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Bio­phar­ma ex­ecs rou­tine­ly shun re­veal­ing the hard truth when it comes to RTFs. And some peo­ple at the FDA think that's a big prob­lem

Within drug development circles, there’s nothing quite as embarrassing as a refuse-to-file letter from the FDA. So it’s probably no big surprise to hear that the average biopharma outfit prefers to hide under any available rock before frankly explaining what derailed their applications right from the start.

FDA staffers took a close look at 103 RTF letters — out of 2,475 applications, or 4% of the total — that were sent privately to drug developers, counting 644 reasons why the agency barred the door to a new drug application. The agency’s hands are tied on public disclosures, though, leaving it to the companies to offer an explanation. And that has left companies free to either publicly ignore what happened, or simply mislead people about the setback.

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Paul Hudson, Sanofi CEO (Raphael Lafargue/Abaca/Sipa USA; Sipa via AP Images)

One of the gi­ant vac­cine play­ers push­es back against a ‘fun­da­men­tal shift’ spurred by mR­NA. But is the CEO just whistling past the grave­yard?

If one thing is completely clear, the pandemic has rewritten the rule book on fast vaccine development, with the new mRNA jabs from Moderna $MRNA and BioNTech $BNTX — partnered with Pfizer — emerging as head and shoulders above what’s been seen from the giants that have dominated this field for decades.

Every year, the new flu vaccines have underscored how erratic their protection has been, starting with some educated but often errant guessing on dominant strains. And now Sanofi/GSK has stumbled badly, forced to start over on Covid-19 after failing among the most vulnerable subjects. Merck tried, late, then failed and immediately bowed out. AstraZeneca $AZN has been bedeviled by questions about its vaccine’s efficacy, particularly regarding the new variants and older people.

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The Moderna Covid-19 vaccine being administered to Katie Podlaski at Duquesne University, Jan. 28 (Gene J. Puskar/AP Images)

Is it time to stock up on wine? This pan­dem­ic could stretch out — and that has some ma­jor mar­ket im­pli­ca­tions

Bernstein analyst Ronny Gal has some good news and some bad news related to the pandemic.

So what do you want to hear first?

It’s the end of the week, so let’s start off on something sweet before we turn to the sour.

In Gal’s seasoned opinion, there are positive notes being sounded in the fight against Covid-19. These new variants, he writes, are still being knocked back by the approved vaccines, and the mRNA jabs from Moderna and Pfizer/BioNTech demonstrated enough of a knockout punch against the Brand A virus to allow for a drop of efficacy on the variants while still offering herd immunity.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Giovanni Caforio, Bristol Myers Squibb CEO (Pablo Martinez Monsivais/AP Images)

The fi­nal hours and days are tick­ing away on a $6B bet as dead­line looms on a sus­pense­ful FDA de­ci­sion

The clock is ticking down to the year-end deadline for an FDA approval of liso-cel, and the suspense is killing investors.

You’ll recall that Bristol Myers CEO Giovanni Caforio insisted at the last minute of negotiations with Celgene execs that they had to replace cash on the table with a CVR $BMYRT tied to 3 key drug approvals by a certain deadline.

That’s all 3. Miss one, and anyone holding on to the $9 CVR would get nothing. For Bristol Myers, it’s a $6 billion play.

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Stéphane Bancel, Moderna CEO (Adam Glanzman/Bloomberg via Getty Images)

It's a big day for Mod­er­na — and the world — as the FDA stamps an EUA on their vac­cine. And there are some im­por­tant lessons to re­mem­ber

The FDA came through with an emergency authorization for Moderna’s mRNA vaccine for Covid-19 late Friday, in keeping with the fast delivery expected from regulators following a unanimous panel vote in its favor Thursday.

The approval has the greatest impact in the US, where Moderna is expected to rapidly start rolling out tens of millions of doses, even as a bitter wrangle develops over what is happening with Pfizer/BioNTech’s supply chain. In this case, unlike Pfizer, the biotech is marketing its very first product. Now, it has to literally deliver on schedule, while facing the same kind of skepticism that greeted the 10-year-old development revolutionary when they set out to build a pipeline.

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John Connolly speaks on an Endpoints News panel at the 2018 BIIS PharmCube/Endpoints conference in Shanghai (File photo)

John Con­nol­ly has a new mis­sion to tack on to his role at the Park­er In­sti­tute: in­ter­im chief of a buzzy biotech backed by a pair of bil­lion­aires

John Connolly, the new chief scientist at the Parker Institute for Cancer Immunotherapy, has a fresh mission on his plate.

Connolly’s been tapped to take the interim CEO spot at 3T Biosciences, a buzzy Bay Area startup that’s joined the whole cell therapy 2.0 movement with the help of 2 tech billionaires who have shown a big interest in cancer drug development: Peter Thiel and Sean Parker, who lent his name and direct involvement to his eponymous nonprofit.

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CRISPR up­start ticks off an­oth­er box on the IPO prep list as RA, SVB Leerink step in on a mega-raise

With 2020 set to bring the curtain down on a biotech IPO boom unlike anything we’ve seen before, you have to wonder which companies are setting the stage to try and follow up with their own S-1 in 2021. And Locanabio may be in the mix after today.

The San Diego-based biotech just brought in a mega-round, always helpful ahead of any IPO. In this case, that’s $100 million from a slate of investors that’s adding groups with a well-known taste for IPO strategies: Vida Ventures, RA Capital, Invus, Acuta Capital and an investment arm of market maker SVB Leerink. Rajul Jain, an MD who had been on the executive team at Kite before joining Vida with Arie Belldegrun, is moving to the Locanabio board.