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.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Tony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Kid­ney dis­ease drug­mak­er Goldfinch Bio shuts down

Goldfinch Bio, attempting to make treatments for kidney diseases and diabetic nephropathy, is shutting down.

President and CEO Tony Johnson confirmed to Endpoints News Friday afternoon that the biotech shut down after “fundraising challenges in the current macro-environment.” Fierce Biotech first reported the news.

Johnson, who joined in 2017 after a stint as SVP of early clinical development at AstraZeneca, said in a text that the company “entered the ABC process recently,” referring to an assignment for the benefit of the creditors, which provides a different wind-down avenue than a bankruptcy.

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Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Steve Harr, Sana Biotechnology CEO

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

Sana Biotechnology is finally headed to the clinic.

Thursday afternoon, the biotech announced the FDA had cleared its application to start a clinical trial for its allogeneic, or “off-the-shelf,” CAR-T cell therapy targeting the antigen CD19 for patients with B-cell lymphomas and leukemias. Sana said its therapy, dubbed SC291, was designed to evade the immune system, which could help cell therapy produce a more durable response in patients, a concern that has followed such off-the-shelf therapies that use donor cells as opposed to a patient’s own cells.

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