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COVID Lab-Leak And The Attack On Common Sense

COVID Lab-Leak And The Attack On Common Sense

Authored by Charlie Tidmarsh via RealClear Wire,

Most of us learned about the virus we now…

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COVID Lab-Leak And The Attack On Common Sense

Authored by Charlie Tidmarsh via RealClear Wire,

Most of us learned about the virus we now call SARS-CoV-2 just over three years ago, on January 6, 2020. Reports of a fast-spreading respiratory infection that was hospitalizing and killing people in the southern Chinese city of Wuhan quickly became the dominant news story, and by January 20 the first domestic case was registered in Washington State. We were told, first, that coronaviruses of this kind were known to spread among bat populations in China, and that the virus likely leapt from bat to human at a live-animal market in Wuhan. The pangolin was the likely culprit. (Three years later, it’s the raccoon-dog.) But all the while, lurking in plain sight, was the Wuhan Institute of Virology, a biosafety-level 4 lab with funding from the United States’ National Institutes of Health (NIH) that openly engages in coronavirus research. It felt only natural to ask: Could this virus have originated in a lab?

Qualified people asked this question from the beginning. Asking it is not the same as asking whether Covid-19 was engineered by bad actors, state or otherwise, with terroristic intent. No one worth paying attention to was talking about bioterrorism. What many scientists and journalists were asking about instead was the increasingly mainstream theory that this novel coronavirus did not, in fact, make first contact with humans via an animal (the zoonotic origin theory). They wondered, rather, whether it was the product of one or another virus research method—“gain of function” being the key term here, referring to a set of practices ranging from benign to necessary to highly risky—and had subsequently “leaked” out of the Wuhan Institute of Virology and into the civilian world, unintentionally.

Today, both the U.S. Department of Energy and the FBI endorse the lab-origin position as the most likely. But efforts to discredit the theory as racist and conspiratorial in 2020 and 2021 were swift, unequivocal, and bewildering.

Bret Weinstein, the evolutionary biologist whose dramatic pillorying by a student mob at Evergreen State in 2017 sparked broader conversations about cancellations on university campuses, was among the first to observe publicly that the SARS2 genome contained something called a furin cleavage site, and that this particular mutation appeared to indicate human interference in the virus’s genetic sequence. The furin site was known to enhance the virus’s infectiousness and quicken its spread in human tissue; it had never been observed in similar, naturally occurring coronaviruses.

Arkansas senator Tom Cotton was also early to mention the possibility of a lab leak; the Atlantic Council responded by dismissing the senator’s statements as evidence of a growing “infodemic” of false claims about Covid.

Nicholas Wade, a former science writer at the New York Times, wrote a remarkable essay for the Bulletin of the Atomic Scientists in 2021 which details not only the scientific plausibility of the lab-leak theory but the connections between the Wuhan lab and the nonprofit EcoHealth Alliance. Wade points out that EcoHealth, with money from the NIH, funded coronavirus research at the Wuhan Institute of Virology. EcoHealth president Peter Daszak was the lead author of a February 2020 letter in the Lancet, signed by 27 scientists, which unequivocally denounced lab-origin speculation as not only incorrect but conspiracy theorizing. (If the lab-leak theory were true, Daszak would potentially be implicated.) As recently as last month, Democratic congressman Raul Ruiz attempted to remove Wade as a witness in a Covid origin hearing, accusing him of espousing racist and white supremacist views.

Meantime, then-president Donald Trump unhelpfully referred to Covid as the “China virus,” a rhetorical move that achieved little more than to offer mainstream liberal media a blank check to write off further discussion of the lab-origin hypothesis as racist drivel. Apoorva Mandavilli at the New York Times mused on Twitter that the lab-leak theory had “racist roots,” and that it was therefore time to stop talking about it. To believe the mainstream media, it was somehow more racist to be skeptical of an internationally funded research institution than it was to place blame on the Chinese cultural practice of wet-market trading.

As has become common today, suppression of the story became the story. Consider the ongoing discourse around Matt Taibbi’s Twitter Files reporting, which has produced a number of breaking stories but is persistently mired in slander to the degree that public interest has shifted away from the content of Taibbi’s reporting and onto the blatant efforts to dismiss it. In the case of Covid’s origins, what should have been a relatively dispassionate conversation has become heated largely because of how powerful individuals and institutions have tried to quash any serious discussion of the lab-leak theory.

We know that our public-health officials were paying attention to the lab-leak possibility as early as the spring of 2020. Recently obtained emails between Anthony Fauci and prominent virologists and epidemiologists show that, despite the lack of consensus about the scientific evidence, a paper in Nature Medicine was rushed to publication in order to preempt the perception that the U.S. government had been caught flat-footed on the question of the virus’s origin. Soon afterward, and despite expressing private uncertainty on the matter, Fauci announced at an April 2020 press conference that he endorsed the paper’s findings. Titled “On the proximate origin of SARS-CoV-2,” the paper claims that “[their] analyses clearly show that SARS-CoV-2 is not a laboratory construct.” It is now one of the most-read scientific papers of all time, with 5.7 million reads and over 2,000 media citations. After the April 2020 press conference, outlets such as ABC News ran snide headlines, such as, “Sorry, conspiracy theorists. Study concludes COVID-19 ‘is not a laboratory construct’.”

