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New Sanofi CEO Paul Hudson met with journalists today at company headquarters in Paris (Credit: Eric Piermont / AFP)

‘There are mo­ments’: Sanofi’s new CEO is think­ing through the R&D strat­e­gy — and on­col­o­gy will be key

PARIS — “When you visit science, everything looks perfect,” says Sanofi’s newly named CEO Paul Hudson, who’s been on the job all of about a month now. “It smells of fresh paint.”

But in a world where everything looks fresh and new and innovative, where all companies boast about being unique and cutting edge, those poignant occasions when something truly special leaps out at you can be rare. And he tells a story of meeting a scientist at Sanofi’s R&D organization — the Harvard-trained Virginia Savova — who had been working on new AI technology that analyzes samples from autoimmune patients that can be used to examine single immune cells. Follow that trail, and it can lead you to some new places in medicine. Places Sanofi wants to go.

“There are moments,” says the CEO. And he wants more of them. A lot more.

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An­oth­er big bio­phar­ma merg­er runs in­to an­oth­er snag at the FTC. What now?

It’s AbbVie’s turn to get hit with a dreaded second request for information from the FTC regarding its $63 billion megamerger with Allergan. 

Right on the heels of the latest delay for the Roche/Spark tie-up, the FTC has some unfinished business with AbbVie, which has its eyes on Allergan’s lucrative Botox franchise.

There is, of course, no word on what the latest FTC inquiry is all about, but the experts say every second request comes with an odds-on demand — running at 80% — for a divestiture to satisfy antitrust concerns.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

In­vestors lost big as Alzheimer’s R&D went over the cliff in 2019. Will they ever come back?

Neurotrope this week joined the long line of biopharma companies that have been mauled by clinical failure for Alzheimer’s drugs. But their crushed shares ($NTRP down from more than $8 in June to penny stock range today) represented just a tiny drop in the bucket of red ink that has drained from players which have pursued the greatest of all Holy Grails in drug R&D. Decades of defeat, headlined by the likes of solanezumab at Eli Lilly stretching to the most recent snafu with Biogen’s aducanumab, have forced a slew of players to change course on their R&D strategy — or just leave it in limbo.

Once again No­var­tis’ car­dio team looks to beat the odds us­ing sketchy da­ta and a fa­mil­iar ar­gu­ment

Whenever a clinical trial team starts touting the “totality” of the data, you know they’re in trouble.

For Novartis’ Entresto (sacubitril/valsartan) team, that’s the early go-to position on their latest round of pivotal data for the blockbuster — which the pharma giant believes has megablockbuster potential. We already knew that Novartis’ team plans to field the drug to regulators in search of a label extension — but now we have a better idea of the hurdles it faces. 

Re­mem­ber that post-mar­ket­ing tri­al? New study con­firms many drug­mak­ers don’t do them — half drag their feet

Earlier this month Sarepta confirmed to us that the post-marketing study the FDA required in their controversial OK for the Duchenne MD drug Exondys 51 — now on the market at $1 million a year — was years behind schedule. 

But it’s right in line with the industry norm — which runs from slow to glacial.

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Vas Narasimhan, Getty Images

The FDA’s very pub­lic slap of No­var­tis’ red face is a warn­ing to the en­tire in­dus­try — don’t down­play it

In drug development, there’s an unwritten rule that the FDA can rely on the deep-pocket global players to produce clean data. The results may be positive or negative, and you’re free to interpret as you please, but the data are reliable.

All the data, from humans right down to the mice. 

Trust in the integrity of the people handing over the data is essential for the current emphasis on accelerated approvals. If the top players start gaming the system, everyone can go back to the clinic and plan to plod through each standard phase of clinical trials, with a long, slow regulatory review at the end.

Remember how well that worked?

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Roger Perlmutter, Merck

Do you want to see what win­ning big in the R&D race looks like in the Big Phar­ma league?

Merck $MRK offered a simple lesson in the economics of winning a megablockbuster R&D race today. And it shouldn’t be missed by anyone.

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Hal Barron, GSK

What makes Hal Bar­ron tick? Look at the peo­ple he’s team­ing up with at GSK

GSK R&D chief Hal Barron is all about people: The people who lead his teams, the people on his teams and the people he’s collaborating with.

If you listened closely to Barron’s one-year review of the effort to turn around GSK’s R&D organization in their Q2 update this week, that came through loud and clear as he flagged a series of new hires, new plans to build research teams and a new cell therapy collaboration we haven’t heard of before. 

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Kamala Harris speaking yesterday at the Des Moines Register Iowa Presidential Candidate Forum [via Getty]

Who’s the tough­est on drug prices? A game of po­lit­i­cal one-up­man­ship is dri­ving the pol­i­cy de­bate in Wash­ing­ton

Earlier this week we got a look at Senator Kamala Harris’ position on drug prices. She’s proposing that HHS take an average price from single-payer systems like the UK, Germany and Canada — which leverage market access for lower prices — and use that to set the US price. Anything drug companies collect above that would be taxed at a rate of 100%.

And the rhetoric is scathing:
While families struggle to make it to the end of the month, pharmaceutical companies are turning record profits. They’re spending nearly as much on advertising as R&D. They’re manipulating their market power to hike prices on lifesaving generic drugs. They’re making twice the profit of the average industry in America and still increased drug prices by 10.5% over the past six months alone. Meanwhile, they are charging dramatically higher prices to American consumers.
That’s an escalation on Joe Biden’s plan, which includes drug importation from those cheaper markets as well as allowing Medicare to negotiate prices — something that virtually all Dems agree on now.