Flori­da judge dis­miss­es Zan­tac can­cer claims against GSK, oth­er phar­mas

GSK can breathe a lit­tle eas­i­er af­ter a Flori­da fed­er­al judge dis­missed thou­sands of claims that Zan­tac and re­lat­ed heart­burn prod­ucts caused can­cer, trig­ger­ing a boost in pre­mar­ket trad­ing on Wednes­day.

Plain­tiffs in the sprawl­ing mul­ti­dis­trict lit­i­ga­tion (MDL) at first at­tempt­ed to link pop­u­lar ran­i­ti­dine heart­burn prod­ucts to 10 types of can­cer, but lat­er with­drew breast, kid­ney, col­orec­tal, prostate and lung. On Tues­day, Judge Robin Rosen­berg tossed the re­main­ing claims in liv­er, blad­der, pan­cre­at­ic, esophageal, and stom­ach can­cers, up­on de­ter­min­ing that the al­le­ga­tions were based on “flawed” and “un­re­li­able” ev­i­dence.

Pfiz­er, Boehringer In­gel­heim and Sanofi, which owned Zan­tac rights at var­i­ous points in time, were al­so named in the suit, in ad­di­tion to Ther­mo Fish­er’s Patheon Man­u­fac­tur­ing Ser­vices.

GSK’s stock $GSK was down 2% on Wednes­day at $37.16, af­ter re­port­ed­ly jump­ing about 14% in ear­ly trad­ing.

“Here, there is no sci­en­tist out­side this lit­i­ga­tion who con­clud­ed ran­i­ti­dine caus­es can­cer, and the Plain­tiffs’ sci­en­tists with­in this lit­i­ga­tion sys­tem­i­cal­ly uti­lized un­re­li­able method­olo­gies with a lack of doc­u­men­ta­tion on how ex­per­i­ments were con­duct­ed, a lack of sub­stan­ti­a­tion for an­a­lyt­i­cal leaps, a lack of sta­tis­ti­cal­ly sig­nif­i­cant da­ta, and a lack of in­ter­nal­ly con­sis­tent, ob­jec­tive, sci­ence-based stan­dards for the even­hand­ed eval­u­a­tion of da­ta,” Rosen­berg wrote in an opin­ion.

Zan­tac was first ap­proved as a pre­scrip­tion med­i­cine for heart­burn in 1983, and af­ter a decade of record sales, GSK be­gan work­ing on an over-the-counter for­mu­la­tion. Sev­er­al OTC forms were cleared in 1995, and those sales rights lat­er passed through the hands of Pfiz­er, Boehringer In­gel­heim and Sanofi. How­ev­er, the drug was re­called in 2019 over un­ac­cept­ably high lev­els of a po­ten­tial car­cino­gen known as ND­MA.

Plain­tiffs ar­gued that ran­i­ti­dine can trans­form in­to ND­MA in the body or on the shelf in high tem­per­a­tures, and in 2020, reg­u­la­tors re­quest­ed the re­call of all ran­i­ti­dine prod­ucts. More than 2,450 plain­tiffs filed suits in the MDL, or had cas­es trans­ferred to the Flori­da fed­er­al court.

“We didn’t ob­serve un­ac­cept­able lev­els of ND­MA in many of the sam­ples that we test­ed,” for­mer act­ing com­mis­sion­er Janet Wood­cock said around the time of the re­call. “How­ev­er, since we don’t know how or for how long the prod­uct might have been stored, we de­cid­ed that it should not be avail­able to con­sumers and pa­tients un­less its qual­i­ty can be as­sured.”

GSK con­tin­ues to ar­gue that “the sci­en­tif­ic con­sen­sus is that there is no con­sis­tent or re­li­able ev­i­dence that ran­i­ti­dine in­creas­es the risk of any can­cer.”

“Yes­ter­day’s rul­ing re­flects the state of that sci­ence and en­sured that un­re­li­able and lit­i­ga­tion-dri­ven sci­ence did not en­ter the fed­er­al court­room,” the com­pa­ny said in a news re­lease.

The re­cent dis­missal does not af­fect thou­sands of on­go­ing cas­es at the state lev­el, many of which in­clude plain­tiffs who ex­it­ed fed­er­al MDL or whose al­leged in­juries had been dropped, a Sanofi spokesper­son told End­points News back in Sep­tem­ber.

GSK said in its an­nounce­ment on Wednes­day that it will “con­tin­ue to de­fend it­self vig­or­ous­ly, in­clud­ing against all claims brought at the state lev­el.”

The com­pa­ny not­ed on its Q3 call last month that 70,000 new claims had been filed in the state of Delaware, the ma­jor­i­ty of which had “not been vet­ted at this point in time.”

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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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.

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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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.

Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

Sanofi re­news so­cial cam­paign to re­mind that vac­cines let peo­ple ‘Dream Big’

Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

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Bill Anderson, incoming Bayer CEO (David Paul Morris/Bloomberg via Getty Images)

Bay­er taps Roche's Bill An­der­son to lead phar­ma gi­ant as CEO

We now know where Roche’s ex-pharma chief Bill Anderson is going.

German pharma giant Bayer announced Wednesday that Anderson will be taking on the role as CEO, less than six weeks after Anderson stepped down from his perch at Roche as head of the group’s pharmaceutical division.

Roche announced back in December that Anderson would depart on Dec. 31 to “pursue opportunities outside of Roche.” His replacement, Genentech vet and Roche’s current head of global product strategy, Teresa Graham, will start her role in March.

Iya Khalil, Merck VP and head of data, AI and genome sciences (Novartis)

Mer­ck-No­var­tis re­volv­ing door spins again as AI leader Iya Khalil switch­es phar­mas

As talk of AI this-and-that gobbles up headline after headline, one Big Pharma is losing its AI leader as she transitions to another drug giant: Iya Khalil will trade in her hat as Novartis’ go-to expert and leader in the space for Merck as VP and head of data, AI and genome sciences next week.

After nearly three years leading the artificial intelligence team at Novartis — as Big Pharma and biotechs alike latch onto the ripening AI-for-drug-discovery mode of operation — Khalil will switch employers to head up a similar post at Merck, where she’ll work out of Cambridge, MA beginning Feb. 13, the company tells Endpoints News.