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Covid-19 roundup: Watchdog criticizes EU Commission over president’s texts; Novavax signs vaccine deal with Israel

The European Ombudsman, an independent investigatory body in the EU, called out the EU Commission for failing to search for text messages between Commission president Ursula von der Leyen and Pfizer chief Albert Bourla.
Albert Bourla
According to Politico

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The European Ombudsman, an independent investigatory body in the EU, called out the EU Commission for failing to search for text messages between Commission president Ursula von der Leyen and Pfizer chief Albert Bourla.

Albert Bourla

According to Politico, text messages between von der Leyen and Bourla were requested by a journalist with netzpolitik.org, a German-language news website that focuses on surveillance and privacy. Those messages were referenced in an article by the New York Times last year on the EU’s purchase of 1.8 billion doses of the Pfizer-BioNTech vaccine.

The NYT article noted that “personal diplomacy played a big role” in the deal between Pfizer and the EU, saying that von der Leyen had been exchanging calls and text messages with Bourla for a month at a low point in the pandemic, after AstraZeneca announced production problems for its vaccine.

And despite the journalist specifically requesting those messages, the ombudsman, Emily O’Reilly, found that the Commission didn’t ask von der Leyen’s office to search for text messages. Rather, the Commission asked for items that met the Commission’s criteria for recording “documents.” Those do not include texts.

As for how O’Reilly responded? It’s maladministration.

“The narrow way in which this public access request was treated meant that no attempt was made to identify if any text messages existed,” O’Reilly said in a statement. “This falls short of reasonable expectations of transparency and administrative standards in the Commission.”

Novavax signs deal with Israel for up to 10 million vaccine doses

Novavax announced a deal this morning with Israel’s Ministry of Health to sell the country several million doses of its Covid-19 vaccine.

Here’s the catch: It’s still not approved in the country.

According to the biotech, the two signed an agreement for Israel to buy five million doses of the vaccine, and then leave open the option for Israel to buy another five million if the country so chooses. Novavax said it will work with the health ministry to obtain necessary authorizations and then finalize plans for distribution in Israel, pending regulatory approval.

Any financial details remain unspecified.

And while the vaccine is awaiting the A-OK from Israel’s health regulator, the biotech’s shot has earned conditional marketing authorization in the EU and an emergency use listing from the WHO. This is while Novavax continues to run two Phase III trials — one in the US and Mexico, and the other in the UK.

Molnupiravir shows activity against Omicron in preclinical in vitro studies

Merck and Ridgeback announced Friday morning that their collaborative antiviral molnupiravir potentially neutralizes the Omicron variant.

Wendy Holman

The two companies said data are in from six preclinical studies in Belgium, Czech Republic, Germany, Poland, the Netherlands and the United States. Ridgeback CEO Wendy Holman said in a statement that “based on its mechanism of action, along with these new findings demonstrating in vitro activity across multiple variants, including Omicron, we anticipate that molnupiravir will continue to be active against variants of concern.”

These researchers didn’t just study how molnupiravir can affect Omicron — they also looked at other variants and tested other drugs.

In one study, researchers in Japan wrote a letter to the editor at NEJM after looking at Gilead’s remdesivir, alongside molnupiravir and Pfizer’s new antiviral against Omicron. They came to the conclusion that all three may show efficacy against Omicron.

However, they expressed that what they found might be limited because of a lack of clinical data, emphasizing that additional data are needed to validate their preliminary findings.

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Government

Revive Therapeutics: Positive Comments From The FDA Regarding Primary Endpoint Change

The outlook for Revive Therapeutics Ltd. (CNSX: RVV, OTCMKTS: RVVTF) Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat…

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The outlook for Revive Therapeutics Ltd. (CNSX: RVV, OTCMKTS: RVVTF) Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19 got a little brighter on Thursday. The U.S Food and Drug Administration appears to be amenable to the company’s submitted request to change the trial’s primary endpoints to a ‘symptoms’ focus, as announced on May 16. Although the FDA did not officially grant primary endpoint change yet, Thursday’s news was enough to catalyze forward-looking investors into action, sending Revive shares higher in the U.S. by +21.06% on the best volume in six weeks.

Revive Therapeutics reported that pursuant to its submitted request to change the trial’s primary endpoints to a ‘symptoms’ focus, it has received “positive comments” from the FDA in regards to its request to amend new primary efficacy endpoints for the current trial. This includes the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in clinical outcome. The positive comments following Revive’s May 16 submission are a constructive sign that the FDA is an ally in the endpoint change process.