The New York Times’s David Wallace-Wells—along with Fauci, for that matter—is right to argue that an indisputable resolution to the Covid-origin question may be not only unattainable but also unnecessary to future pandemic preparedness. What is necessary, however, is a free-speech atmosphere in which Americans are not routinely cowed by elite media institutions into questioning whether they are racist, conspiratorial, or ignorant when they ask rational questions about observable realities.

Aaron Sibarium, soon after the Department of Energy leak, phrased the situation well with a thought experiment on Twitter: “Suppose you are investigating a murder. According to the forensic analysis, there is a 99% chance the exit wound came from a pistol. But the only gun at the scene—and you’ve searched very thoroughly—is an AR-15. This is roughly the epistemic dilemma of the lab leak debate.”

While the 99% figure may be overstated for effect, Sibarium is observing that the strong genetic case for a zoonotic origin has led many serious scientists to conclude that Covid came from an animal. This is still a theory, however—and it’s still in competition with the empirical reality of the Wuhan Institute of Virology, the nature of the institute’s work and its proximity to the epicenter of the outbreak, and even the scientific evidence that favors a lab leak. To date, however, merely observing this possibility continues to prompt scorn from outlets ranging from The New York Times and the Washington Post to the Lancet and Nature, which condemn views held by serious people, such as Wade and Weinstein, as beneath consideration.

This denialism does more than stifle open debate. It erodes our shared empirical reality and shunts significant segments of the population into conversational spaces that will actually breed toxic conspiracy theorizing. That COVID-19 might have come from a lab was from the beginning an intuitive, even common-sense, hypothesis; in rejecting it out of hand and stigmatizing those who proposed it, many of our leading institutions have degraded our future ability to formulate a coherent public response to emergencies.

Encouraging signs have emerged, however. Facebook has now reversed its earlier decision to censor posts discussing a lab origin, and Twitter, under Elon Musk, is opening channels of conversation about Covid that have long been closed. News media is reengaging with the lab-origin theory (even by stealth editing old stories, in some cases) and Congress is conducting investigations. It would be naïve to assume, though, that millions of Americans will forget how their rational questions were dismissed. And it is best that they don’t forget, even as the public conversation of Covid’s origin proceeds, albeit tentatively, in the way it should have done three years ago.

Tyler Durden Wed, 05/10/2023 - 21:00

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Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

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To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

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Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

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Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


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Another country is getting ready to launch a visa for digital nomads

Early reports are saying Japan will soon have a digital nomad visa for high-earning foreigners.

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Over the last decade, the explosion of remote work that came as a result of improved technology and the pandemic has allowed an increasing number of people to become digital nomads. 

When looked at more broadly as anyone not required to come into a fixed office but instead moves between different locations such as the home and the coffee shop, the latest estimate shows that there were more than 35 million such workers in the world by the end of 2023 while over half of those come from the United States.

Related: There is a new list of cities that are best for digital nomads

While remote work has also allowed many to move to cheaper places and travel around the world while still bringing in income, working outside of one's home country requires either dual citizenship or work authorization — the global shift toward remote work has pushed many countries to launch specific digital nomad visas to boost their economies and bring in new residents.

Japan is a very popular destination for U.S. tourists. 

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This popular vacation destination will soon have a nomad visa

Spain, Portugal, Indonesia, Malaysia, Costa Rica, Brazil, Latvia and Malta are some of the countries currently offering specific visas for foreigners who want to live there while bringing in income from abroad.

More Travel:

With the exception of a few, Asian countries generally have stricter immigration laws and were much slower to launch these types of visas that some of the countries with weaker economies had as far back as 2015. As first reported by the Japan Times, the country's Immigration Services Agency ended up making the leap toward a visa for those who can earn more than ¥10 million ($68,300 USD) with income from another country.

The Japanese government has not yet worked out the specifics of how long the visa will be valid for or how much it will cost — public comment on the proposal is being accepted throughout next week. 

That said, early reports say the visa will be shorter than the typical digital nomad option that allows foreigners to live in a country for several years. The visa will reportedly be valid for six months or slightly longer but still no more than a year — along with the ability to work, this allows some to stay beyond the 90-day tourist period typically afforded to those from countries with visa-free agreements.

'Not be given a residence card of residence certificate'

While one will be able to reapply for the visa after the time runs out, this can only be done by exiting the country and being away for six months before coming back again — becoming a permanent resident on the pathway to citizenship is an entirely different process with much more strict requirements.

"Those living in Japan with the digital nomad visa will not be given a residence card or a residence certificate, which provide access to certain government benefits," reports the news outlet. "The visa cannot be renewed and must be reapplied for, with this only possible six months after leaving the countr

The visa will reportedly start in March and also allow holders to bring their spouses and families with them. To start using the visa, holders will also need to purchase private health insurance from their home country while taxes on any money one earns will also need to be paid through one's home country.

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