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BD’s COVID-19 and Flu Combo Test Wins European Clearance

BD’s Covid-19-Flu Combo Test Wins European Clearance



Becton, Dickinson and Co. announced on Wednesday that its diagnostic test kit for both flu and Covid-19 detection has been cleared by European regulatory authorities.

BD (BDX) said that the Viasure SARS-CoV-2 real time detection kit developed by CerTest Biotec, has received the European CE Mark. The kit allows BD MAX system users to run a single module that tests concurrently for Covid-19, influenza (flu) and respiratory syncytial virus (RSV). The BD MAX System, a molecular diagnostic platform, is used in hundreds of laboratories across Europe. Each unit can return results in two to three hours and has the capacity to analyze hundreds of samples over a 24-hour period.

"Together with CerTest, we can offer our customers in Europe a complete solution for Covid-19 diagnostics during the winter season," said BD’s Nikos Pavlidis. "By leveraging our significant installed base and the versatility of the BD MAX System, this test will greatly enhance capacity for SARS-CoV-2 and Influenza testing, enabling clinicians to rapidly diagnose patients and help reduce the spread of Covid-19."

BD added that Viasure test kits are not available for sale in the US. The CE Mark approval comes as BD last month announced that its rapid, point-of-care, SARS-CoV-2 antigen test was granted European regulatory approval. As a result, the US medical device maker expects the test to be commercially available at the end of October.

Shares in BDX are currently down 13% year-to-date, and analysts have a cautiously optimistic take on the stock's outlook. The Moderate Buy consensus splits into 4 Buys versus 3 Holds. Looking ahead, the average analyst price target of $274.83 indicates 16% upside potential lies ahead.

Earlier this month, Goldman Sachs analyst Amit Hazan added the stock to the firm's Conviction Buy list and raised the price target to $279 from $278.

Hazan views the stock's underperformance over the past 12 months as an "improved buying opportunity that we don't often see". (See BDX stock analysis on TipRanks).

The analyst expects "key product issues to dissipate", while Covid-19 testing upside looks increasingly likely. In addition, he believes that a broader recovery will benefit BD's procedure-based sales lines.

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The post BD’s Covid-19-Flu Combo Test Wins European Clearance appeared first on TipRanks Financial Blog.

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Apps to reach record highs in Q3 of 36B downloads and $34B in consumer spending

A new forecast on the state of the app economy indicates the third quarter will see record-breaking revenues spent on apps and games. According to App Annie, consumers worldwide will spend $34 billion on apps and games in Q3, a 20% year-over-year increase



A new forecast on the state of the app economy indicates the third quarter will see record-breaking revenues spent on apps and games. According to App Annie, consumers worldwide will spend $34 billion on apps and games in Q3, a 20% year-over-year increase on spending. The increase indicates that the COVID-19 pandemic’s impact on consumer habits and behavior is having a lasting effect when it comes to how people are now using apps for entertainment, shopping, work, education and more.

App Annie, we should note, made headlines last week for having massaged its data in earlier years using confidential sources, then misrepresented this to its trading firm clients as having been statistically modeled with internal controls to prevent such a thing from occurring. This resulted in a $10+ million securities fraud settlement with the SEC, as firms used the data to make investment decisions, as a result.

But App Annie data today still remains a fairly accurate representation of the mobile market, despite these manipulations, and for now is still one of many top companies that supply large app publishers, marketers and investors with information related to the mobile ecosystem.

The firm said that the largest contributor to app revenue in Q3 continues to be in-game spending and mobile subscriptions — the latter, a focus of lawsuits and increased regulation as both Apple and Google fight to retain their right to a cut of the purchases flowing through their app store platforms. Gaming continues to account for the majority of consumer spend, though non-gaming spending has grown its share over the past few years, thanks to subscriptions.

Android also still continues to outpace iOS on downloads, but the reverse is true when it comes to consumer spending.

Image Credits: App Annie

Downloads in Q3 will have grown by 10% year-over-year to reach a record high of 36 billion, driven by Google Play and particularly downloads in emerging markets like India and Brazil. The strongest growth was also seen in Brazil, the Philippines and Mexico, and the Latin American market has begun to catch the attention of global publishers now, as well, as one with growth potential.

Industries driving download growth include travel, education and medical — all three of which have had pandemic impacts. Travel app downloads grew 35% quarter-over-quarter on Google Play and 15% on iOS as the summer travel season has picked up amidst widespread vaccine rollout. Medical and education apps, of course, have pandemic ties, as users turned to mobile technology to keep up with online learning and with doctors’ appointments, COVID testing and vaccine appointments.

But iOS still reigns when it comes to revenue generated by mobile apps, accounting for 65% of app stores’ consumer spending globally, which is in line with the past four quarters.

