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.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Re­gen­eron halts place­bo en­roll­ment in Covid-19 cock­tail tri­al af­ter IDMC finds 'clear' ef­fi­ca­cy — but there are no da­ta yet

Despite having already received an emergency use authorization for its Covid-19 antibody in non-hospitalized patients last November, Regeneron continued to conduct trials to evaluate the cocktail’s effectiveness. Now, the big biotech has received some good news from their IDMC.

On the IDMC’s recommendation, Regeneron will be shutting down enrollment in the placebo group of a Phase III outpatient trial for their REGN-COV program — a mix of casirivimab with imdevimab — after investigators found “clear clinical efficacy” in both doses compared to the control, the company announced Thursday. CSO George Yancopoulos also said in a statement that the cocktail can neutralize emerging strains of the novel coronavirus.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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