Covid-19 roundup: North Ko­rea at­tempt­ed to steal Pfiz­er vac­cine tech; WHO OKs As­traZeneca shot de­spite South Africa woes

Pfiz­er was re­cent­ly sub­ject to a cy­ber­at­tack from North Ko­rea, South Ko­re­an of­fi­cials said Tues­day, as the reclu­sive na­tion sought Covid-19 vac­cine tech­nol­o­gy.

It wasn’t im­me­di­ate­ly clear when the at­tack oc­curred or whether it was suc­cess­ful, and a Pfiz­er rep wasn’t able to com­ment, the Wash­ing­ton Post re­port­ed. But news of the hack­ing at­tempt came de­spite North Ko­re­an leader Kim Jong Un in­sist­ing that his coun­try has not been af­fect­ed by the pan­dem­ic.

Ha Tae-ke­ung, a South Ko­re­an op­po­si­tion law­mak­er and mem­ber of the gov­ern­ment’s in­tel­li­gence com­mit­tee, dis­closed the at­tack and added that the coun­try had ob­served a 32% in­crease in North Ko­re­an cy­ber­at­tacks over the last year.

This is not the first time North Ko­rea has been ac­cused of try­ing to steal in­for­ma­tion on coro­n­avirus vac­cines and treat­ments. Back in No­vem­ber, Mi­crosoft said both North Ko­rea and Rus­sia tried to dig­i­tal­ly ran­sack phar­ma­ceu­ti­cal com­pa­nies and vac­cine re­searchers, though the at­tempts were most­ly un­suc­cess­ful. South Ko­rea had al­so pre­vi­ous­ly thwart­ed a North Ko­re­an hack­ing at­tempt in­to lo­cal phar­ma com­pa­nies last year.

North Ko­rea has al­so turned to cy­ber­at­tacks more fre­quent­ly dur­ing the pan­dem­ic as a way to fund its econ­o­my. Last week, the UN re­port­ed ev­i­dence “strong­ly” point­ed to­ward the coun­try con­duct­ing a $281 mil­lion theft in Sep­tem­ber.

Though it makes claims to the con­trary, North Ko­rea has re­quest­ed vac­cines through CO­V­AX and is slat­ed to re­ceive 2 mil­lion dos­es of the As­traZeneca/Ox­ford shot, the pro­gram re­port­ed ear­li­er this month.

As­traZeneca shot ap­proved by WHO as South Africa woes con­tin­ue

The WHO ap­proved a new Covid-19 vac­cine for emer­gency use Mon­day — and it’s the As­traZeneca/Ox­ford Uni­ver­si­ty shot.

With the OK, the vac­cine is now able to be dis­trib­uted to low­er-in­come na­tions with­out their own reg­u­la­to­ry bod­ies at a much more rapid pace, NBC News re­port­ed. The As­traZeneca shot makes up the vast ma­jor­i­ty of CO­V­AX vac­cines, with more than 330 mil­lion dos­es slat­ed to be doled out start­ing in late Feb­ru­ary.

“We now have all the pieces in place for the rapid dis­tri­b­u­tion of vac­cines. But we still need to scale up pro­duc­tion,” WHO di­rec­tor-gen­er­al Tedros Ad­hanom Ghe­breye­sus said at a news brief­ing.

The vac­cine has been hailed as a cheap­er al­ter­na­tive to its mR­NA ri­vals from Pfiz­er/BioN­Tech and Mod­er­na. But it’s not all ros­es for the shot as re­ports have emerged that it is not very ef­fec­tive at pre­vent­ing mild and mod­er­ate Covid-19 cas­es stem­ming from the virus vari­ant that first emerged in South Africa.

There has been much back and forth be­tween As­traZeneca and South Africa in the last cou­ple of weeks, with the coun­try paus­ing its roll­out of the com­pa­ny’s shots. South Africa has since been seek­ing to sell, swap or re­turn 1 mil­lion dos­es af­ter they proved on­ly 21.9% ef­fec­tive against mild or mod­er­ate cas­es in a Phase I/II tri­al, the Eco­nom­ic Times re­port­ed, and start­ed in­oc­u­lat­ing med­ical work­ers with J&J’s one-shot vac­cine in a Phase II­Ib tri­al in­stead.

Ear­ly Tues­day morn­ing, a South African news­pa­per al­so said the coun­try would be shar­ing the As­traZeneca vac­cine with oth­er coun­tries in the African Union.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

Covid-19 roundup: J&J boost­er shot da­ta show promise; CD­C's ACIP meet­ing this week to dis­cuss Pfiz­er boost­ers

J&J revealed a summary of new Covid-19 vaccine data today, including new results showing booster shots may help with protection.

A Phase III study (ENSEMBLE 2) looked at booster shots at two different points in time: a second shot 56 days after the first shot, or a second shot six months after the first. The eight-week shot showed increased protection against symptomatic Covid-19, with the following levels of protection:

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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