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SNMMI Leadership Update: SNMMI Strong: Advancing the Profession through Advocacy, Collaboration, and Awareness




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Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data

The bioprocessing industry uses recombinant mammalian cell lines to generate therapeutic biologic drugs. To ensure consistent product quality of the therapeutic proteins, it is imperative to have a controlled production process. Regulatory agencies and the biotechnology industry consider cell line "clonal origin" an important aspect of maintaining process control. Demonstration of clonal origin of the cell substrate, or production cell line, has received considerable attention in the past few years, and the industry has improved methods and devised standards to increase the probability and/or assurance of clonal derivation. However, older production cell lines developed before the implementation of these methods, herein referred to as "legacy cell lines," may not meet current regulatory expectations for demonstration of clonal derivation. In this article, the members of the IQ Consortium Working Group on Clonality present our position that the demonstration of process consistency and product comparability of critical quality attributes throughout the development life cycle should be sufficient to approve a license application without additional genetic analysis to support clonal origin, even for legacy cell lines that may not meet current day clonal derivation standards. With this commentary, we discuss advantages and limitations of genetic testing methods to support clonal derivation of legacy cell lines and wish to promote a mutual understanding with the regulatory authorities regarding their optional use during early drug development, subsequent to Investigational New Drug (IND) application and before demonstration of product and process consistency at Biologics License Applications (BLA) submission.




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Bioavailability Based on the Gut Microbiota: a New Perspective [Review]

The substantial discrepancy between the strong effects of functional foods and various drugs, especially traditional Chinese medicines (TCMs), and the poor bioavailability of these substances remains a perplexing problem. Understanding the gut microbiota, which acts as an effective bioreactor in the human intestinal tract, provides an opportunity for the redefinition of bioavailability. Here, we discuss four different pathways associated with the role of the gut microbiota in the transformation of parent compounds to beneficial or detrimental small molecules, which can enter the body’s circulatory system and be available to target cells, tissues, and organs. We further describe and propose effective strategies for improving bioavailability and alleviating side effects with the help of the gut microbiota. This review also broadens our perspectives for the discovery of new medicinal components.




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A Rapid Review of Available Evidence to Inform Indicators for Routine Monitoring and Evaluation of Respectful Maternity Care

ABSTRACTBackground:Some opportunities to routinely capture and improve respectful maternity care (RMC) during facility-based childbirth include quality improvement (QI) initiatives, community-based monitoring efforts through community score cards (CSC), and performance-based financing (PBF) initiatives. But there is limited guidance on which types of RMC indicators are best suited for inclusion in these initiatives. We sought to provide practical evidence-based recommendations on indicators that may be used for routine measurement of RMC in programs.Methods:We used a rapid review approach, which included (1) reviewing existing documents and publications to extract RMC indicators and identify which have or can be used in facility-based QI, CSCs, and PBF schemes; (2) surveying RMC and maternal health experts to rank indicators, and (3) analyzing survey data to select the most recommended indicators.Results:We identified 49 indicators spanning several domains of RMC and mistreatment including dignified/nondignified care, verbal and physical abuse, privacy/confidentiality, autonomy/loss of autonomy, supportive care/lack thereof, communication, stigma, discrimination, trust, facility environment/culture, responsiveness, and nonevidence-based care. Based on the analysis of the survey data, we recommend 33 indicators (between 2 and 6 indicators for each RMC domain) that may be suited for incorporation in both facility-based QI and CSC-related monitoring efforts.Conclusion:Integrating RMC indicators into QI and CSC initiatives, as well as in other maternal and neonatal health programs, could help improve RMC at the facility and community level. More research is needed into whether RMC can be integrated into PBF initiatives. Integration of RMC indicators into programs to improve quality of care and other health system outcomes will facilitate routine monitoring and accountability around experience of care. Measurement and improvement of women's experiences will increase maternal health service utilization and improve quality of care as a means of reducing maternal and neonatal morbidity and mortality.




