Month: November 2021

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FDA Panel Backs First-of-a-Kind COVID-19 Pill From Merck

A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus.

A Food and Drug Administration panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy.

The recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on the FDA to recommend extra precautions before the drug is prescribed, including pregnancy tests for women of child-bearing age.

The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn’t be used in vaccinated patients, who weren’t part of the study and haven’t been shown to benefit.

The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end. The pill is already authorized in the United Kingdom.

The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and U.S. officials brace for the arrival of the new omicron variant.

Merck hasn’t specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of the coronavirus.

But that uncertainty frustrated many panelists as they grappled with whether to back the treatment for millions of Americans.

“With no data saying it works with new variants, I really think we need to be careful about saying that this is the way to go,” said Dr. David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted to back the drug.

Effectiveness, dangers

The panel’s narrow-but-positive recommendation came despite new data from Merck that paint a less compelling picture of the drug’s effectiveness than just a few weeks earlier.

Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo. That effect was significantly less than the 50% reduction it first announced based on incomplete results.

That smaller-than-expected benefit amplified experts’ concerns about the drug’s toxicity for fetuses.

FDA scientists told the panelists earlier Tuesday that company studies in rats showed the drug caused toxicity and birth defects when given at very high doses. Taken together, FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.”

FDA is weighing a blanket restriction against any use in pregnant women or allowing it in rare cases. Some panelists said the option should be left open for pregnant mothers who have high-risk COVID-19 and may have few other treatment options.

Dr. Janet Cragan, who backed the drug, said that even with tight restrictions, some pregnant women would inevitably take the drug.

“I don’t think you can ethically tell a woman with COVID-19 that she can’t have the drug if she’s decided that’s what she needs,” a panel member and staffer with the Centers for Disease Control and Prevention. “I think the final decision has to come down to the individual woman and her provider.”

Merck’s drug uses a novel approach to fight COVID-19: It inserts tiny errors into the coronavirus’ genetic code to stop it from reproducing. That genetic effect has raised concerns that the drug could spur more virulent strains of the virus. But FDA regulators said Tuesday that risk is theoretical and seems unlikely.

Pfizer drug

While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drugmaker Pfizer is close behind with its own pill under review.

Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns raised with Merck’s drug.

Pfizer said this week that its drug shouldn’t be affected by the omicron variant’s mutations.

The U.S. government has agreed to purchase 10 million treatment courses of Pfizer’s drug, if it’s authorized. That’s more than three times the government’s purchase agreement with Merck for 3.1 million courses of molnupiravir.

Both drugs require patients to take multiple pills, twice a day for five days.

Source: Voice of America

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Space Junk Forces Spacewalk Delay, Too Risky for Astronauts

NASA called off a spacewalk Tuesday because of menacing space junk that could puncture an astronaut’s suit or damage the International Space Station.

Two U.S. astronauts were set to replace a bad antenna outside of the space station. But late Monday night, Mission Control learned that a piece of orbiting debris might come dangerously close. There wasn’t enough time to assess the threat so station managers delayed the spacewalk until Thursday.

It’s the first time a spacewalk has been canceled because of threat from space junk.

The space station and its crew of seven have been at increased risk from space junk since Russia destroyed a satellite in a missile test two weeks ago.

It wasn’t immediately clear whether the object of concern was part of the Russian satellite wreckage. During a news conference Monday, NASA officials said the November 15 missile test resulted in at least 1,700 satellite pieces big enough to track, and thousands more too small to be observed from the ground but still able to pierce a spacewalker’s suit.

NASA officials said astronauts Tom Marshburn and Kayla Barron faced a 7% greater risk of a spacewalk puncture because of the Russian-generated debris. But they said it was still within acceptable limits based on previous experience.

Marshburn and Barron arrived at the space station earlier this month.

Source: Voice of America

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UnionPay International partners with M2M to drive digital transformation in Africa

CASABLANCA, Morocco, Nov. 29, 2021 /PRNewswire/ — UnionPay International (UPI) and M2M jointly announced a partnership to accelerate digital financial transformation in Africa, creating new frontiers by leveraging two entities’ strong core capabilities and footprints.

This partnership sets an ambitious product roadmap that allows M2M to provide innovative and customer-centric payment solutions to support issuers, acquirers, fintechs, processors and aggregators across more than 40 countries worldwide.

