CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went be­fore a Sen­ate com­mit­tee Wednes­day and de­clared he’s fight­ing. “Every one of the de­ci­sions we have reached has been made by ca­reer FDA sci­en­tists based on sci­ence and da­ta, not pol­i­tics,” he ex­claimed, adding that “FDA will not per­mit any pres­sure from any­one to change that. I will fight for sci­ence.”

A few hours lat­er, he was un­der­mined by Pres­i­dent Don­ald Trump when a re­porter asked if he was okay with stricter vac­cine guide­lines that the FDA was said to be cook­ing up. “That has to be ap­proved by the White House. We may or may not ap­prove it. That sounds like a po­lit­i­cal move,” he de­cid­ed.

The re­marks set up an­oth­er crit­i­cal junc­ture for the agency and its be­lea­guered com­mis­sion­er, who has been work­ing over­time to bol­ster pub­lic con­fi­dence in the FDA and his lead­er­ship since Hahn’s dis­as­trous per­for­mance as­sist­ing the pres­i­dent tout false con­va­les­cent plas­ma fig­ures.

The pres­i­dent then ques­tioned the need to length­en the ap­proval time­line, fore­cast­ing “great re­sults” ahead and again fram­ing the FDA’s moves as po­lit­i­cal:

Be­cause when you have Pfiz­er, John­son and John­son, Mod­er­na, these great com­pa­nies com­ing up with the vac­cines and they’ve done test­ing and every­thing else. I’m say­ing, why would they have to be adding great length to the process.

It sound­ed to me, ex­treme­ly po­lit­i­cal. Why would they do this, when we come back with these great re­sults. And I think you will have those great re­sults.

The new FDA stan­dards re­port­ed­ly passed muster at HHS on Tues­day and there was an ex­pec­ta­tion that it would get a green light from the White House, ac­cord­ing to a Politi­co re­port that cites two sources fa­mil­iar with the time­line. Trump re­port­ed­ly spoke with HHS sec­re­tary Alex Azar be­fore the press con­fer­ence.

Un­der the new guid­ance, vac­cine de­vel­op­ers must fol­low at least half the par­tic­i­pants for 60 days fol­low­ing the sec­ond dose, as well as ac­crue five or more cas­es of se­vere Covid-19 in the place­bo group, be­fore they can seek an EUA.

It’s still pos­si­ble the new EUA rules are al­lowed to go in­to ef­fect by Trump. But for an agency ac­cus­tomed to bi­par­ti­san def­er­ence from its po­lit­i­cal su­pe­ri­ors, it’s now sail­ing in un­chart­ed wa­ters work­ing un­der a pres­i­dent who de­mands key de­ci­sions be rout­ed through a com­mand-and-con­trol struc­ture firm­ly con­trolled by him or trust­ed lieu­tenants. And by hav­ing Trump la­bel their work as “ex­treme­ly po­lit­i­cal,” it rais­es new ques­tions on what mes­sag­ing, if any, FDA lead­ers can em­ploy that would both sat­is­fy the pres­i­dent and the sci­en­tif­ic com­mu­ni­ty.

Trump be­gan Wednes­day’s press con­fer­ence by en­cour­ag­ing Amer­i­cans to en­roll in Covid-19 vac­cine tri­als, and then tout­ed some ques­tion­ably star­ry num­bers on treat­ments in the pipeline. “We are see­ing promis­ing re­sults that are mon­o­clon­al an­ti­bod­ies which help the im­mune sys­tem fight the virus,” Trump said, halt­ing­ly read­ing a script.

But the first ques­tion he took was on the peace­ful trans­fer of pow­er af­ter the elec­tion. He re­fused to com­mit to it.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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Elizabeth Warren (Michael Brochstein/Sipa USA)(Sipa via AP Images)

Sen­a­tors call for hear­ing to ex­am­ine how Medicare will han­dle Bio­gen's new Alzheimer's drug

Two top Senate Finance committee senators on Thursday called for a hearing to examine the questions and challenges for Medicare arising from the FDA’s recent approval of Biogen’s Aduhelm, the controversial new drug approved to treat Alzheimer’s disease.

In a letter to Senate Finance chair Ron Wyden (D-OR) and ranking member Mike Crapo (R-ID), subcommittee chair Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) hinted at making policy changes to enable Medicare to more directly connect prescription drug pricing to clinical effectiveness. They raised questions about the “dramatic implications for our health care system” from the approval, which they said “stretch well beyond the scope of FDA’s jurisdiction.”

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James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.