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Designing and Evaluating Scalable Child Marriage Prevention Programs in Burkina Faso and Tanzania: A Quasi-Experiment and Costing Study

ABSTRACTBackground:A significant number of girls are married as children, which negatively impacts their health, education, and development. Given the sheer numbers of girls at risk of child marriage globally, the challenge to eliminate the practice is daunting. Programs to prevent child marriage are typically small-scale and overlook the costs and scalability of the intervention.Implementation:This study tested and costed different approaches to preventing child marriage in rural Burkina Faso and Tanzania. The approaches tested were community dialogue, provision of school supplies, provision of a livestock asset, a model including all components, and a control arm. A quasi-experimental design was employed with surveys undertaken at baseline and after 2 years of intervention. We examined the prevalence of child marriage and school attendance controlling for background characteristics and stratified by age group. Programmatic costs were collected prospectively.Results:Among those in the community dialogue arm in Burkina Faso, girls aged 15 to 17 years had two-thirds less risk (risk ratio [RR]=0.33; 95% confidence interval [CI]=0.19, 0.60) of being married and girls aged 12 to 14 years had a greater chance of being in school (RR=1.18; 95% CI=1.07,1.29) compared to the control site. In Tanzania, girls aged 12 to 14 years residing in the multicomponent arm had two-thirds less risk of being married (RR=0.33; 95% CI=0.11, 0.99), and girls 15 to 17 in the conditional asset location had half the risk (RR=0.52; 95% CI=0.30, 0.91). All the interventions tested in Tanzania were associated with increased risk of girls 12 to 14 years old being in school, and the educational promotion arm was also associated with a 30% increased risk of girls aged 15 to 17 years attending school (RR=1.3; 95% CI=1.01, 1.67). Costs per beneficiary ranged from US$9 to US$117.Conclusion:The study demonstrates that minimal, low-cost approaches can be effective in delaying child marriage and increasing school attendance. However, community dialogues need to be designed to ensure sufficient quality and intensity of messaging. Program managers should pay attention to the cost, quality, and coverage of interventions, especially considering that child marriage persists in the most hard-to-reach rural areas of many countries.




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Emergence of a Novel Coronavirus Disease (COVID-19) and the Importance of Diagnostic Testing: Why Partnership between Clinical Laboratories, Public Health Agencies, and Industry Is Essential to Control the Outbreak




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What happens when laboratory reference ranges change? [Commentary]




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Levothyroxine prescribing and laboratory test use after a minor change in reference range for thyroid-stimulating hormone [Research]

BACKGROUND:

Prescribing of levothyroxine and rates of thyroid function testing may be sensitive to minor changes in the upper limit of the reference range for thyroid-stimulating hormone (TSH) that increase the proportion of abnormal results. We evaluated the population-level change in levothyroxine prescribing and TSH testing after a minor planned decrease in the upper limit of the reference range for TSH in a large urban centre with a single medical laboratory.

METHODS:

Using provincial administrative data, we compared predicted volumes of TSH tests with actual TSH test volumes before and after a planned change in the TSH reference range. We also determined the number of new levothyroxine prescriptions for previously untreated patients and the rate of changes to the prescribed dose for those on previously stable, long-term levothyroxine therapy before and after the change in the TSH reference range.

RESULTS:

Before the change in the TSH reference range, actual and predicted monthly volumes of TSH testing followed an identical course. After the change, actual test volumes exceeded predicted test volumes by 7.3% (95% confidence interval [CI] 5.3%–9.3%) or about 3000 to 5000 extra tests per month. The proportion of patients with newly "abnormal" TSH results almost tripled, from 3.3% (95% CI 3.2%–3.4%) to 9.1% (95% CI 9.0%–9.2%). The rate of new levothyroxine prescriptions increased from 3.24 (95% CI 3.15–3.33) per 1000 population in 2013 to 4.06 (95% CI 3.96–4.15) per 1000 population in 2014. Among patients with preexisting stable levothyroxine therapy, there was a significant increase in the number of dose escalations (p < 0.001) and a total increase of 500 new prescriptions per month.

INTERPRETATION:

Our findings suggest that clinicians may have responded to mildly elevated TSH results with new or increased levothyroxine prescriptions and more TSH testing. Knowledge translation efforts may be useful to accompany minor changes in reference ranges.




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Cancer Labs Pivot to Battle COVID-19 [News in Depth]

As cancer researchers shutter their labs to comply with COVID-19–related work restrictions, some are turning their attention, resources, and technical know-how to the challenge of tackling the deadly coronavirus.




