AstraZeneca staffers targeted in suspected hacking scheme

 After China, Iran and Russia, North Korea is the latest to be fingered for attempting to steal Western research into COVID-19. Its target? AstraZeneca.

North Korean hackers used sham recruiting schemes to try to breach AstraZeneca’s systems in recent weeks, Reuters reported, citing two people familiar with the matter.

The alleged cyberattacks, which are not thought to have been successful, came as the British drugmaker was knee-deep in developing a COVID-19 vaccine while working on a coronavirus antibody cocktail.

The hacking targeted a “broad set of people,” including those working on COVID research, according to one Reuters source.

The hackers disguised themselves as recruiters on LinkedIn and WhatsApp. In messages sporting fabricated job offers came e-documents with malicious code designed to gain access to the target employee's computer, the sources told the newswire.

Judging by the hackers’ tools and techniques, the sources said they looked to be part of an ongoing hacking scheme by Pyonyang. The campaign, which previously focused on military and media organizations, has pivoted to COVID-related entities, three people who have investigated the attacks told Reuters.

Biopharma companies have routinely been targeted in cyberattacks, but reported hacking incidents and attempts appear to have surged during the pandemic.

Before North Korea, cybersecurity officials from the U.S., U.K. and Canada accused hackers with Russian intelligence ties of trying to steal information and intellectual property around COVID-19 vaccines by using malware. Russia itself has denied any involvement in the attacks. To combat the accusations, Russia facilitated a licensing deal between local drugmaker R-Pharm and AstraZeneca to produce and distribute doses of the company’s experimental COVID shot AZD1222.

In the suspected North Korean attack on AZ, some of the social media accounts used were registered with email addresses from Russia in a bid to mislead investigators, one of Reuters’ sources said.

In addition, China and Iran have also been named by the U.S. government for launching cyberattacks aimed at stealing COVID-related research from pharma companies and health agencies.

India’s Dr. Reddy’s Laboratories was recently forced to isolate all data centers and shut key plants globally after detecting a cyber breach. That incident came on the heels of the company's clearance to start a phase 2/3 trial of Russia’s COVID vaccine, Sputnik V.

https://www.fiercepharma.com/pharma/astrazeneca-staffers-targeted-suspected-hacking-amid-work-covid-vaccine-report

Prevail's gene therapy Orphan drug in Europe for dementia type

 

• The European Commission has designated orphan designation to Prevail Therapeutics' (PRVL +1.2%) investigational AAV9 gene therapy, PR006 for the treatment of frontotemporal dementia with a GRN mutation (FTD-GRN)
• The Company expects to initiate enrollment in Phase 1/2 PROCLAIM trial of PR006 in next month, and anticipates to provide a biomarker and safety analysis on a subset of patients in the PROCLAIM trial in 2021.
• Earlier, the gene therapy received US Orphan Drug and Fast Track designation for the same indication.
• https://seekingalpha.com/news/3640000-prevails-gene-therapy-orphan-drug-in-europe-for-type-of-dementia

FDA OKs limited access to Profound Medical's Sonalleve device for bone tumor

 

• The FDA has signed off on a Humanitarian Device Exemption (HDE) for Profound Medical's (PROF +5.4%) Sonalleve system for the treatment of osteoid osteoma, a benign bone tumor that occurs in children and young adults.
• HDE, aimed at facilitating the development of medical devices for rare diseases affecting pediatric patients, allows for the sale of a certain number of devices at a profit prior to full approval. In this case, the ceiling, called the annual distribution number, is 8,000 units.
• https://seekingalpha.com/news/3640010-fda-oks-limited-access-to-profound-medicals-sonalleve-device-for-type-of-bone-tumor

Baltimore County Schools Closed Monday, Tuesday Due To Ransomware Attack

 Well, it's becoming evident in Baltimore, Maryland, that teaching remotely in the pandemic is not sustainable as hackers have hit Baltimore County Public Schools (BCPS) with a ransomware attack, forcing the school system to close schools for Monday and Tuesday, reported CBS Baltimore. 

"Due to the recent ransomware attack, Baltimore County Public Schools will be closed for students on Monday, November 30, and Tuesday, December 1. BCPS offices will be open and staff will receive additional information about Monday and Tuesday," BCPS tweeted.

In another post, BCPS said, "this provides much-needed time for our staff to continue working on setting up the instructional platform and to communicate next steps regarding devices. On Mon. and Wed., free student meals will be available at 300+ locations as usual, including all middle and high schools."

The school system ended the statement by saying, "We understand how challenging this situation is for families and staff, and we thank you for your patience as we work through this crisis. Please note that future daily updates will be available at 5 pm."

On Friday, the 11 News I-Team reported that Maryland state auditors found significant risks within the BCPS network.

Days before the ransomware attack was discovered, early last week, findings from the Office of Legislative Audits showed BCPS did not properly secure sensitive personal information. 

At the moment, there's still no source behind the ransomware attack or much money hackers want to restore computer network systems. 

