PRV Watch

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PRV Watch

PRV Watch

@PRVWatch

Tracking FDA Priority Review Voucher (PRV) issuances, sales, redemptions and other FDA/Biotech news.

Katılım Ocak 2025
67 Takip Edilen547 Takipçiler
PRV Watch
PRV Watch@PRVWatch·
Marty Makary introduced the Commissioner's National Priority Voucher pilot program last year with 22 vouchers issued and 7 approvals under the program so far. Will the next FDA Commissioner continue to issue Commissioner National Priority Vouchers?
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PRV Watch
PRV Watch@PRVWatch·
In the last 10 days there have been three Priority Review Voucher sales disclosed .... $180M, $195M and $187.5M
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PRV Watch
PRV Watch@PRVWatch·
@GeneInvesting When did they formal confirm this? last I saw was in an industry conference they mentioned consideration of it but hadn't seen a formal confirmation yet.
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PRV Watch
PRV Watch@PRVWatch·
$PRME Prime Medicine released their Q1 results today. No new update on their plans to file a BLA for PM359, an ex vivo prime-edited autologous stem cell therapy for Chronic Granulomatous Disease. Prime was originally going to seek approval using the plausible mechanism pathway following positive proof-of-concept data from two patients treated in its Phase 1/2 study. Those patients were 18 and 57 years old. I think they’ll delay filing to recruit one more patient that is <18years to then be eligible for a Rare Pediatric Disease Priority Review Voucher upon approval.
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PRV Watch
PRV Watch@PRVWatch·
@AlecGaffney @LizzyLaw_ Not sure I agree in this context. The centre director is part of the CNPV council that votes on the drug. The centre director reviews the recommendation of the primary review team, the CNPV council and their own view to provide the final recommendation.
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Lizzy Lawrence
Lizzy Lawrence@LizzyLaw_·
SCOOP: Sanofi has asked the FDA to pull its type 1 diabetes drug, Tzield, out of the Commissioner's drug review voucher program. The move comes after acting CDER director Tracy Beth Høeg disagreed with a staff decision to approve the drug. statnews.com/2026/05/06/san…
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PRV Watch
PRV Watch@PRVWatch·
Commissioner's National Priority Voucher issued to Bizengri (zenocutuzumab-zbco) for advanced unresectable or metastatic cholangiocarcinoma. Partner Therapeutics announced on April 14th that they had already submitted the sBLA for this indication so decision expected soon.
U.S. FDA@US_FDA

A drug that treats an ultra-rare cancer that forms in the bile ducts, zenocutuzumab-zbco, has been granted the 22nd voucher under the FDA’s Commissioner’s National Priority Voucher pilot program. fda.gov/industry/commi…

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PRV Watch
PRV Watch@PRVWatch·
Sun Pharma announced today that they have sold their Priority Review Voucher for $195M . They were issued the PRV this year for Sezaby after successfully suing the FDA for being denied the voucher in 2022.
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PRV Watch
PRV Watch@PRVWatch·
Seen a big step up in FDA comms and content on social media over last few months. Kudos to whoever is behind @US_FDA
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PRV Watch
PRV Watch@PRVWatch·
@idalopirdine Agreed but it’s the FDA they routinely have access to MNPI, why a specific concern for this pilot?
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Snaking
Snaking@idalopirdine·
@PRVWatch Im afraid these mutually agreed data points would undoubtedly include the primary endpoint
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PRV Watch
PRV Watch@PRVWatch·
FDA Real-time clinical trials pilot; 🔹Proof-of-concept real-time clinical trials with AstraZeneca and Amgen. 🔹FDA can see in real time predefined efficacy and safety datapoints from the ongoing clinical trial. 🔹AZ conducting a Phase II for acalabrutinib+venetoclax+rituximab in untreated mantle cell lymphoma in partnership with Paradigm Health to enable real-time visibility to the FDA. 🔹Amgen planning a Phase Ib for tarlatamab in small cell lung carcinoma. 🔹Within the pilot will assess both data real-time and that submitted traditionally during the trial. 🔹FDA opened a RFI on this new pilot.
U.S. FDA@US_FDA

🔴 LIVE NOW: FDA Commissioner @DrMakaryFDA announces FDA's real-time clinical trials initiative. This is a milestone moment for modernizing drug development. Watch: youtube.com/live/hPT6X4SKO…

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PRV Watch
PRV Watch@PRVWatch·
Rocket Pharmaceuticals announced today that it sold a Priority Review Voucher for $180M, below the $205M for the last reported PRV sale earlier this year.
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PRV Watch
PRV Watch@PRVWatch·
When the Commissioner's National Priority Voucher pilot program was first announced in June 2025 there were only going to be five vouchers issued, now at a total of 21. Here's an overview of all the vouchers issued and their current status'
PRV Watch tweet media
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PRV Watch
PRV Watch@PRVWatch·
7 rare pediatric disease priority review vouchers have been issued so far this year, already more than the 6 issued across all of last year.
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PRV Watch
PRV Watch@PRVWatch·
@Josh__Hardman Can't comment on reasoning for why they didn't get a CNPV but thought id flag that Augmentin XR was awarded a CNPV which did not require a full NDA as it was already approved (but discontinued)
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PRV Watch retweetledi
U.S. FDA
U.S. FDA@US_FDA·
Following President Trump’s directive to accelerate medical treatments for serious mental illnesses, FDA announced major steps to support the development of serotonin-2A agonists & related products—a class of medications historically referred to as "psychedelic" drugs. ✅ National priority vouchers for psilocybin (for treatment-resistant depression and major depressive disorder) ✅ National priority voucher for methylone (for post-traumatic stress disorder) ✅ First-ever noribogaine study authorized for alcohol use disorder ✅ Advancing guidance for sponsors developing these products Learn more: fda.gov/news-events/pr…
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Keşfet

@GeneInvesting @AlecGaffney @LizzyLaw_ @US_FDA @idalopirdine @elonmusk @BarackObama @taylorswift13