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Establishment of the T1D Exchange Quality Improvement Collaborative (T1DX-QI)

The T1D Exchange established a learning platform by evaluating the current state of care and engaging 10 diabetes clinics in collaborative quality improvement (QI) activities. Participating clinics are sharing data and best practices to improve care delivery for people with type 1 diabetes. This article describes the design and initial implementation of this platform, known as the T1D Exchange Quality Improvement Collaborative. This effort has laid a foundation for learning from variation in type 1 diabetes care delivery via QI methodology and has demonstrated success in improving processes through iterative testing cycles and transparent sharing of data.




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Li-Fraumeni Exploration Consortium Data Coordinating Center: Building an Interactive Web-Based Resource for Collaborative International Cancer Epidemiology Research for a Rare Condition

Background:

The success of multisite collaborative research relies on effective data collection, harmonization, and aggregation strategies. Data Coordination Centers (DCC) serve to facilitate the implementation of these strategies. The utility of a DCC can be particularly relevant for research on rare diseases where collaboration from multiple sites to amass large aggregate datasets is essential. However, approaches to building a DCC have been scarcely documented.

Methods:

The Li-Fraumeni Exploration (LiFE) Consortium's DCC was created using multiple open source packages, including LAM/G Application (Linux, Apache, MySQL, Grails), Extraction-Transformation-Loading (ETL) Pentaho Data Integration Tool, and the Saiku-Mondrian client. This document serves as a resource for building a rare disease DCC for multi-institutional collaborative research.

Results:

The primary scientific and technological objective to create an online central repository into which data from all participating sites could be deposited, harmonized, aggregated, disseminated, and analyzed was completed. The cohort now include 2,193 participants from six contributing sites, including 1,354 individuals from families with a pathogenic or likely variant in TP53. Data on cancer diagnoses are also available. Challenges and lessons learned are summarized.

Conclusions:

The methods leveraged mitigate challenges associated with successfully developing a DCC's technical infrastructure, data harmonization efforts, communications, and software development and applications.

Impact:

These methods can serve as a framework in establishing other collaborative research efforts. Data from the consortium will serve as a great resource for collaborative research to improve knowledge on, and the ability to care for, individuals and families with Li-Fraumeni syndrome.




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Labeling 3' Termini of Double-Stranded DNA Using the Klenow Fragment of E. coli DNA Polymerase I

The Klenow fragment, which retains the template-dependent deoxynucleotide polymerizing activity and the 3' -> 5' exonuclease of the holo-enzyme but lacks its powerful 5' -> 3' exonuclease activity, is used to fill recessed 3' termini of dsDNA. In this protocol, fragments suitable as templates for the end-filling reaction are produced by digestion of DNA with an appropriate restriction enzyme. The Klenow enzyme is then used to catalyze the attachment of dNTPs to the recessed 3'-hydroxyl groups.




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Detecting {beta}-Galactosidase-Labeled Cells

β-Galactosidase has been used extensively both as a label in enzyme immunoassays and for immunocytochemistry. One good substrate is 5-bromo-4-chloro-3-indolyl-β-d-galactopyranoside (X-gal), which gives an intense blue product. The product is stable and insoluble in alcohol as well as H2O.




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Luxury condo at Garden City, basic furniture, now available

If you are looking for a quiet, convenient living environment that is close to Hanoi center, this condominium is your best choice. The condo has southwest-facing door and north-facing window, comprising a living room, a kitchen, two bedrooms, two bathrooms and a private yard, cr...




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Cheap Room available, 238 Lane, behind the Flower Market, Tay Ho district, Quang An ward

Cheap Room available Location: Lane 238 Au Co, behind Quang Ba flower market, Tay Ho district, Hanoi Have 2 room for rent The room has a bed king size, wardrobe, cushion, air-conditioner for rent 2,500,000 vnd There is a kitchen including fridge, microwave, kitchen cabinet, gas...




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Real estate agents reveal 11 reasons why your home is unsellable

Business Insider asked real-estate agents across the U.S., and they point out 11 reason that prevent your home from being sold.





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Forza Street Now Available for iOS and Android

Microsoft and Turn 10 Studios announced Forza Street is now available worldwide for free on iOS and Android.

View the launch trailer below:

Here is an overview of the game:

This all-new Forza experience lets you jump into the game for quick, under-a-minute races where you compete to unlock new cars and upgrade parts to grow your car collection. We are excited for iOS and Android players to jump into this free to play mobile experience designed to be played anytime, anywhere, and excite anyone who loves cars.

