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Biden Admin Negotiates Deal To Give WHO Authority Over US Pandemic Policies

Biden Admin Negotiates Deal To Give WHO Authority Over US Pandemic Policies

Authored by Kevin Stocklin via The Epoch Times (emphasis ours),

The…

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Biden Admin Negotiates Deal To Give WHO Authority Over US Pandemic Policies

Authored by Kevin Stocklin via The Epoch Times (emphasis ours),

The Biden administration is preparing to sign up the United States to a “legally binding” accord with the World Health Organization (WHO) that would give this Geneva-based UN subsidiary the authority to dictate America’s policies during a pandemic.

A logo is pictured outside a building of the World Health Organization (WHO) in Geneva, Switzerland. (Denis Balibouse/Reuters)

Despite widespread criticism of the WHO’s response to the COVID pandemic, U.S. Health and Human Services (HHS) Secretary Xavier Becerra joined with WHO Director-General Tedros Adhanom Ghebreyesus in September 2022 to announce “the U.S.-WHO Strategic Dialogue.” Together, they developed a “platform to maximize the longstanding U.S. government-WHO partnership, and to protect and promote the health of all people around the globe, including the American people.”

These discussions and others spawned the “zero draft” (pdf) of a pandemic treaty, published on Feb. 1, which now seeks ratification by all 194 WHO member states. A meeting of the WHO’s Intergovernmental Negotiating Body (INB) is scheduled for Feb. 27 to work out the final terms, which all members will then sign.

Written under the banner of “the world together equitably,” the zero draft grants the WHO the power to declare and manage a global pandemic emergency. Once a health emergency is declared, all signatories, including the United States, would submit to the authority of the WHO regarding treatments, government regulations such as lockdowns and vaccine mandates, global supply chains, and monitoring and surveillance of populations.

Centralized Pandemic Response

“They want to see a centralized, vaccine-and-medication-based response, and a very restrictive response in terms of controlling populations,” David Bell, a public health physician and former WHO staffer specializing in epidemic policy, told The Epoch Times. “They get to decide what is a health emergency, and they are putting in place a surveillance mechanism that will ensure that there are potential emergencies to declare.”

The WHO pandemic treaty is part of a two-track effort, coinciding with an initiative by the World Health Assembly (WHA) to create new global pandemic regulations that would also supersede the laws of member states. The WHA is the rule-making body of the WHO, comprised of representatives from the member states.

“Both [initiatives] are fatally dangerous,” Francis Boyle, professor of international law at Illinois University, told The Epoch Times. “Either one or both would set up a worldwide medical police state under the control of the WHO, and in particular WHO Director-General Tedros. If either one or both of these go through, Tedros or his successor will be able to issue orders that will go all the way down the pipe to your primary care physicians.”

Physician Meryl Nass told The Epoch Times: “If these rules go through as currently drafted, I, as a doctor, will be told what I am allowed to give a patient and what I am prohibited from giving a patient whenever the WHO declares a public health emergency. So they can tell you you’re getting remdesivir, but you can’t have hydroxychloroquine or ivermectin. What they’re also saying is they believe in equity, which means everybody in the world gets vaccinated, whether or not you need it, whether or not you’re already immune.”

Regarding medical treatments, the accord would require member nations to “monitor and regulate against substandard and falsified pandemic-related products.” Based on previous WHO and Biden administration policy, this would likely include forcing populations to take newly-developed vaccines while preventing doctors from prescribing non-vaccine treatments or medicines.

Circumventing America’s Constitution

A key question surrounding the accord is whether the Biden administration can bind America to treaties and agreements without the consent of the U.S. Senate, which is required under the Constitution. The zero draft concedes that, per international law, treaties between countries must be ratified by national legislatures, thus respecting the right of their citizens to consent. However, the draft also includes a clause that the accord will go into effect on a “provisional” basis, as soon as it is signed by delegates to the WHO, and therefore it will be legally binding on members without being ratified by legislatures.

