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.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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