House committee wants former FDA commissioner to come clean on Covid-related political interference

Stephen Hahn and Donald Trump, AP Images

The House Se­lect Sub­com­mit­tee on the Coro­n­avirus Cri­sis on Mon­day ques­tioned for­mer FDA com­mis­sion­er Stephen Hahn on whether he ac­qui­esced to po­lit­i­cal pres­sure in au­tho­riz­ing the use of hy­drox­y­chloro­quine and con­va­les­cent plas­ma ear­ly in the pan­dem­ic, de­spite lim­it­ed ev­i­dence of their ef­fec­tive­ness.

Hahn pub­licly dis­avowed any po­lit­i­cal in­ter­fer­ence in any of his agency’s EUA de­ci­sions, but be­hind the scenes, the pres­sure clear­ly caught up with him. As End­points News pre­vi­ous­ly re­port­ed last May, when the FDA an­nounced the con­va­les­cent plas­ma EUA at a Sun­day evening press con­fer­ence last Au­gust with for­mer Pres­i­dent Trump in tow, Hahn false­ly claimed that the plas­ma might in­crease sur­vival by 35% over­all, when in ac­tu­al­i­ty it was a 35% rel­a­tive re­duc­tion in mor­tal­i­ty.

He lat­er apol­o­gized, claim­ing he mis­spoke, but an in­ter­nal email that the House com­mit­tee al­so re­turns to shows ear­li­er that Sun­day, he was plan­ning to make the in­flat­ed claim all along.

‘Giv­en the sus­tained cam­paigns to pro­mote the use of du­bi­ous coro­n­avirus treat­ments, the Se­lect Sub­com­mit­tee seeks to un­der­stand the full ex­tent and im­pact of Trump Ad­min­is­tra­tion of­fi­cials’ ef­forts to in­flu­ence these FDA de­ci­sions,’ sub­com­mit­tee chair Jim Clyburn (D-SC) wrote in a let­ter to Hahn on Mon­day. Amy Aber­nethy, for­mer FDA deputy com­mis­sion­er who has since moved over to Ver­i­ly, al­so texted Hahn in April, al­most 2 weeks af­ter the HCQ EUA was is­sued, point­ing to a study find­ing chloro­quine was po­ten­tial­ly un­safe.

‘I will send you the slides on the Brazil study. Bot­tom line is that the dose of CQ[chloro­quine] rec by Chi­nese led to in­creased deaths and car­dio­vas­cu­lar events. DSMB [Da­ta and Safe­ty Mon­i­tor­ing Board] stopped study for safe­ty,’ she texted. The EUA for hy­drox­y­chloro­quine was re­voked two months lat­er. The House sub­com­mit­tee, which is seek­ing an in­ter­view with Hahn, is al­so seek­ing to un­der­stand the full ex­tent of Trump of­fi­cials’ ef­forts to in­ter­fere with the FDA’s coro­n­avirus vac­cine au­tho­riza­tions. While Trump’s chief of staff Mark Mead­ows re­port­ed­ly gave Hahn an ul­ti­ma­tum to re­sign or au­tho­rize the vac­cine, Trump al­so tweet­ed, ‘Get the dam [sic] vac­cines out NOW, Dr. Hahn.’

But Hahn, who did not re­spond to a re­quest for com­ment, pre­vi­ous­ly in­sist­ed the po­lit­i­cal pres­sure did not sway him. Sim­i­lar­ly, Anand Shah, the for­mer top FDA of­fi­cial in med­ical and sci­en­tif­ic af­fairs, told End­points that the pres­sure didn’t have an im­pact on their de­ci­sion mak­ing.

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Joan Perelló, Sanifit CEO

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Most people know if they’re ‘Team Pfizer’ or ‘Team Moderna,’ but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novovax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as ‘Covid-19 Vaccine Janssen.’

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Ugur Sahin (L) and Özlem Türeci (Bernd von Jutrczenka/picture-alliance/dpa/AP Images)

Pfizer and BioNTech are planning to file for full approval of their Covid-19 vaccine for all of those over the age of 12 after they said longer-term analysis of the vaccine in teens continued to show strong protection against symptomatic cases of Covid-19 more than four months after the second dose.

With no serious safety concerns at least 6 months after the second dose for those ages 12 through 15, the companies said the data will form the basis for a planned upgrade from EUA to supplemental Biologics License Application (sBLA).

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Back in June, Sanofi unveiled a big project to reshape its R&D around the future of mRNA, and followed that up Monday by taking a step toward achieving that goal.

The French drugmaker signed a deal with Chinese tech giant Baidu to access its AI algorithm for mRNA-based therapeutics, Baidu said Monday morning. It’s for an undisclosed sum, but Baidu noted its platforms will be used to ‘contribute to the optimization of mRNA sequences’ in Sanofi’s drug development processes.

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Ronald Lorijn, NeuExcell CEO

Pennsylvania’s already well-established biotech scene got word of a boost last week with several announcements, including the building of a massive life sciences manufacturing center in Pittsburgh thanks to some funding from an area nonprofit and a local university. But those jawns in Philadelphia aren’t letting go of its stranglehold on the state easily.

NeuExcell Therapeutics, a preclinical gene therapy biotech that focuses on neurodegenerative diseases, announced that it signed a deal with The Discovery Labs in King of Prussia, about 25 miles northwest of downtown Philly.

Ameet Mallik, Rafael Holdings CEO

Ameet Mallik left Novartis to claim the CEO spot at Rafael Holdings back in May, taking the reins from founder Howard Jonas. Now — one month after a stock-crushing pivotal failure in pancreatic cancer that sent Rafael’s team back to the drawing board — Mallik is taking off for greener pastures.

Mallik will hand his chief executive responsibilities back to Jonas on Feb. 1 as part of an overhaul that’s set to shake up the highest rungs of the company, Rafael announced Monday.

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Bluebird bio may, at long last, get a gene therapy approved in the US.

The Cambridge, MA biotech announced Monday that the FDA had accepted and given priority review for Zynteglo, its gene therapy for the rare blood disorder beta-thalassemia. The announcement sets up an expedited FDA decision by May 20, 2022.

A priority review doesn’t guarantee approval, and more than a few recent biotechs have been spurned after receiving the designation, including Incyte, Sesen, and Provention. But it represents a substantial step forward for a therapy that has seen repeated setbacks and an application that was slapped down with a refuse-to-file letter.
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