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U.S. FDA sets January target to decide on approval of Pfizer’s Covid-19 shot

The U.S. health regulator will review Pfizer Inc. and German partner BioNTech SE’s application for full approval of their Covid-19 vaccine in people 16 years and older by January 2022, the companies said on July 16.

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U.S. FDA sets January target to decide on approval of Pfizer’s COVID-19 shot

(Reuters) – The U.S. health regulator will review Pfizer (PFE.N) and German partner BioNTech SE’s (22UAy.DE) application for full approval of their COVID-19 vaccine in people 16 years and older by January, the companies said on Friday.

The vaccine is among the three being used in the United States under the Food and Drug Administration’s emergency use authorization alongside shots from Johnson & Johnson (JNJ.N) and Moderna Inc (MRNA.O).

Pfizer/BioNTech finished submitting their application for a full U.S. approval in May and the agency will review the data under its “priority review” pathway.

Syringe and vial are seen in front of displayed new Pfizer logo in this illustration taken, June 24, 2021. REUTERS/Dado Ruvic/Illustration

The FDA in May expanded the emergency use of the two-shot vaccine to children 12 through 15 years of age.

The companies said on Friday they intend to submit an application to support approval of the vaccine in this age group once the required data six months after the second vaccine dose is available.

Moderna also filed for full U.S. approval of its COVID-19 vaccine for adults early in June. read more

Reporting by Manojna Maddipatla in Bengaluru; Editing by Sriraj Kalluvila

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-decide-pfizer-covid-19-vaccine-approval-by-january-2022-2021-07-16

 

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GSK to part ways with ‘most’ Bellus Health employees a year after $2B buy

Many of the employees behind GSK’s late-stage investigational drug for chronic cough will be let go at the end of March.
Roberto Bellini
“After having…

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Many of the employees behind GSK’s late-stage investigational drug for chronic cough will be let go at the end of March.

Roberto Bellini

“After having completed the transition activities linked to the GSK acquisition, most Bellus Health employees will be wrapping up their involvement with the company on March 31,” Roberto Bellini, the longtime CEO of Bellus, wrote Thursday on LinkedIn.

A year ago, GSK bought the Canadian biotech for $2 billion for Bellus’ Phase 3 chronic cough candidate, which was expected to compete with Merck’s P2X3 antagonist. That drug was rejected by the FDA for a second time in December.

In his LinkedIn post, Bellini said it was the “end of an era.” He’s now a managing partner at life sciences investor BSquared Capital.

“We’re excited to see GSK complete the last legs of the journey and fulfill our mission of getting this important product to the chronic cough patient community,” Bellini wrote.

GSK, which completed the deal in June, did not disclose the number of roles impacted. In his LinkedIn post, Bellini tagged about 40 people whose profiles list them as Bellus employees.

“During the GSK-Bellus acquisition, we retained employees to a predetermined date to ensure the successful integration of the business,” a GSK spokesperson told Endpoints News. “As often is the case during this process, redundancies may occur.”

GSK is currently running two Phase 3 trials for its lead drug from Bellus, a P2X3 antagonist known as camlipixant or BLU-5937. Data are expected next year, the drugmaker has said.

“We look forward to continuing to drive the CALM Phase 3 clinical development program forward to address the unmet needs of patients living with refractory chronic cough,” the spokesperson wrote.

GSK has described camlipixant as one of its top clinical prospects, and chief commercial officer Luke Miels has said the company projects peak sales in the “single billion dollar” range.

Chronic cough can interrupt daily activities, impair people’s ability to work and disrupt social experiences as some say the condition has been stigmatized due to the Covid-19 pandemic. The pharma has estimated about 10 million people in the US and EU experience refractory chronic cough for more than a year.

Merck has said it’s going through feedback from the FDA’s latest no-go for gefapixant, its chronic cough candidate. The treatment is approved in the EU, Switzerland and Japan.

Other companies in the category include startup Nocion Therapeutics, which this month reeled in $62 million for a Phase 2b this year testing whether its alternative approach to treatment can work. Aldeyra Therapeutics, meanwhile, “deprioritized” its mid-stage treatment candidate in January.

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TikTok’s duet, green screen and stitch turn political point-scoring into an art form

TikTok’s features for combining different users’ videos have sparked a wave of creativity. They’ve also formed an arena for political arguments and…

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TikTok's features for combining users' videos lend themselves to political disputes. Quick et al, CC BY-NC-SA

Since its astronomical rise in popularity during the 2020 COVID-19 lockdowns, TikTok has played an increasing role in all aspects of American life, including politics, from the White House briefing key TikTok creators on the war in Ukraine to Joe Biden’s presidential campaign launching a TikTok account.

The U.S. House of Representatives passed legislation on March 13, 2024, seeking to force TikTok’s China-based parent company to sell the app or face a ban in the U.S. Even if this legislation passes the Senate and Biden signs it into law, it’s unlikely TikTok will go away before the 2024 U.S. presidential election. Any law banning TikTok is likely to be challenged in court, and the app won’t simply disappear from people’s phones overnight.

Given that TikTok is almost certain to play a role in the 2024 election, it’s important to examine how TikTok helps shape political expression and discussion. With communications scholar Mackenzie Quick, I recently published a journal article exploring how American TikTok users use the app’s stitch, duet and green screen features to stoke partisan conflict.

Getting together

TikTok says its mission is to “inspire creativity and bring joy.” In 2019, it introduced several features to help bolster that mission: duet, green screen and stitch. Duet allows you to post your video side by side with a video from another TikTok user. Green screen allows you to superimpose your video on a video from another TikTok user. Stitch allows you to append your video to the end of a short clip from a video from another TikTok user.

TikTok offers several ways to add your video commentary to other people’s tiktoks.

