Drugs

Jazz Unloads Priority Voucher for $200 Million

In a significant deal that underscores the rising valuation of regulatory fast-tracks in the biopharma sector, Jazz Pharmaceuticals announced it has sold its FDA Priority Review Voucher (PRV) for $200 million to an undisclosed purchaser. The transaction was disclosed during Jazz’s presentation at the J.P. Morgan Healthcare Conference in San Francisco.

Priority Review Vouchers are awarded by the agency to companies that obtain approvals for treatments targeting rare pediatric diseases or, in some cases, other underserved indications. These vouchers can be sold or transferred and entitle the holder to an accelerated six-month review of a future drug application, compared to the standard 10-month FDA review timeline.

PRVs have become a tradable asset within pharmaceutical deal-making, and valuations have soared in recent years as major biopharma firms seek to expedite the regulatory timelines of high-value products. Previous PRV transactions have ranged between approximately $150 million and $175 million, making the $200 million sale by Jazz one of the highest prices recorded to date.

The PRV sold by Jazz is directly linked to the company’s approval last year of Modeyso (dordaviprone), a targeted therapy for an aggressive form of brain cancer with an H3 K27M mutation. Jazz acquired the drug and its development program through a $935 million acquisition of Chimerix in 2025, a move that strategically expanded Jazz’s oncology portfolio.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome