Zach Brennan
@ZacharyBrennan
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Senior Editor, Endpoints News - covering the FDA, Capitol Hill, and biotech/pharma - reach me at [email protected], Signal: zacharybrennan.20
Washington, DC
Joined June 2012
Newly appointed CDER chief George Tidmarsh now takes over as acting CBER director, following Vinay Prasad’s departure, per email from Makary.
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RT @ArmstrongDrew: Pressure on Prasad has been building for weeks as he's put his hands on several controversial decisions on vaccines and….
endpoints.news
CBER chief Prasad overrides reviewers, approves Moderna's Covid shot only for at-risk kids 6mo-11yrs, marking his third override of review team recommendations.
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RT @politico: FDA commissioner @MartyMakary defends Chief Medical and Scientific Officer Vinay Prasad from criticism, calling him an “impec….
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RT @SarahKarlin: "After the Sarepta mess, the worry isn’t that the FDA will stand for one or the other of those philosophies. It’s that whe….
endpoints.news
FDA reverses decision on Sarepta's Elevidys gene therapy after political pressure, allowing resumed sales to ambulatory patients despite earlier safety concerns and deaths
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There was talk of rooting out COI at HHS, but RFK overhauling the vaccine injury compensation program is a massive conflict of interest (even if the proceeds will go to his son)
endpoints.news
HHS Secretary Robert F. Kennedy Jr. plans to reform Vaccine Injury Compensation Program, pushing for vaccine makers to pay more and expedite claims after earning millions from referrals.
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RT @ArmstrongDrew: I mean, what even is going on here.
endpoints.news
The FDA has given the OK for Sarepta Therapeutics to resume offering its gene therapy Elevidys for ambulatory patients with Duchenne muscular dystrophy.
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RT @angelicapeebles: I'm told this is the case from Brazil. Regulators there determined the boy likely died from flu intensified by immunos….
fda.gov
The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy.
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RT @maxonwifi: Scoop with @ZacharyBrennan: Flu vaccine framework in the works at FDA, per a senior agency official. Oh, and the official re….
endpoints.news
FDA developing new flu vaccine framework to address strain selection and efficacy issues. FDA official hints at regulatory action on Valneva's Ixchiq chikungunya vaccine due to safety concerns.
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Updated: In a follow-up conversation on the safety study, the senior official said Sarepta could make a change to the dosing or manufacturing, and test it on the next 10 or 12 boys, and show the liver-related issues were improved.
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Exclusive: $SRPT would have to conduct new studies to get back on market, FDA official says - CBER review staff are 'unanimous' that Elevidys should never return to market
endpoints.news
FDA official: Sarepta Therapeutics must conduct new studies to prove Elevidys' safety after deaths, with CBER reviewers unanimously opposing market return.
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Political or professional? Makary's overhaul of CDER, CBER may reshape leadership norms -
endpoints.news
FDA leadership changes under Makary raise concerns as outsiders Prasad and Tidmarsh take key roles, potentially shifting from career positions to political ones amid staff departures and policy...
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RT @JohnCendpts: This is really clever. Marry an oncolytic approach with autologous CAR-T. The cancer-specific virus sets up the @cancer ce….
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FDA now saying up to 5 companies can win one of these new vouchers in the pilot.
Companies aligned with U.S. national priorities can now submit statements of interest for participation in the Commissioner’s National Priority Voucher (CNPV) pilot program. Statements of interest are capped at 350 words! More details here:
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RT @19joho: How are @VPrasadMDMPH and @DrMakaryFDA going to fix this perception and restore trust?. They are the medical establishment and….
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Quite the uproar over Prasad's past, especially since the CBER director role is not a political one (or is it?).
🚨 ALERT 🚨 . VINAY PRASAD, THE LEFTIST SABOTEUR UNDERMINING TRUMP’S @US_FDA, MUST BE FIRED NOW!. We have a crisis at the FDA! A wolf in sheep’s clothing is sabotaging President Trump’s bold “Make America Healthy Again” (MAHA) agenda! Dr. Vinay Prasad @VPrasadMDMPH, a
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New rare disease treatments not getting the same reception as they did under Marks.
$REPL rejection follows the rejection of $CAPR and $RARE drugs, and the FDA's actions against $SRPT. CBER Director Vinay Prasad is setting a different tone than his predecessor.
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