Categories
Life Style

First US drug approved for a liver disease surging around the world

[ad_1]

Coloured TEM of a section through liver tissue in a case of hepatic steatosis (fatty liver disease).

Liver tissue from a person with extra fat in the organ.Credit: IKELOS GmbH/Dr. Christopher B. Jackson/Science Photo Library

For the first time, the US Food and Drug Administration has approved a drug to treat an obesity-linked liver disease that is on the rise around the globe and is becoming a leading driver of liver failure and transplants.

The drug, called resmetirom, has been shown to reduce scar tissue in the liver and other hallmarks of a disease called metabolic dysfunction-associated steatohepatitis (MASH). MASH is often associated with the metabolic turmoil that can accompany obesity and diabetes, and in severe cases can lead to liver failure or cancer.

The disease affects an estimated 5% of the world’s adults. “It’s a huge population,” says Na Li, a hepatologist at Ohio State University Wexner Medical Center in Columbus. “And I think we have made a big step forward to improve their care.”

Worth the wait?

That step has been a long time coming: despite the clear need, pharmaceutical companies have struggled to develop a successful treatment for MASH. Last year, Intercept Pharmaceuticals in Morristown, New Jersey, abandoned a highly anticipated drug called obeticholic acid, amid concerns from the US Food and Drug Administration (FDA) that its modest effectiveness was not enough to outweigh safety risks.

“Many trials over the years have failed, even those that initially looked promising,” says Li. “That’s the tragedy we’ve had.”

MASH is caused by an accumulation of toxic, fatty molecules in the liver. Over time, this leads to inflammation and tissue damage. As the liver begins to accumulate scar tissue, a process called fibrosis, its ability to function declines. (MASH was called nonalcoholic steatohepatitis, or NASH, until professional societies adopted new nomenclature last year.)

Resmetirom boosts the liver’s ability to respond to thyroid hormone, which in turn stimulates the organ’s metabolism of fatty acids. In a year-long, multinational clinical trial in 966 people with MASH, researchers found that the drug reduced inflammation and fat build-up in 30% of participants who received the highest dose of resmetirom, compared with about 10% of those who took a placebo1. Fibrosis improved in about 26% of the highest-dose group, compared with 14% of the placebo group, making resmetirom the first candidate MASH drug to reduce fibrosis. It will be marketed as Rezdiffra and will be available to people with moderate to severe liver scarring.

Long-term benefits in doubt

The drug’s effectiveness, coupled with relatively mild side effects, was exciting and suggested that there could finally be a way to treat MASH, says Maya Balakrishnan, a gastroenterologist at Baylor College of Medicine in Houston, Texas. But the FDA granted resmetirom accelerated approval: for the drug to stay on the market, its developer, Madrigal Pharmaceuticals in Conshohocken, Pennsylvania, will eventually need to provide long-term evidence that it produces meaningful benefits.

“Only time will tell,” says Balakrishnan. “In the end, what matters is: does this drug improve survival?”

In the meantime, researchers are eagerly anticipating results from a study of semaglutide, a popular weight-loss drug, against MASH. Weight loss has been associated with a reduction in MASH severity, but an early clinical trial of semaglutide in participants with MASH yielded mixed results: some hallmarks of the disease improved, but liver fibrosis did not2. Still, researchers hope that semaglutide could help, and that the larger ongoing trial will provide clearer results, says Li.

In the meantime, resmetirom could be the best recourse for people with MASH. But physicians must be clear about the limited data on the drug when they discuss resmetirom with their patients, says Balakrishnan.

Access will be another issue, she says. Many of the people most in need of treatment are members of disadvantaged communities in which obesity and diabetes are prevalent. They often have limited access to health care, and it’s not yet known how much resmetirom will cost. “Who are the patients who are going to be able to access the medication?” says Balakrishnan. “It’s definitely a big concern.”

Potential blockbuster

Access in other countries will have to wait. Madrigal Pharmaceuticals’ clinical trials of resmetirom focused on the United States, says Claudia Oliveira, a pathologist at the University of São Paulo in Brazil. “We did not get the opportunity to see this drug in patients in Latin America,” she says. “But we all have expectations about the drug, because the results of the trial were very, very interesting.”

“Madrigal is a small company and chose to focus on a more limited geographic footprint for our trials,” a spokesperson for the company told Nature.

That decision likely helped speed the company’s first approval, says Norberto Chavez Tapia, a hepatologist at Médica Sur in Mexico City. Soon, he predicts, resmetirom will be investigated in clinical trials around the world.

