steve usdin

Washington Editor, BioCentury. Author: Bureau of Spies & Engineering Communism.

[BioCentury @BioCentury]

CARsgen’s satri-cel gives CAR T its first solid tumor approval — and the first market test of whether disease control can support the modality’s cost, complexity, and safety burden. https://t.co/am2eoxk45U

[BioCentury @BioCentury]

Regenxbio gene therapy back on track -- as if Makary & Prasad never happened. Part of a reversion to the mean at FDA. https://t.co/4tofYlSX3c

[C-SPAN Classroom @CSPANClassroom]

#OTD in 1953, Julius and Ethel #Rosenberg were executed for conspiracy to commit espionage during the #RedScare. Learn more from author @steveusdin1 and others: https://t.co/ijlq1owxeM.

#USHistory #APUSH #APGov #GovChat #SSChat #EdChat #OTDH #OnThisDay

[steve usdin @steveusdin1]

Continuing signs of political involvement at FDA
The ouster of Marty Makary as FDA commissioner could be a chance to depoliticize the agency’s decision-making. It looks like the Trump administration is not seizing the opportunity. While FDA is moving swiftly to reverse controversial setbacks that occurred under Makary, evidence is emerging of ongoing political influence.
Since Makary’s departure, political appointees have continued to meet with companies pressing to reverse regulatory decisions. A White House lawyer attended a meeting with Replimune’s CEO and FDA political appointees in May. Hours later, the CEO said the company and FDA had “aligned on a path forward.”
More examples, details at: https://t.co/gJ8RgEonqp

[BioCentury @BioCentury]

Senate bill seeks to make it easier to designate entities as Chinese military companies. The designation makes China biopharmas subject to Biosecure. https://t.co/jvjtp8y72L

[BioCentury @BioCentury]

uniQure reversal puts natural-history controls back in play for rare neuro $QURE https://t.co/pgdLATcrj6

[steve usdin @steveusdin1]

There have been a lot of allegations that under Makary FDA leaders overruled staff – something Makary denied. Now there are receipts. Acting CDER Director Michael Davis placed a memo [https://t.co/JKcmDM4SsI] in the record outlining how his predecessor, Tracy Beth Høeg, repeatedly overruled career staff to quash approval of an sBLA from Sanofi for Tzield teplizumab to delay progression of type 1 diabetes.
Davis’s memo calls into question the integrity of the commissioner’s national priority voucher (CNPV) process, highlighting how it empowered political appointees to overrule career staff without providing evidence or documentation to support decisions. Davis also contradicts former Commissioner Marty Makary’s assertion that drugs were selected for CNPVs based on nominations from review staff.
Much more at: https://t.co/NZ4NrbX7kC

[steve usdin @steveusdin1]

@AlecGaffney Congrats!

[Recursion @RecursionPharma]

💡“Just like we simulate molecules and we simulate biology, what if we could simulate our trials before we run them?”

In this clip from CEO and President Najat Khan's conversation with Selina Koch for the @BioCentury Show, she talks about where AI is making an impact on clinical trials.

💠Recursion’s approach is focused in three areas, Najat says.

1. Improving patient stratification - “Can you improve the signal to noise to know which patients would better respond?”

2. Smarter protocol design and simulating the protocol.

3. Improving recruitment and enrollment. “80% of trials don’t recruit on time.”

👉 Watch the full conversation here: https://t.co/cfAjGVS6os

[BioCentury @BioCentury]

Approval of Sanofi's Tzield by @US_FDA is another sign the Makary era is over https://t.co/6x3mHMpoAr

[BioCentury @BioCentury]

Rhythm builds case for Phase III in Prader-Willi. Six-month setmelanotide data show improvements across weight, hyperphagia and behavior, while Elicio and Neumora suffer clinical setbacks https://t.co/4rPuiXem4b

[BioCentury @BioCentury]

It’s about time: How the political calendar will shape biopharma’s future. Elections and legislative deadlines will likely keep Kennedy in place through November, slow FDA leadership changes, and set the pace for FDA reform https://t.co/ytjK27DOrX

[BioCentury @BioCentury]

The combination of GHO Capital and CBC Group creates a global #healthcare investor that can invest broadly across healthcare sectors and geographies with a combined $21B AUM https://t.co/DuuSdcOAfc

[BioCentury @BioCentury]

WuXi AppTec's listing as Chinese military company focuses attention Biosecure, additional measures aimed at reducing U.S. biopharmas' engagement with China. https://t.co/rMdSGo8P91

[BioCentury @BioCentury]

Bipartisan bill seeks to limit U.S. in-licensing from China: Legislation exerts pressure on Trump administration to curtail biopharma engagement with China https://t.co/ejBz3w9yy6

[Jeff Cranmer @jeff_cranmer]

More jitters in Washington as congressional concern grows over integration of China, U.S. biopharma. Legislation to limit in-licensing, add biotech to outbound investment controls pressures Trump to curtail biopharma engagement w China, says @steveusdin1 https://t.co/to6ox2lLuh

[BioCentury @BioCentury]

French pharma #Servier is taking a page out of its oncology playbook to build out a neurology franchise, starting with the $1.6B acquisition of #sevasemten from Edgewise Therapeutics. BioCentury's @StephenPHansen speaks with Servier's David Lee https://t.co/efSfyzUDl2

[BioCentury @BioCentury]

The benefits of @US_FDA reviewing trials in 'real time' are uncertain, but the process of making trials ready for real-time review could be transformative https://t.co/nfrvujC20t

[IDSA @IDSAInfo]

The White House’s proposed rule would fundamentally alter the U.S. approach to science, drive away multitudes of researchers and eliminate the promise of lifesaving cures for decades to come.

Our full response: https://t.co/OgTGddcpU0