Short-term gov­ern­ment spend­ing bill in­cludes reau­tho­riza­tions of or­phan drug cred­its and oth­er phar­ma perks

As bi­par­ti­san talks for a longer-term gov­ern­ment spend­ing bill con­tin­ue, House Ap­pro­pri­a­tions Chair Rosa De­Lau­ro (D-CT) to­day filed a one-week con­tin­u­ing res­o­lu­tion to keep the gov­ern­ment fund­ed and avert a shut­down on Fri­day at mid­night.

The short-term Band-Aid al­so in­cludes sev­er­al reau­tho­riza­tions that are of in­ter­est to the phar­ma in­dus­try as they had been cut out of a re­cent­ly passed FDA-in­dus­try user fee deal, which was tagged on­to the last short-term fund­ing ex­ten­sion.

The idea be­hind those ex­clu­sions from the user fee deal was to make time for adding in oth­er re­forms re­lat­ed to ac­cel­er­at­ed ap­provals, reg­u­lat­ing lab-de­vel­oped tests and cos­met­ics, and more.

This time around, how­ev­er, those oth­er rid­ers may not be hitch­ing a ride.

In­stead, the De­Lau­ro bill in­cludes $6.9 mil­lion in or­phan drug grants (up from $6.3 mil­lion last year) to de­fray the costs of de­vel­op­ing drugs for rare dis­eases or con­di­tions, in­clud­ing qual­i­fied test­ing ex­pens­es. The grants pro­gram, run by FDA, has fund­ed clin­i­cal re­search since 1983, in­clud­ing tri­als that led to the ap­proval of more than 80 prod­ucts.

An­oth­er $5.7 mil­lion (about $500,000 more than last year) would be au­tho­rized, if the De­Lau­ro bill pass­es, for the reau­tho­riza­tion of the Best Phar­ma­ceu­ti­cals for Chil­dren pro­gram, which in­cen­tivizes spon­sors with ad­di­tion­al mar­ket­ing ex­clu­siv­i­ty to com­plete pe­di­atric clin­i­cal stud­ies. As of ear­ly June, the FDA is­sued more than 500 writ­ten re­quests for such pe­di­atric tri­als.

In ad­di­tion to sev­er­al med­ical de­vice-re­lat­ed reau­tho­riza­tions (e.g. hu­man­i­tar­i­an de­vice ex­emp­tion), it al­so in­cludes a week­long reau­tho­riza­tion of the part of FDA law that al­lows the agency to re­quire cer­tain drug and bi­o­log­ic ap­pli­ca­tion hold­ers to make safe­ty-re­lat­ed la­bel­ing changes based on new safe­ty in­for­ma­tion that be­comes avail­able af­ter an ap­proval.

The bill al­so reau­tho­rizes a sec­tion of the FDA Reau­tho­riza­tion Act of 2017 that re­quires the FDA to re­port on cer­tain gener­ic drug ap­pli­ca­tions sub­ject to pri­or­i­ty re­view or with a com­pet­i­tive gener­ic ther­a­py des­ig­na­tion.

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.

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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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.