After that, depending on the drug’s price and effects on transplants and survival, resmetirom could be welcomed in many health-care systems, says Tapia: “It’s a very attractive drug for us, worldwide.”

[ad_2]

Source Article Link

Categories
News

Spotify Complains That Apple Hasn’t Approved Update With Subscription Pricing and Links in EU

[ad_1]

Apple has not approved a Spotify app update that adds information on subscription pricing and links its website, Spotify complained today in an email to the European Commission (via The Verge). Spotify says that Apple has not “acknowledged nor responded” to its App Store submission.

Apple vs Spotify feature2
The European Commission on March 4 fined Apple almost $2 billion and said that Apple abused its dominant position in the market by preventing music streaming services from telling users about more affordable subscription prices outside of their iOS apps. The EC said that it is “illegal under EU antitrust rules” for Apple to keep developers from telling customers about cheaper music subscription options.

Apple was told that it must “remove anti-steering provisions” in the European Union, and so on March 5, Spotify submitted an app update that included subscription pricing tiers and options to pay without using in-app purchase. Spotify says that it has not had a response from Apple since submitting the update.

Spotify told the European Commission that Apple’s lack of response is “yet another example” of how Apple “will seek to circumvent and/or not comply with the Commission’s decision.” Spotify asked the EC to require Apple to approve the app update.

In a statement to The Verge, Spotify also said that Apple’s delay “directly conflicts” with Apple’s statements about processing app submissions within 24 hours, and “flies in the face of the timeline for adoption” from the EC.

It’s been nine days now and we’re still waiting to hear from Apple about our app submission to show EU consumers pricing and a link to our website, which we are now authorized to do by the European Commission’s decision on the music streaming case. Apple’s delay directly conflicts with their claim that they turn around reviews on app submissions within 24 hours, and it also flies in the face of the timeline for adoption the Commission laid out.

The ruling from the European Commission that requires Apple to eliminate anti-steering rules is separate from the app ecosystem changes that Apple made in the European Union with iOS 17.4 to comply with the Digital Markets Act (DMA).

Under the terms of the DMA, Spotify is allowed to distribute a Spotify app to EU users outside of the ‌App Store‌, but it would be required to pay Apple’s Core Technology Fee for each user. Spotify currently does not pay Apple any commission.

The DMA also permits Spotify to direct users to make purchases on its website while also providing information on in-app promotions, discounts, and deals, but again, Spotify would need to agree to Apple’s updated business terms and fees to implement these changes. Spotify has not clarified if it adopted Apple’s new terms or if its update has been submitted without doing so.

[ad_2]

Source Article Link

Categories
News

Deals: TOKK Fingerprint TSA Approved Lock PL 16

TOKK Fingerprint

Imagine a world where you no longer have to remember combinations or keep track of tiny keys. A world where your unique fingerprint is all you need to secure and access your belongings. That world is here, thanks to the TOKK™ Fingerprint TSA Approved Lock PL 16. This lock is not just a gadget; it’s a game-changer, a travel companion, and a guardian of your valuables.

The TOKK™ Fingerprint Lock is designed to offer you quick access in under 0.5 seconds. It can be programmed with up to 10 fingerprints, making it perfect for family use or shared access. The lock supports 360° any direction press fingerprint identification, meaning you don’t have to worry about the perfect angle or position. Just press and go!

Key Features of the TOKK™ Fingerprint TSA Approved Lock PL 16

  • Super durable steel shackle for robust protection
  • Quick access in under 0.5 seconds
  • Can be programmed with up to 10 fingerprints
  • Weatherproof, functioning in temperatures ranging from -4F to +158F
  • Powered by a Li-ion battery, providing up to 3 months of standby time after a 45-minute charge
  • 3-color LED status indicator
  • TSA-approved, making it suitable for airport luggage, travel backpacks, etc.

The TOKK™ Fingerprint Lock is not just about convenience; it’s about security too. The super durable steel shackle offers robust protection, ensuring your belongings stay safe. The lock is also TSA-approved, making it suitable for airport luggage, travel backpacks, and more. You can travel with peace of mind, knowing that airport security can access your luggage if necessary without damaging your lock.

But what about the battery life, you ask? The lock is powered by a Li-ion battery, which after a mere 45-minute charge, provides up to 3 months of standby time. And with the 3-color LED status indicator, you’ll always know when it’s time to recharge. The lock is also weatherproof, functioning in temperatures ranging from -4F to +158F, making it a reliable companion for all your adventures.

The package includes the TOKK™ Fingerprint TSA Approved Lock PL 16, a charging cable, and a user manual. And the best part? It ships to the US. So why wait? Embrace the future of security with the TOKK™ Fingerprint TSA Approved Lock PL 16 today. It’s not just a lock; it’s a lifestyle upgrade.

