FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Pe­ter Marks ap­peared be­fore a vir­tu­al SVB Leerink au­di­ence yes­ter­day and said that his staff at FDA’s CBER is on the verge of work­ing around the clock. Man­u­fac­tur­ing in­spec­tions, pol­i­cy work and spon­sor com­mu­ni­ca­tions have all been pushed down the to-do list so that they can be re­spon­sive to Covid-re­lat­ed in­ter­ac­tions. And the agency’s ob­jec­tive right now? “To save as many lives as we can,” Marks said, liken­ing the mor­tal­i­ty on the cur­rent out­break as equiv­a­lent to “a nu­clear bomb on a small city.”

Pe­ter Marks FDA

The FDA is work­ing as hard as they can to win back the con­fi­dence of the gen­er­al pub­lic, Marks added. “There are forces cur­rent­ly that are cre­at­ing … in­cred­i­ble doubt in vac­cines in this coun­try … it makes me shud­der.”

Lat­er that day at a cam­paign ral­ly in Flori­da, Pres­i­dent Don­ald Trump cast as­per­sions on the mo­ti­va­tions of FDA staff to in­sti­tute stronger guide­lines for the com­ing vac­cine EUAs. Us­ing the pro­noun they, Trump cit­ed un­named of­fi­cials, telling his sup­port­ers: “They are try­ing to do a lit­tle bit of a po­lit­i­cal hit. ‘Let’s de­lay the vac­cine just a lit­tle bit.’ Did you no­tice that?”

The agency has been square­ly in his sights since an Aug. 22 tweet where he said: “The deep state, or who­ev­er, over at the FDA is mak­ing very dif­fi­cult for drug com­pa­nies to get peo­ple in or­der to test the vac­cines and ther­a­peu­tics. Ob­vi­ous­ly, they are hop­ing to de­lay the an­swer un­til af­ter No­vem­ber 3rd. Must fo­cus on speed, and sav­ing lives!”

Mean­while, FDA chief Stephen Hahn ap­pears to be get­ting no sup­port from his di­rect su­pe­ri­or, Alex Azar. The HHS sec­re­tary told Trump on Wednes­day that Hahn act­ed alone in push­ing the new guide­lines, ac­cord­ing to a Politi­co re­port that cites a se­nior ad­min­is­tra­tion of­fi­cial and an­oth­er per­son briefed on the call. Now, se­nior Trump of­fi­cials want to see a “fuller jus­ti­fi­ca­tion” from Hahn and the FDA.

While the new stan­dards may still be ap­proved by Trump, their cur­rent sta­tus is un­clear.

Marks’ CBER has 1,200 staffers tasked with reg­u­lat­ing bi­o­log­ics, cell ther­a­pies, and vac­cines. At the SVB Leerink fo­rum he con­firmed that, af­ter a pos­i­tive read­out from one or more of the piv­otal tri­als, the tri­als would be un­blind­ed, al­low­ing spon­sors and the agency to mon­i­tor pa­tients for Covid-19. Elec­tron­ic phar­ma­covig­i­lance will be used to mon­i­tor ef­fi­ca­cy for short, medi­um and long-term im­mu­ni­ty.

Marks went on to ex­plain that a stream­lined EUA re­view will al­low for a flex­i­ble CMC eval­u­a­tion. The usu­al bits like con­sis­ten­cy be­tween lots and some el­e­ments of QA/QC val­i­da­tion can be sub­mit­ted in a fuller BLA, af­ter the EUA.

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

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Charles Baum, Mirati CEO

Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hoge, Moderna president (Moderna)

On morn­ing of FDA Covid-19 ad­comm, Mod­er­na com­pletes PhI­II en­roll­ment, putting them neck-and-neck with Pfiz­er

Weeks away from a potential EUA application, Moderna announced they have completed enrollment in their 30,000-person Phase III Covid-19 vaccine trial, with over a third of volunteers non-white and a quarter over the age of 65.

The announcement caps what has been the most closely-watched recruitment race in the history of drug development, as Pfizer and Moderna rushed to get enough volunteers to prove whether or not experimental vaccines could actually protect people from contracting Covid-19. Pfizer reached that mark on Sept. 15. Moderna said around the same time that they would slow down enrollment to ensure they enrolled enough participants from minority and at-risk groups.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

HHS secretary Alex Azar (at the podium) and FDA commissioner Stephen Hahn (Pete Marovich/Getty Images)

Covid-19 roundup: Azar open­ly plan­ning Hahn ouster — re­port; Vul­ner­a­ble pop­u­la­tions like­ly to get vac­cines by Jan­u­ary

The relationship between HHS secretary Alex Azar and FDA commissioner Stephen Hahn has deteriorated to the point where Azar has suggested replacing Hahn, according to a Politico report.

Azar was angered by the FDA’s pushback of the Trump administration’s proposals for authorizing Covid-19 vaccines, so much so that he began openly floating potential replacements for Hahn. The report cited six unnamed sources that said Azar discussed bringing up Hahn’s removal to the White House.

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