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Albert Bourla, Pfizer CEO (AP Images)

Full steam ahead, Pfiz­er goes bar­gain hunt­ing in an age of coro­n­avirus — with a spe­cial fo­cus on can­cer and rare dis­eases

Pfizer made a splash this week with its plans to spend $500 million on Covid-19 research. But the pharma giant isn’t letting a pandemic interfere with the M&A it needs to fulfill its longterm mission.

In fact, the outbreak may even lend them a hand in finding clinical-stage assets for the pipeline — if only the biotech execs and boards they approach fully understand the position they’re in.

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A slice of half-baked remde­sivir da­ta takes a dark turn — but we're still wait­ing for a de­fin­i­tive study

We have another fuzzy snapshot of clinical trial data on Gilead’s remdesivir in coronavirus patients, and at first glance this one looks bleak for the most advanced therapy now in the clinic for Covid-19.

The Financial Times and STAT both reported on an abstract of the Chinese study, this one using a control group that appeared temporarily on the WHO site after it was posted accidentally. It’s still not been peer reviewed, but Salim Syed at Mizuho summarized the numbers:

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen’s top ex­ec­u­tive crew has a big cred­i­bil­i­ty is­sue. And they seem de­ter­mined to make it worse

First came the pandemic “superspreader” event at the Marriott Long Wharf that created a simmering public relations nightmare for Biogen $BIIB. And now here comes the big credibility issue on their lead Phase III Alzheimer’s drug that will likely dog their steps for months to come — at the least.

Yesterday’s Q&A with analysts on their Q1 call turned into a tough — and extremely unusual — press conference as analysts repeatedly pushed hard for some specifics on just why the big biotech decided to push back its timeline on the aducanumab filing from “early 2020” to sometime in Q3.

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FDA Commissioner Stephen Hahn and President Donald Trump at a press briefing on March 19, 2020. (AP Images)

Biotech ex­ecs warn that the FDA is fum­bling their re­sponse to the Covid-19 open-door promise, de­lay­ing progress

A few days ago the FDA touted a procedure for Covid-19 meds that committed the agency to immediate action for developers, formalizing a high-speed response that’s been promised for weeks.

Bioregnum Opinion Column by John Carroll

Decisions that once required months would be measured in hours under the Coronavirus Treatment Acceleration Program. “In many cases” trial protocols could be hammered out in less than a single day. If you had a potential solution to the crisis, the appropriate staffer would be in touch “to get studies underway quickly.”

It would be the ultimate high-speed regulatory pathway from Phase I to approval. Red tape was banished.

But it’s clear that for some — and quite likely many — biopharma execs, the actual agency response has not measured up to the promise. Beyond the front ranks of advanced companies in the field, like Gilead, or for drugs endorsed by President Trump, it may not even come close.

“The first response is this form letter everyone gets,” says one biotech CEO who’s reached out to the FDA on Covid-19. And when you try to cut through that, the ball gets dropped as it is passed from top officials to the frontline staff actually charged with getting things done.

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A small, ob­scure biotech just won big with their IPO. In this mar­ket. Are you kid­ding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Category 6 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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Robert Hariri, SmarterTogether via Youtube

FDA OKs a tri­al for a new Covid-19 ther­a­py af­ter an un­usu­al pub­lic­i­ty cam­paign touts its po­ten­tial — with help from Rudy Giu­liani

After taking to the Wall Street Journal to tout the potential of taking their lead natural killer cell therapy and leapfrogging from cancer to Covid-19, while gaining an influential advocate in the White House, Celularity CEO Robert Hariri now has the IND he was looking for from the FDA to start testing this approach in patients.

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President Trump speaks during a press briefing with FDA commissioner Stephen Hahn (left) and White House coronavirus response coordinator Deborah Birx (right) of the coronavirus task force, at the White House, Thursday, March 19, 2020, in Washington. (AP Photo/Evan Vucci)

No, Mr. Pres­i­dent, you can’t just or­der up out­break meds with the snap of your fin­gers

Donald Trump was in classic freestyle speaking mode on Thursday as he talked up the immediate production of drugs that can fight the new coronavirus.

Chloroquine got the big headlines, with Trump noting that it can be prescribed without anyone worrying about whether or not it would kill people. Then there was remdesivir, Gilead’s experimental anti-viral that the president said was “essentially approved.” And Trump vowed to slash through any “red tape” separating Americans from coronavirus drugs.

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The top 10 bio­phar­ma pipeline blowups, set­backs and sna­fus for H2 2019

Every 6 months, as longtime followers will know, I like to list the top 10 disasters in clinical R&D. And it seems like every new round-ups the ante a little more on just what qualifies for a top blooper of the year.

H2 2019 is certainly a standout, with a Big Pharma data scandal, a couple of blockbuster M&A busts and a whole run of Alzheimer’s setbacks to contemplate as we watch the Biogen saga play out. Not only does the Alzheimer’s field continue to crater, but we watched antibiotics come apart in the last 6 months of 2019.

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Paul Hudson, Sanofi

Weak pipeline? Why, Sanofi ex­ecs are sud­den­ly over the moon about their prospects

It’s amazing what a vague top-line report on a Phase II study plus a relatively small bolt-on deal can do to a Big Pharma’s future prospects.

I’d say just ask new Sanofi CEO Paul Hudson, but you don’t have to. He’ll readily volunteer his growing enthusiasm now that he’s had a chance to settle into his leadership role. And you haven’t even been given a glimpse of what’s around the corner.

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Yes, Gilead CEO Daniel O’Day is ready to ink some deals. No, you won’t see him sweat it

A bevy of analysts turned out for Gilead’s Q4 call Tuesday night looking for some of the old sizzle about the future that used to excite them in the past. What they got was a lecture on steady improvement, sound judgment and proper dealmaking — along with a plateful of slightly disappointing numbers that left more than a few feeling a bit deflated by the end.

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