Sarepta Announces Voluntary Pause of Elevidys Shipments in US
The Food and Drug Administration asked Sarepta to pause shipments of the drug on Friday following news reports of a patient death in a clinical trial for another Sarepta therapy that works in a similar way. The company initially refused, which drew backlash.
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Yahoo
25 minutes ago
- Yahoo
MeMed develops rapid infection differentiation test
MeMed has developed MeMed BV Flex, a rapid infection differentiation test that distinguishes between bacterial and viral infections. This test is set to widen the accessibility of MeMed BV to decentralised, Clinical Laboratory Improvement Amendments (CLIA)-waived settings, using a few drops of blood from a finger prick to deliver results within 15 minutes. Designed for near-patient use, the test operates on an improved version of MeMed's current platform. It has been verified in a prospective analytical trial, showing performance on par with laboratory methods. According to the published study, measurements of capillary and venous blood demonstrated high concordance in terms of all the host proteins examined, along with the MeMed BV score, suggesting that there is alignment between the sample types. The company noted that a multi-centre pivotal trial is currently underway to support regulatory submission and confirm clinical accuracy, following initial discussions with the US Food and Drug Administration (FDA). By using host response data, MeMed BV aims to aid physicians with the information needed to make informed treatment decisions and decrease needless antibiotic use. MeMed CEO and co-founder Eran Eden said: 'Accurately and simultaneously measuring multiple proteins from just a few drops of blood, in a rapid and easy-to-use format, has been a long-standing challenge. 'By pairing this breakthrough with machine learning, we've enhanced our platform, which, once cleared, can help extend host-response testing across broader decentralised use. It's a major step toward our next goal of reaching one million patients and enables a plug-and-play engine for our broader pipeline, from MeMed Severity to future sepsis and immune-status assays.' Last year, MeMed secured the FDA's breakthrough device designation for its MeMed Severity test, which is designed to improve the management of patients with suspected acute infections and sepsis. "MeMed develops rapid infection differentiation test" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
CNN
30 minutes ago
- CNN
5 things to know for July 25: Thailand-Cambodia, France, AI, Sanctuary city lawsuit, Skydance-Paramount merger
In addition to telling time, smartwatches can track your steps, heart rate, blood pressure and sleeping patterns. Now, a smartwatch has helped search and rescue teams locate a small plane after it crashed into the dense forests near West Yellowstone, Montana. Here's what else you need to know to get up to speed and on with your day. More than 100,000 civilians have been displaced following a second day of violence along the disputed 500-mile land border between Thailand and Cambodia. At least 16 people were also reportedly killed, officials from both countries said. Tensions between the Southeast Asian neighbors have been boiling for months. Around 4:30 a.m. local time on Friday, clashes broke out with Cambodian troops using small arms and heavy weapons and Thai troops responding with artillery fire. On Thursday, when Thailand deployed fighter jets to attack Cambodian military targets, Cambodia vowed to 'respond decisively.' French President Emmanuel Macron said on Thursday that France will recognize a Palestinian state in an announcement at the UN General Assembly in September. France will be the first member of the UN Security Council and the G7 nations to do so. 'We must build the state of Palestine, ensure its viability, and ensure that by accepting its demilitarization and fully recognizing Israel, it contributes to the security of all in the Middle East. There is no alternative,' he wrote on X. Macron also called for an immediate ceasefire, access to humanitarian aid for the population of Gaza, the release of all hostages and the demilitarization of Hamas. Secretary of State Marco Rubio said the US 'strongly rejects' Macron's plan. The Department of Health and Human Services (HHS) has started using artificial intelligence, and behind the scenes, the practice has caused some alarm. An AI project known as Elsa is supposed to help speed up drug and medical device approvals