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There’s one end­point that the boom­ing bio­phar­ma in­dus­try has failed at mis­er­ably: fi­nan­cial tox­i­c­i­ty

One of the big themes in R&D over the past few years has been the onslaught of spending on developing new oncology drugs. The FDA has encouraged early approvals, opening the door to smaller trials as an onslaught of investment cash made it possible for small players to go the distance.

Big Pharma, meanwhile, has enjoyed the comfort of better scientific insights and the arrival of some huge new PD-1s on the scene. Next up: A tsunami of combo therapies coming at you from the US, Europe and China — the new factor in drug hunting.

Al Sandrock

Bio­gen's Al San­drock says the FDA needs to ap­prove their con­tro­ver­sial Alzheimer's drug — now

Al Sandrock is an outspoken champion for aducanumab. And he clearly believes that the FDA needs to approve it now — overriding the controversy it’s sparked — or face criticism from patients clamoring for some kind of medication to slow the disease.

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Stephen Hahn (via Senate HELP Committee)

Stephen Hahn gets through Sen­ate’s soft­ball job in­ter­view — but most­ly plays dodge­ball on the is­sues fac­ing the FDA

Anyone looking for fresh insights on what kind of FDA commissioner Stephen Hahn will be got precious few clues during Wednesday’s Senate hearing on the nomination.

Over more than 2 hours of exchanges, Hahn repeatedly stood behind his devotion to “science and data congruent with the law.” But he carefully steered clear of taking any stand that might upset the White House, avoiding the chance to voice a clear call to ban flavored e-cigarettes — at a time President Donald Trump is reportedly balking at the move.

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Elizabeth Warren speaks during the Nevada Democrats' "First in the West" event at Bellagio Resort & Casino on November 17, 2019 in Las Vegas, Nevada (Getty Images)

Eliz­a­beth War­ren pro­pos­es us­ing com­pul­so­ry li­cens­ing, an­titrust ac­tions to break bio­phar­ma’s con­trol of drug pric­ing — and here are the block­busters she’s tar­get­ing first

Nancy Pelosi’s drug pricing bill may have sparked some industrial strength headaches on the money side of biopharma, but Elizabeth Warren seems determined to become biopharma’s Nightmare on Pennsylvania Avenue.

Warren, one of the top-ranked candidates for the Democratic presidential nomination backing Medicare for all, is circulating a new plan that promises to break the industry’s grip on drug prices — and she has some very specific examples of how she would do it.

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From $0 to $12B in an in­stant. Here's why bio­phar­ma loves risky Alzheimer's stud­ies

Anyone who is struggling to understand why biopharma companies are willing to sink billions into pivotal trials built around failed theories on how to treat Alzheimer’s need only check out SVB Leerink analyst Geoffrey Porges’ note on Biogen this morning for insight.
Porges had a chance to consult with a key opinion leader in the field who wasn’t involved in the aducanumab studies at Biogen but who is optimistic about the company’s chances of winning an approval for the drug. The analyst’s unnamed expert was bullish that the single positive study that showed a reduction in the rate of decline among patients — EMERGE — would be enough to win an approval as the first disease-modifying drug for the memory-wasting disease.

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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.