The generic version of the COVID-19 oral antiviral therapy candidate nirmatrelvir has been approved by the World Health Organization Prequalification of Medicines Program (WHO PQ), as stated by the Indian pharmaceutical company Hetero.

This is the first prequalification for a generic form of PAXLOVID, an oral antiviral medicine manufactured by Pfizer and designated by the WHO as the best therapeutic option available for high-risk patients. Nirmatrelvir and ritonavir were strongly advised by the WHO for mild and moderate COVID-19 patients who were at the greatest risk of being admitted to the hospital, such as those who were immunosuppressed, elderly, or hadn’t had a vaccine.

Nirmatrelvir 150 mg (2 pills) and ritonavir 100 mg are both included in the combo pack, which Hetero is marketing as NIRMACOM (1 tablet). Only by prescription, it must be started within five days after the onset of symptoms and as soon as COVID-19 has been diagnosed. The production of NIRMACOM will take place at Hetero’s facilities in India.

In order to produce and market a generic version of Pfizer’s COVID-19 oral antiviral therapy candidate, nirmatrelvir, in low- and middle-income nations, Hetero engaged in a non-exclusive voluntary licencing agreement with Medicines Patent Pool.

Oceanit, a mind to market company, announced that the US FDA has granted Emergency Use Authorization (EUA) for over-the-counter (OTC) use for ASSURE-100 Rapid Covid-19 Home Test.

ASSURE-100 was previously granted FDA EUA for point-of-care use on February 28, 2022. Oceanit’s at-home test EUA application followed from an entirely new and separate clinical study that was completed and submitted for review to the FDA on May 24, 2022.

“Once the FDA reviewer was able to get to our application, it went quickly, but the process required timely Oceanit responses, typically within 48 hours of a question or request for clarification. This requirement had the Oceanit team flying across the country to collect data or use special equipment,” said Dr. Patrick Sullivan, Oceanit’s CEO, “However, once we developed a rhythm with the FDA team, we were impressed that they also worked evenings and weekends to get this done.” Oceanit’s ASSURE-100 was one of thirteen Covid-19 OTC tests authorized by FDA this year.

Rapid antigen tests are less expensive and faster than traditional polymerase chain reaction (PCR) tests, offering people an easy and low-cost way to protect family members, classmates, and co-workers during, especially important for the holidays. At-home rapid testing makes it possible for individuals to know their infection status quickly and monitor health over time. A positive result enables the infected person to inform personal decisions, such as isolating or seeking medical treatment, as necessary.

The FDA OTC authorization is a huge milestone for Oceanit, a Hawaii-based technology company of just 200 people.

“I’m very proud of the Oceanit team for creating an affordable rapid test with market-leading accuracy,” said Dr. Sullivan. “Despite being a small team, we did the science, created a user-friendly design, and executed national clinical studies. We set out to develop the simplest, most intuitive, and affordable instrument-free rapid antigen test in the world – and accomplished just that.”

“ASSURE-100 can detect a Covid-19 infection earlier in a person’s infection cycle compared with most other rapid tests on the market, enabling informed decisions – and preventing spread,” Sullivan continued. “Together with vaccines, the ASSURE-100 Rapid Covid-19 Home Test will help our communities stay safe as we go back to our normal routines at work, school, and spending time with family and friends.”

During the development of the ASSURE-100 Rapid Covid-19 Test, Oceanit received support from The Queens Medical Center in Hawai’i, The US Navy Office of Naval Research (ONR), the Defense Advanced Research Project Agency (DARPA), and the Defense Logistics Agency (DLA), as well as the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics’ (RADx) Program, the University of Hawaii School of Tropical Medicine, and Adventists Health Castle Medical Center, among others. Oceanit is grateful for the local community, and global support, of small business innovation in Hawai’.

The ASSURE-100 Rapid Covid-19 Home Test is now labelled by the FDA for serial asymptomatic testing, meaning that people can test themselves regularly to monitor their infection status even without symptoms. ASSURE-100 kits contain only three simple components – a swab, vial, and test cassette – making them easy to use and affordable. The shallow nasal antigen test delivers a result in 20 minutes. Oceanit’s clinical trials for ASSURE-100 over-the-counter use demonstrated an excellent lower limit of detection, sensitivity of 84.7% (positive percent agreement) and specificity of 100% (negative percent agreement) in patients suspected of Covid-19 infection.

Ultrasound sensor specialist Novosound has signed a commercial partnership agreement with PAVmed Inc., the Nasdaq-listed diversified medical technology company, to develop technology aimed at advancing intravascular imaging. The PAVmed agreement furthers Novosound’s move into healthcare, and its regional expansion into North America.

