NIH as­so­ciate di­rec­tor an­nounces de­par­ture to pri­vate sec­tor, join­ing an­ti-ag­ing biotech

The as­so­ciate di­rec­tor of the Na­tion­al In­sti­tute of Health’s Of­fice of Leg­isla­tive Pol­i­cy and Analy­sis (OL­PA) is leav­ing her gov­ern­ment post to join CEO James Pey­er at Cam­bri­an Bio­Phar­ma.

Adri­enne Hal­lett made the an­nounce­ment via her LinkedIn pro­file Wednes­day morn­ing, link­ing to a state­ment from act­ing NIH di­rec­tor Lawrence Tabak.

In her role at OL­PA, Hal­lett over­saw and man­aged rep­re­sent­ing bio­med­ical re­search to Con­gress and pres­i­den­tial ad­min­is­tra­tions, on top of lead­ing 120 staff in ad­vanc­ing pol­i­cy goals, co­or­di­nat­ing re­spons­es to over­sight in­ves­ti­ga­tions and more.

Tabak’s state­ment not­ed Hal­lett’s work in Con­gress, tout­ing her record im­prov­ing NIH’s fed­er­al ap­pro­pri­a­tions by more than 40% since she start­ed work­ing for the agency in 2015.

“I want to thank Adri­enne for her ded­i­ca­tion to cul­ti­vat­ing NIH’s re­la­tion­ship with Con­gress over the past sev­er­al years,” Tabak said.

Be­yond that, Tabak added that Hal­lett played a crit­i­cal role as an ad­vi­sor to NIH brass as the agency im­ple­ment­ed sex­u­al ha­rass­ment re­port­ing re­quire­ments, new stan­dards re­lat­ing to pa­tient con­fi­den­tial­i­ty and ad­dressed struc­tur­al racism in bio­med­ical re­search.

Be­fore her time at NIH, she worked with the US Sen­ate’s ap­pro­pri­a­tions com­mit­tee for 14 years, mov­ing up to staff di­rec­tor on the La­bor, HHS, and Ed­u­ca­tion sub­com­mit­tee and lat­er a se­nior pol­i­cy ad­vi­sor be­fore mov­ing to NIH.

As for her new gig, she will be leav­ing for Cam­bri­an on Feb. 25 to be­come the biotech’s new VP of glob­al pol­i­cy and strate­gic ini­tia­tives.

Cam­bri­an CEO James Pey­er told End­points News that he first con­nect­ed with Hal­lett through a mu­tu­al friend.

“We start­ed talk­ing about a year ago,” Pey­er said, adding that Hal­lett will be work­ing with foun­da­tions, gov­ern­ment in­sti­tu­tions and oth­er groups for in­vest­ments in­to Cam­bri­an’s pipeline, along with long-term ob­jec­tives such as be­ing able to run more pri­ma­ry pre­ven­tion tri­als.

“Her job will be to help us fig­ure out how to run tri­als and how to find great part­ners,” Pey­er added.

This an­nounce­ment is the newest de­vel­op­ment for the com­pa­ny, less than two weeks af­ter un­wrap­ping Cam­bri­an’s newest pipeline com­pa­ny, Is­ter­ian Biotech, which is cur­rent­ly fo­cused on in­hibitor drugs for TG2, a hard-to-tar­get pro­tein that could have im­pact in the ex­tra­cel­lu­lar space.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Credit: Shutterstock

New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Troy Tazbaz, FDA's newly-named director of the Digital Health Center of Excellence (Oracle via YouTube)

Or­a­cle ex­ec­u­tive Troy Tazbaz named new FDA di­rec­tor of dig­i­tal health

The FDA has found a brand new director of the Digital Health Center of Excellence in Troy Tazbaz, a former senior vice president at Oracle.

According to Tazbaz’s LinkedIn, he took a five-month break after leaving an 11-year career at Oracle before joining the FDA in January. Stat News first reported the hire. Tazbaz also said on his LinkedIn that he biked all the way from Chesapeake Bay to the San Francisco Bay over 58 days during his career break.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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