Work from home fuelling cyber attacks, says global financial watchdog

 Financial firms may need to bolster their defences in the face of rocketing cyber attacks after employees began working from home, the Financial Stability Board (FSB) said on Tuesday.

The FSB, which coordinates financial rules for the G20 group of nations, said remote working since economies went into lockdown to fight COVID-19 opened up new possibilities for cyber attacks. Working from home (WFH) is expected to stay in some form across the financial services industry and beyond.

“Most cyber frameworks did not envisage a scenario of near-universal remote working and the exploitation of such a situation by cyber threat actors,” the FSB said in a report to G20 ministers and central banks.

The report is a first take on lessons learned from the pandemic’s impact on financial stability.

COVID-19 was the first major test of tougher financial rules put in place after the 2008 global financial crisis and most parts of the system coped well, the FSB said.

Lockdown restrictions are easing but financial firms have told employees they will be allowed to work from home several days a week permanently, and the rest of the time in the office.

Cyber activities such as phishing, malware and ransomware grew from fewer than 5,000 per week in February 2020 to more than 200,000 per week in late April 2021, the FSB said.

“Financial institutions have generally been resilient but they may need to consider adjustments to cyber risk management processes, cyber incident reporting, response and recovery activities, as well as management of critical third-party service providers, for example cloud services,” the FSB said.

The FSB, chaired by Federal Reserve Vice Chair Randal Quarles and comprising regulators and central banks from leading financial centres, will publish a final report in October setting out its next steps.

It has already made proposals for strengthening the resilience of money market funds which suffered severed stresses during last year’s market turmoil.

https://www.reuters.com/article/health-coronavirus-g20-regulation/work-from-home-fuelling-cyber-attacks-says-global-financial-watchdog-idUSL8N2OO2B4

Biogen, Innocare in License and Collaboration Agreement for MS Treatment

  Biogen Inc. (Nasdaq: BIIB) and InnoCare Pharma Limited (HKEX: 09969) today announced that they have entered into a license and collaboration agreement for orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor (BTKi) for the potential treatment of multiple sclerosis (MS). Orelabrutinib is a covalent BTKi with high selectivity and the ability to cross the blood-brain barrier, and is currently being studied in a multi-country, placebo-controlled Phase 2 trial in relapsing-remitting MS.

Orelabrutinib inhibits BTK, which is a key enzyme that is part of the signaling cascade of immune cells including B cells and myeloid cells. With the ability to cross the blood brain barrier, orelabrutinib has the potential to inhibit B cell and myeloid cell effector functions in the central nervous system (CNS), and may provide a clinically meaningful benefit on progression in all forms of MS. By addressing the progressive biology of the disease, orelabrutinib may offer people living with MS an additional treatment option and the possibility to slow disease progression.

“Given the complex and chronic nature of MS, we believe the unique characteristics of orelabrutinib, combining high selectivity and CNS penetrance, may translate to potential clinical advantages relative to other BTKi programs,” said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. “For over 30 years, Biogen has led in MS research and today has a leading portfolio of MS products. We are focused on developing next-generation approaches that we hope will improve outcomes for those living with progressive and relapsing forms of MS.”

“Biogen is a recognized leader in neuroscience and we believe this transaction will help advance the development of orelabrutinib in MS,” said Jasmine Cui, Ph.D., Co-Founder, Chairwoman and Chief Executive Officer at InnoCare. “We are excited about the potential of orelabrutinib for the treatment of patients with all forms of MS given the potential efficacy and safety profile, plus a promising level of blood-brain barrier penetration. BTK inhibitors may have the potential to transform the treatment paradigm of autoimmune diseases, in particular MS.”

Under the terms of the agreement, Biogen will have exclusive rights to orelabrutinib in the field of MS worldwide and certain autoimmune diseases outside of China (including Hong Kong, Macau and Taiwan), while InnoCare will retain exclusive worldwide rights to orelabrutinib in the field of oncology and certain autoimmune diseases in China (including Hong Kong, Macau and Taiwan). InnoCare will receive a $125 million upfront payment and is eligible to receive up to $812.5 million in potential development milestones and potential commercial payments should the collaboration achieve certain development, commercial milestones and sales thresholds. InnoCare is also eligible to receive tiered royalties in the low to high teens on potential future net sales of any product resulting from the collaboration. Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions.

https://www.globenewswire.com/news-release/2021/07/12/2261563/0/en/Biogen-and-Innocare-Announce-License-and-Collaboration-Agreement-For-Orelabrutinib-an-Innovative-CNS-Penetrant-BTK-Inhibitor-For-the-Potential-Treatment-of-Multiple-Sclerosis.html

Athletes may have more than twice the risk of irregular heart rhythm

 Athletes appear to be almost two and half times more likely than non-athletes to experience irregular heart rhythms (atrial fibrillation), suggests new research published in the British Journal of Sports Medicine.

In addition, those athletes involved in mixed sports such as football, rugby or netball appear to have the highest risk when compared with athletes taking part in endurance sports such as Nordic skiing, orienteering or rowing.