Dave Hughes, CEO and Co-Founder of Novosound, said: “PAVmed has a strong track record in delivering commercial stage medical technology across medical devices, diagnostics, and digital health – the group is the ideal partner for Novosound as we increasingly gain traction in the international healthcare sector.”

Lishan Aklog, M.D., Chairman and Chief Executive Officer of PAVmed, said: “We believe Novosound’s proprietary ultrasound technology has the potential to be a once-in-a-generation breakthrough in medical imaging. We are excited to partner with Novosound with the goal of revolutionising the global intravascular imaging market.”

Novosound recently secured its latest investment, a £3.7 million round led by Par Equity, supported by Foresight Group (via the Foresight Williams Technology EIS Fund), Kelvin Capital, and Scottish Enterprise.

Paul Munn, Partner, Par Equity, said: “Novosound has developed best-of-class remote sensor technology that is applicable across multiple sectors, the company continues to rack up international business wins including most recently with PAVmed, and Par is pleased to continue to support Dave and his team in the months and years ahead.”

Novosound’s patented thin-film manufacturing process, which eliminates conventional limitations in ultrasound sensors including the high cost of high-resolution imaging, also underpins the company’s pioneering non-destructive testing (NDT) products – the Kelpie, Belenus, and Nebula.

The company has announced a series of international contract wins over the last twelve months, including with aerospace groups BAE Systems and GE Aviation, and Israeli-based digital health company dSound.

Johnson & Johnson, the world’s largest, most diversified healthcare products company, announced it has completed its acquisition of Abiomed, Inc. Abiomed is now part of Johnson & Johnson and will operate as a standalone business within Johnson & Johnson’s MedTech segment.

“We are excited to officially welcome the talented Abiomed team to Johnson & Johnson. Their patient-first philosophy aligns with Our Credo and Our Purpose to change the future of health for humanity,” said Joaquin Duato, Chief Executive Officer of Johnson & Johnson. “This acquisition marks another important step on Johnson & Johnson’s path to accelerating growth in our MedTech business and delivering innovative medical technologies to more people around the world.”

Ashley McEvoy, Executive Vice President and Worldwide Chairman of MedTech at Johnson & Johnson, added, “The completion of this acquisition allows Johnson & Johnson MedTech to expand our portfolio in the high growth cardiovascular markets, adding solutions for heart recovery to our global market leading Biosense Webster electrophysiology business. Fueled by Johnson & Johnson’s global scale and commercial and clinical strength, we are excited to explore the opportunities and possibilities ahead to reach even more patients with critical unmet need.”

Johnson & Johnson’s tender offer for all outstanding shares of Abiomed for an upfront payment of $380.00 per share in cash, corresponding to an enterprise value of approximately $16.6 billion, which includes cash acquired, expired at 11:59 p.m., New York City time, on December 21, 2022. Abiomed shareholders will also receive a non-tradeable contingent value right (“CVR”) entitling the holder to receive up to $35.00 per share in cash if certain commercial and clinical milestones are achieved. American Stock Transfer & Trust Company, LLC, the depositary for the tender offer, has advised Johnson & Johnson that approximately 25,759,195 shares of Abiomed common stock were validly tendered and not properly withdrawn in the tender offer, representing approximately 57.1% of the then-outstanding shares of Abiomed’s common stock. All of the conditions to the tender offer have been satisfied, and on December 22, 2022, Athos Merger Sub, Inc. (“Purchaser”), a wholly-owned subsidiary of Johnson & Johnson, accepted for payment, and will as promptly as practicable pay for, all shares validly tendered and not properly withdrawn in the tender offer.

The acquisition was completed on December 22, 2022 through a merger of Purchaser with and into Abiomed in accordance with Section 251(h) of the General Corporation Law of the State of Delaware without a vote of Abiomed stockholders. In connection with the merger, shares of Abiomed that were not tendered in the tender offer were acquired by Johnson & Johnson and converted into the right to receive $380.00 per share in cash plus a CVR.

The transaction will not have a material impact on financial results for 2022. As previously announced, the transaction will accelerate pro forma MedTech and Johnson & Johnson enterprise revenue growth. It is also expected to be slightly dilutive to neutral to adjusted earnings per share in the first year, considering the impact of financing, and then accretive by approximately $0.05 in 2024, and increasingly accretive thereafter.

Spineart, a leading provider of spine surgery implants and eCential Robotics, a growth MedTech company that designs and produces an open system unifying robotics, surgical navigation, and 2D/3D robotic imaging, today announced they entered a long-term collaboration agreement.

The collaboration between the two companies involves research and development, marketing, and commercialization. Training centers for augmented spine surgery trial, both in the United States and Europe, will be available to surgeons in 2023. With a streamlined workflow and a smartphone-inspired user interface, spine surgeons will benefit from eCential Robotics’ state-of- the-art integrated platform, fully compatible with Spineart’s comprehensive and proven portfolio of innovative spine implants.