Get this deal>

Filed Under: Deals





Latest timeswonderful Deals

Disclosure: Some of our articles include affiliate links. If you buy something through one of these links, timeswonderful may earn an affiliate commission. Learn about our Disclosure Policy.

Categories
News

PowerGo pocket 5,000mAh airline approved power bank

PowerGo pocket 5,000mAh airline approved transparent power bank

A reliable and efficient power source is crucial to keep our devices running on a daily basis. One such solution comes in the form of PowerGo, a lightweight, portable wireless charging power bank. This device stands out due to its unique combination of features, which include wireless charging capabilities, a high power output, and the ability to charge multiple devices simultaneously.

Wireless charging is a key feature of PowerGo. It is capable of charging a phone, watch, and earphones wirelessly. This eliminates the need for multiple cables and allows for a more streamlined and clutter-free charging experience. However, it’s worth noting that devices need to support magnetic wireless charging to utilize this feature. Pre-launch early bird pledges are now available for the avant-garde project from roughly $39 or £33 (depending on current exchange rates).

“Are you tired of running out of battery on your phones, phones or the other mobile devices when you need them the most? We understand the frustration, and that’s why we bring you our cutting-edge PowerGo – the ultimate solution to keep your devices powered up on the go, which can be used for both wired and wireless charging. Designed with convenience, capacity, and style in mind, PowerGo is a game-changer in the world of portable charging.”
PowerGo power bank features

PowerGo’s power output is another aspect that sets it apart. The power bank has a maximum power output of 15W for phones or earphones and 2.5W for watches. This high power output means that devices can be charged quickly and efficiently, reducing the amount of time users need to wait for their devices to recharge.

Wireless charging

In addition to wireless charging, PowerGo also includes a USB-A port with Quick Charge (QC) protocol and a USB Type-C port with both QC and Power Delivery (PD) protocols. These features allow for faster charging times and greater compatibility with a wide range of devices.

“Immerse yourself in the futuristic and stylish vibe of PowerGo’s transparent body. With its crystal-clear casing, the inner workings of PowerGo are on display, showcasing its sleek circuitry and innovative technology. It’s not just a power bank but a fashion statement.”

One of the most impressive features of PowerGo is its ability to charge up to three devices simultaneously. This is achieved through its expandable charging cable and wireless charging capabilities. This feature is particularly useful for those who frequently use multiple devices and need to keep them all charged.

Assuming that the PowerGo funding campaign successfully raises its required pledge goal and fullfilment progresses smoothly, worldwide shipping is expected to take place sometime around February 2024. To learn more about the PowerGo transparent airline approved power bank project watch the promotional video below.

Transparent power bank

PowerGo’s battery capacity is another notable feature. With a capacity of 5,000mAh, it can provide enough power to fully charge most smartphones at least once. Despite its high battery capacity, the power bank can be fully recharged in approximately 1.3 hours thanks to its 18W charging power.

“As long as you have PowerGo, you don’t have to worry about running out of power on your phone, earphones or other electronic devices when you’re on a business trip. And you don’t need to prepare your own wires. By utilizing the wireless charging function of PowerGo or the built-in expandable cable, you can solve all your charging needs and enjoy easier business trips!”

Despite its powerful capabilities, PowerGo is incredibly lightweight and portable. Weighing only 200g, it’s easy to carry around, making it ideal for those who are always on the go. Its compact design also means it can easily fit in a pocket or bag.

Furthermore, PowerGo is an airline-approved power bank. This means that it meets the safety standards set by airlines and can be carried on flights without any issues. This is a significant advantage for frequent travelers who need to keep their devices charged during long flights.

Lightweight and compact

PowerGo power bank wireless charging

PowerGo is a versatile and efficient power bank that offers wireless charging, a high power output, and the ability to charge multiple devices simultaneously. Its lightweight and portable design, combined with its airline-approved status, make it an excellent choice for those who need a reliable power source on the go.

For a complete list of all available early bird pledges, stretch goals, extra media and material specifications for the transparent airline approved power bank, jump over to the official PowerGo crowd funding campaign page by investigating the link below.

Source : Kickstarter

Disclaimer: Participating in Kickstarter campaigns involves inherent risks. While many projects successfully meet their goals, others may fail to deliver due to numerous challenges. Always conduct thorough research and exercise caution when pledging your hard-earned money.

Filed Under: Gadgets News, Top News





Latest timeswonderful Deals

Disclosure: Some of our articles include affiliate links. If you buy something through one of these links, timeswonderful may earn an affiliate commission. Learn about our Disclosure Policy.

