FDA ex­e­cutes an abrupt about-face as sole-source con­tract for ex-agency chief Mark Mc­Clel­lan draws the spot­light

Mark Mc­Clel­lan

Af­ter nom­i­nat­ing Scott Got­tlieb for FDA com­mish last year, Mark Mc­Clel­lan, his for­mer boss at the agency, of­fered a warm en­dorse­ment for the move.

“(Got­tlieb) knows how to get things done in a pol­i­cy en­vi­ron­ment, work­ing with not just peo­ple in Wash­ing­ton, but in­dus­try, pa­tient groups and all kinds of stake­hold­ers on im­por­tant pub­lic health ini­tia­tives,” Mc­Clel­lan told the cam­pus pa­per at Duke, where he is di­rec­tor of the Duke-Mar­go­lis Cen­ter for Health Pol­i­cy.

That close re­la­tion­ship raised a few eye­brows, though, when the FDA re­cent­ly set up a con­tract where Mc­Clel­lan’s cen­ter was the sole al­lowed bid­der. Mc­Clel­lan’s role as a board mem­ber of phar­ma gi­ant J&J al­so came in­to the harsh spot­light.

From the re­quest for pro­pos­al:

The pri­ma­ry ob­jec­tive of this ef­fort is to pro­vide sup­port­ing re­search, iden­ti­fy key is­sues, and con­vene ap­pro­pri­ate sub­ject mat­ter ex­perts to help in­form ma­jor ini­tia­tives for process im­prove­ment and reg­u­la­to­ry sci­ence re­lat­ed to FDA com­mit­ments un­der the 2018 reau­tho­riza­tion of the Pre­scrip­tion Drug User Fee Act (PDU­FA VI) and the 21st Cen­tu­ry Cures Act leg­is­la­tion.

Politi­co raised some point­ed crit­i­cism, as did the Wash­ing­ton Post.

Jer­ry Avorn

“It frankly makes no sense that the on­ly place you could go from this is the Duke cen­ter run by a drug com­pa­ny ad­vo­cate,” Jer­ry Avorn, a pro­fes­sor of med­i­cine at Har­vard Med­ical School, told the Post. “The very fact that they could have thought this was a good idea, even to the point of pub­lish­ing the re­quest for pro­pos­al, is im­por­tant be­cause of what it re­flects about the de­ci­sion-mak­ing process with­in FDA and the ad­min­is­tra­tion.”

And then, yes­ter­day, the FDA sud­den­ly did an about face, say­ing that they had be­come aware of oth­er groups that could of­fer a ri­val bid. A spokesper­son sent this state­ment:

Since post­ing our orig­i­nal sole source award an­nounce­ment on­line, we have be­come aware of oth­er or­ga­ni­za­tions who be­lieve that they can sub­mit a com­pet­i­tive pro­pos­al to con­duct the need­ed re­search and re­lat­ed ac­tiv­i­ties. As a re­sult, FDA has de­cid­ed to change the an­nounce­ment from a sole source award to an open com­pet­i­tive grant.

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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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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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.

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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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.

UP­DAT­ED: In­di­v­ior's Shaun Thax­ter heads to prison, join­ing In­sys' John Kapoor among jailed opi­oid ex­ecs

Update: An earlier version of this article misidentified the jailed Insys CEO. Former CEO John Kapoor was sentenced to 5.5 years in prison in January. Endpoints News regrets the error.

The Justice Department’s years-long battle with Indivior has arrived at a rare place: the jailing of a pharmaceutical executive.

A US district court sentenced long-running Indivior CEO Shaun Thaxter to 6 months in federal prison for his role in company efforts to mislead a major healthcare provider about the safety and abusability of their opioid addiction drug Suboxone, which generated billions in revenue over the last decade. Thaxter joins former Insys CEO John Kapoor as one of the only two executives to face prison time for their roles in the opioid epidemic.