TikTok describes these features as giving users “the most creative tools available” and providing a way for users “to engage with the world of content that’s made … by the ever-creative TikTok community.” Given these descriptions, it appears that these tools were designed to increase creativity, interaction and connections.

They can be used in playful ways or used by subject matter experts to convey information. For example, some veterinarians use TikTok to convey pet health information.

However, a platform’s statements about how it intends its features to be used and how people actually use them can be quite different. While these features are often used in TikTok’s preferred ways, our research found that in political tiktoks, people often used the tools to double down on their political positions and attack those who don’t agree with them. In a time of volatile political divisiveness, these features can function as outlets for people to express their strongly held political views.

blurred photo of a woman's face superimposed ove a text list
A TikTok user makes a political statement using the app’s green screen feature. Quick et al, CC BY-NC-SA

Scoring points

Reinforcement and insults were recurring themes in our study. For instance, the green screen feature was often used to incorporate “evidence” in the background to support the creator’s claims. With this feature, “evidence” was often presented in the form of news articles or posts from other social media platforms.

One post from a conservative-leaning creator features a screenshot of the Apple iTunes music store charts to show the popularity of a song called “Let’s Go Brandon,” a conservative rallying cry and coded insult against Biden. This creator presents the song’s position at No. 1 in the music store as proof that the conservative viewpoint is popular. “Evidence” is a loose term and could be anything that supported the creator’s viewpoint.

We found the duet feature was often used to communicate nonverbally, often to poke fun at someone with opposing political views. Eye rolling, smirking and head shaking were common gestures. In one video, a conservative creator starts a chain – an extended succession of duets – of women who support former President Donald Trump. A liberal-leaning creator uses the duet feature to join the chain with video of themselves holding a clothes iron out to the side to make it appear as though the iron is burning the original creator’s hand.

Side-by-side photos of people with faces blurred
TikTok’s duet feature is often used to show support or opposition to a political statement. Quick et al, CC BY-NC-SA

Stitches functioned similarly to duets, but people tended to use the feature as a chance to verbally respond and refute the previous creator’s point. These uses show that on political TikTok, personal feelings and proving others wrong matter more than constructive debate.

The who and why of political TikTok

While regulation of the app is a political issue, understanding how political conversations occur across TikTok remains important for understanding an increasingly polarized American electorate. When considering political discussions on TikTok, however, it’s important to remember that the app’s features don’t force users to do anything. Users actively shape their experiences in digital spaces.

Also, as political communication scholars Daniel Kreiss and Shannon McGregor note, it’s important to proceed with caution when discussing the effects of technology on polarization because not all groups experience polarization the same way. For instance, the Black Lives Matter movement may be seen as polarizing for disrupting existing power structures, but its goal is to fight for equality, and it’s important to consider that context when looking at the group’s use of technology.

The lesson is to consider who is engaging in polarizing content and why they are doing so. While some users expressing themselves via these TikTok features aim to simply prove others wrong, akin to petty arguments, others may be critiquing and challenging the powerful.

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

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International

Global Population Set To Fall For First Time In 700 Years

Global Population Set To Fall For First Time In 700 Years

Authored by Steve Watson via Modernity.news,

A major study published in scientific…

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Global Population Set To Fall For First Time In 700 Years

Authored by Steve Watson via Modernity.news,

A major study published in scientific journal The Lancet has found that the global population will start to fall within decades due to vastly reduced fertility rates and may never recover.

The study, funded by the Bill & Melinda Gates Foundation, found that by the year 2050, 155 of 204 countries are on course to have birth rates lower than required to sustain the population level.

It notes that as of 2021, the “total fertility rate” worldwide was 2.23, hovering only just above the 2.1 children per woman needed to maintain population growth.

That figure has fallen from 4.84 in 1950, with researchers predicting it will decrease to 1.83 in 2050 and go as low as 1.59 by 2100.

The study notes that by that time only 26 countries will have birth rates that outpace the number of people dying, with “most of the world transitioning into natural population decline”.

A fall in population would mark the first time in seven centuries such an occurrence has taken place.

The last time it happened was after the Black Death bubonic plague pandemic killed as many as 50 million people in the mid-1300s, reducing the global population from 400 million to 350 million.

Commenting on the study, it’s co-author Dr Natalia Bhattacharjee said declining fertility rates “will completely reconfigure the global economy and the international balance of power and will necessitate reorganising societies”.

Bhattacharjee, lead research scientist at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, also noted that a major consequence will be increased immigration from countries where there is still a “baby boom,” such as sub-Saharan Africa, in order to make up workforce shortages in nations with aging populations.

Professor Stein Emil Vollset, senior author from IHME, also noted that the world is “facing staggering social change through the 21st century” due to population decline.

The findings are exactly what the likes of Elon Musk have been warning of for years, describing population decline as a ‘civilisational threat’ and urging that humanity is literally going to disappear if something is not done to reverse the trend.

While Eco loons rage about ‘moral issues’ with having children, the potential causes of fertility decline, such as plastics and chemical shrinking penises and sperm counts, are relatively ignored.

The stark reality is that birth rates globally are collapsing and almost every country is on course to have shrinking populations by the end of the century. 

In countries like South Korea and Japan, there are twice as many people are dying as there are being born. You don’t have to be a mathematic genius to do the calculations on what’s going to happen very soon.

These countries are already considering embracing mass migration, with South Korea’s Justice Minister recently declaring the country faces a “demographic catastrophe” and potential extinction otherwise.

Despite this horrifying reality, it is now commonplace in modern culture for young people to genuinely believe they need to abandon their human instincts to reproduce, all for the greater good:

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Tyler Durden Fri, 03/22/2024 - 07:20

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