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Cap­ping Pas­cal So­ri­ot’s big turn­around, the an­a­lysts at Cowen say As­traZeneca is poised for a stel­lar year

Big Pharmas typically don’t get a lot of respect for R&D efforts. Their ROI is bad on a massive annual bill, there’s too much late-stage failure, analysts fret about the endurance of big franchises and the impact of generic competition.

Even as Pascal Soriot is staunching the bleeding around a badly handled Phase III readout for their Covid-19 vaccine, though, the AstraZeneca CEO is taking a bow today as Cowen lavishes praise on the pipeline and near-term prospects for the multinational — for the second year in a row.

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Overnight for­tunes are be­ing made in biotech these days — and it's both en­cour­ag­ing and more than a lit­tle bit scary

Just to complete the last leg of a running story I’ve been tracking for a few weeks, Olema $OLMA has come through its IPO from the Thursday night pricing at $19 a share with a market cap just north of $2 billion.

That leaves newly-named CEO Sean Bohen holding a batch of 1,110,896 shares with a strike price of $4.82. As of Tuesday morning, the stock is now trading at $53.40, giving him a portfolio value of $53.4 million. Not bad for someone who was hired in September.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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The FDA's in­sid­er re­view on ad­u­canum­ab was all about pol­i­tics, not sci­ence, and it threat­ens pa­tients and the bio­phar­ma in­dus­try alike

The FDA deserves kudos for drawing a line in the sand over their review of Covid-19 vaccines. They’ve made it clear — after deep skepticism began to appear following the debacle over convalescent plasma — just what they will need to see before handing out an EUA, thus saving the agency’s rep for enforcing standards essential to maintaining public trust in drugs.

That same integrity, though, has gone missing from the FDA’s stance on Biogen’s Alzheimer’s drug aducanumab. Despite a statistical analysis that highlights the conflicting nature of the Biogen $BIIB data, a post hoc dumpster dive operation to find supportive data and a move to shine up small cohort results as backup proof of efficacy, the FDA division responsible for Alzheimer’s chose to endorse adu for use among millions of patients.

Sean Bohen (file photo)

Sean Bo­hen just wrote the hand­book on how to make a quick for­tune in biotech

If you ask anyone in drug development about what motivates them — or even if you don’t — you’re going to get a regular double-barreled blast about patients and unmet medical needs if you’re covering this industry. Less discussed and just as important during a heady IPO boom is a shot at the overnight fortunes that are on offer in the middle of a pandemic.

Sean Bohen’s team at Olema just spelled it all out in an S-1 that can serve as a compactly written handbook on the subject — provided you know the background.

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Norbert Bischofberger, Kronos CEO (Kronos Bio)

What are the right in­gre­di­ents for a block­buster uni­corn IPO? Nor­bert Bischof­berg­er has some thoughts on that

2020 will stand out in the history of biotech for a variety of reasons, starting with the unprecedented, rapid-fire response to Covid-19. But somewhere in the top 5 there will be a special spotlight on the IPO boom, which has been funneling billions of dollars into drug development and offering some key players a shot at rock star status — and rock star money.

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Am­gen posts up­beat as­sess­ment of PhII KRAS da­ta on AMG510 — but there's no clear pic­ture of what re­searchers saw

It’s not unusual to be left wanting after reading a top-line press release on closely-watched trial data. But Amgen is taking it to a whole new level with its Phase II snapshot on the KRAS G12c drug sotorasib — aka AMG 510.

The drug’s one solid shot at breakthrough status is in lung cancer, where researchers found evidence of efficacy in early-stage work. Now, they’re up to Phase II data, which execs earlier maintained could pave the way to a quick OK, and the team is giving little away.

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Pfizer CEO Albert Bourla (AP Images)

Alone in the spot­light, Pfiz­er CEO Bourla swears pure in­ten­tions in the rush to de­vel­op a Covid-19 vac­cine. But will the pub­lic be­lieve it?

Now that Moderna has shifted expectations on pivotal data for its Covid-19 vaccine to some time just after the election and AstraZeneca has been stalled by a safety issue, the sole player that can deliver a shot through an emergency use authorization this month is Pfizer.

And Pfizer CEO Albert Bourla wants no part of the political furor that has swelled around that topic.

In an open letter, Bourla lamented the spotlight that President Trump directed at Pfizer during the first chaotic presidential debate. Trump — who has just tested positive for the coronavirus, pushing the pandemic back into the headlines — is shoving Pfizer into gale force political winds by insisting that a vaccine could be OK’d in the next few weeks. And the CEO insists that politics has nothing to do with the crash R&D project Pfizer has mounted with BioNTech to get an mRNA jab onto the market as soon as possible.

Sean Bo­hen's break from bio­phar­ma is over. The ex-As­traZeneca CMO has re­tired his Big Phar­ma jer­sey and is now — hap­pi­ly — run­ning a lit­tle biotech

The last I had heard about Sean Bohen, he had stepped out of his high-profile job as chief medical officer at AstraZeneca at the beginning of 2019 as CEO Pascal Soriot triggered a broad-ranging R&D shakeup. And then, earlier this week, I got a chance to catch up.

It turns out that Bohen decided at the time that he would not just jump into a new job in the booming biopharma business. As an oncologist, he had worked on the big programs at AstraZeneca, and before that he was at Genentech. That was good for a ticket to just about anyplace in the big biopharma world. But he felt it was time to stop and think things through.

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Phar­ma's bat­tered rep gets a mod­est facelift in the lat­est in­dus­try rat­ings from Gallup — but it's still look­ing pret­ty bad

When the pandemic started up earlier this year, quite a few pharma execs felt it was the perfect opportunity to mend fences with the American people — which had developed a largely contemptuous view of drug makers. Nothing symbolized the industry’s public relations predicament better than the Gallup poll last September, which had pharma bumped to the very bottom of a long list of industries ranked by the public’s opinion.

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