ElevateBio CEO David Hallal (file photo)
March 15, 2021 06:30 AM EDT
Financing
Cell/Gene Tx
Manufacturing

El­e­vate­Bio adds an­oth­er $525M to its war chest as it looks to build on next-gen man­u­fac­tur­ing 'base­cam­p'

Kyle Blankenship

Managing Editor

Despite immense clinical promise, small cell and gene therapy players have faced a chronic manufacturing bottleneck tied to limited cash and specialized expertise. Born from the idea of disrupting the manufacturing business model in that space, ElevateBio has scored its biggest fundraising round yet to clear the logjam.

ElevateBio closed a massive $525 million Series C it will use to keep building its next-gen startup engine and one-stop-shop cell and gene therapy manufacturing “ecosystem,” the biotech said Monday.

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April 19, 2021 06:00 AM EDT

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

Mark White

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Brad Bolzon (Versant)
April 21, 2021 06:00 AM EDT
Financing
Startups

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

John Carroll

Editor & Founder

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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April 21, 2021 01:23 PM EDTUpdated 01:44 PM
Pharma
FDA+

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Zachary Brennan

Senior Editor

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)
April 21, 2021 11:45 AM EDTUpdated 04:15 PM
Coronavirus
In Focus

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

Jason Mast

Editor

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

April 21, 2021 09:51 AM EDTUpdated 10:40 AM
FDA+

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

Zachary Brennan

Senior Editor

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Jenny Rooke (Genoa Ventures)
April 22, 2021 07:32 AM EDTUpdated 08:12 AM
People
Financing

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

Kyle Blankenship

Managing Editor

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Saurabh Saha at Endpoints News' #BIO19
April 22, 2021 06:28 AM EDTUpdated 06:42 AM
Financing

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Amber Tong

Senior Editor

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.

Josh Hoffman, Zymergen CEO (Zymergen)
April 22, 2021 07:32 AM EDTUpdated 04:47 PM
Financing
Manufacturing

Zymer­gen's bid to dis­rupt a $3T in­dus­tri­al man­u­fac­tur­ing mar­ket goes vi­ral, earn­ing a mas­sive $500M IPO

Kyle Blankenship

Managing Editor

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It’s not a story you hear every day: A biotech company that doesn’t use its platform to develop therapeutics? Despite some raised eyebrows early on, Emeryville, CA-based Zymergen has convinced investors that its plan to disrupt industrial manufacturing is worth the bet and now it’s priced an eye-popping IPO to take its mission to the next level.

April 21, 2021 01:10 PM EDTUpdated 23 hours ago
FDA+
Manufacturing

Why re­mote drug man­u­fac­tur­ing eval­u­a­tions won't re­al­ly re­duce FDA's back­log of in­spec­tions

Zachary Brennan

Senior Editor

For the first several months of the pandemic last spring, the FDA continued to plow through its user fee-enabled work on new drug and biologic applications, meeting nearly all of its goal dates.

But by last fall and into the winter, complete response letters and other delays began arriving in companies’ mailboxes as the agency struggled to catch up to a growing backlog of both domestic and foreign drug manufacturing inspections.

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El­e­vate­Bio adds an­oth­er $525M to its war chest as it looks to build on next-gen man­u­fac­tur­ing 'base­cam­p'

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Zymer­gen's bid to dis­rupt a $3T in­dus­tri­al man­u­fac­tur­ing mar­ket goes vi­ral, earn­ing a mas­sive $500M IPO

Why re­mote drug man­u­fac­tur­ing eval­u­a­tions won't re­al­ly re­duce FDA's back­log of in­spec­tions