We've sched­uled your Type T meet­ing with FDA com­mish Scott Got­tlieb, where you can learn the art of rapid fire R&D

Here we’re in­tro­duc­ing the Type T(wit­ter) meet­ing with the head of the FDA on stream­lined drug de­vel­op­ment.

Any­body who’s been pay­ing at­ten­tion to our sur­veys of the End­points 100 would not be sur­prised to learn that a large ma­jor­i­ty of biotech ex­ecs have a big crush on FDA com­mis­sion­er Scott Got­tlieb. One big rea­son for the love af­fair be­tween the in­dus­try and the com­mish is that from the ex­ecs’ per­spec­tive Got­tlieb’s push­ing to make the agency far more re­spon­sive to crit­i­cism and the need to bat­ter down some long­stand­ing hur­dles in the way of drug de­vel­op­ers. And they want it done with­out toss­ing the gold stan­dard of R&D out the win­dow and mak­ing it a free-for-all.

On Sun­day, Got­tlieb took to one of his fa­vorite bul­ly pul­pits, Twit­ter, to out­line some re­cent moves at the FDA de­signed to help you. And he pro­vides a good overview of where the FDA is look­ing to im­prove, and how de­vel­op­ers can make some need­ed up­grades as well.

So here we go:

JC: A lot of this boils down to the cost of drug de­vel­op­ment, which is steep by any stan­dard.

JC: Per­haps some com­pa­nies could do a much bet­ter job with R&D dis­ci­pline?

JC: What­ev­er is dri­ving it, R&D costs are un­sus­tain­able. And that hurts con­sumers.

JC: Here’s one trend that Got­tlieb doesn’t like at all.

JC: And here’s why it’s hap­pen­ing.

JC: Here’s what we need to do to stop it.

JC: What we’re talk­ing about here is change for the bet­ter. No one is killing the FDA’s gold stan­dard. Do you need me to re­peat that?

JC: We have to be much more ef­fi­cient about R&D, whether you like it or not.

JC: So why don’t you give up your go-it-alone ap­proach? (There’s no sign this is hap­pen­ing in any sig­nif­i­cant num­bers.)

JC: Here’s a pop­u­lar no­tion that every­one sup­ports.

JC: Faster, bet­ter, cheap­er tri­als — what’s not to like?

JC: We told you about those sur­ro­gate end­points here. They are plen­ty pop­u­lar in bio­phar­ma.

JC: As usu­al, on­col­o­gy is lead­ing the way. Every­one must fol­low. But how do you do that in car­dio? Or di­a­betes? Who would pay for it?

 

JC: Here’s some­thing on de­vices, which I don’t cov­er.

 

JC: New stan­dards at FDA are aimed at mak­ing the agency more re­spon­sive in ways that can be clear­ly tracked.

JC: One fi­nal com­mer­cial break be­fore the ex­it.


Im­age: Scott Got­tlieb. SHUT­TER­STOCK

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

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Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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Roger Perlmutter, Merck R&D chief (YouTube)

Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.

Once a gem, now just a rock, Take­da punts PhI­II IBD drug as ri­vals mus­cle ahead

Back in 2016, when then-Shire CEO Flemming Ørnskov picked up a promising clinical-stage IBD drug from Pfizer, the Boston-based biotech dubbed it SHP647 and moved it into the gem section of the pipeline, with rosy expectations of registration-worthy Phase III data ahead.

This was a drug that the EC wanted Takeda to commit to selling off before it gave their blessing to its acquisition of Shire, to settle some deep-seated concerns revolving around the potential market overlap with their blockbuster rival Entyvio. And Takeda, which took on a heavy debt load to buy Shire, clearly wanted the cash to pay down debt.

Ear­ly sur­vival da­ta boost Zio­phar­m's 'con­trolled IL-12' im­munother­a­py for glioblas­toma

An unconventional pairing of a gene therapy and an oral drug that promises to attack recurrent or progressive glioblastoma with controlled release of IL-12 has turned up more promising — if early — overall survival data. On top of boosting its case as a monotherapy, the data can also bode well for a combination with Regeneron’s PD-1 inhibitor, Libtayo.

Both the treatment and its developer, Ziopharm Oncology, have come a long way. The stock price peaked in 2015 but cratered in 2016 following a patient death in a Phase I.