Forza Street was also designed to be an evolving experience. The game is based in a street racing world with interesting characters, mystery, and  intrigue,  explored through a narrative driven campaign, weekly Spotlight Events, and limited time Themed Events, all of which provide players an opportunity to expand their car collections. For players looking for an additional challenge, weekly Rivals events let them take their collections against other players in the community in leaderboard based asynchronous challenges.

As a special gift to everyone who plays Forza Street between today and June 5 2020, players will receive a 2017 Ford GT and added in-game credits and gold to help you unlock new cars and grow your car collection! Don’t miss out on this chance to get this rare supercar added to your garage.

For gamers joining the fun via the Samsung Galaxy Store, we have two more gifts for you: anyone who downloads through the Galaxy Store on their Samsung devices will receive the 2015 Ford Mustang GT with a custom Galaxy themed paint. If players have the latest Galaxy S20 devices, they will also receive the 2015 Chevrolet Corvette Z06 with a Custom Galaxy, and in-game credits and gold.

Want to play Forza Street across multiple device? We got you covered – Forza Street supports Xbox Live. When you sign in with Xbox Live, players will be able to unlock Xbox Achievements and transfer game progress across your Windows, iOS, and Android devices.

A life-long and avid gamer, William D'Angelo was first introduced to VGChartz in 2007. After years of supporting the site, he was brought on in 2010 as a junior analyst, working his way up to lead analyst in 2012. He has expanded his involvement in the gaming community by producing content on his own YouTube channel and Twitch channel dedicated to gaming Let's Plays and tutorials. You can contact the author at wdangelo@vgchartz.com or on Twitter @TrunksWD.

Full Article - https://www.vgchartz.com/article/443397/forza-street-now-available-for-ios-and-android/




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Soya protein can help make lab-grown beef with the texture of meat

Lab-grown ‘meat’ often uses gelatin produced in slaughterhouses to give artificial beef a meat-like texture – but substituting soya protein can achieve that without killing animals




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AI Faces Speed Bumps and Potholes on Its Road From the Research Lab to Everyday Use

Rigid IT departments and job-hopping data scientists are just two of the challenges that make implementing machine learning harder than you might think



  • robotics
  • robotics/artificial-intelligence

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Want a Really Hard Machine Learning Problem? Try Agriculture, Says John Deere Labs

John Deere, the nearly 200-year-old tractor manufacturer, now considers itself a software company



  • robotics
  • robotics/artificial-intelligence

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Labrador Systems Developing Affordable Assistive Robots for the Home

A startup led by robotics veterans is announcing a pre-seed funding round with participation from Amazon's Alexa Fund and iRobot Ventures




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Cerebras Unveils First Installation of Its AI Supercomputer at Argonne National Labs

Argonne will use the CS-1 to help discover cancer therapies and understand colliding blackholes




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Fortnite Party Royale Event Skin 'Nightlife' available from Epic Games Item Shop



The new Nightlife reactive skin is now live ahead of the Fortnite Party Royale event which starts later today.




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RPGCast – Episode 342: “It’s Not Available Digitally”

Final Fantasy XI announces its plans for its golden years. Fossil Fighters still exists. Then Phil either recommends or doesn’t recommend Avernum. I’m still not...




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China releases five prominent labour rights activists




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Coronavirus Lockdown 3.0: Suspension of labour laws by fiat can only be an immediate-term response to the current crisis

There has been talk for some time now about easing labour laws, already seen in industry circles as being too rigid and acting as a drag on growth, specifically to facilitate emerging from the lockdown. And it’s not just a question of emerging from it, there’s also the issue of surviving what looks like being a brutal and prolonged global economic downturn. It was reported on Friday that ordinances were being issued in some states.





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In mystery investigation of two Canadian scientists, a request for Ebola, henipavirus from the Wuhan lab

The shipment of Ebola and henipavirus samples to Wuhan has given rise to groundless conspiracy theories involving Xiangguo Qiu. But there is no evidence whatsoever tying her to COVID-19




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China releases five prominent labour rights activists

Five prominent labour activists have returned to their homes more than a year after they were arrested in coordinated raids in the southern Chinese city of Shenzhen, according to people close to them and a Hong Kong-based rights group.




