Pfizer CEO Albert Bourla (AP Images)

Alone in the spot­light, Pfiz­er CEO Bourla swears pure in­ten­tions in the rush to de­vel­op a Covid-19 vac­cine. But will the pub­lic be­lieve it?

Bioreg­num Opin­ion Col­umn by John Car­roll

Now that Mod­er­na has shift­ed ex­pec­ta­tions on piv­otal da­ta for its Covid-19 vac­cine to some time just af­ter the elec­tion and As­traZeneca has been stalled by a safe­ty is­sue, the sole play­er that can de­liv­er a shot through an emer­gency use au­tho­riza­tion this month is Pfiz­er.

And Pfiz­er CEO Al­bert Bourla wants no part of the po­lit­i­cal furor that has swelled around that top­ic.

In an open let­ter, Bourla lament­ed the spot­light that Pres­i­dent Trump di­rect­ed at Pfiz­er dur­ing the first chaot­ic pres­i­den­tial de­bate. Trump — who has just test­ed pos­i­tive for the coro­n­avirus, push­ing the pan­dem­ic back in­to the head­lines — is shov­ing Pfiz­er in­to gale force po­lit­i­cal winds by in­sist­ing that a vac­cine could be OK’d in the next few weeks. And the CEO in­sists that pol­i­tics has noth­ing to do with the crash R&D project Pfiz­er has mount­ed with BioN­Tech to get an mR­NA jab on­to the mar­ket as soon as pos­si­ble.

Now, we are ap­proach­ing our goal and de­spite not hav­ing any po­lit­i­cal con­sid­er­a­tions with our pre-an­nounced date, we find our­selves in the cru­cible of the U.S. Pres­i­den­tial elec­tion. In this hy­per-par­ti­san year, there are some who would like us to move more quick­ly and oth­ers who ar­gue for de­lay. Nei­ther of those op­tions are ac­cept­able to me.

Right now, Bourla rep­re­sents the en­tire bio­phar­ma in­dus­try, and the stakes for every­one are enor­mous. If Trump does push through a vac­cine with­out the da­ta nec­es­sary to sat­is­fy most peo­ple about its safe­ty and ef­fi­ca­cy, the fall­out will go a long way to de­stroy­ing pub­lic con­fi­dence in the FDA and the abil­i­ty of the drug gi­ants to act re­spon­si­bly. It will al­so in­cite a sharp pub­lic back­lash against the first vac­cine, threat­en­ing herd im­mu­ni­ty.

FDA com­mis­sion­er Stephen Hahn opened that door by scram­bling to OK con­va­les­cent plas­ma with the sketchi­est of da­ta, read­i­ly tout­ing the ther­a­py by Trump’s side. His protests about in­tegri­ty and an abil­i­ty to re­sist pres­sure from Trump are mean­ing­less.

So it’s all on Bourla, who runs one of the largest phar­ma com­pa­nies on the globe. And he has to con­vince a deeply skep­ti­cal pub­lic — which has reg­u­lar­ly as­signed phar­ma to the low­est rungs of pub­lic re­gard — that Pfiz­er can be trust­ed to act in their best in­ter­est.

That’s a tough act, par­tic­u­lar­ly as Bourla now rep­re­sents a deep-seat­ed hope in bio­phar­ma that the in­dus­try has a shot at re­demp­tion in the pub­lic’s eyes by com­ing up with good drugs and vac­cines to end the pan­dem­ic.

What is im­por­tant, says Bourla in his let­ter, is that the glob­al death toll from the pan­dem­ic is ap­proach­ing a mil­lion peo­ple. And Pfiz­er will con­tin­ue to meet the cru­cial chal­lenge of reign­ing it in by trav­el­ing “at the speed of sci­ence.”

Sec­ond, we would nev­er suc­cumb to po­lit­i­cal pres­sure. The on­ly pres­sure we feel—and it weighs heavy—are the bil­lions of peo­ple, mil­lions of busi­ness­es and hun­dreds of gov­ern­ment of­fi­cials that are de­pend­ing on us. We’ve en­gaged with many elect­ed lead­ers around the globe through this health cri­sis, but Pfiz­er took no in­vest­ment mon­ey from any gov­ern­ment. Our in­de­pen­dence is a pre­cious as­set.

Third, our pri­or­i­ty is the de­vel­op­ment of a safe and ef­fec­tive vac­cine to end this pan­dem­ic. I have a du­ty to Pfiz­er’s 171-year his­to­ry to hon­or our lega­cy of dis­cov­er­ing and man­u­fac­tur­ing high-qual­i­ty med­i­cines. We will nev­er cut a cor­ner. Pfiz­er’s pur­pose is sim­ple: “Break­throughs that Change Pa­tients’ Lives.” It’s our North Star.

Bourla’s ap­peal like­ly won’t change the po­lit­i­cal de­bate that is now boil­ing around this is­sue. That can on­ly die down once the votes are count­ed and the bat­tle against the virus con­tin­ues. And if Pfiz­er does seek and get an EUA be­fore the elec­tion, don’t ex­pect any res­ur­rec­tion of pub­lic opin­ion re­gard­ing phar­ma — even if it’s a good vac­cine. In this frac­tious en­vi­ron­ment, no one gets the ben­e­fit of doubt. Least of all phar­ma.

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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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: 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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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.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

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.

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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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.