Last month, the public school system in Yazoo County, Mississippi, revealed that it paid upwards of $300k to help recover its network that was overrun by a ransomware incident.

There have been major US hospital systems hit with "paralyzing" ransomware attacks this fall. 

So the real consequence of a school system going offline because of a ransomware attack is that children may not be able to learn for as long as the systems are down - as seen in Baltimore this week.  

https://www.zerohedge.com/technology/baltimore-county-schools-closed-monday-tuesday-due-ransomeware-attack

Russian hospital says it began civilian coronavirus vaccinations last week

 Russia has delivered the first known batch of Sputnik V vaccines for civilian use to a hospital just south of Moscow, which said on Monday it began vaccinating the local population last week.

Russia, which is rushing to keep up with Western drugmakers in the race for a coronavirus shot, has said interim trial results show its Sputnik V vaccine to be 92% effective at protecting people from COVID-19.

Domodedovo’s Central City Hospital said on its website that residents wanting for inoculation had to register on a government website in advance and bring along a negative COVID-19 test result and ID documents on the day.

Coronavirus cases have surged in Russia since September, but authorities have resisted imposing a tough lockdown and have said that targeted measures are enough to cope with the crisis.

Authorities confirmed 26,338 new coronavirus cases on Monday, including 6,511 in Moscow and 3,691 in St Petersburg, taking the national total to 2,295,654 since the pandemic began.

They also reported 368 deaths in the last 24 hours, pushing the official death toll to 39,895.

https://www.reuters.com/article/us-health-coronavirus-russia-sputnik/russian-hospital-says-it-began-civilian-coronavirus-vaccinations-last-week-idUSKBN28A1TW

No COVID-19 vaccine, no normal life, UK minister suggests

 People who refuse a vaccine for COVID-19 could find normal life curtailed as restaurants, bars, cinemas and sports venues could block entry to those who don’t have proof they are inoculated, Britain’s new vaccine minister said on Monday.

Several major COVID-19 vaccines have been announced in recent weeks, raising hopes that the world could soon return to some semblance of normality after the coronavirus killed 1.46 million people and wiped out a chunk of the global economy.

The British minister responsible for the vaccine rollout, Nadhim Zahawi, said getting vaccinated should be voluntary but that Google, Facebook and Twitter should do more to fact-check opposing views of vaccines.

Asked by the BBC if there would be an immunity passport, Zahawi said a person’s COVID-19 vaccine status might be included in a phone app that would inform local doctors of a person’s status.

“But also I think you’d probably find that restaurants and bars and cinemas and other venues, sports venues, will probably also use that system as they’ve done with the app,” Zahawi told the BBC.

“The sort of pressure will come both ways: from service providers - who will say ‘look, demonstrate to us that you have been vaccinated’ - but also we will make the technology as easy and accessible as possible.”

Health authorities in many countries have become increasingly concerned in recent years by the growth of anti-vaccine groups, which are especially active on social media.

Asked if it would become virtually impossible to do anything without the vaccine, Zahawi said: “I think people have to make a decision but I think you’ll probably find many service providers will want to engage in this in the way they did with the app.”

Zahawi declined to give any specific date on a vaccine rollout as none have yet been approved for public use.

The message, he said, should be that a vaccine is good for the community and the country.

https://www.reuters.com/article/us-health-coronavirus-britain-vaccines/no-covid-19-vaccine-no-normal-life-uk-minister-suggests-idUSKBN28A24O

UK appoints COVID-19 vaccine rollout minister as country preps for launch

 The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine.

According to press reports, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) could become one of the first bodies to approve the vaccine.

According to the Financial Times, the MHRA could approve the vaccine by 7^th December after the companies announced supportive data from a phase 3 trial mid-way through November.

Zahawi will therefore face the difficult task of overseeing distribution arrangements for the shot, which must be stored at around -70c during transit to retain its integrity.

A minister for business and industry, Zahari will temporarily relinquish responsibility for most of his duties at the Department for Business, Energy and Industrial Strategy (BEIS).

The interim arrangement will see the MP for Stratford-on-Avon serve as a joint minister between the BEIS and the Department for Health and Social Care.

The vaccines can only be kept in a fridge for up to five days before being administered, although Pfizer has designed a “pizza box” style transportation container.

The UK has ordered 40 million doses of the two-shot product, which could be up to 95% effective in preventing diseases, according to the companies’ top-line data.

Although the European Medicines Agency technically has authority to authorise medicines for the UK until December 31 under Brexit transition arrangements, the MHRA can temporarily authorise products in cases of urgent need.

The government has also written to the MHRA, asking it to use the same process to authorise the rival vaccine from AstraZeneca and Oxford University.

As reported by pharmaphorum, the MHRA’s forthcoming spilt from the EMA could potentially allow it to be more agile in its decision-making after Brexit.

Emergency approval is also expected in the US next week, the FT added, with shipments starting across the country within 24 hours of the announcement.

https://pharmaphorum.com/news/uk-appoints-vaccine-rollout-minister-as-country-preps-for-swift-approval/