Sen. Chuck Grassley (R-IA) with Sens. Marsha Blackburn (R-TN) and Ron Johnson (R-WI) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors call on NIH to take ac­tion on slow-to-re­port clin­i­cal tri­al spon­sors

With tens of bil­lions in an­nu­al ap­pro­pri­a­tions, a group of four Re­pub­li­can sen­a­tors is pub­licly won­der­ing why the Na­tion­al In­sti­tutes of Health can’t do a bet­ter job of en­sur­ing tax­pay­er-fund­ed re­search is pub­lished in a time­ly man­ner, they said in a let­ter sent last week to NIH act­ing di­rec­tor Lawrence Tabak.

The let­ter comes as a re­cent HHS in­spec­tor gen­er­al re­port found that 72 clin­i­cal tri­als re­quir­ing re­sults to be sub­mit­ted in 2019 or 2020 were sub­mit­ted on time, late or not sub­mit­ted at all. While NIH con­curred with the Au­gust re­port’s rec­om­men­da­tions and said it would take steps to ad­dress them, the sen­a­tors are cu­ri­ous as to what ex­act­ly NIH is do­ing on the mat­ter.

“When Amer­i­can tax­pay­ers spend bil­lions of dol­lars on fed­er­al pro­grams, they ex­pect ac­count­abil­i­ty, trans­paren­cy, and re­sults,” Sens. Mar­sha Black­burn (TN), Chuck Grass­ley (IA), Roger Mar­shall (KS) and Ron John­son (MO) wrote. “HHS OIG’s re­port makes clear that the NIH must do more to hold grant re­cip­i­ents ac­count­able, so that the pub­lic is able to ac­cess time­ly clin­i­cal tri­al re­sults.”

They al­so sought a list from NIH of the 37 grant re­cip­i­ents that failed to com­ply with fed­er­al and NIH re­port­ing re­quire­ments in 2019 and 2020. And for the 21 re­searchers who failed to com­ply with fed­er­al re­port­ing re­quire­ments but were al­lowed to be­gin new NIH-fund­ed tri­als be­fore sub­mit­ting the re­sults of their pre­vi­ous clin­i­cal tri­als, the sen­a­tors want to know how much the NIH gave them.

Till Bruck­n­er, founder of the non­prof­it TranspariMED, which is work­ing to reg­is­ter and ful­ly re­port clin­i­cal tri­als, said in a state­ment:

Fi­nal­ly, U.S. pol­i­cy mak­ers are wak­ing up to the im­mense cost of re­search waste in pub­licly fund­ed clin­i­cal tri­als. TranspariMED looks for­ward to learn­ing how many NIH-fund­ed tri­als have failed to com­ply with fed­er­al and NIH re­port­ing re­quire­ments since 2007, and what NIH will do to en­sure that their re­sults are made pub­licly avail­able.

President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

DC court over­rules PhRMA's bid to shut down drug im­ports from Cana­da

The DC Circuit Court has struck a blow against the pharmaceutical lobbying group PhRMA and other plaintiffs’ attempt to stop states from importing drugs from Canada.

Joined alongside public health group Partnership for Safe Medicines and advocacy group Council for Affordable Health Coverage, PhRMA was rebuffed by Judge Timothy Kelly on Monday, who dismissed the civil suit due to a lack of standing.

Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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