Luciana Borio (Susan Walsh/AP Images)

Bob Nelsen's ARCH adds FDA, biode­fense ex­per­tise with ap­point­ment of Lu­ciana Bo­rio

Once vet­ted by the Biden team to lead the FDA as com­mis­sion­er, Lu­ciana Bo­rio is now com­pil­ing quite the ré­sumé.

Bo­rio has now been named a ven­ture part­ner at Bob Nelsen’s ARCH Ven­ture Part­ners, and Nelsen told End­points News, “She will be in­volved in projects across the port­fo­lio, in­clud­ing on­go­ing projects in man­u­fac­tur­ing, clin­i­cal tri­als, gene ther­a­py and gene edit­ing, cell ther­a­py, and de­liv­ery. We are ex­plor­ing mul­ti­ple projects in in­fec­tious dis­ease, and next gen­er­a­tion man­u­fac­tur­ing.”

Bo­rio an­nounced her new role via tweet on Fri­day. The role will al­low her to show­case her FDA and Na­tion­al Se­cu­ri­ty Coun­cil-re­lat­ed ex­per­tise to ad­vance in­no­va­tion, sci­ence, and pub­lic health, Pfiz­er board mem­ber and for­mer FDA com­mis­sion­er Scott Got­tlieb, said.

Bob Nelsen

Nelsen and Bo­rio have worked close­ly in the past. He pre­vi­ous­ly told End­points News that he spent last spring in his Seat­tle home, talk­ing on the phone with Bo­rio about her work run­ning pan­dem­ic pre­pared­ness on the NSC, and fum­ing with her about the dire state of Amer­i­can man­u­fac­tur­ing. Those talks helped lead to the launch of Nelsen’s $800 mil­lion bi­o­log­ics man­u­fac­tur­ing start­up Re­silience.

Bo­rio, who pre­vi­ous­ly served as the FDA’s act­ing chief sci­en­tist and as VP at that non­prof­it in­vest­ment firm In-Q-Tel, serves as a se­nior fel­low for glob­al health at the Coun­cil on For­eign Re­la­tions for about the last year. Bo­rio did not re­spond to a re­quest for com­ment on whether she would keep that role at the CFR. She al­so serves as a mem­ber of CEPI’s sci­en­tif­ic ad­vi­so­ry com­mit­tee, where she pro­vides Covid-re­lat­ed guid­ance and work on the pub­lic-pri­vate part­ner­ship’s $3.5 bil­lion plan to re­duce the threat of fu­ture pan­demics and epi­demics.

And she played a hand in Pres­i­dent Biden’s race to nom­i­nate an FDA com­mis­sion­er, ac­cord­ing to one for­mer agency of­fi­cial.

Dur­ing the saga around the first ac­cel­er­at­ed ap­proval for Sarep­ta Ther­a­peu­tics’ DMD drug eteplirsen, Bo­rio — then FDA’s act­ing chief sci­en­tist — wrote to then-FDA com­mis­sion­er Robert Califf with fears that cur­rent act­ing com­mis­sion­er Janet Wood­cock “chilled sci­en­tif­ic de­bate with­in (the FDA Cen­ter for Drug Eval­u­a­tion and Re­view) and re­duced the lev­el of par­tic­i­pa­tion by the re­view team dur­ing the fi­nal stages of the de­ci­sion-mak­ing process.”

A for­mer se­nior FDA of­fi­cial said it was this dis­pute that led Wood­cock to push Bo­rio out of the FDA en­tire­ly, af­ter Bo­rio cir­cu­lat­ed an in­ter­nal memo con­cern­ing Wood­cock’s role with Sarep­ta. This for­mer of­fi­cial al­so said he thinks Bo­rio, who was vet­ted but ul­ti­mate­ly not nom­i­nat­ed to lead FDA, might have a hand in ic­ing Wood­cock’s fail­ure to land a nom­i­na­tion, too.

Ar­ti­cle up­dat­ed with com­ment from Bob Nelsen.

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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In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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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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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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Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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Robert Hariri, Celularity CEO (Vivien Killilea/Getty Images for Brain Mapping Foundation)

Celu­lar­i­ty warns of loom­ing lay­offs, spot­lights ear­ly pro­grams as mon­ey runs dry

Celularity has warned “a substantial portion” of its employees that layoffs could be looming in the face of a reprioritization effort. In the same breath, it touted some of its very early next-gen candidates in degenerative diseases and oncology.

“While Celularity is hopeful that there will be no need to substantially reduce its headcount, the notifications were provided in accordance with applicable law and to maintain full transparency with its employees,” the news release reads, in part.

Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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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.