Image Credits: App Annie

Consumer spending on iOS apps grew 15% year over year to $22 billion, and 15% year-over-year on Google Play to reach around $12 billion. Most of this revenue is generated by gaming apps, which account for 66% of the spend across both apps stores. In terms of non-gaming apps, iOS commands 76% of consumer spending. Much of the growth outside of gaming, across both platforms, comes from entertainment apps, photo and video apps, social media and dating apps, the firm says.

The U.S. and China are the largest iOS markets for consumer spending, with Japan, the U.S. and Taiwan accounting for the strongest growth. On Google Play, the U.S., Japan and South Korea were the largest markets by consumer spend, but Japan, Russia and Australia drove the growth.

While examinations of revenue and downloads have historically helped to paint a broad picture of the state of the mobile economy, as markets mature there’s greater interest in user engagement with apps — like those consumers already have installed on their devices.

A report from an App Annie competitor Sensor Tower, also out today, dives into active users, sessions and retention metrics for games and non-games alike. The firm found that the top 500 apps worldwide now average 91.7 million monthly active users and this number has grown by 8.4% year-over-year during the second quarter, up from 84.6 million in Q2 2020.

Image Credits: Sensor Tower

Business apps saw the highest compound annual growth rate (CAGR) between Q1 2018 and Q2 2021, climbing nearly 42% over that time frame, Sensor Tower said. Meanwhile, consumers in Q2 2021 spent the most time in entertainment apps, with each of the top 100 seeing nearly 29 minutes of daily usage, on average.

Image Credits: Sensor Tower

Among games, shooter genre games — like PUBG Mobile and Garena Free Fire — saw the most daily active users in Q2, as the top 50 games in this genre averaged 7.6 million daily active users. In terms of weekly actives, however, hypercasual games came out on top.

Sensor Tower also credits earlier increases in active users across apps to the COVID-19 pandemic as users who turned to mobile devices during lockdowns. But after a slight dip in Q3 2020, growth in active users has now returned to pre-pandemic levels, it said.

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A new oral antiviral drug for COVID is being tested in humans – can it make a difference?

Molnupiravir is showing promise for treating and controlling the spread of COVID-19.



Despite the effectiveness of vaccines, we still need drugs to treat COVID. Even people who have been double vaccinated stand a small chance of getting COVID and ending up moderately or even severely ill. There are drugs to treat COVID, but they have to be given in hospital.

One promising drug that could improve things is molnupiravir, an antiviral that’s moving into the final stages of testing in humans. Researchers are hoping it can be used both to treat and prevent COVID. Importantly, it can be taken as a pill – meaning people wouldn’t need to be hospitalised to receive it.

This drug reduces the ability of SARS-CoV-2, the virus that causes COVID, to replicate. It works by mimicking one of the building blocks of the virus’s genetic material. When the virus reproduces, it builds a new copy of its RNA, and the drug ends up being incorporated into it.

When the virus then reproduces, the molnupiravir causes mutations to accumulate in the virus’s RNA, which increase every time it replicates. Eventually, this causes an “error catastrophe”, where excessive mutations stop the virus from being able to reproduce altogether, and it dies off.

How well does it work?

So far, a small trial has looked at the effects of molnupiravir in 202 COVID patients (not in hospital) who had started having symptoms. Participants were randomly allocated to receive molnupiravir or a placebo, with different doses of the antiviral being tested.

The trial’s results have been published as a preprint, meaning they are yet to be formally reviewed by other scientists. Still, the trial showed that after three days of treatment, infectious SARS-CoV-2 virus was found significantly less often in participants taking 800mg of molnupiravir (2%) compared to those taking a placebo (17%).

By day five, the virus was not detected in any participants receiving 400mg or 800mg of molnupiravir, but was still found in 11% of those taking a placebo. The trial, therefore, suggests that molnupiravir can reduce and eliminate infectious SARS-CoV-2 in patients with mild COVID. Indeed, it’s the fact that molnupiravir speeds up the clearance of the virus that suggests it could be useful not just for treating COVID but also lessening the chance of it spreading.

Having worked well in patients with mild COVID-19, the next question is whether molnupiravir can help those who are severely ill. faboi/Shutterstock

But to know just how useful it will be, we need to see what happens in further trials. Molnupiravir is currently also being assessed in newly hospitalised patients with COVID, with this study aiming to find out if early molnupiravir treatment can reduce the time it takes for patients with severe COVID to clear the virus. No results have been disclosed so far.

