Biden is look­ing be­yond Wood­cock or Sharf­stein for FDA com­mis­sion­er — re­port

Nei­ther Janet Wood­cock nor Joshua Sharf­stein is like­ly to be nom­i­nat­ed as the per­ma­nent FDA com­mis­sion­er, Steve Us­din at Bio­Cen­tu­ry re­ports.

Janet Wood­cock

The White House is look­ing for al­ter­na­tives to Wood­cock, the act­ing chief and long­time CDER di­rec­tor, af­ter op­po­si­tion from sev­er­al De­mo­c­ra­t­ic sen­a­tors who are call­ing on oth­ers to block her nom­i­na­tion if her name is put forth, ac­cord­ing to Us­din. Sharf­stein, the for­mer prin­ci­pal deputy FDA com­mis­sion­er and cur­rent Johns Hop­kins pro­fes­sor, is out of the run­ning al­to­geth­er.

As the va­can­cy at the helm of an agency tasked with over­see­ing the de­vel­op­ment and re­view of Covid-19 vac­cines be­came more con­spic­u­ous by the day — prompt­ing the New York Times to ask, “Who will be the next FDA chief?” — dis­tinct camps had formed around the two lead­ing can­di­dates.

Wood­cock earned plau­dits ear­ly from pa­tient ad­vo­ca­cy or­ga­ni­za­tions and bio­phar­ma­ceu­ti­cal com­pa­nies, the same groups that have spo­ken out against Sharf­stein for lack of ex­pe­ri­ence.

Joshua Sharf­stein

But there was a par­tic­u­lar group of ac­tivists who made their dis­dain for Wood­cock clear: those fight­ing the opi­oid abuse epi­dem­ic. And they be­lieve Wood­cock should be held re­spon­si­ble for “one of the worst reg­u­la­to­ry agency fail­ures in U.S. his­to­ry,” not on­ly over­see­ing but de­fend­ing “harm­ful opi­oid de­ci­sions.”

Sen­a­tors from some of states worst hit by the opi­oid cri­sis were re­port­ed to be her fiercest op­po­nents, in­clud­ing Sen­a­tors Mag­gie Has­san from New Hamp­shire, Ed Markey from Mass­a­chu­setts and Joe Manchin from West Vir­ginia.

Less pub­li­cized, per­haps, was the harsh cri­tique that some in­dus­try in­sid­ers re­served for Wood­cock over what they per­ceived as the loos­en­ing of the FDA’s reg­u­la­to­ry stan­dards, man­i­fest­ed in her de­ci­sion to over­rule FDA staffers and ap­prove Sarep­ta’s eteplirsen with­out clin­i­cal proof that their Duchenne mus­cu­lar dy­s­tro­phy drug works.

In a re­cent let­ter to Pub­lic Cit­i­zen, Wood­cock shut down the watch­dog’s pro­pos­al of a fire­wall be­tween reg­u­la­tors and drug com­pa­nies, ar­gu­ing it would un­nec­es­sar­i­ly “re­duce the ef­fi­cien­cy of FDA’s re­view process and cause de­lays in drug de­vel­op­ment.”

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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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.”

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.

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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