Ned Sharp­less is not play­ing with the FDA’s gold stan­dard — any more than Scott Got­tlieb did

Ned Sharp­less got a chance to out­line just what kind of act­ing FDA chief he’ll be in the wake of Scott Got­tlieb’s de­par­ture from the agency. And aside from a more con­ser­v­a­tive se­lec­tion of socks, he’s clear­ly plan­ning to adopt the ex­act same fash­ions laid down by his pre­de­ces­sor.

Ned Sharp­less. (DARR BEIS­ER/NA­TION­AL CAN­CER IN­STI­TUTE)

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In an all-hands-on-deck ad­dress to staffers, Sharp­less promised to fit the Got­tlieb mold per­fect­ly, vow­ing to main­tain the agency’s gold stan­dard on drug ap­provals while do­ing what he can to keep the copy­cats com­ing to help tamp down on drug costs.

So let me re­as­sure you, I am not plan­ning any rad­i­cal changes from what the FDA has been try­ing to ac­com­plish.

Bioreg­num Opin­ion Col­umn by John Car­roll

That’s a theme that will be mu­sic to the ears of the bio­phar­ma in­dus­try, which quick­ly swooned to Got­tlieb’s en­er­getic mes­sages on speed­ing ap­provals when­ev­er ap­pro­pri­ate while hold­ing the line on safe­ty and ef­fi­ca­cy stan­dards. The fu­ture of the FDA proved to be a huge is­sue at the start of Pres­i­dent Don­ald Trump’s term in of­fice, as Trump en­ter­tained some lib­er­tar­i­an no­tions that fright­ened the be­je­sus out of com­pa­nies that clear­ly want­ed a more re­cep­tive reg­u­la­to­ry ap­proach — with­out any reg­u­la­to­ry an­ar­chy that would de­stroy the val­ue of an FDA OK.

Sharp­less got right to it. His bot­tom line:

Nec­es­sar­i­ly, there will be course ad­just­ments as new facts emerge, but es­sen­tial­ly, I feel I am walk­ing in­to an or­ga­ni­za­tion on a good tra­jec­to­ry, and my main job is to fig­ure out how keep that go­ing.

Now how to do that:  let me sug­gest two guid­ing prin­ci­ples.

First, I be­lieve our ef­forts should re­ly on and be guid­ed by the sci­ence. As a re­searcher, I am used to let­ting da­ta dri­ve my de­ci­sion-mak­ing, and I know this has al­ways been the ap­proach at FDA.

Sec­ond, when wran­gling with the com­plex is­sues that face the agency, we will keep top of mind our mis­sion of pro­tect­ing and pro­mot­ing pub­lic health, and what that means to the Amer­i­can pub­lic.

So that’s what will steer my pri­or­i­ties as act­ing com­mis­sion­er: a com­mit­ment to sci­ence-based de­ci­sion-mak­ing and pri­or­i­tiz­ing our ef­forts for the ben­e­fit of the pub­lic health.

That mes­sage on con­ti­nu­ity ex­tends to the agency’s work hus­tling up less ex­pen­sive knock­offs.

I promise you, for ex­am­ple, that we’ll con­tin­ue our im­por­tant and suc­cess­ful work to in­crease com­pe­ti­tion and reign in pre­scrip­tion drug costs through ad­vances in our gener­ic drug and biosim­i­lars pro­grams

And we’ll con­tin­ue to do every­thing we can to make the de­vel­op­ment of new treat­ments and cures more ef­fi­cient across our med­ical prod­uct cen­ters, while en­sur­ing that we main­tain FDA’s gold stan­dard of safe­ty and ef­fi­ca­cy.

What could be more re­as­sur­ing to the in­dus­try, law­mak­ers and the pub­lic?

In­ter­est­ing­ly, Got­tlieb’s de­par­ture from the FDA was al­so marked by his in­sis­tence that the rank-and-file drug de­vel­op­ers of the world need­ed to do more to adopt the re­forms he had pushed, look­ing for faster, more ef­fi­cient ways to de­vel­op drugs. The chal­lenge for Sharp­less will be to see if he con­tin­ues that push as an in­dus­try train­er look­ing to get some out-of-shape de­vel­op­ers up to speed with the new or­der. And that means urg­ing reg­u­la­tors as well to get the lead out.

Scott Got­tlieb

Con­ti­nu­ity may sound like the ex­act right mes­sage here and now. But if that be­comes a con­ser­v­a­tive ap­proach to main­tain­ing stan­dards and tra­di­tions, plea­sure may soon be re­placed by an un­easy feel­ing that the FDA may once again be­come more of an ob­sta­cle and less of a part­ner. And that won’t be wel­come.

Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Covid-19 roundup: BioN­Tech go­ing head-to-head with Mod­er­na as PhI­II mR­NA launch looms; Tri­al on Shin­zo Abe’s once-fa­vorite an­tivi­ral is in­con­clu­sive

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $7.3B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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An­oth­er four biotechs scratch out the first num­ber and ask for more as IPO boom con­tin­ues

Four more biotechs are raising their offers in an already record year for biotech IPOs.

Softbank-backed Relay Therapeutics scratched out its original $200 million filing and proposed a $250 million raise that would make them a $1.5 billion company. CAR-T developer Poseida Therapeutics bumped itself up $74 million to $224 million. Off-the-shelf cell therapy startup Nkarta upped from $150 million to $215 million — and then priced even higher, at $252 million. France’s Inventiva did its own modest reset, raising its bar from $102 million to $108 million.