A larger trial, with 1,850 participants, is now looking to see if molnupiravir is better than a placebo at preventing serious disease and death in non-hospitalised adults with COVID. And a phase 3 trial (the final stage of human testing) is now recruiting participants – across 17 different countries – to see whether early molnupiravir treatment of COVID-positive people prevents others living in the same household from getting infected. Previous research has already shown molnupiravir can stop SARS-CoV-2 spreading in this manner among ferrets.

If it performs well in these trials, molnupiravir’s impact could be huge. Given the severity of illness that can be caused by SARS-CoV-2, an effective antiviral would be a valuable weapon to have in the clinical armoury – particularly if molnupiravir continues to be as fast acting as it has so far in testing. Patients suffering from COVID can become very sick very quickly.

The fact that it is taken orally is also potentially very helpful, as this would make it easy to use in the early stages of infection, as it could be self-administered outside of hospital. Also, molnupiravir can be produced in large quantities and doesn’t require cold transportation. Vaccines and physical measures to control the spread of the virus would still be the primary tactics for managing COVID, but this drug could complement both.

Where did it come from?

Developing antiviral drugs notoriously takes a long time. The fact that molnupiravir is available 18 months into the pandemic is because it wasn’t developed specifically for COVID. It is a broad-spectrum antiviral – meaning it can act against a wide variety of viruses. Its development started back in 2013 at Emory University in the US.

A woman with a viral infection blowing her nose
Because of how it works, molnupiravir is a promising treatment for a number of illnesses caused by RNA viruses. Dragana Gordic/Shutterstock

The focus then was on finding an antiviral drug for the treatment of equine encephalitis virus infection, a major threat for human and animal public health in the Americas. The initial antiviral drug in development was known as EIDD-1931. Broad testing confirmed that it was able to inhibit several RNA viruses from replicating, including influenza virus, multiple coronaviruses and respiratory syncytial virus.

However, when EIDD-1931 was given orally to monkeys it was quickly metabolised, decreasing its antiviral activity. To address this, scientists created an inactive drug (known as a prodrug) that is then converted into the active drug in the body. EIDD-1931’s prodrug is molnupiravir.

Initially, molnupiravir’s developers applied to the US Food and Drug Administration for permission to test it in humans as a treatment for seasonal influenza. However, after COVID emerged, and it was shown to have an effect against SARS-CoV-2, a request was submitted to test it against this virus too. One day, it’s possible that it could be used to treat a number of different diseases.

Peter Barlow is currently in receipt of funding from the Medical Research Council for projects unrelated to this piece. He has previously received funding from the Chief Scientist Office (Scotland) on a project investigating host defence peptides as therapeutics for rhinovirus infection (ETM/389). He is currently chair of the British Society for Immunology Inflammation Affinity Group.

Filipa Henderson Sousa does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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CDC Panel Considers Delaying Booster Jabs Decision By 1 Month To “Wait For More Evidence”

CDC Panel Considers Delaying Booster Jabs Decision By 1 Month To "Wait For More Evidence"

Last night, the FDA – as expected – authorized the emergency use of booster doses of the Pfizer-BioNTech mRNA jab for patients over the age of 65, the..



CDC Panel Considers Delaying Booster Jabs Decision By 1 Month To "Wait For More Evidence"

Last night, the FDA - as expected - authorized the emergency use of booster doses of the Pfizer-BioNTech mRNA jab for patients over the age of 65, the immuno-compromised, and the occupationally vulnerable.

Now, it's the CDC's turn. The panel is preparing to wrap up a two-day meeting on Wednesday, where it is deliberating a more specific set of guidelines regarding the booster jab and who will initially be eligible, and when.

Before we get into specifics, it's worth noting that after the first day of discussion, some of the advisors were so befuddled by the rationale for boosters that they suggested putting off the CDC's decision for a month to wait for more evidence. Such a decision would probably have driven the Biden Administration crazy.

According to the AP, "the uncertainties were yet another reminder that the science surrounding boosters is more complicated than the Biden administration suggested when the president and his top aides rolled out their plan at the White House last month."

On Wednesday, "the CDC panelists heard a series of presentations Wednesday outlining the knotty state of science on boosters. On one hand, the COVID-19 vaccines continue to offer strong protection against severe illness, hospitalization and death. On the other hand, there are signs of more low-grade infections among the vaccinated as immunity wanes."

Ultimately, the function of the CDC panel is to "refine exactly who will be eligible" as Politico put it. For the booster jab, the focus will be on defining who's at "high risk". The discussions are expected to conclude Thursday afternoon.

Politico has five key takeaways from day one, and what to expect on day two (text courtesy of Politico):

The goals of vaccination might be changing:

Data from the large clinical trials used to authorize Covid-19 vaccines in the United States suggested they offered strong protection against even mild infection, raising hopes that the shots would confer so-called sterilizing immunity — preventing vaccinated people from spreading the virus.

