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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

Stéphane Bancel (AP Photo/Charles Krupa)

Mod­er­na to se­cure a UK pres­ence with $1B+ in new man­u­fac­tur­ing and R&D fa­cil­i­ties

As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five, the company is also looking to make a serious investment in the UK.

According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines.

Moderna will establish this new mRNA Innovation and Technology Centre to develop mRNA vaccines for a wide range of respiratory diseases, including Covid-19.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.