Furthermore—and perhaps unexpectedly—the FDA agreed that Revive Therapeutics may unblind the pre-dose-selection data for the first 210 patients of the study to further support the new primary endpoint. In essence, the FDA is giving Revive an opportunity to look directly at a portion of the data to make sure they want to proceed with the proposed endpoint change. Up to this point, the entire dataset of the 715 patients already tabulated in the trial have been blinded to the company.

Revive will submit a Data Access Plan to the FDA in early June 2022 with the aim to unblind the pre-dose selection data and submit the amended study protocol with the new primary efficacy endpoints to the FDA.

Under FDA Guidance for Clinical Trial Sponsors, knowledge of unblinded interim comparisons from a clinical trial is generally not necessary for those conducting or sponsoring it. Further, such knowledge can bias the outcome of the study by inappropriately influencing its continuing conduct or the plan of analyses. Unblinded interim data and results of comparative interim analyses, therefore, should generally not be accessible by anyone other than Data Monitoring Committee (DMC)—aka Data Safety Monitoring Board (DSMB) in the current trial—or the statisticians performing these analyses and presenting them to the DMC.

So for Revive Therapeutics to be allowed to peek under the hood before proceeding with symptoms endpoint change may be inferred as a goodwill gesture by the FDA.

Furthermore, Revive Therapeutics confirmed that the DSMB is scheduled to meet thereafter to evaluate the interim clinical and safety data and may make a recommendation on the study. This could involve the recommendation to continue or halt the study due to positive efficacy based on the resolution of symptoms of COVID-19—assuming the primary endpoint change to symptoms is approved. The DSMB could also recommend that the FDA consider Bucillamine for potential Emergency Use Authorization for the treatment of COVID-19 symptoms, should the data support such a recommendation.

The DSMB has previously met on three separate occasions and supported the continuation of the study each time. To date, no serious adverse events or safety concerns have been reported.

TDR will have additional coverage as events warrant.

The post Revive Therapeutics: Positive Comments From The FDA Regarding Primary Endpoint Change appeared first on The Dales Report.

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Sheila Ochugboju named Executive Director of Alliance for Science

Boyce Thompson Institute (BTI) is pleased to welcome Sheila Ochugboju as the new Executive Director of the Alliance for Science (AfS), a global communications…

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Boyce Thompson Institute (BTI) is pleased to welcome Sheila Ochugboju as the new Executive Director of the Alliance for Science (AfS), a global communications initiative dedicated to promoting access to scientific innovation as a means of enhancing food security, improving environmental sustainability, and raising the quality of life globally. Her start date is June 1.

Credit: Image provided/Sheila Ochugboju

Boyce Thompson Institute (BTI) is pleased to welcome Sheila Ochugboju as the new Executive Director of the Alliance for Science (AfS), a global communications initiative dedicated to promoting access to scientific innovation as a means of enhancing food security, improving environmental sustainability, and raising the quality of life globally. Her start date is June 1.

“We are delighted that Dr. Ochugboju will soon be joining us,” said BTI President David Stern. “The Alliance plays a vital role in connecting a range of stakeholders with up-to-date and vital information about how scientific advances can contribute to the future of the planet’s health, an effort that aligns perfectly with BTI’s mission to advance and communicate scientific discovery in plant biology to improve agriculture, protect the environment, and enhance human health.”

“We are fortunate to have someone with Sheila’s experience, connections and vision in this role,” Stern added.

Ochugboju is a leader in science communication and has been a global advocate for science technology and innovation for more than 20 years. She was most recently the Head of Strategic Communications at the Africa Centres for Disease Control and Prevention (Africa CDC), supporting vaccine delivery communication across Africa and advocating for vaccine equity.

She is also a founding member of the Network of African Women Environmentalists (NAWE), leading in the development of flagship initiatives and products such as the Earth Science Cafes, The Youth Earth Guardians and Landscape Mentors network and the Earth Reflections Podcast, which was rated amongst the leading environment podcasts in Africa in 2020.

“I am excited to join the Boyce Thompson Institute, because together with the Alliance for Science we can offer new lenses, tools, and partnerships to transform how the world understands the role of science in addressing global challenges,” said Ochugboju. “The COVID-19 pandemic, climate change and now food security challenges are teaching everyone that good science communication can literally save lives and livelihoods.”

Founded in 2014, AfS is a global communications initiative that seeks to counter misinformation about agricultural biotechnology, climate change, nuclear power, vaccines, COVID-19 and other contemporary science issues.

To support its work, the Alliance relies on a global network of about 14,000 science allies who engage in their local communities to advance science-based policies. AfS has trained more than 900 science champions, including scientists, farmers, journalists, healthcare professionals and students, in 48 countries to communicate effectively about biotechnology.