But over time, scientists have realized that the vaccines' ability to ward off mild infection is waning, although protection against severe disease and death remains strong overall.

CDC panel member Sarah Long, a pediatrics professor at Drexel University's College of Medicine, urged her colleagues to differentiate between ensuring the vaccines prevent hospitalizations versus all infection.

"I don't think there's any hope that a vaccine, such as the ones we have, will prevent infection after the first maybe couple of weeks that you have those extraordinary immediate responses," she said.

The elderly show the clearest need for boosters at this point:

Antibodies from vaccination decrease over time among all age groups. But vaccine recipients 80 and older develop lower levels of neutralizing antibodies post-vaccination than younger adults do, said Natalie Thornburg, a respiratory virus immunology specialist at the CDC.

That means that older people's antibodies may drop to undetectable levels faster, at which point their memory immune cells play a larger role in protecting them against Covid-19. But older people also may produce fewer memory cells than younger people whose immune systems are stronger — suggesting that older people would benefit from a third vaccine dose.

Ruth Link-Gelles of the U.S. Public Health Service said current data shows significant drops in the efficacy of both the Pfizer and Moderna shots in people 65 and older in the time the Delta variant has dominated the domestic infection landscape.

But Thornburg cautioned against viewing vaccines' protection as an on-off switch. "Immunity is not simply a binary" in which individuals are either protected or not against the coronavirus, she said. Most people are able to maintain some level of cellular immunity, which is likely enough to protect vaccine recipients from severe disease even after antibody levels drop off.

Nursing-home residents face special risks, even with a boost

Boosters may not be enough to fully protect residents of nursing homes, according to modeling data presented by Rachel Slayton of the U.S. Public Health Service. While boosters may help reduce the number of cases in long-term care facilities, she said, that depends on their inherent efficacy and on the vaccination coverage among facility staff.

High community transmission will likely lead to more infections in nursing homes because staff can more easily import the virus, Slayton said. It's unclear whether booster doses could help curb transmission of the virus among vaccinated individuals.

Experts are worried about confusing the public

Members of the CDC's vaccine advisory committee expressed concerns Wednesday about green-lighting boosters from one brand over others with authorized Covid vaccines available to Americans, noting the potential for public perception and logistical issues. The panel is tasked with recommending to the CDC how the FDA's vaccine policy should be implemented in real-world settings.

Long suggested that the group wait for more information on so-called mix-and-match doses — the ability to vaccinate someone with one brand's primary series with the option for a different manufacturer's booster later — before signing off on just the Pfizer booster, asking “whether we’re willing to panic half the recipients of Moderna."

“I don’t want to jeopardize anyone," she said of delaying a booster decision. "At the same time, it’ll be very, very difficult to have a little less than half of the population who would be eligible to receive" a booster if people can only get the brand that matches their initial series.

Moderna has asked FDA to authorize its booster shot, and Johnson & Johnson has begun submitting booster data to the agency with an eye to filing an application.

Amanda Cohn of the CDC urged committee members to consider the recommendations they're making now as "interim policies" that will change as more data surfaces. The National Institutes of Health is conducting a study on mixing vaccine doses, with results expected later this year.

"This is a rapidly moving target," she said.

The booster rollout could be messy

Still, there are a number of challenges to approving only one brand's vaccine for boosting.

Immunocompromised Americans have already been permitted to seek out third doses of the Pfizer or Moderna vaccines because of concerns they may not have mounted a sufficient immune response to the first two shots. While they've been told they can receive the other brand's shot if they can't access the one they initially got, FDA isn't expected to allow mixing brands for people outside that category, which could sow further confusion.

More than 98 percent of Americans participating in a CDC safety monitoring program who have gotten additional doses stuck with the same brand they originally received. But it's unclear how many of those studied actually fell under the CDC's definition of immunocompromised since patients only have to attest to their eligibility — no doctor's note required — meaning there are few obstacles keeping people interested in boosters from acquiring them, anyway.

Declining to allow mixing Pfizer and Moderna doses beyond the immunocompromised could make administering boosters in long-term care facilities difficult if residents received different brands, said Molly Howell, an immunization program manager at the North Dakota Department of Health.

“I don’t know that it’s realistic to keep going back with different brands," she said.

* * *

Ironically, the deliberations on the booster jabs are happening during the slowest week for first-dose vaccinations since July (despite NY's mandate looming on Monday). Remember, all of the deliberation so far have  focused on the Pfizer jab. Regulators will decide on boosters for people who have received the Moderna or J&J jabs in the coming weeks. One thing we already know: Pfizer boosters won't be recommended for patients who received a different brand the first time around (though exceptions to this have already and will likely continue to be made).

Tyler Durden Thu, 09/23/2021 - 09:34

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