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Alabama High School Student Names NASA’s First Mars Helicopter

Around 28,000 names were submitted to NASA’s “Name the Rover” essay contest for K-12 students





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Labour confession: Len McCluskey's blunt analysis of Jeremy Corbyn's impact revealed



AS THE Labour Party prepares itself for four years under the leadership of Sir Keir Starmer, the leader of Unite the Union explained how he believes Jeremy Corbyn has changed the face of the party forever.




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Two labs hit problems in Salmonella typing test

Two laboratories did not achieve a good performance in the initial 2018 quality control test on Salmonella typing, according to a new report. The National Reference Laboratories (NRLs) of EU member states participate in quality control tests which consist of proficiency tests on Salmonella. Performance is assessed annually by testing ability to identify 20 Salmonella... Continue Reading



  • Genetic Testing
  • World
  • Dutch National Institute for Public Health and the Environment (RIVM)
  • european reference laboratory (EURL)
  • national reference laboratory (NRL)
  • PFGE
  • Salmonella
  • serotyping
  • whole genome sequencing (WGS)

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Alphabet’s Sidewalk Labs scraps its ambitious Toronto project

Residents rebelled over plans to collect and use their data, among other things.




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Coronavirus vaccine could be available for public by September, Oxford professor says

Read our live coronavirus updates HERE Coronavirus: the symptoms




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Labour calls for inquiry into high number of BAME NHS staff deaths related to coronavirus

Read our live coronavirus updates HERE




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Police &apos;flabbergasted&apos; as man spared jail after coughing in officer&apos;s face while claiming to have Covid-19

Police have been left "flabbergasted" after a man who coughed in an officer's face claiming to have Covid-19 was spared jail. .




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Moment dad watches birth of first child on Zoom after social distancing rules stopped him being with wife during labour

This is the heartwarming moment a new dad watched the birth of his first child on Zoom after coronavirus social distancing rules stopped him from being in hospital with his wife.




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Confusion after Government website states &apos;no coronavirus home tests available for key workers today&apos; despite promising them to millions

The Government's new portal for arranging coronavirus tests has sparked confusion today, following a message suggesting home tests had run out by 9am.




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Labour leader Sir Keir Starmer steps up demand for lockdown &apos;exit strategy&apos;: the British public deserve to be treated like adults

Labour leader Sir Keir Starmer has called for a coronavirus lockdown "exit strategy" with the Government facing increasing pressure to reveal its next steps.




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Labour proposes legislation for fast-tracked fund for domestic abuse services hit by Covid-19 crisis

Labour has proposed legislation to deliver a dedicated fast-tracked fund for domestic abuse services affected by the coronavirus crisis.




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US spies say Covid-19 not man-made but do not rule out Chinese lab accident

Coronavirus was "not man-made or genetically modified," US intelligence agencies have said.




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Donald Trump claims he&apos;s seen evidence to suggest coronavirus originated in Chinese lab

Donald Trump has claimed he has seen evidence that coronavirus may have originated in a Chinese virology lab.




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WHO says coronavirus &apos;natural in origin&apos; after Trump&apos;s Chinese lab claim

A senior World Health Organisation (WHO) official has insisted Covid-19 is "natural in origin" after Donald Trump claimed to have seen evidence that the outbreak originated from a laboratory in China.




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NHS staff &apos;breaking down&apos; on coronavirus frontline, Labour MP and A&amp;E doctor warns

NHS staff are "breaking down" on the frontline of the fight against coronavirus, a Labour MP and A&E doctor has warned.




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Mike Pompeo claims US has &apos;significant amount of evidence&apos; coronavirus emerged from Chinese laboratory

Secretary of State Mike Pompeo has claimed that the US has "a significant amount of evidence" that the new coronavirus emerged from a Chinese laboratory.




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Labour urges Government to &apos;get ahead of the game&apos; on plans for public wearing face masks

Ministers have been urged to "get ahead of the game" by assuring the public about what their plans are for stockpiling face masks before lockdown measures are eased.




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Government says &apos;questions to be asked&apos; about coronavirus origin after Mike Pompeo claims Covid-19 began in Wuhan laboratory

There are "questions to be asked" about where coronavirus came from, Boris Johnson's spokesperson has said.




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National Lottery website down: Britons unable to check results or enter Lotto draw as online services &apos;unavailable&apos;

The National Lottery website is down due to a power failure, leaving users unable to check results or enter Wednesday's draw.




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Labradors trained to sniff out knotweed from gardens