“Becoming UPI’s certified Third Party Service Provider (TPSP) is a major milestone underscoring our drive to be a one-stop shop and a service payment platform that truly offer clients solutions covering the entire value chain of payments including issuing, acquiring and processing of expanding UPI’s transactions worldwide”, said Mr Rachid SAIHI, CEO of M2M Group. “Thanks to this partnership, M2M Group will be among the first payments actors in Africa to provide end to end processing solutions for UPI’s transactions”.

“We are delighted to collaborate with M2M to facilitate the digital financial transformation in Africa”, said Mr Luping Zhang, General Manager of Africa Branch, UnionPay International. ” UnionPay International continues to offer high quality, cost-effective, innovative payment services through shared growth in the region and contribute value towards the global payment ecosystem”.

At the forefront of the digital era, M2M Group leverages more than 30 years of worldwide innovation and expertise. M2M Group is a leading software company that provides multichannel electronic payments and eGov solutions and services that enable convenience and trust for anyone, anywhere, anytime, and any device. M2M Group’s solutions address a wide range of applications accelerating digital convergence, enhancing user experience and boosting business agility and profitability. M2M Group is listed on Casablanca’s Stock Exchange.

With over 160 million UnionPay cards issued outside of mainland China, UnionPay has expanded its acceptance network to 180 countries and regions in recent years. At present, UnionPay cards are widely accepted in Africa across all sectors, effectively meeting the diverse purchasing needs of UnionPay cardholders visiting and living on the continent. Over 10 African countries have issued UnionPay cards, including Kenya, Tanzania, Uganda, Ghana, South Africa, eSwatini, Madagascar and Mauritius. The Nilson Report (Issue 1154) shows that UnionPay ranks first among all card schemes in card issuance and transaction volume. UnionPay has launched various innovative payment products in Africa in response to the worldwide digital transformation and financial inclusion.

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Adagio Therapeutics Reports That None of the Mutations Present in SARS-CoV-2 Variant, Omicron, Are Associated with Escape from ADG20 Neutralization In Vitro

Additional in vitro studies to determine neutralization activity of ADG20 against Omicron are ongoing

ADG20 EUA submissions planned for prevention and treatment of COVID-19 in mid-2022

Inventory build continues in anticipation of EUA in second half of 2022, with 4 million doses available for distribution over the next two years

WALTHAM, Mass., Nov. 29, 2021 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc., (Nasdaq: ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today provided information related to the potential of its lead SARS-CoV-2 antibody, ADG20, to address the Omicron SARS-CoV-2 variant, and other known variants of concern. ADG20 is an investigational monoclonal antibody (mAb) product candidate designed to provide broad and potent neutralizing activity against SARS-CoV-2, including variants of concern, for the prevention and treatment of COVID-19 with potential duration of protection for up to one year in a single injection.

“The continued global scale of the COVID-19 pandemic has led to increased levels of immune pressure on the virus, which is driving the emergence of variants containing mutations associated with escape from common classes of neutralizing antibodies induced by natural infection or vaccination. Unlike most antibodies currently available under EUA, ADG20 has been shown to target an epitope that is highly conserved among clade I sarbecoviruses and that is not readily targeted by the endogenous neutralizing antibody response,” said Laura Walker, Ph.D., co-founder and chief scientific officer of Adagio. “Due to the highly conserved and immunorecessive nature of the epitope recognized by ADG20, we expect that ADG20 will retain activity against Omicron, as we have observed in in vitro models with all other variants of concern identified previously. Further, none of the mutations present in the spike protein of the Omicron variant have been associated with escape from ADG20 neutralization.   ADG20 was engineered for potent and broadly neutralizing activity in anticipation of both the rapid antigenic evolution of SARS-CoV-2 and the emergence of future SARS-like viruses with pandemic potential.”

“ADG20 was uniquely designed to combine breadth, potency and duration of protection against SARS-CoV-2 for up to one year in a single injection. We did this anticipating that SARS-CoV-2 would continue to evolve and potentially render some early therapies and vaccines obsolete,” said Tillman Gerngross, Ph.D., co-founder and chief executive officer of Adagio. “Our global clinical trials are advancing with potential EUA submissions in mid-2022 for both prevention and treatment of COVID-19. We continue to engage with the FDA and other regulatory bodies and governmental agencies to discuss potential acceleration of development plans and the need for a portfolio of therapeutic solutions to combat the COVID-19 pandemic.”

Given the significant potential health crisis resulting from the emergence of Omicron, Adagio is undertaking a number of activities to support ADG20’s utility in addressing this newly emerged variant of concern, including:

  • Conducting in vitro studies to evaluate the expected binding and neutralizing activity of ADG20 against Omicron. Initial data from these studies is anticipated by the end of the year; and
  • Recruiting patients in Adagio’s Phase 2/3 COVID-19 treatment trial, known as STAMP, across several clinical sites in South Africa (along with ongoing clinical trial efforts globally) in an effort to generate clinical data for ADG20 against infections due to the Omicron variant.