Jerome Trividic, Spineart CEO, commented: “There’s a strong cultural and geographical fit between our companies. Combining and leveraging eCential Robotics’ technology in navigation and robotics with Spineart’s expertise in Minimally Invasive Spine Surgery, is the ultimate expression of our Quality, Innovation, Simplicity philosophy. We strongly believe that our combined efforts will rapidly establish the integrated platform as the reference in augmented spine surgery with navigation and robotic assistance”.

Stéphane Lavallée, eCential Robotics CEO, declared: “We are pleased to collaborate with Spineart, a robust and fast-growing partner, which enables us to develop and market the equivalent of the smartphone for medical robots. Thanks to our “open” strategy, eCential Robotics is already collaborating, and will intensify its partnerships, with several technology companies and implant manufacturers to associate our platform with diverse 3D imaging devices and proprietary applications”.

Abbott announced that its FreeStyle Libre 3 sensor is now compatible with the mylife™ Loop solution from partners, Ypsomed and CamDiab, creating a smart, automated process to deliver insulin based on real-time glucose data. This automated insulin delivery system (AID) solution is now available in Germany and will be available in additional European countries beginning in 2023.

Advanced diabetes technologies, such as AID systems, are designed to help people living with diabetes improve their glucose control and reduce the burden of daily diabetes management. Integrating CamDiab’s CamAPS FX mobile app and Ypsomed’s mylifeTM YpsoPump®  with accurate2, real-time data from Abbott’s FreeStyle Libre 3 sensor, the connected solution continuously monitors a person’s glucose levels, and automatically adjusts and delivers the right amount of insulin at the right time, removing the guesswork of insulin dosing and helping people with diabetes reach better treatment targets.

“Our FreeStyle Libre portfolio is already helping to improve the lives of 4.5 million people around the world who are living with diabetes,” said Jared Watkin, senior vice president of Abbott’s diabetes care business. We’re partnering with diabetes and digital health technology leaders like Ypsomed and CamDiab to deliver new innovative solutions that make diabetes care as easy as possible, so people can spend less time worrying about their diabetes and more time living.

According to JDRF’s Type 1 Diabetes Index (T1D Index), the average person living with Type 1 diabetes in Germany loses 18.5 healthy years when their diabetes is not adequately managed. Healthy years lost represents time lost to ill health, disability or other complications from living with Type 1 diabetes. Nearly five healthy years could be restored if they had access to devices that monitor glucose and automate insulin delivery. Globally, 673,000 more people could be alive in 2040 if everyone had access to technology that automates glucose monitoring and insulin delivery.

“As healthcare providers, one of the biggest challenges of insulin therapy is when glucose levels get dangerously low,” said Dr. Rich Bergenstal, Executive Director of the International Diabetes Center, HealthPartners Institute in Minneapolis, Minnesota. “Technological innovations, like automated insulin delivery systems, can ease some of that uncertainty by continuously monitoring a person’s glucose levels and delivering the right insulin dosage, which can ultimately improve time in range. And better glucose control reduces diabetes complications.”

Ultrasound sensor specialist Novosound has signed a commercial partnership agreement with PAVmed Inc., the Nasdaq-listed diversified medical technology company, to develop technology aimed at advancing intravascular imaging. The PAVmed agreement furthers Novosound’s move into healthcare, and its regional expansion into North America.

Dave Hughes, CEO and Co-Founder of Novosound, said: “PAVmed has a strong track record in delivering commercial stage medical technology across medical devices, diagnostics, and digital health – the group is the ideal partner for Novosound as we increasingly gain traction in the international healthcare sector.”

Lishan Aklog, M.D., Chairman and Chief Executive Officer of PAVmed, said: “We believe Novosound’s proprietary ultrasound technology has the potential to be a once-in-a-generation breakthrough in medical imaging. We are excited to partner with Novosound with the goal of revolutionising the global intravascular imaging market.”

Novosound recently secured its latest investment, a £3.7 million round led by Par Equity, supported by Foresight Group (via the Foresight Williams Technology EIS Fund), Kelvin Capital, and Scottish Enterprise.

Paul Munn, Partner, Par Equity, said: “Novosound has developed best-of-class remote sensor technology that is applicable across multiple sectors, the company continues to rack up international business wins including most recently with PAVmed, and Par is pleased to continue to support Dave and his team in the months and years ahead.”

Novosound’s patented thin-film manufacturing process, which eliminates conventional limitations in ultrasound sensors including the high cost of high-resolution imaging, also underpins the company’s pioneering non-destructive testing (NDT) products – the Kelpie, Belenus, and Nebula.

The company has announced a series of international contract wins over the last twelve months, including with aerospace groups BAE Systems and GE Aviation, and Israeli-based digital health company dSound.