Previous studies have shown that physical activity can improve cardiovascular health and is associated with reduced illness and deaths, but they have suggested there is a threshold beyond which exposure to increasing levels of exercise is linked to heart issues including atrial fibrillation—a condition that can raise the risk of stroke, heart failure and other heart-related problems.

UK researchers led by Canterbury Christ Church University in Canterbury set out to review existing studies on the subject and explore what impact the type of sport in which athletes took part had on their risk of atrial fibrillation to reach a more conclusive picture of overall prevalence among athletes.

They reviewed and analyzed 13 suitable studies that were published between 1990 and December 2020 which had looked at athletes who took part in sports including cycling, running, swimming, Nordic skiing, orienteering, rowing, football, rugby, and netball.

The 13 studies included data on 70,478 participants, collectively, which included 63,662 controls and 6,816 athletes.

The authors found that the risk of atrial fibrillation was 2.46 times higher among athletes than non-athletes.

When the authors split the studies into those that involved participants with and without cardiovascular disease risk factors (such as type 2 diabetes and high blood pressure), they found there was no significant difference in the relative risk of atrial fibrillation in athletes and non-athletes with these risk factors.

However, in athletes and non-athletes without cardiovascular disease risk factors athletes had a significantly higher relative risk (3.7 times higher) of atrial fibrillation than non-athletes.

In addition, younger athletes (aged under 55) had a much higher risk (3.6 times) of atrial fibrillation than older athletes (aged 55 and older) who were 76% more likely to have the condition than non-athletes.

Analysis also showed that athletes taking part in mixed sports rather than endurance sports had a higher risk of atrial fibrillation.

Their study had some limitations such as the fact that it analyzed research with different approaches such as case control and cohort design, and there was limited data on female athletes, making it difficult to look at the relative risk of atrial fibrillation by gender.

Nevertheless, the researchers conclude: "Athletes have a significantly greater likelihood of developing atrial fibrillation compared with non-athlete controls.

"Younger aged athletes have a greater relative risk of atrial fibrillation compared with older athletes; however, exercise dose parameters, including training and competition history, as well as potential gender differences for the risk of atrial fibrillation requires future research."

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Explore further

Left atrial fibrosis may explain increased risk of arrhythmias in endurance athletes

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More information: Risk of atrial fibrillation in athletes: a systematic review and meta-analysis, British Journal of Sports Medicine (2021). DOI: 10.1136/bjsports-2021-103994

https://medicalxpress.com/news/2021-07-athletes-irregular-heart-rhythm.html

Aging population to hit economy like a 'ton of bricks' - U.S. commerce sec

President Joe Biden does not yet have enough support from fellow Democrats to secure $400 billion in spending for at-home care for the elderly and disabled that the economy desperately needs, Commerce Secretary Gina Raimondo told Reuters on Monday.

Raimondo, who is paying for round-the-clock care for her own 90-year-old mother, said America's aging demographics were going to hit the country "like a ton of bricks" without increased federal aid, and warned the current situation was "untenable."

Failure to act, she said in an interview, would harm the U.S. economy by making it difficult for women - who fell out of the workforce by the millions during the COVID-19 pandemic - often to look after out-of-school children or parents - to return to work or remain in the workforce.

As post-World War Two baby boomers become senior citizens, there is a dangerous deficit of caregivers looming, Biden officials and many experts on aging say.

Currently, 16.5% of the U.S. population of 328 million people, or 54 million, are over the age of 65, the latest census shows. By 2030, that number will rise to 74 million. The number of people over the age of 85, who generally need the most care, is growing even faster.

Biden in March proposed boosting Medicaid, the federal medical program for lower-income Americans, by $400 billion over a decade to fund at-home care for elderly and disabled people, and increasing wages for caregivers. He remains committed to that $400 billion figure, Raimondo said.

She said details of the pending reconciliation bill - a Democrats-only budget measure that will include parts of Biden's spending plans not included in a pared-down bipartisan infrastructure bill - were still being worked out.

But not all Democrats are on board for the increased care spending, she said.

"It will be a battle to get enough of it funded in the reconciliation package. We still have to make the case for it ... and that's part of the reason why I'm pounding the drum."

Democrats hold a slim majority in the House of Representatives, while the Senate is split 50-50. That means all Senate Democrats must be on board to pass a budget measure with the tie-breaking vote of Vice President Kamala Harris.

Raimondo said she is continuing to meet with skeptics, including moderate Democratic Senator Joe Manchin. "It's not so much that people are opposed, but $400 billion is a lot of money, and they have questions that deserve good answers."

'IT IS A CRISIS'

She said the pandemic had raised awareness about the lack of affordable care for children, the elderly and disabled, and even some Republicans - who opposed adding such spending to the infrastructure package - saw the need for change.

Raimondo said 1.5 million women still had not returned to the workforce after exiting during the pandemic to care for children whose schools had closed, and elderly and disabled relatives.

