US President Joe Biden (Photo by Lenin Nolly/NurPhoto via AP)

Biden signs stop­gap fund­ing through next week as ne­go­tia­tors prep for larg­er om­nibus bill

Pres­i­dent Joe Biden this af­ter­noon signed a stop­gap fund­ing bill that will keep the fed­er­al gov­ern­ment open through the end of next week while House and Sen­ate ap­pro­pri­a­tors hash out a year-long so­lu­tion.

The Sen­ate yes­ter­day evening passed the stop­gap bill by a vote of 71-19, fol­low­ing a House vote on Wednes­day of 224-201 in fa­vor. The bill in­cludes sev­er­al punt­ed reau­tho­riza­tions for an­oth­er week. The pro­vi­sions in­clude $6.9 mil­lion in or­phan drug grants for next year and an­oth­er $5.7 mil­lion for the reau­tho­riza­tion of the Best Phar­ma­ceu­ti­cals for Chil­dren pro­gram.

But House and Sen­ate ap­pro­pri­a­tions lead­ers are putting to­geth­er a much larg­er, $1.7 tril­lion om­nibus bill for next year that needs to get done be­fore next Fri­day, and will like­ly in­clude longer reauths for those items and more.

In fact, the bill could po­ten­tial­ly in­clude all sorts of FDA- and phar­ma-re­lat­ed pro­vi­sions — every­thing from ac­cel­er­at­ed ap­proval re­forms to ways to im­prove di­ver­si­ty in clin­i­cal tri­als to an over­haul of lab-de­vel­oped test reg­u­la­tions — de­pend­ing on how the spend­ing lev­els are set.

Sen­ate Ap­pro­pri­a­tions Com­mit­tee Chair Patrick Leahy (D-VT) said in a state­ment on Tues­day that he and vice chair Richard Shel­by (R-AL) and House Ap­pro­pri­a­tions Com­mit­tee Chair Rosa De­Lau­ro (D-CT) “reached a bi­par­ti­san, bi­cam­er­al frame­work that should al­low us to fin­ish an om­nibus ap­pro­pri­a­tions bill that can pass the House and Sen­ate and be signed in­to law by the Pres­i­dent.”

De­tails of what’s in that fi­nal pack­age, text of which could ar­rive as soon as Mon­day, have been hard to come by.

Yale’s Resh­ma Ra­machan­dran, board chair of the non­prof­it Doc­tors for Amer­i­ca, told End­points News that there are, “Pos­i­tive signs from both sides of aisle on AA [ac­cel­er­at­ed ap­proval] re­forms and even clin­i­cal tri­al di­ver­si­ty.”

Sen­ate Ma­jor­i­ty Whip Dick Durbin (D-Ill.) told Politi­co to­day that an over­haul of the way the FDA reg­u­lates di­etary sup­ple­ments is off the ta­ble. But pret­ty much any­thing else — from AA re­forms to an over­haul of the way lab-de­vel­oped tests are reg­u­lat­ed — could be on the ta­ble.

The Al­liance for a Stronger FDA added in an email on Fri­day:

A num­ber of pos­si­ble add-ons could im­pact FDA, no­tably whether House E&C and Sen­ate HELP can ne­go­ti­ate an agree­ment on the pol­i­cy and pro­gram lan­guage stripped from the Sep­tem­ber’s user fee reau­tho­riza­tions. Even if such an agree­ment is reached, un­cer­tain­ty re­mains whether it will be added in the om­nibus in the face of dozens of Mem­bers and in­ter­est groups try­ing to add their pri­or­i­ties to the Om­nibus bill.

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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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.”

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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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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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.