Xavier Becerra, new HHS secretary, at his nomination hearing (Greg Nash/Pool via AP Images)

Drug­mak­ers brace for a pric­ing fight as Xavier Be­cer­ra is con­firmed as the next HHS sec­re­tary

By a ra­zor-thin mar­gin of 50-49, all Sen­ate De­moc­rats and Maine Re­pub­li­can Su­san Collins on Thurs­day con­firmed for­mer Cal­i­for­nia At­tor­ney Gen­er­al Xavier Be­cer­ra as the head of the De­part­ment of Health and Hu­man Ser­vices (HHS) — set­ting the stage for what may be ma­jor pric­ing bat­tles with the bio­phar­ma in­dus­try.

The par­ti­san di­vide over Be­cer­ra’s nom­i­na­tion came as De­moc­rats lined up be­hind Be­cer­ra’s tough stance against drug­mak­ers and for Oba­macare, among oth­er is­sues, while Re­pub­li­cans lam­bast­ed his lack of med­ical and sci­en­tif­ic ex­pe­ri­ence, as well as his tough stance against the phar­ma­ceu­ti­cal in­dus­try.

“I think we can all agree the price we’re pay­ing for some of these pre­scrip­tion drugs is far high­er than it should be. All you have to do is trav­el to an­oth­er coun­try to find we’re pay­ing way more,” Be­cer­ra said in his Sen­ate com­mit­tee hear­ing in Feb­ru­ary to re­view his nom­i­na­tion.

Aaron Kessel­heim, a pro­fes­sor of med­i­cine at Har­vard Med­ical School and a fac­ul­ty mem­ber in the Di­vi­sion of Phar­ma­coepi­demi­ol­o­gy and Phar­ma­coeco­nom­ics at Brigham and Women’s Hos­pi­tal, said he’s not con­cerned that Be­cer­ra is not a doc­tor; “be­ing a med­ical doc­tor trains you to have in­sight in­to pa­tient care, but it does not give you spe­cial in­sight in­to be­ing an ef­fec­tive HHS Sec­re­tary, as we learned from the dis­as­trous Tom Price ad­min­is­tra­tion.”

Aaron Kessel­heim

In terms of drug pric­ing, Kessel­heim said he thought Be­cer­ra could “right away take some steps to ad­dress Part B drug pric­ing, since right now Medicare en­gages in no over­sight of Part B prices; it just pays the ASP [av­er­age sales price] plus a small per­cent. This could in­clude ideas such as en­forc­ing ac­cu­rate re­port­ing of ASPs, re­duc­ing spend­ing on bi­o­log­ic drugs with biosim­i­lars by bring­ing them all un­der the same re­im­burse­ment code, shift­ing cer­tain drugs from Part B to Part D (with as­so­ci­at­ed lim­its on OOP [out of pock­et] costs), and in­sti­tut­ing the Med­PAC rec­om­men­da­tion to cre­ate a CM­MI [Cen­ters for Medicare & Med­ic­aid Ser­vices (CMS) In­no­va­tion Cen­ter] demon­stra­tion project to ne­go­ti­ate prices of Part B drugs. Ul­ti­mate­ly, he may need to de­vel­op the me­chan­ics of a sys­tem to ne­go­ti­ate fair drug prices based on their clin­i­cal ben­e­fits if such a ne­go­ti­a­tion process is ap­proved by Con­gress, since it will most nat­u­ral­ly be housed with­in CMS.”

As At­tor­ney Gen­er­al of Cal­i­for­nia, Be­cer­ra led the state to be­come the first in the na­tion to ban pay-for-de­lay agree­ments, which can de­lay the en­try of gener­ic drugs to mar­ket, and he de­feat­ed a chal­lenge to the law from the As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines (AAM), the gener­ic phar­ma­ceu­ti­cal in­dus­try group.

“I took on a num­ber of these drug­mak­ers by go­ing be­hind the cur­tain on how they reached their pric­ing and we were able to prove there was col­lu­sion go­ing on,” he added in the Feb­ru­ary hear­ing. He al­so has sought to right the wrongs of the opi­oid epi­dem­ic.

