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.

Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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Kenji Yasukawa, Astellas CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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