Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Phar­ma in the crosshairs: How the FTC is ex­pand­ing its an­titrust pow­ers un­der its new chair

Less than a month since her Sen­ate con­fir­ma­tion, the new, young and staunch­ly pro­gres­sive Fed­er­al Trade Com­mis­sion chair Lina Khan is ready to up the pres­sure on un­fair busi­ness prac­tices, in­clud­ing at the largest phar­ma com­pa­nies. To do that, Khan is rolling back re­stric­tions on an­titrust in­ves­ti­ga­tions and po­ten­tial­ly open­ing the flood gates on Big Phar­ma M&A.

On Thurs­day, Khan led a vote to ap­prove a se­ries of res­o­lu­tions that di­rect agency staff to ramp up its in­ves­ti­ga­tions, via sub­poe­nas or oth­er­wise, around sev­en spe­cif­ic en­force­ment pri­or­i­ties, in­clud­ing phar­ma com­pa­nies, PBMs, and hos­pi­tals. While the com­mis­sion has his­tor­i­cal­ly re­quired its an­titrust staff to ob­tain the full com­mis­sion’s ap­proval to be­gin such in­ves­ti­ga­tions, the FTC will now be able to open in­ves­ti­ga­tions or is­sue sub­poe­nas with on­ly one com­mis­sion­er’s ap­proval, and that in­cludes in­ves­ti­ga­tions in­to phar­ma com­pa­nies.

“These tar­get­ed res­o­lu­tions would stream­line in­ves­ti­ga­tions that fall with­in these sub­ject ar­eas, en­abling more ex­pe­di­tious in­ves­ti­ga­to­ry process. This is par­tic­u­lar­ly im­por­tant giv­en that we are in the midst of a mas­sive merg­er boom,” Khan said in re­marks at one of the first pub­lic meet­ings for FTC’s com­mis­sion­ers in decades. The FTC in March set up an in­ter­na­tion­al work­ing group to more close­ly eval­u­ate phar­ma com­pa­ny merg­ers in light of con­cerns around drug pric­ing and an­ti­com­pet­i­tive be­hav­ior.

Khan al­so led the with­draw­al of a pri­or state­ment from the FTC from 2015, which she said will recom­mit the com­mis­sion to its man­date to po­lice un­fair meth­ods of com­pe­ti­tion even if they are out­side the am­bit of two an­titrust laws, known as the Sher­man or Clay­ton Acts. The FTC’s two Re­pub­li­cans op­posed all of the mea­sures passed on Thurs­day, and Khan’s po­si­tion­ing shows how the FTC will be a more par­ti­san agency than in the past. Ama­zon has al­ready sought to re­cuse Khan from an­titrust in­ves­ti­ga­tions be­cause of her past com­ments on the on­line re­tail gi­ant.

Ro­hit Chopra

One of the three De­mo­c­ra­t­ic com­mis­sion­ers, Ro­hit Chopra, is still await­ing Sen­ate con­fir­ma­tion to head the Con­sumer Fi­nan­cial Pro­tec­tion Bu­reau thanks to a Biden nom­i­na­tion, but his de­par­ture and the FTC’s even par­ti­san split that’s com­ing (be­fore Biden nom­i­nates an­oth­er FTC com­mis­sion­er) will not ham­per any in­ves­ti­ga­tions that De­moc­rats want to open as a change made Thurs­day will mean Re­pub­li­can com­mis­sion­ers won’t be able to block such in­ves­ti­ga­tions.

And while Khan, just 32 years old, push­es ahead with the strength­en­ing of FTC’s abil­i­ty to go af­ter bad ac­tors, in­clud­ing with a rule­mak­ing fix on Thurs­day, a re­cent Supreme Court de­ci­sion ham­strung the com­mis­sion’s abil­i­ty to se­cure bil­lions of dol­lars in re­lief for con­sumers in a wide va­ri­ety of cas­es, leav­ing the door open for bio­phar­ma com­pa­nies to quick­ly end cer­tain cas­es in­volv­ing an­ti­com­pet­i­tive prac­tices.

“While rule­mak­ing is no sub­sti­tute for a per­ma­nent fix to our Sec­tion 13(b) au­thor­i­ty to ob­tain mon­e­tary re­lief, trade rules can help en­sure that busi­ness­es will no longer be able to take ad­van­tage of con­sumers and ce­ment their mar­ket po­si­tion by en­gag­ing in prac­tices that do peo­ple re­al harm un­til we catch them and take them to court the first time,” De­mo­c­ra­t­ic com­mis­sion­er Re­bec­ca Kel­ly Slaugh­ter wrote in a re­lat­ed state­ment.

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.

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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Lars Fruergaard Jørgensen, Novo Nordisk CEO (Christopher Goodney/Bloomberg via Getty Images)

No­vo Nordisk notch­es big GLP-1 sales amid re­bound­ing sup­plies, but cau­tions on fu­ture 'pe­ri­od­ic con­straints'

With Novo Nordisk’s obesity treatment Wegovy fully back in stock in December, sales are beginning to soar, the Danish pharma reported during its annual earnings call on Wednesday. Total scripts of the glucagon-like peptide 1 (GLP-1) Wegovy topped 37,000 weekly in mid-January, a hockey stick uptick from end-of-year levels below 15,000 per week.

The new prescriptions come on top of the overall momentum of Novo obesity drug sales in 2022, although the then supply-constrained Wegovy was only part of that. Sibling obesity med Saxenda accounted for DKK 10.7 billion ($1.58 billion) of the total DKK 16.9 billion ($2.49 billion), or about 63%, in Novo Nordisk’s reported obesity segment sales.

Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)

Go­ing block­buster hunt­ing, Vas Narasimhan out­lines vi­sion for ‘pure-play’ No­var­tis

By the time 2023 is over, Novartis expects to be moving much lighter: It will have spun out its generics subsidiary Sandoz, completed layoffs of thousands of staffers worldwide and put in new internal structures for running the company.

And it will be ready to hunt for blockbusters.

CEO Vas Narasimhan underscored Novartis’ upcoming transformation into a “pure-play” company, reiterating across a series of calls — one with reporters, two with investors and analysts — that the new structure would boost its R&D productivity and sharpen its focus on big, new medicines.

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