Stephen Hahn (AP Images)

New Hahn-era texts show the ex­tent of the Trump White House­'s in­volve­ment in vac­cine EUA process

In the lead-up to the FDA’s is­suance of its first Covid-19 vac­cine EUA to Pfiz­er in Dec. 2020, there was a lot of po­lit­i­cal grum­bling and le­git­i­mate con­cern that the White House might try to speed up the au­tho­riza­tion process to help for­mer Pres­i­dent Don­ald Trump’s re­elec­tion cam­paign.

On the flip side, how­ev­er, there was con­cern of the op­po­site, that the vac­cine’s EUA might be un­nec­es­sar­i­ly de­layed, lead­ing to more deaths so as to avoid any mis­con­cep­tion that the de­ci­sion was po­lit­i­cal­ly mo­ti­vat­ed.

At the time, just pri­or to the first EUA, for­mer Pres­i­dent Trump and his deputies were re­port­ed to be pri­vate­ly crit­i­ciz­ing FDA of­fi­cials for not mov­ing faster.

One se­nior of­fi­cial even told Politi­co on Dec. 2, 2020: “It’s crazy to imag­ine the Eu­ro­pean Union or U.K. may ap­prove a vac­cine de­vel­oped in the Unit­ed States be­fore us though, right?”

And thanks to re­cent­ly re­leased text mes­sages from FDA’s Free­dom of In­for­ma­tion Of­fice, ex­changes be­tween FDA and White House of­fi­cials fur­ther con­firmed this spat over be­ing first.

Fox News re­porter John Roberts texted for­mer FDA com­mis­sion­er Steven Hahn on Dec. 1, 2020 — 10 days be­fore the Pfiz­er vac­cine EUA was is­sued — about the White House tak­ing the FDA “to the wood­shed” over its re­view pace, and ask­ing Hahn if he want­ed to clar­i­fy. Hahn then took the dis­parag­ing com­ment to for­mer White House chief of staff Mark Mead­ows, seek­ing clar­i­fi­ca­tion.

The fol­low­ing morn­ing, Hahn texted Mead­ows at 5:13 AM to in­form him that the UK was about to sign off on Pfiz­er’s Covid-19 vac­cine — which would make the UK’s de­ci­sion faster than the US.

The UK’s MHRA signed off on the Pfiz­er vac­cine lat­er that morn­ing, spurring a flur­ry of texts from Mead­ows to Hahn. Mead­ows al­so sum­moned Hahn and CBER Di­rec­tor Pe­ter Marks to Mead­ows’ of­fice, al­though the FDA’s FOIA of­fice has redact­ed the bulk of the ex­change.

The next six mes­sages of the text ex­change are al­most en­tire­ly redact­ed, and then the night be­fore the EUA is to be is­sued for Pfiz­er’s vac­cine, Mead­ows asks Hahn to call him, which Hahn re­sponds to say that he has, and then sends him this text:

Giv­en the fact that more than 65,000 peo­ple died in Dec. 2020 from Covid-19, and the sen­si­tive na­ture of get­ting the Pfiz­er Covid-19 vac­cine out as rapid­ly as pos­si­ble, as well as the po­lit­i­cal ram­i­fi­ca­tions, it’s not sur­pris­ing that the White House was this in­volved in want­i­ng to be in­formed on the EUA time­line.

But these text mes­sages al­so show some of the ways in which the White House kept the FDA com­mis­sion­er on a short leash and pushed the FDA to speed its re­view process, even as the agency was work­ing at a speed nev­er be­fore seen for any med­ical prod­uct in the agency’s his­to­ry, par­tic­u­lar­ly as it would be ad­min­is­tered to hun­dreds of mil­lions of peo­ple.

As with Pfiz­er’s EUA, Hahn al­so in­formed Mead­ows the night be­fore the agency is­sued its EUA for Mod­er­na’s Covid-19 vac­cine.

The FDA’s FOIA of­fice pre­vi­ous­ly re­leased text mes­sages from Hahn’s dis­cus­sions around for­mer Pres­i­dent Trump’s Covid-19 di­ag­no­sis, as well as ear­li­er com­mu­ni­ca­tions around what types of drugs might work against Covid.

Of­fi­cials from with­in the White House al­so were for­ward­ing po­ten­tial, but ul­ti­mate­ly in­ef­fec­tive Covid-19 treat­ment in­for­ma­tion to Hahn.

Top Trump ad­vi­sor Hope Hicks for­ward­ed an email on a treat­ment called “Cell Ar­mour” to Katie Miller, for­mer com­mu­ni­ca­tions di­rec­tor for Vice Pres­i­dent Mike Pence, who then for­ward­ed it on to Hahn, who said he would look in­to it.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Ivana Magovčević-Liebisch, Vigil Neuroscience CEO

FDA lifts par­tial clin­i­cal hold on Vig­il Neu­ro­science's TREM2 an­ti­body, re­mov­ing dos­ing cap

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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