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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,800+ biopharma pros reading Endpoints daily — and it's free.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,800+ biopharma pros reading Endpoints daily — and it's free.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,800+ biopharma pros reading Endpoints daily — and it's free.

Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.