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MedTech

Europe pools resources into COVID-19 R&D initiative ‘CARE’

Adnan Kayyali

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7Europe pools resources into COVID-19 R&D initiative ‘CARE’

Accelerated R&D in Europe (CARE) has been launched by a European consortium forming a united front dedicated to COVID-19 R&D for better and more accessible treatments for COVID-19 throughout the continent. It is the first endeavor of its kind and seeks to research, create, and develop new drugs and antibodies as effective therapies for COVID-19.

CARE comprises 37 public-private partners, including universities, research centers, small and medium enterprises, academic professionals, scientists, in association with the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Innovative Medicines Initiative (IMI). Their combined capabilities aim to bolster COVID-19 R&D efforts for a more stable future.

“Beyond the scientific excellence of the different teams involved in this very ambitious project, CARE is bringing together 37 partners in an alliance pooling their expertise and know-how around an ambitious five-year work plan to develop therapeutics against the current COVID-19 pandemic”, said Executive Director of the VRI-Inserm and CARE Coordinator, Professor Yves Levy. “We are very grateful for the financial support provided by the Innovative Medicine Initiative that will enable us to implement this plan.”

By means of a computer modeling and simulation technique called ‘in silico’ screening and analysis, researchers will search through and examine existing treatments of other ailments related to covid-19, and viruses like it, to be repurposed for COVID-19.

After analyzing and profiling possible candidates, top picks will undergo the first rounds of testing. From there, the most promising options will move on to the next stages involving human participants.

With the combined efforts and resources of every member and the drive and spirit to work fast and collaborate, CARE might be able to hit turbo on COVID-19 R&D, and hopefully achieve life-saving results.

“COVID-19 is a once in a lifetime scientific challenge for our generation,” said Kumar Saikatendu, Director of Global Research Externalization, Takeda. “CARE aims to create effective therapies with a positive safety profile for current and future coronaviral outbreaks. We hope to move fast and have a meaningful impact in a timely manner.” 

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MedTech

J&J single dose COVID-19 vaccine receives FDA emergency use authorization

Inside Telecom Staff

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single dose COVID-19 vaccine

Johnson & Johnson’s single dose COVID-19 vaccine has received its Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to prevent COVID-19 in individuals 18 years of age and older.   

The vaccine was developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, and received authorization based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”

According to a company statement, J&J will look to make its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The company has begun shipping its COVID-19 vaccines to the U.S. government and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S.

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “A vaccine that protects against COVID-19, especially against the severe outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide.”

The company plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. “The U.S. government will manage allocation and distribution of the vaccine in the U.S. This will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP) guidelines,” the statement read.

In parallel, J&J recently announced its submission of a European Conditional Marketing Authorization Application to the European Medicines Agency as well as its filing for an Emergency Use Listing (EUL) with the World Health Organization for its COVID-19 vaccine candidate.

“We are thankful for the efforts of all those who have volunteered to participate in our clinical trials, our scientists, collaborators, clinical trial sites and investigators. Through the combined commitment of everyone involved, we have been able to discover, develop and manufacture a single dose COVID-19 vaccine to protect people around the world,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. 

According to the company, the vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C).

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MedTech

Wearable tech market to more than double in growth by 2026

Inside Telecom Staff

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Wearable tech

Over the years, fitness technology has grown from the bulky fridge-like mainframes to the sleek finesse of fitbits, containing more processing power than the computers that put a human on the moon.

For context, innovative tech has gone from having a dedicated room to a dedicated pocket, allowing us to work, study and monitor our health. 

Which is exactly why wearable tech is regarded as an emerging trend that integrates electronics to the daily activities and fits into the changing lifestyles and can be worn on any part of the body. As such, experts predict that the next market with this same growth potential will be wearable technologies market.

A report from Mordor Intelligence projects that the Wearable Technology Market was valued at USD 27.91 billion in 2020 and is expected to reach USD 74.03 billion by 2026 and work at a CAGR of 17.65 percent over the forecast period (2021 – 2026).