at the FDA, a division of HHS. Six current and former FDA officials told CNN that Elsa can be useful for generating meeting notes and summaries, or email and communique templates, but it also invented studies and misrepresented research. In at least one instance — when an employee asked Elsa to generate something for a project — it insisted that the research area was not in the FDA's purview, even though it was. Elsa also cannot help with the lengthy assessment process that agency scientists undertake to determine whether drugs and devices are safe and effective because it can't access many of the files needed to answer basic questions. The Justice Department has filed a lawsuit against New York City over its so-called 'sanctuary city' policies. The move comes just days after the Trump administration blamed those policies for the shooting of an off-duty US Customs and Border Protection officer in an apparent robbery gone wrong. As part of the administration's widespread crackdown on undocumented immigrants, similar lawsuits have also been filed against Colorado, Illinois, Los Angeles, New York state, the city of Rochester, New York, and several New Jersey cities, the DOJ said in a statement. NYC Mayor Eric Adams said the city will review the lawsuit. 'Keeping New Yorkers safe also means making sure they feel safe, and we have been clear: no one should be afraid to dial 911, send their kids to school or go to the hospital, and no New Yorker should feel forced to hide in the shadows,' Adams said in a statement. The FCC approved the pending merger between Skydance Media and Paramount Global on Thursday. Voting 2-1 along party lines, the commissioners gave the go-ahead to the $8 billion deal, which has been mired in allegations of political interference stemming from President Trump's scathing criticism and his lawsuit against Paramount's CBS News division. But on July 1, Paramount agreed to pay $16 million toward Trump's future presidential library to resolve his legally dubious suit about an edit made to a '60 Minutes' interview with then-Vice President Kamala Harris before the November presidential election. Although Paramount and the FCC both insisted that the payout was unrelated to the merger review process, many likened it to a 'bribe.' GET '5 THINGS' IN YOUR INBOX If your day doesn't start until you're up to speed on the latest headlines, then let us introduce you to your new favorite morning fix. Sign up here for the '5 Things' newsletter. Amy Sherald, who gained national fame for her official portrait of former first lady Michelle Obama in 2018, was told that the museum had 'concerns' about one of her paintings. The head of human resources at the New York-based tech company and her boss were seen embracing on the 'kiss cam' during a Coldplay concert. Video of the encounter quickly went viral. The 12-year-old baseball player faced suspension for what he did last week after hitting a game-winning home run. High cocoa costs are prompting a major confectionery company to hike prices for chocolate candy. 'What have you done?' Victoria Beckham, the soccer star's wife, asked when she saw it. Legendary jazz musician Chuck Mangione diesThe noted flugelhorn player, trumpeter and composer became known for his signature tune 'Feels So Good,' which spent 25 weeks on the Billboard Hot 100 chart, peaking at #4 in 1978. Throughout his six-decade career in music, Mangione received 14 Grammy nominations and won the award twice. He also made recurring appearances on the Fox animated series 'King of the Hill,' where he played a tongue-in-cheek version of himself. Which city may soon become the first modern capital in the world to run completely out of water?A. Kabul, AfghanistanB. Mexico City, MexicoC. Baghdad, IraqD. Sanaa, Yemen Take me to the quiz! $250That's how much the US plans to charge international visitors for a new 'visa integrity fee.' The provision was included in President Trump's recently enacted domestic policy bill. 'Crazy!! My House got Home Invaded Saturday While I was in Indianapolis performing for the WNBA all star game & instead of Focusing on finding the Suspects, they focus on some cannabis.' — GloRilla on X. The Grammy-nominated rapper is facing felony drug charges after police responded to her Georgia home following a separate report of a burglary in progress. 🌤️ Check your local forecast to see what you can expect. This Swiss river is so clean that locals use it to commute to their jobs. Today's edition of 5 Things AM was edited and produced by CNN's Andrew Torgan.