“After a comprehensive executive search, we are thrilled to have found someone like Dr. Ochugboju, who has the knowledge and ability to broaden the horizon of the Alliance for Science and bring resources to counter misinformation across a more substantial expanse of scientific endeavor, especially including climate change,” said Ronnie Coffman, Professor of Global Development at Cornell University and Interim Director of AfS.  

Ochugboju graduated with a degree in Medical Biochemistry and then received her Ph.D. in Plant Biochemistry from Royal Holloway, University of London in 1996. She was awarded the Daphne Jackson Trust Post-Doctoral Research Fellowship, based at the Centre for Ecology & Hydrology, St. Hilda’s College, University of Oxford in 1998.

She has lived and worked in Africa, Europe and the Middle East. In 2016, she received a WINGS WorldQuest Women of Discovery Award for developing and leading pioneering African science, technology and innovation projects. Ochugboju was also appointed as a Global Roving Ambassador for the county government of Kisumu, Kenya, in charge of the portfolio for Transformative Science and Urban Resilience.

About Boyce Thompson Institute:

Opened in 1924, Boyce Thompson Institute is a premier life sciences research institution located in Ithaca, New York. BTI scientists conduct investigations into fundamental plant and life sciences research with the goals of increasing food security, improving environmental sustainability in agriculture, and making basic discoveries that will enhance human health. Throughout this work, BTI is committed to inspiring and educating students and to providing advanced training for the next generation of scientists. BTI is an independent nonprofit research institute that is also affiliated with Cornell University. For more information, please visit BTIscience.org.

 

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Spread & Containment

Lab, crab and robotic rehab

I was in Berkeley a couple of months back, helping TechCrunch get its proverbial ducks in a row before our first big climate event (coming in a few weeks,…

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I got previews of a number of projects I hope to share with you in the newsletter soon, but one that really caught my eye was FogROS, which was just announced as part of the latest ROS (robot operating system) rollout. Beyond a punny name that is simultaneously a reference to the cloud element (fog/cloud — not to mention the fact that the new department has killer views of San Francisco and frequent visitor, Karl) and problematic French cuisine, there’s some really compelling potential here.

I’ve been thinking about the potential impact of cloud-based processing quite a bit the last several years, independent of my writing about robots. Specifically, a number of companies (Microsoft, Amazon, Google) have been betting big on cloud gaming. What do you do when you’ve seemingly pushed a piece of hardware to its limit? If you’ve got low enough latency, you can harness remote servers to do the heavy lifting. It’s something that’s been tried for at least a decade, to varying effect.

Image Credits: ROS

Latency is, of course, a major factor in gaming, where being off by a millisecond can dramatically impact the experience. I’m not fully convinced that experience is where it ought to be quite yet, but it does seem the tech has graduated to a point where off-board processing makes practical sense for robotics. You can currently play a console game on a smartphone with one of those services, so surely we can produce smaller, lighter-weight and lower-cost robots that rely on a remote server to complete resource-intensive tasks like SLAM processing.

The initial application will focus on AWS, with plans to reach additional services like Google Cloud and Microsoft Azure. Watch this space. There are many reasons to be excited. Honestly, there’s a lot to be excited about in robotics generally right now. This was one of the more fun weeks in recent memory.

V Bionic's exoskeleton glove shown without its covering.

Image Credits: V Bionic

Let’s start with the ExoHeal robotic rehabilitation gloves. The device, created by Saudi Arabian V Bionic, nabbed this year’s Microsoft Imagine Cup. The early-stage team is part of a proud tradition of healthcare exoskeletons. In this case, it’s an attempt to rehab the hand following muscle and tendon injuries. Team leader Zain Samdani told TechCrunch:

Flexor linkage-driven movement gives us the flexibility to individually actuate different parts of each finger (phalanges) whilst keeping the device portable. We’re currently developing our production-ready prototype that utilizes a modular design to fit the hand sizes of different patients.

Image Credits: Walmart

This is the third week in a row Walmart gets a mention here. First it was funding for GreyOrange, which it partnered with in Canada. Last week we noted a big expansion of the retail giant’s deal with warehouse automation firm, Symbotic. Now it’s another big expansion of an existing deal — this time dealing with the company’s delivery ambitions.

Like Walmart’s work with robotics, drone delivery success has been…spotty, at best. Still, it’s apparently ready to put its money where its mouth is on this one, with a deal that brings DroneUp delivery to 34 sites across six U.S. states. Quoting myself here:

The retailer announced an investment in the 6-year-old startup late last year, following trial deliveries of COVID-19 testing kits. Early trials were conducted in Bentonville, Arkansas. This year, Arizona, Florida, Texas and DroneUp’s native Virginia are being added to the list. Once online, customers will be able to choose from tens of thousands of products, from Tylenol to hot dog buns, between the hours of 8 a.m. and 8 p.m.

