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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Covid-19 roundup: HHS may strug­gle to ab­sorb Op­er­a­tion Warp Speed; Eu­rope has no plans for a fourth vac­cine dose

Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.

But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.

Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Flori­da man con­vict­ed of fal­si­fy­ing clin­i­cal tri­al re­sults sen­tenced to over 2 years in prison

A Florida man who falsified medical records in connection to clinical trials was sentenced to 30 months in prison in federal court Thursday.

Daniel Tejeda, 35, of Clewiston, was also ordered to pay $2.1 million in restitution. Tejeda was a project manager and study manager for the CRO Tellus Clinical Research, and made it appear that subjects were participating in trials when they weren’t. Two other research workers from Florida were sentenced in the same case in August for 46 and 30 months, respectively.