CNN
an hour ago
- CNN
5 things to know for July 25: Thailand-Cambodia, France, AI, Sanctuary city lawsuit, Skydance-Paramount merger
In addition to telling time, smartwatches can track your steps, heart rate, blood pressure and sleeping patterns. Now, a smartwatch has helped search and rescue teams locate a small plane after it crashed into the dense forests near West Yellowstone, Montana. Here's what else you need to know to get up to speed and on with your day. More than 100,000 civilians have been displaced following a second day of violence along the disputed 500-mile land border between Thailand and Cambodia. At least 16 people were also reportedly killed, officials from both countries said. Tensions between the Southeast Asian neighbors have been boiling for months. Around 4:30 a.m. local time on Friday, clashes broke out with Cambodian troops using small arms and heavy weapons and Thai troops responding with artillery fire. On Thursday, when Thailand deployed fighter jets to attack Cambodian military targets, Cambodia vowed to 'respond decisively.' French President Emmanuel Macron said on Thursday that France will recognize a Palestinian state in an announcement at the UN General Assembly in September. France will be the first member of the UN Security Council and the G7 nations to do so. 'We must build the state of Palestine, ensure its viability, and ensure that by accepting its demilitarization and fully recognizing Israel, it contributes to the security of all in the Middle East. There is no alternative,' he wrote on X. Macron also called for an immediate ceasefire, access to humanitarian aid for the population of Gaza, the release of all hostages and the demilitarization of Hamas. Secretary of State Marco Rubio said the US 'strongly rejects' Macron's plan. The Department of Health and Human Services (HHS) has started using artificial intelligence, and behind the scenes, the practice has caused some alarm. An AI project known as Elsa is supposed to help speed up drug and medical device approvals at the FDA, a division of HHS. Six current and former FDA officials told CNN that Elsa can be useful for generating meeting notes and summaries, or email and communique templates, but it also invented studies and misrepresented research. In at least one instance — when an employee asked Elsa to generate something for a project — it insisted that the research area was not in the FDA's purview, even though it was. Elsa also cannot help with the lengthy assessment process that agency scientists undertake to determine whether drugs and devices are safe and effective because it can't access many of the files needed to answer basic questions. The Justice Department has filed a lawsuit against New York City over its so-called 'sanctuary city' policies. The move comes just days after the Trump administration blamed those policies for the shooting of an off-duty US Customs and Border Protection officer in an apparent robbery gone wrong. As part of the administration's widespread crackdown on undocumented immigrants, similar lawsuits have also been filed against Colorado, Illinois, Los Angeles, New York state, the city of Rochester, New York, and several New Jersey cities, the DOJ said in a statement. NYC Mayor Eric Adams said the city will review the lawsuit. 'Keeping New Yorkers safe also means making sure they feel safe, and we have been clear: no one should be afraid to dial 911, send their kids to school or go to the hospital, and no New Yorker should feel forced to hide in the shadows,' Adams said in a statement. The FCC approved the pending merger between Skydance Media and Paramount Global on Thursday. Voting 2-1 along party lines, the commissioners gave the go-ahead to the $8 billion deal, which has been mired in allegations of political interference stemming from President Trump's scathing criticism and his lawsuit against Paramount's CBS News division. But on July 1, Paramount agreed to pay $16 million toward Trump's future presidential library to resolve his legally dubious suit about an edit made to a '60 Minutes' interview with then-Vice President Kamala Harris before the November presidential election. Although Paramount and the FCC both insisted that the payout was unrelated to the merger review process, many likened it to a 'bribe.' GET '5 THINGS' IN YOUR INBOX If your day doesn't start until you're up to speed on the latest headlines, then let us introduce you to your new favorite morning fix. Sign up here for the '5 Things' newsletter. Amy Sherald, who gained national fame for her official portrait of former first lady Michelle Obama in 2018, was told that the museum had 'concerns' about one of her paintings. The head of human resources at the New York-based tech company and her boss were seen embracing on the 'kiss cam' during a Coldplay concert. Video of the encounter quickly went viral. The 12-year-old baseball player faced suspension for what he did last week after hitting a game-winning home run. High cocoa costs are prompting a major confectionery company to hike prices for chocolate candy. 'What have you done?' Victoria Beckham, the soccer star's wife, asked when she saw it. Legendary jazz musician Chuck Mangione diesThe noted flugelhorn player, trumpeter and composer became known for his signature tune 'Feels So Good,' which spent 25 weeks on the Billboard Hot 100 chart, peaking at #4 in 1978. Throughout his six-decade career in music, Mangione received 14 Grammy nominations and won the award twice. He also made recurring appearances on the Fox animated series 'King of the Hill,' where he played a tongue-in-cheek version of himself. Which city may soon become the first modern capital in the world to run completely out of water?A. Kabul, AfghanistanB. Mexico City, MexicoC. Baghdad, IraqD. Sanaa, Yemen Take me to the quiz! $250That's how much the US plans to charge international visitors for a new 'visa integrity fee.' The provision was included in President Trump's recently enacted domestic policy bill. 'Crazy!! My House got Home Invaded Saturday While I was in Indianapolis performing for the WNBA all star game & instead of Focusing on finding the Suspects, they focus on some cannabis.' — GloRilla on X. The Grammy-nominated rapper is facing felony drug charges after police responded to her Georgia home following a separate report of a burglary in progress. 🌤️ Check your local forecast to see what you can expect. This Swiss river is so clean that locals use it to commute to their jobs. Today's edition of 5 Things AM was edited and produced by CNN's Andrew Torgan.