“Whoever drafted this clause knew as much about U.S. constitutional law and international law as I did, and deliberately drafted it to circumvent the power of the Senate to give its advice and consent to treaties, to provisionally bring it into force immediately upon signature,” Boyle said. In addition, “the Biden administration will take the position that this is an international executive agreement that the president can conclude of his own accord without approval by Congress, and is binding on the United States of America, including all state and local democratically elected officials, governors, attorney generals and health officials.”

There are several U.S. Supreme Court decisions that may support the Biden administration in this. They include State of Missouri v. Holland, in which the Supreme Court ruled that treaties supersede state laws. Other decisions, such as United States v. Belmont, ruled that executive agreements without Senate consent can be legally binding, with the force of treaties.

There are parallels between the WHO pandemic accord and a recent OECD global tax agreement, which the Biden administration signed on to but which Republicans say has “no path forward” to legislative approval. In the OECD agreement, there are punitive terms built in that allow foreign countries to punish American companies if the deal is not ratified by the United States.

As with the OECD tax agreement, administration officials are attempting to appeal to international organizations to impose policies that have been rejected by America’s voters. Under the U.S. Constitution, health care does not fall under the authority of the federal government; it is the domain of the states. The Biden administration found this to be an unwelcome impediment to its attempts to impose vaccine and mask mandates on Americans, when courts ruled that federal agencies did not have the authority to do so.

To circumvent that, they went to the WHO, for either the regulations or the treaty, to get around domestic opposition,” Boyle said.

According to the zero draft, signatories would agree to “strengthen the capacity and performance of national regulatory authorities and increase the harmonization of regulatory requirements at the international and regional level.” They will also implement a “whole-of-government and whole-of-society approach at the national level” that will include national governments, local governments, and private companies.

The zero draft stated that this new accord is necessary because of “the catastrophic failure of the international community in showing solidarity and equity in response to the coronavirus disease (COVID-19) pandemic.”

A report from the WHO’s Independent Panel for Pandemic Preparedness and Response (pdf) characterized the WHO’s performance as a “toxic cocktail” of bad decisions. Co-chair Ellen Johnson Sirleaf told the BBC it was due to “a myriad of failures, gaps and delays.” The solutions proposed by that report, however, did not suggest more local autonomy or diversified decision-making, but rather greater centralization, more power, and more money for the WHO.

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Tyler Durden Mon, 02/20/2023 - 22:00

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Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

In response to the virus pandemic and nationwide…

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Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

In response to the virus pandemic and nationwide Black Lives Matter riots in the summer of 2020, some elite colleges and universities shredded testing requirements for admission. Several years later, the test-optional admission has yet to produce the promising results for racial and class-based equity that many woke academic institutions wished.

The failure of test-optional admission policies has forced Dartmouth College to reinstate standardized test scores for admission starting next year. This should never have been eliminated, as merit will always prevail. 

"Nearly four years later, having studied the role of testing in our admissions process as well as its value as a predictor of student success at Dartmouth, we are removing the extended pause and reactivating the standardized testing requirement for undergraduate admission, effective with the Class of 2029," Dartmouth wrote in a press release Monday morning. 

"For Dartmouth, the evidence supporting our reactivation of a required testing policy is clear. Our bottom line is simple: we believe a standardized testing requirement will improve—not detract from—our ability to bring the most promising and diverse students to our campus," the elite college said. 

Who would've thought eliminating standardized tests for admission because a fringe minority said they were instruments of racism and a biased system was ever a good idea? 

Also, it doesn't take a rocket scientist to figure this out. More from Dartmouth, who commissioned the research: 

They also found that test scores represent an especially valuable tool to identify high-achieving applicants from low and middle-income backgrounds; who are first-generation college-bound; as well as students from urban and rural backgrounds.

All the colleges and universities that quickly adopted test-optional admissions in 2020 experienced a surge in applications. Perhaps the push for test-optional was under the guise of woke equality but was nothing more than protecting the bottom line for these institutions. 

A glimpse of sanity returns to woke schools: Admit qualified kids. Next up is corporate America and all tiers of the US government. 

Tyler Durden Mon, 02/05/2024 - 17:20

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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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