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Another Tacit Admission That COVID Mandates Were A Disastrous Mistake

Another Tacit Admission That COVID Mandates Were A Disastrous Mistake

Authored by Ian Miller via The Brownstone Institute,

Pandemic restrictions…

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Another Tacit Admission That COVID Mandates Were A Disastrous Mistake

Authored by Ian Miller via The Brownstone Institute,

Pandemic restrictions were an unmitigated failure, and the evidence base against the politicians and “experts” who imposed them and demanded compliance continues to grow.

And it raises some substantial questions about holding those responsible accountable for their actions. Especially as mask mandates return in certain parts of the country, with hints of more on the way.

Recently a new government report from the United Kingdom was released to little fanfare, which not-so-surprisingly mirrors the fanfare resulting from the release of new data from the CDC itself, showing how vaccine efficacy has fallen to zero.

Finally, Rochelle Walensky did acknowledge publicly that the vaccines couldn’t stop transmission. However it was already far too late to matter. 

But all along the agency has strongly stated that the mRNA shots were effective at preventing hospitalizations. Or at least that the latest booster was effective, tacitly acknowledging that the original 2-dose series has lost whatever impact it once had.

What The Evidence Says About NPI’s

The UK’s Health Security Agency (HSA) recently posted a lengthy examination on the effectiveness of non-pharmaceutical interventions at preventing or slowing the spread of COVID-19 in the country. 

And at the risk of revealing a spoiler alert, it’s not good news for the COVID extremists determined to bring mask mandates back. 

The goal of the examination was laid out succinctly; the UK’s HSA intended to use primary studies on NPIs within the community to see how successful or unsuccessful they were at reducing COVID infections.

The purpose of this rapid mapping review was to identify and categorise primary studies that reported on the effectiveness of non-pharmaceutical interventions (NPIs) implemented in community settings to reduce the transmission of coronavirus (COVID-19) in the UK.

Streamlined systematic methods were used, including literature searches (using sources such as Medline, Embase, and medRxiv) and use of systematic reviews as sources to identify relevant primary studies.

Unsurprisingly, they found that the evidence base on COVID interventions was exceptionally weak. 

In fact, roughly 67 percent of the identified evidence was essentially useless.. In fact two-thirds of the evidence identified was modeling. 

Two-thirds of the evidence identified was based on modeling studies (100 out of 151 studies).

There was a lack of experimental studies (2 out of 151 studies) and individual-level observational studies (22 out of 151 studies). Apart from test and release strategies for which 2 randomised controlled trials (RCTs) were identified, the body of evidence available on effectiveness of NPIs in the UK provides weak evidence in terms of study design, as it is mainly based on modelling studies, ecological studies, mixed-methods studies and qualitative studies.

This is a key learning point for future pandemic preparedness: there is a need to strengthen evaluation of interventions and build this into the design and implementation of public health interventions and government policies from the start of any future pandemic or other public health emergency.

Modeling, as we know, is functionally useless, given that it’s hopelessly prone to bias, incorrect assumptions and the ideological needs of its creators. 

The two paragraphs which followed are equally as important.

Low quality evidence is not something that should be relied upon for decision making purposes, yet that’s exactly what the UK, US and many other countries did. Fauci, the CDC, and others embraced modeling as fact at the beginning of the pandemic. They then repeatedly referenced shoddy, poor quality work because it confirmed their biases throughout its duration, with unsurprising results.

And this government report concurs; stating simply and devastatingly, “there is a lack of strong evidence on the effectiveness of NPIs to reduce COVID-19 transmission, and for many NPIs the scientific consensus shifted over the course of the pandemic.”

Of course the scientific consensus shifted over the course of the pandemic because, as we learned, it became politically expedient for it to shift.

As their paragraphs on the available evidence show, there was little solid, high-quality data showing that NPI’s were having a significant impact on the spread of the virus, a reality that had been predicted by decades of pandemic planning. 

But the consensus shifted towards NPIs and away from something approaching Sweden’s strategy or the Great Barrington Declaration, simply because Fauci, the CDC, and other “experts” demanded it shift to suit their ideological aims.

The few high-quality studies on say, masking, that were conducted during the pandemic showed that there was no benefit from mask wearing at an individual or population level. And that is why the Cochrane review came to its now infamous conclusion.

Instead of acknowledging that they were relying on poor quality evidence, the “experts” operated with an unjustified certainty that their interventions were based on following “The Science™.” At every turn, when criticized or questioned, they would default back to an appeal to authority; that the consensus in the scientific community unequivocally believed that the evidence showed that lockdowns, mandates, travel restrictions, and other NPIs were based on the best available information.

After initially determining that the UK should follow Sweden’s example and incorporate a more hands-off approach that relied on protecting the elderly while allowing immunity to build up amongst the younger, healthy populations, Boris Johnson panicked, at the behest of Neil Ferguson, and terrified expert groups. Tossing out decades of planning out of fear, while claiming publicly to be following science. 

Instead, a systemic, detailed review of the evidence base relied on by those same experts has now concluded that there never was any high-quality information suggesting that pandemic policies were justifiable. Only wishful thinking from an incompetent, arrogant, malicious “expert” community, and unthinking, unblinking compliance from terrified politicians using restrictions and mandates without care or concern for adverse effects.

While this new report wasn’t specifically designed to determine how effective NPIs were in reducing transmission, it’s clear and obvious conclusions give away that answer too. 

If it were easy to prove that COVID policies and mandates had a positive impact on the spread of the virus, there would be dozens of high-quality studies showing a benefit. And those high-quality studies would be covered in this report, with a strong recommendation to reinstate such mandates in future pandemics. 

Instead, there’s nothing.

Just exhortations to do better next time, to follow the actual high-quality evidence and not guesswork. 

Based on how little accountability there’s been for the “experts” and politicians who lied about “The Science™,” there’s little doubt that when presented with the next opportunity they’ll be sure to handle it in exactly the same way. 

Abandoning evidence in favor of politics.

*  *  *

Reprinted from the author’s Substac

Tyler Durden Thu, 10/12/2023 - 05:00

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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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