Based on the data being generated, Adagio plans to engage with health authorities and government agencies to accelerate development and supply of ADG20 to combat SARS-CoV-2 and its variants of concern.

ADG20 and Variants of Concern
The neutralizing antibody response induced by SARS-CoV-2 infection and vaccination is dominated by three classes of receptor binding domain (RBD)-directed antibodies (Class 1, Class 2 and Class 3), which often share common escape mutations. The newly emerged Omicron (B.1.1.529) variant identified in South Africa contains mutations associated with resistance to a large proportion of these commonly elicited antibodies, which may be due to immune pressure on these antigenic sites. Data for most antibodies available under EUA or in late-stage clinical development show they target one of these three dominant antigenic regions within the RBD.

In vitro studies have shown that ADG20 binds to a highly conserved epitope within the RBD that is not targeted by any of the common classes of neutralizing antibodies induced by SARS-CoV-2 infection and vaccination. Thus, unlike many other clinical-stage antibodies, which were isolated from COVID-19 patients and recognize epitopes that are also targeted by endogenous neutralizing antibodies, there is limited immune pressure on the ADG20 binding site. The ADG20 epitope has remained conserved in 99.99% of the nearly 4 million full length SARS-CoV-2 viral sequences deposited in the GISAID database as of October 15, 2021, and, as shown in in vitro studies, ADG20 retains activity against prior variants of concern including Alpha, Beta, Delta, and Gamma. For the Omicron variant, none of the mutations present in the spike protein are associated with escape from ADG20 neutralization. Based on published epitope mapping and structural studies, Adagio anticipates that ADG20 will retain neutralizing activity against the Omicron variant whereas other mAb products may lose substantial activity against this variant.

Previously disclosed in vitro data demonstrated retained neutralizing activity of ADG20 against a diverse panel of circulating SARS-CoV-2 variants, including the recently emerged Lambda, Mu and Delta plus variants. Notably, findings from these in vitro studies showed that ADG20 demonstrated potent neutralizing activity against all SARS-CoV-2 variants of concern tested, including those with reduced susceptibility to mAb products currently available under EUA or in late-stage development.

About ADG20
ADG20, an investigational monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is advancing through global clinical trials for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2. ADG20 was designed and engineered to possess high potency and broad neutralization activity against SARS-CoV-2 and additional clade 1 sarbecoviruses by targeting a highly conserved epitope in the receptor binding domain. ADG20 was further engineered to provide an extended half-life for durable protection. ADG20 has demonstrated potent neutralizing activity against the original SARS-CoV-2 virus, SARS-CoV-2 variants of concern Alpha, Beta, Delta, and Gamma, other SARS-CoV-2 variants to date, and additional SARS-like viruses in preclinical studies. ADG20 is administered in clinical trials by a single intramuscular injection. To date, ADG20 has been well-tolerated in a Phase 1 trial with no safety signals identified through a minimum of three months follow-up across all cohorts. ADG20 has not been approved for use in any country, and safety and efficacy have not yet been established.

About Adagio Therapeutics
Adagio (Nasdaq: ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, including COVID-19 and influenza. The company’s portfolio of antibodies has been optimized using Adimab’s industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with the potential for a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagio’s portfolio of SARS-CoV-2 antibodies includes multiple non-competing, broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers to support the completion of clinical trials and initial commercial launch, ensuring the potential for broad accessibility to people around the world. For more information, please visit www.adagiotx.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the timing, progress and results of our preclinical studies and clinical trials of ADG20, including the timing of our planned EUA submissions, initiation, modification and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; the expected neutralizing activity of ADG20 against the Omicron variant; our ability to obtain and maintain regulatory approvals for, our product candidates; our ability to identify patients, including in specific populations, with the diseases treated by our product candidates and to enroll these patients in our clinical trials; our expectations regarding the scope of any approved indication for ADG20; and the risk/benefit profile of our product candidates to patients; our manufacturing capabilities and strategy, including plans for doses available in the near future; and our ability to successfully commercialize our product candidates. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, the impacts of the COVID-19 pandemic on our business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, and the uncertainties and timing of the regulatory approval process. Other factors that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in Adagio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and in Adagio’s future reports to be filed with the SEC, including Adagio’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021. Such risks may be amplified by the impacts of the COVID-19 pandemic.  Forward-looking statements contained in this press release are made as of this date, and Adagio undertakes no duty to update such information except as required under applicable law.