"We can't afford for half of our workforce - women - to be held back and held out of the workforce because they can't get excellent and adequate childcare or eldercare," she said.

The current system - relying on women taking care of relatives for free, or paying mostly women of color to provide care at poverty wages - was not sustainable, she said.

"Just giving those women a raise would be a huge boost to our economy ... and a huge drag on the economy if we don't get it done," Raimondo said.

"It is a crisis," she said. "The president's behind it and most Democrats are behind it. We're going to work to get the rest of them behind it. But if we don't, we're going stay at it, because ... it's an untenable situation."

https://www.marketscreener.com/news/latest/Aging-population-to-hit-U-S-economy-like-a-ton-of-bricks-U-S-commerce-secretary--35841412/ 

U.S. starts review for national Medicare coverage policy for Biogen's Aduhelm

 The U.S. government on Monday started a review process for national Medicare coverage of Biogen Inc's Alzheimer's drug, Aduhelm, that was recently approved by the country's health regulator.

The Centers for Medicare & Medicaid Services expects to give a proposed decision within 6 months and a final decision within 9 months. (https://go.cms.gov/3hzMa6H)

https://www.marketscreener.com/quote/stock/BIOGEN-INC-4853/news/Biogen-nbsp-U-S-starts-review-for-national-Medicare-coverage-policy-for-Biogen-s-Aduhelm-35841427/

Moderna Outlines Pregnancy Outcome Study Details For Its COVID-19 Shot

 

• In a few days, Moderna Inc MRNA 2.8% will start a trial designed to evaluate pregnancy outcomes in women after receiving the Company's COVID-19 shot during their pregnancy.
• According to an update posted on the ClinicalTrials.gov website, the trial will begin on July 22, targeting the enrollment of 1,000 participants.
• The observational study with a 21-month follow-up period is expected to complete in January 2024. 
• During the period, the primary data from pregnant women and their healthcare providers will be collected for the study.
• The Centers for Disease Control and Prevention recommended that pregnant females receive the messenger-RNA-based COVID-19 vaccines developed by Pfizer Inc PFE 0.33%/ BioNTech SE BNTX 0.79% and Moderna.
• Also, Monday, Moderna announced a supply agreement with the government of Argentina for 20 million doses of its COVID-19 vaccine or its updated variant booster vaccine candidate, if authorized.
• Delivery will start from 1Q of 2022.

https://www.benzinga.com/general/biotech/21/07/21940441/moderna-outlines-pregnancy-outcome-study-details-for-its-covid-19-shot

Acutus Medical Reports Prelim 2Q Financial Results

 Acutus Medical, Inc. (“Acutus” or the “Company”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today reported preliminary unaudited results for the second quarter of 2021.

Recent Highlights and Upcoming Events:

• Preliminary net sales for the second quarter of 2021 are expected to be in the range of $4.6 to $4.7 million, compared to $3.6 million in the first quarter of 2021 and $1.1 million in the same quarter last year.

• Increased worldwide installed base of second generation AcQMap consoles to 68 as of June 30, 2021, up from 57 as of March 31, 2021 – bringing the total installed base of AcQMap consoles to 70 as of June 30, 2021.

• Received US Investigational Device Exemption to commence the study of the AcQBlate Force-Sensing Ablation Catheter and System in the treatment of paroxysmal and persistent atrial fibrillation.

• In-person presence at the annual Heart Rhythm Society meeting in Boston, from July 28 to July 31, including the Company’s first dedicated Rhythm Theater Symposium.

“We are pleased with the momentum we observed during the second quarter, especially in our direct businesses which grew over 40% sequentially as compared to the first quarter of 2021,” said Vince Burgess, President and CEO of Acutus. “Our expanded product offerings, recently approved and launched next generation versions of our access and mapping products, and improved commercial execution all contributed to these strong operating results. Our US business led overall performance in the quarter, while our UK and Europe teams continued to drive solid execution amidst continuing regional COVID-19 disruptions. We are making good progress across the three strategic growth drivers that we established earlier this year, and we look forward to sharing further updates throughout the year.”

Mr. Burgess continued, “The upcoming Heart Rhythm Society meeting will be our first in-person opportunity to showcase our broad range of highly novel access, diagnostic and therapy products to the electrophysiology community at large. In addition, we will host our first dedicated Rhythm Theater Symposium, where physician collaborators will detail their own cutting-edge treatment strategies utilizing Acutus’ complete line of EP products. A particular focus will be the move away from one-size-fits-all ablation approaches for patients with complex disease to a more tailored method using Acutus’ mapping system to guide a so-called ‘Core-to-Boundary’ patient-specific, adaptive approach. This approach has the potential to bring simplicity, efficiency and improved outcomes to the large and growing cohort of patients suffering from complex arrhythmias who presently have limited options. Presentations during our Rhythm Theater will also unveil Acutus’ unique strategy to bring its own image-guided, force-sensing enabled Pulsed Field Ablation therapy platform to market.”

https://finance.yahoo.com/news/acutus-medical-reports-preliminary-unaudited-200100586.html