x 0.5 The product was filtered off, washed with H 2 O/MeCN 4:1 (2 x 0.5 and DMAP (16.1 g, 0.132 mmol, 0.10 HCI (950 mL, 0.95

FDA
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Private equity firms back PCI Pharma in bet on drug production

BioPharma Drive: Drug Pricing

Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Bain Capital, Kohlberg and Mubadala joined to invest in biopharmaceutical CDMO PCI Pharma on July 14, 2025. PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially.

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Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights

The Premier Consulting Blog

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., The drug product is packaged and shipped as a solid powder.

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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

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Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

FDA Law Blog: Biosimilars

These particular CRLs were issued in response to original and supplemental drug and biological product applications submitted to the Agency between 2020 and 2024 that ultimately gained approval. 355(l) ) requires that action packages (which include CRLs, if issued) for approved original NDAs and BLAs (i.e.,

FDA
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Optimizely Configured Commerce Spire CMS Enhancement

Perficient: Drug Development

Install third-party NPM Packages Installing third-party NPM Packages in Optimizely Configured Commerce Spire CMS is a new functionality included in Optimizely’s most recent release. Optimizely uses the Workspaces feature of NPM to link the blueprint packages and the Spire package.