Contacts:
Media Contact:
Dan Budwick, 1AB
Dan@1abmedia.com

Investor Contact:
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

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Biden Meets with CEOs on Supply Chain Issues

U.S. President Joe Biden met at the White House Monday with chief executives of major retailers to learn about supply chain challenges during the busy holiday season.

“The business leaders we gathered here today represent a broad swath of American shopping: brick and mortar and online stores, national and local grocery chains, our nation’s largest retailer, and makers and sellers of toys, electronics and health supplies,” the president said.

“I want to hear from each of you about what you’re seeing this holiday season,” he told the business leaders.

The Biden administration has been struggling to fix supply chain problems, including backlogged ports and a shortage of truck drivers to haul goods across the country. The supply chain issues, fuel prices that rose markedly earlier this year and other factors have contributed to rising U.S. inflation.

Walmart CEO Doug McMillon said, “While we’re all concerned about the supply chain, we have more inventory than we did a year ago, and we have the inventory that we need to be able to support the business.”

He told the meeting virtually, “We are seeing progress. The port and transit delays are improving.” Walmart has seen a 26% increase in shipping containers getting through U.S. ports in the past month, according to McMillon.

Food Lion President Meg Ham told the meeting the company’s supply chain “is strong and robust, and we have ample product inside of our stores for customers to choose from during this holiday.”

The White House said other participants at Monday’s meeting, both in person and virtual, included the CEOs of Best Buy, Samsung North America, Qurate Retail Group, Todos Supermarket, Etsy, Mattel, CVS Health and Kroger.

Source: Voice of America

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New Twitter CEO Steps From Behind the Scenes to High Profile

Newly named Twitter CEO Parag Agrawal has emerged from behind the scenes to take over one of Silicon Valley’s highest-profile and politically volatile jobs.

But his prior lack of name recognition, coupled with a solid technical background, appears to be what some big company backers were looking for to lead Twitter out of its current morass.

A 37-year-old immigrant from India, Agrawal comes from outside the ranks of celebrity CEOs, which include the man he’s replacing, Jack Dorsey, Facebook’s Mark Zuckerberg or SpaceX and Tesla’s Elon Musk. Those brand-name company founders and leaders have often been in the news — and on Twitter — for exploits beyond the day-to-day running of their companies.

Having served as Twitter’s chief technology officer for the past four years, Agrawal’s appointment was seen by Wall Street as a choice of someone who will focus on ushering Twitter into what’s widely seen as the internet’s next era — the metaverse.

Agrawal is a “‘safe’ pick who should be looked upon as favorably by investors,” wrote CFRA Research analyst Angelo Zino, who noted that Twitter shareholder Elliott Management Corp. had pressured Dorsey to step down.

Elliott released a statement Monday saying Agrawal and new board chairman Bret Taylor were the “right leaders for Twitter at this pivotal moment for the company.” Taylor is president and chief operating officer of the business software company Salesforce.

Agrawal joins a growing cadre of Indian American CEOs of large tech companies, including Sundar Pichai of Google parent Alphabet, Microsoft’s Satya Nadella and IBM’s Arvind Krishna.

He joined San Francisco-based Twitter in 2011, when it had just 1,000 employees, and has been its chief technical officer since 2017. At the end of last year, the company had a workforce of 5,500.

Agrawal previously worked at Microsoft, Yahoo and AT&T in research roles. At Twitter, he’s worked on machine learning, revenue and consumer engineering and helping with audience growth. He studied at Stanford and the Indian Institute of Technology, Bombay.

While Twitter has high-profile users like politicians and celebrities and is a favorite of journalists, its user base lags far behind old rivals like Facebook and YouTube and newer ones like TikTok. It has just over 200 million daily active users, a common industry metric.

As CEO, Agrawal will have to step beyond the technical details and deal with the social and political issues Twitter and social media are struggling with. Those include misinformation, abuse and effects on mental health.

Agrawal got a fast introduction to life as CEO of a high-profile company that’s one of the central platforms for political speech online. Conservatives quickly unearthed a tweet he sent in 2010 that read “If they are not gonna make a distinction between muslims and extremists, then why should I distinguish between white people and racists.”

As some Twitter users pointed out, the 11-year-old tweet was quoting a segment on “The Daily Show,” which was referencing the firing of Juan Williams, who made a comment about being nervous about Muslims on an airplane.

Twitter did not immediately respond to a message for comment on the tweet.

Source: Voice of America