Hack­ers steal Pfiz­er, BioN­Tech da­ta in EMA breach as cy­ber­se­cu­ri­ty at­tacks heat up

It’s been a good week for Covid-19 vac­cines, and per­haps an even bet­ter one for the hack­ers try­ing to steal Covid-19 vac­cine da­ta.

In a brief note Wednes­day, the Eu­ro­pean Med­i­cines Agency an­nounced that it had been “the sub­ject of a cy­ber-at­tack.” Pfiz­er and their Ger­man biotech part­ner BioN­Tech con­firmed their da­ta had been “un­law­ful­ly ac­cessed’ as part of the breach, al­though they cau­tioned to Reuters that they did not be­lieve par­tic­i­pants’ per­son­al in­for­ma­tion had been changed and that the EMA had as­sured them the hack would not in­ter­fere with the time­line for ap­proval.

Stolen doc­u­ments could po­ten­tial­ly give use­ful in­for­ma­tion to oth­er coun­tries de­vel­op­ing a vac­cine, as well as in­for­ma­tion on oth­er com­pa­nies and sys­tems in­volved in de­vel­op­ing and dis­trib­ut­ing it.

The lat­est in­ci­dent adds to a string of vac­cine-di­rect­ed cy­ber­se­cu­ri­ty at­tacks that have re­port­ed­ly struck through­out the pan­dem­ic. News re­ports of such ef­forts have picked up in re­cent weeks.

In May, as vac­cine ef­forts were ac­cel­er­at­ing, US of­fi­cials warned Chi­nese hack­ers were tar­get­ing vac­cine re­search, prompt­ing a swift de­nial from the Chi­nese gov­ern­ment.

In Ju­ly, though, Britain’s Na­tion­al Cy­ber Se­cu­ri­ty Cen­tre re­leased a re­port ac­cus­ing Russ­ian-backed groups, in­clud­ing one known as “Cozy Bear,” of tar­get­ing phar­ma­ceu­ti­cal com­pa­nies work­ing on vac­cines. The Cen­tre said that US and Cana­di­an of­fi­cials shared their as­sess­ment, and The Tele­graph re­port­ed that the As­traZeneca-Ox­ford ef­fort had been at­tacked. Rus­sia de­nied in­volve­ment.

Then last month, Mi­crosoft said that a Russ­ian group named “Fan­cy Bear” and two North Ko­re­an groups named “Zinc” and “Ceri­um” at­tempt­ed to break in­to sys­tems at 7 phar­mas and re­searchers in 5 coun­tries. That in­clud­ed brute force ef­forts to at­tempt mil­lions of po­ten­tial pass­words and phish­ing schemes where hack­ers would pose as World Health Or­ga­ni­za­tion of­fi­cials and so­lic­it peo­ple’s pass­words.

Last week, IBM said that hack­ers backed by for­eign gov­ern­ments had turned their at­ten­tion to the com­pa­nies that main­tain the cold chain nec­es­sary to ship and store mR­NA vac­cines. Among oth­er ef­forts, ad­ver­saries posed as an ex­ec­u­tive from the ma­jor cold chain com­pa­ny Haier Med­ical and so­licit­ed user­names and pass­words. The at­tacks were glob­al, IBM said.

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

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.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

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

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.

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

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

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.

Brad Bolzon (Versant)

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

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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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

In a sup­ply chain short­age workaround, Aus­trali­a's Vic­to­ria state aims to build its own mR­NA fa­cil­i­ty

As countries all around the world have experienced troubles with vaccine shortages, Australia’s Victoria state is developing its own mRNA manufacturing facility in an effort to up its number of vaccinated residents.

Victoria will spend $39 million to set up the facility, which could be the first in the southern hemisphere, Reuters reported. The mRNA technology is used in the Pfizer-BioNTech and Moderna vaccines, and has gotten more attention, as adenovirus-based vaccines from AstraZeneca and J&J have had reports of rare, but similar blood clots in some patients. There have been no reports of major side effects in either Moderna or Pfizer’s jab.

Jenny Rooke (Genoa Ventures)

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

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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