Categories
News

Microsoft & Activision deal approved by UK regulators

microsoft & activision

The Microsoft & Activision deal has now received full approval from UK regulators, the news was announced today after an initial confirmation last month that the changes Microsoft had made were enough for the regulators.

Microsoft announced last month that it would sell Activision’s Cloud Streaming rights to Ubisoft and this allowed for the deal to be approved with the UK regulators.

As a result of this concession, the CMA agreed to look afresh at the deal and launched a new investigation in August. That investigation has completed today with the CMA clearing this narrower transaction.

The new deal will stop Microsoft from locking up competition in cloud gaming as this market takes off, preserving competitive prices and services for UK cloud gaming customers. It will allow Ubisoft to offer Activision’s content under any business model, including through multigame subscription services. It will also help to ensure that cloud gaming providers will be able to use non-Windows operating systems for Activision content, reducing costs and increasing efficiency.

The Microsoft & Activision deal is expected to be finally concluded before the end of 2023, ads soon as we get some details on exactly when it will be finalized, we will let you know.

Source Gov UK

Image Credit: Dimitris Chapsoulas

Filed Under: Gaming News, Technology News





Latest timeswonderful Deals

Disclosure: Some of our articles include affiliate links. If you buy something through one of these links, timeswonderful may earn an affiliate commission. Learn about our Disclosure Policy.

Categories
News

INIU PowerNova airline approved 140w power bank battery pack

INIU PowerNova airline approved 140w power bank

The INIU PowerNova is a high-capacity power bank that has been designed with the modern, tech-savvy consumer in mind. This 140W, 27,000 mAh battery pack is not just a portable charger, but a versatile charging hub that can cater to a variety of devices, from laptops to smartphones, and even gaming consoles like the SteamDeck.

One of the standout features of the INIU PowerNova is its 140W fast charge capability. This feature allows it to charge high power demand devices rapidly, making it an ideal companion for long journeys, outdoor excursions, camping trips, and international travels.

INIU PowerNova

For instance, it can charge a Macbook Pro 16” to 59%, a Steam Deck to 57%, an iPad Pro M2 to 64%, an iPhone 15 Pro Max to 71%, and a Samsung S23 Ultra to 75% in just 30 minutes. This level of efficiency and speed is a testament to the power bank’s robust performance. Early bird bargains are now available for the clever project from roughly $110 or £91 (depending on current exchange rates).

The INIU PowerNova is not just about speed, but also versatility. It features three charging ports: a PD 3.1 140W USB-C in/out port, a PD 45W USB-C fast charging port, and a USB-A port. This variety of ports makes it compatible with various cable types, allowing it to rapidly charge all your devices, regardless of their make or model.

Airline approved power bank

airline approved battery pack

Other battery packs you may find interesting :

Moreover, the INIU PowerNova is designed to be a multi-device fast charging hub. It uses intelligent power distribution technology to ensure fast charging for multiple devices simultaneously. This means you can charge your laptop, smartphone, and tablet all at the same time, without compromising on the charging speed of any device.

Another noteworthy feature of the INIU PowerNova is its support for pass-through charging. This feature allows you to charge the battery pack while also charging your devices. This can be particularly useful in situations where you have limited access to power outlets, such as during travel or camping.

Assuming that the INIU PowerNova funding campaign successfully raises its required pledge goal and the project completion progresses smoothly, worldwide shipping is expected to take place sometime around November 2023. To learn more about the INIU PowerNova airline approved power bank project check out the promotional video below.

140w Battery pack

The INIU PowerNova is a high-capacity power bank that offers fast charging capabilities, versatility, and convenience. Its 140W fast charge, multi-device fast charging, and pass-through charging features make it a reliable power solution for a variety of devices and situations. Whether you’re on a long journey, an outdoor excursion, or simply need a reliable power source for your devices, the INIU PowerNova is a battery pack that delivers on its promises.

For a complete list of all available pledge options, stretch goals, extra media and material specifications for the airline approved power bank, jump over to the official INIU PowerNova crowd funding campaign page by following the link below.

Source : Kickstarter

Disclaimer: Participating in Kickstarter campaigns involves inherent risks. While many projects successfully meet their goals, others may fail to deliver due to numerous challenges. Always conduct thorough research and exercise caution when pledging your hard-earned money.

Filed Under: Gadgets News, Top News





Latest timeswonderful Deals

Disclosure: Some of our articles include affiliate links. If you buy something through one of these links, timeswonderful may earn an affiliate commission. Learn about our Disclosure Policy.