The report published that the ability to connect to the Internet and the establishment of data exchange between a network and a device is the driving factor that led to increases wearable tech. The study considered several wearable technologies, including Smartwatches, Head Mounted Displays, Smart Clothing, Ear Worn, Fitness Trackers, Sleep Aides and wellness devices among others.

The report tracks both the volume and value of these products at a global level and region level in specific. The wearable tech market has evolved owing to the emergence of sensors among other technology.

Incorporating these sensors into a dedicated wearable device driven by the impact of smartphones being used daily, on the GPS, or the IMU (consist of accelerometer, gyroscope, and magnetometer), the report explained, mentioning that they have helped the fitness tracking wearable to monitor body activities using these sensors. 

“The smartwatch category is also experiencing a rise, owing to the additional features, like the brand that suits the everyday lifestyle. Smartwatches are seeing a surge in new users, including the older population, because wearable makers, such as Apple and Fitbit, are adding health-monitoring features that appeal to older people and keep them updated about their health status in real-time,” the Mordor Intelligence report continued.

A perfect example of this is Apple’s features such as a fall detection app and an EKG monitor to the Apple Watch Series 4, while Fitbit added a feature to detect sleep apnea. According to the report, Apple’s 2019 fiscal year noted that it got nearly as much revenue from sales of its collection of wearable products and accessories as it derived from selling its old Mac computers which appears well on its way to becoming its second most significant line of products after the iPhone and its third-largest business category overall after its smartphone and services segment.

The company’s booming wearables and accessories segment helped to make up for the declining iPhone sales. In the period, sales of wearable and accessories products grew 54 percent in the last quarter of 2019 compared to the prior year to USD 6.5 billion, the report further explained.

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MedTech

Chronic heart and kidney failure to be treated by implantable device

Karim Hussami

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implantable device

While all sectors in our lives are being updated with the recent technological trends and ways to facilitate people’s lives, new technologies are being created to help people with their health amongst other issues.

As such, Paragate Medical, an NGT3 VC portfolio company, has developed a remote, implantable device solution for heart and kidney failure patients.

Most remote solutions use telematics to offer some type of remote monitoring, however founders Dr. Yair Feld, Nitai Hanani, and the team at Paragate have developed a solution that monitors and provides 24/7 home-based care to patients coping with chronic heart and kidney failure.

Mechanical bypass of the kidneys

Relatively recent research has shown that heart failure is a significant risk factor for kidney disease. As in, when the heart is no longer pumping efficiently, it becomes congested with blood, causing pressure to build up in the main vein connected to the kidneys and leading to congestion of blood in the kidneys, too.

Diuretics are currently the gold standard treatment but of the 26 million heart failure patients annually around the world, over one third are diuretic resistant, according to CORDIS, EU research results.

“Current solutions for fluid overload in diuretic resistant patients such as IV diuresis, ultrafiltration therapy and peritoneal dialysis all carry complications and are acute treatments which do not prevent recurrence,” the research said.

Paragate’s IPUD (Implantable Peritoneal Ultrafiltration Device) is a minimally invasive and fully implantable device that serves as a mechanical bypass of the kidneys. It actively, continuously, and non-aggressively removes excess fluid from the body to keep patients balanced at home.

How does it work?

IPUD improves the clinical condition of fluid overloaded patients by continuously removing extracellular fluids with a unique implantable peritoneal ultrafiltration device, operating non-aggressively and independently from the kidneys’ function.

The device is minimally invasive and the flat absorption device interfaces with the intraperitoneal membrane and applies a hydrostatic pressure gradient. It then continuously and slowly absorbs systemic isotonic extracellular fluid and drains it to the urinary system preventing recurred accumulation.

The device has a projected service life of 3 years and recharging the device has been made simple for the patients via wireless charging, needed on a weekly basis.

The company conducted successful preclinical studies and is planning to begin the clinical trials this year.

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