The Fed­er­al Trade Com­mis­sion’s re­cent an­nounce­ment that it would crack down on phar­ma­ceu­ti­cal com­pa­nies’ merg­ers al­so plays right in­to Be­cer­ra’s work on an­titrust is­sues.

And his ad­vo­ca­cy for us­ing march-in rights to uni­lat­er­al­ly low­er drug prices in cas­es where the gov­ern­ment has in­vest­ed in their de­vel­op­ment (such as with Gilead’s Covid-19 drug remde­sivir) has al­so riled the in­dus­try.

“Ob­vi­ous­ly the use of march-in rights would be a huge deal,” Ben Ip­poli­to, res­i­dent schol­ar at the Amer­i­can En­ter­prise In­sti­tute, told End­points News. “I don’t know if that has a high enough ben­e­fit-to-cost ra­tio to take on or not, par­tic­u­lar­ly giv­en all the oth­er pri­or­i­ties they’ve al­ready got … and if Con­gress ends up work­ing on drug pric­ing leg­is­la­tion any­ways.”

Lau­ren Aron­son

He not­ed that any push to use march-in might push the bio­phar­ma in­dus­try away from de­vel­op­ing treat­ments that march-in rights could ap­ply to, “which seems like it un­der­mines the point of fund­ing the re­search.”

On the flip side, sev­er­al non­prof­its specif­i­cal­ly fo­cused on drug prices praised his con­fir­ma­tion and are prepar­ing for him to take ac­tion.

Lau­ren Aron­son, ex­ec­u­tive di­rec­tor of the Cam­paign for Sus­tain­able Rx Pric­ing, com­mend­ed Con­gress for Be­cer­ra’s con­fir­ma­tion and for his “pledg­ing to work across par­ty lines to low­er drug prices and hold Big Phar­ma ac­count­able.” David Mitchell, a can­cer pa­tient and founder of Pa­tients for Af­ford­able Drugs Now, al­so called Be­cer­ra’s con­fir­ma­tion “a win for pa­tients across the coun­try who are strug­gling with high drug prices.”

Stephen Ubl

Phar­ma in­dus­try groups, mean­while, pledged to work with Be­cer­ra.

Stephen Ubl, pres­i­dent and CEO of in­dus­try group PhRMA, said in a state­ment that the in­dus­try looks for­ward to work­ing with HHS “to help ad­dress our na­tion’s lead­ing pri­or­i­ties: get­ting COVID-19 un­der con­trol and im­prov­ing health care af­ford­abil­i­ty and ac­cess for all Amer­i­cans.”

AAM of­fered their con­grat­u­la­tions and said they look for­ward to work­ing with him “to ad­vance poli­cies that en­hance the com­pet­i­tive­ness of safe, ef­fec­tive, af­ford­able gener­ics and biosim­i­lars.”

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Covid-19 vac­cine halt drags on, an FDA ap­point­ment at long last, the great CRO con­sol­i­da­tion, 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.

Conference season is upon us, and while we’d much prefer to be wandering down the hallways and presentation rooms in person, the team is ready to cover the most consequential data coming out of these scientific meetings. Get in touch early if you have news to share.

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Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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As­traZeneca-Alex­ion merg­er slides through FTC re­view af­ter sup­posed M&A crack­down pos­es no bar­ri­ers

The AstraZeneca-Alexion megamerger received a good sign Friday, despite warning signs of the tides turning against large M&A pharma deals.

US regulators at the FTC have cleared the acquisition for approval, AstraZeneca announced, all but signing off on the deal to go through once it officially closes in the third quarter. AstraZeneca originally said it was planning to buy out Alexion back in December for $39 billion.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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David Stack, Pacira Biosciences CEO

In high­ly un­usu­al move, Paci­ra sues med­ical jour­nal for li­bel over its non-opi­oid painkiller

A New Jersey biotech whose only approved drug is used as a painkiller after surgeries is suing a scientific journal, its editors and a handful of authors for libel after the publication printed numerous papers and editorials that the company says discredited the drug.

Pacira Biosciences filed the complaint against the American Society of Anesthesiologists in the US District Court for New Jersey on Wednesday afternoon. A February issue of the group’s journal Anesthesiology printed three articles and other content full of “bias” that “seriously disparaged” the drug Exparel, Pacira claimed.