Freigegeben für die Berichterstattung über das Unternehemn Wingcopter bis zum 25.01.2026. Mit Bitte um Urhebervermerk v.l.: Jonathan Hesselbarth, Tom Plümmer und Ansgar Kadura von Wingcopter GmbH. Image Credits: © Jonas Wresch / KfW

There are still more question marks around this stuff than anything, and I’ve long contended that drone delivery makes the most sense in remote and otherwise hard to reach areas. That’s why something like this Wingcopter deal is interesting. Over the next five years, the company plans to bring 12,000 of its fixed-wing UAVs to 49 countries across Sub-Saharan Africa. It will cover spots that have traditionally struggled with infrastructural issues that have made it difficult to deliver food and medical supplies through more traditional means.

“With the looming food crisis on the African continent triggered by the war in Ukraine, we see great potential and strong social impact that drone-delivery networks can bring to people in all the countries in Sub-Saharan Africa by getting food to where it is needed most,” CEO Tom Plümmer told TechCrunch. “Especially in remote areas with weak infrastructure and those areas that are additionally affected by droughts and other plagues, Wingcopter’s delivery drones will build an air bridge and provide food from the sky on a winch to exactly where it is needed.”

Legitimately exciting stuff, that.

Image Credits: Dyson

In more cautiously optimistic news, Dyson dropped some interesting news this week, announcing that it has been (and will continue) pumping a lot of money into robotic research. Part of the rollout includes refitting an aircraft hangar at Hullavington Airfield, a former RAF station in Chippenham, Wiltshire, England that the company purchased back in 2016.

Some numbers from the company:

Dyson is halfway through the largest engineering recruitment drive in its history. Two thousand people have joined the tech company this year, of which 50% are engineers, scientists, and coders. Dyson is supercharging its robotics ambitions, recruiting 250 robotics engineers across disciplines including computer vision, machine learning, sensors and mechatronics, and expects to hire 700 more in the robotics field over the next five years. The master plan: to create the UK’s largest, most advanced, robotics center at Hullavington Airfield and to bring the technology into our homes by the end of the decade.

The primary project highlighted is a robot arm with a number of attachments, including a vacuum and a human-like robot hand, which are designed to perform various household tasks. Dyson has some experience building robots, primarily through its vacuums, which rely on things like computer vision to autonomously navigate. Still, I say “cautiously optimistic,” because I’ve seen plenty of non-robotics companies showcase the technology as more of a vanity project. But I’m more than happy to have Dyson change my mind.

Image Credits: Hyundai

Hyundai, of course, has been quite aggressive in its own robotics dreams, including its 2020 acquisition of Boston Dynamics. The carmaker this week announced that part of its massive new $10 billion investment plans will include robotics, with a focus of actually bringing some of its far-out concepts to market.

Another week, another big round for logistics/fulfillment robotics, as Polish firm Nomagic raised $22 million to expand its offerings. The company’s primary offering is a pick and place arm that can move and sort small goods. Khosla Ventures and Almaz Capital led the round, which also featured European Investment Bank, Hoxton Ventures, Capnamic Ventures, DN Capital and Manta Ray.

Amazon Astro with periscope camera

The periscope camera pops out and extends telescopically, enabling Astro to look over obstacles and on counter tops. A very elegant design choice. Image Credits: Haje Kamps for TechCrunch

We finally got around to reviewing Amazon’s limited-edition home robot, Astro, and Haje’s feelings were…mixed:

It’s been fun to have Astro wandering about my apartment for a few days, and most of the time I seemed to use it as a roving boom box that also has Alexa capabilities. That’s cute, and all, but $1,000 would buy Alexa devices for every thinkable surface in my room and leave me with enough cash left over to cover the house in cameras. I simply continue to struggle with why Astro makes sense. But then, that’s true for any product that is trying to carve out a brand new product category.

A tiny robot crab scuttles across the frame. Image Credits: Northwestern University

And finally, a tiny robot crab from Northwestern University. The little guy can be controlled remotely using lasers and is small enough to sit on the side of a penny. “Our technology enables a variety of controlled motion modalities and can walk with an average speed of half its body length per second,” says lead researcher, Yonggang Huang. “This is very challenging to achieve at such small scales for terrestrial robots.”

Image Credits: Bryce Durbin/TechCrunch

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