Ned Sharpless (via AP Images)

Ned Sharp­less in fi­nal run­ning for FDA com­mish with MD An­der­son ex­ec and Har­vard prof — re­ports

The Trump ad­min­is­tra­tion is ap­par­ent­ly down to three fi­nal can­di­dates for the top FDA job as a dead­line for nom­i­na­tion looms. Act­ing com­mis­sion­er Ned Sharp­less is con­tend­ing with Stephen Hahn, chief of ra­di­a­tion on­col­o­gy at MD An­der­son, and Har­vard der­ma­tol­ogy pro­fes­sor Alexa Boer Kim­ball, ac­cord­ing to re­ports.

Stephen Hahn

Con­spic­u­ous­ly ab­sent from the group is Brett Giroir, the con­tro­ver­sial as­sis­tant sec­re­tary of HHS who re­port­ed­ly en­joyed the fa­vor of Alex Azar, his boss at the de­part­ment. Azar end­ed up not rec­om­mend­ing him to the White House for fear of a dif­fi­cult Sen­ate con­fir­ma­tion, sources told Bio­Cen­tu­ry.

First re­port­ed by the Wall Street Jour­nal and lat­er con­firmed by Bio­Cen­tu­ry, news about the list broke on the same day for­mer FDA lead­ers and pa­tient ad­vo­ca­cy non­prof­its came out with ring­ing en­dorse­ment of Sharp­less. Mark Mc­Clel­lan, An­drew von Es­chen­bach, Robert Califf and Mar­garet Ham­burg signed a let­ter voic­ing sup­port for Sharp­less — who was di­rec­tor of the Na­tion­al Can­cer In­sti­tute — as did dozens of groups in­clud­ing Friends of Can­cer Re­search, the Na­tion­al Brain Tu­mor So­ci­ety and the Leukemia and Lym­phoma So­ci­ety.

Alexa Kim­ball

Trump must make a de­ci­sion about the com­mis­sion­er of food and drugs by No­vem­ber 1, 210 days af­ter Scott Got­tlieb made an abrupt ex­it in the mid­dle of a wide­ly ad­mired tenure.

Lend­ing cre­dence to the com­mon per­cep­tion that Sharp­less was his cho­sen suc­ces­sor, Got­tlieb of­fered his own rec­om­men­da­tion in a tweet that is “pinned” to the top of his Twit­ter pro­file to­day:

As ear­ly as June the WSJ has sug­gest­ed that Kim­ball, chief ex­ec­u­tive of the Har­vard Med­ical Fac­ul­ty Physi­cians at Beth Is­rael Dea­coness Med­ical Cen­ter, was in the run­ning along­side an un­named doc­tor at MD An­der­son. Hahn was not iden­ti­fied un­til late Wednes­day but has emerged as a lead­ing can­di­date, the pa­per re­port­ed cit­ing peo­ple fa­mil­iar with the mat­ter.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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Winselow Tucker, Eli Lilly's new Loxo unit chief commercial officer

Eli Lil­ly plucks a new com­mer­cial chief from Bris­tol My­ers in man­age­ment shuf­fle as HR chief re­tires

Eli Lilly has found a new chief commercial officer from among the ranks at Bristol Myers Squibb, as it says farewell to its longtime head of human resources Stephen Fry.

Fry announced on Thursday his plans to retire after more than 35 years with Lilly. He’ll vacate his seat as SVP of human resources and diversity at the end of the year, and current Loxo CCO Eric Dozier is slated to take his place. As a result, BMS’ Winselow Tucker is joining the team as Loxo CCO at the end of the month.

Simba Gill, Evelo Biosciences CEO

Sim­ba Gill heads back to Flag­ship af­ter sev­en-year run as Evelo CEO

Evelo Biosciences is on the hunt for a new CEO, with its founding chief Simba Gill switching to the chairman post to free up time for his new gig at Evelo’s incubator, Flagship Pioneering.

Gill will trade in his former Flagship title of venture partner with the higher-up role of executive partner, after originally joining in 2015. He’ll serve as CEO of Evelo until his successor is chosen, and at Flagship his priorities will be counseling and supporting the venture firm’s portfolio companies.

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Elcin Barker Ergun, Menarini Group CEO

Amid Roche and Sanofi's oral SERD set­backs, Menar­i­ni gets speedy re­view at FDA

Menarini and Radius Health are getting a speedy review at the FDA for their oral SERD breast cancer drug months after the field opened up with competitors failing and fleeing.

It was a one-two-three punch in March, April and May as Sanofi flunked its first big test for its oral selective estrogen receptor degrader (SERD), Roche also flamed out in a Phase II and G1 Therapeutics ended its program after scoping out the data and potential partners.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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