Supply chain issues and an inspection backlog have hindered manufacturing’s seemingly endless boom, following an influx of money. But a new threat looms over the industry: a strain of Windows malware.
BIO-ISAC, an international organization that addresses threats to the bio economy, issued the warning on its website Monday, saying that a ‘large biomanufacturing facility’ was involved in an attack in spring 2021, and the same malware was noticed at a second facility in October 2021. The organization expedited the threat advisory in the public’s interest and has issued a statement to manufacturers: Assume that you are a target, and review security protocol accordingly.
The malware goes beyond polymorphic malware, which, according to PC Magazine, only rewrites part of the computer code to avoid being detected. This version of the malware completely recodes itself during each connection, when first connecting to the internet. That makes it easier to prevent leaving behind a signature, further evading antivirus programs. Dubbed Tardigrade, Wired found that a malware analyst at BioBright tested the malware 100 different times, and each time, it built itself in a different way.
‘Additionally, if it’s not able to communicate with the command and control server, it has the capability to be more autonomous and self-sufficient, which was completely unexpected,’ the analyst, Callie Churchwell, told the magazine.
Tardigrade still has the ability to make decisions within a network, even if it’s cut off from its hackers, Wired said. That means it could spread through USB drives or autonomously through interconnections. The report from BIO-ISAC hints that the threat could be trying to steal information about medical innovations. To prevent this from happening, BIO-ISAC says that manufacturers should do the following:
Review your biomanufacturing network segmentation
Work with biologists and automation specialists to create a ‘crown jewels’ analysis for your company
Test and perform offline backups of key biological infrastructure
Inquire about lead times for key bio-infrastructure components
Assume you are a target
The first variant of the malware was dubbed Smoke Loader, while the suspected second variant is called Dofoil. It has reached a random batch of Amazon Web Services, GoDaddy and Akamai.
‘Recompiling occurs after a network connection in the wild that could be a call to a command and control (CnC) server to download and execute the complier,’ the report says. ‘Allows the system to change portions/all the functions based on CnC like a normal loader system but with a level of autonomy that is unexpected.’
Cybersecurity threats have been omnipresent as the world has shifted to be even more dependent on the internet. The EMA, WHO and US Department of Health and Human Services have all come under cyber attack, along with hospital systems.
While actors in China and Russia have consistently worked to steal intellectual property about drugs and manufacturing processes during the pandemic, every instance isn’t always disclosed publicly, Charles Carmakal, the CTO of the cybersecurity firm Mandiant, told Wired. If you have IP stolen, legally, companies don’t have to disclose that.
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Joan Perelló, Sanifit CEO
Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.
Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.
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If both its BioNTech-partnered Covid-19 vaccine and in-house antiviral live up to their full promises, Pfizer may be sitting on a $100 billion goldmine in 2022.
That’s according to SVB Leerink analyst Geoffrey Porges, who released his latest forecast early Tuesday complete with a lengthy breakdown of all the intricate factors going into his calculation. Bottom line: universal boosting and pediatric recommendations will shore up global Covid vaccine sales to $59 billion in 2021 and $48 billion in 2022, or $107 billion in cumulative sales.
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Neil Desai, Aadi Bioscience CEO (via YouTube)
The FDA on Tuesday approved Aadi Bioscience’s first drug and the first treatment approved specifically for patients with an ultra-rare and aggressive form of sarcoma that occurs mostly in women.
The approval of the drug, known as Fyarro, is for those with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), and is based on a Phase II trial.
Results showed an overall response rate as assessed by independent review of 39% (12/31), with two patients achieving a complete response after prolonged follow up, Aadi said. The company also said that among responders, 92% had a response lasting greater than or equal to six months; 67% had a response lasting greater than or equal to 12 months; and 58% had a response lasting greater than or equal to two years.
Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)
As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.
GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.
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Pascal Soriot, AstraZeneca CEO (Chris Ratcliffe/Bloomberg via Getty Images)
While Europe is in the midst of a massive fourth Covid-19 surge, the UK has largely avoided the high levels of hospitalizations and deaths seen on the rest of the continent. And AstraZeneca CEO Pascal Soriot suggested Tuesday the reason for Britain’s better fortunes could be his company’s vaccine.
In a one-on-one interview with BBC Radio 4, a reporter asked Soriot whether he was disappointed over the UK’s decision not to use the AstraZeneca/Oxford shot as a booster. Soriot responded by touting the vaccine’s T cell response, saying some data have shown it may be more durable than mRNA shots in older people, where the focus had largely been on antibodies.
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The FDA’s backlog of drug manufacturing facility inspections continues to be a sore spot for the agency, as FDA said Monday that a total of 52 new drug (but no biologics) applications still remain delayed due to the backlog from the pandemic.
And while the agency has maintained that it won’t issue a CRL for a delayed inspection, the number of delayed applications is rising as FDA said in May that 48 new drug applications have been delayed due to FDA’s inability to conduct pre-approval, pre-market, or pre-license inspections as of last March.
Dragonfly Therapeutics is doing better and better in getting Big Pharma on its TriNKET platform. First Celgene, then BMS, and now Merck — again.
After Merck licensed its first candidate from the platform back in November 2020, the pharma giant is back for seconds as part of a 2018 collaboration between the two companies, which was initially focused on a number of solid tumor targets.
The companies expanded their collaboration last year with an agreement to develop and commercialize NK cell engaging immunotherapies for multiple targets in oncology, infectious diseases and immune disorders.
In an effort to combat rising Covid-19 cases worldwide, the World Health Organization has struck a deal to license serological technology for antibody testing and provide it royalty-free to low- and middle-income countries in the hopes of boosting production.
The WHO’s Covid-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) finalized the deal with the Spanish National Research Council (CSIC), a public research institute, on Tuesday. It’s the first test license signed by the MPP, a United Nations-backed public health organization, and included in the WHO pool, according to the organizations. It covers all related patents and biological material necessary for manufacturing the tests, and CSIC has agreed to provide know-how and training.
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