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“Being A Doctor And Courageous Runs In My Family”: French Scientist Behind Hydroxychloroquine Treatment For COVID-19

"Being A Doctor And Courageous Runs In My Family": French Scientist Behind Hydroxychloroquine Treatment For COVID-19

Authored by Terri Wu…

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"Being A Doctor And Courageous Runs In My Family": French Scientist Behind Hydroxychloroquine Treatment For COVID-19

Authored by Terri Wu via The Epoch Times (emphasis ours),

Didier Raoult, a renowned French microbiologist, announced hydroxychloroquine (HCQ) as an effective cure for COVID-19 on Feb. 25, 2020. The following month, former U.S. President Donald Trump cited his research and called the drug a “game changer.” Since then, Dr. Raoult has been engulfed in a global controversy.

Virologist Didier Raoult addresses a press conference on COVID-19 at the IHU medical institute in Marseille on April 20, 2022. (Christophe Simon/AFP via Getty Images)

Initially, in March 2020, the Food and Drug Administration (FDA) granted HCQ, a drug widely used against malaria and arthritis, an emergency use authorization (EUA) for treating COVID-19.

However, on May 22, 2020, the Lancet medical journal published a now-retracted study saying that HCQ brought about a much higher risk of death and heart problems in hospitalized COVID-19 patients, citing data from nearly 100,000 patients in over 600 hospitals. The authors noted the mortality rate of the total surveyed population was 11.1 percent, while the death rate was 16 percent and higher for the groups given various HCQ treatments—nearly double that of the control group, which was not given HCQ treatment.

The study preceded a series of decisions by health authorities. In three days, the World Health Organization (WHO) suspended a clinical trial of HCQ for COVID-19. During the same week, France also banned its use on COVID-19 patients, revoking an emergency authorization of HCQ for COVID-19 issued two weeks earlier.

On June 15, 2020, the FDA revoked the EUA of HCQ, citing cardiac adverse events and other side effects. Six months later, the FDA approved EUAs for Pfizer-BioNTech and Moderna COVID-19 vaccines, emergency authorizations contingent on “no adequate, approved, and available alternatives,” according to the FDA announcement.

“Chloroquine or hydroxychloroquine was prescribed 1 billion times in the year of 2006. So it means that if 10 percent of the people died with this, that would have made 100 million people die of heart attack, which is stupid,” Dr. Raoult told The Epoch Times. HCQ is a newer and improved version of chloroquine.

He said he and other experts wrote to the Lancet, saying the study’s findings were impossible. A few months later, the journal retracted the paper. When retracting the article on June 4, 2020, the authors said they could “no longer vouch for the veracity of the primary data sources.” They also apologized for causing “any embarrassment or inconvenience” to the journal and its readers.

A day before the retraction of the paper, the WHO announced it was resuming the clinical trial of HCQ on COVID-19. On June 20, 2020, the U.S. National Institutes of Health (NIH) halted its clinical trial, citing no harm and no benefit of HCQ on COVID-19 patients. A month later, the WHO also discontinued its HCQ treatment arm for COVID-19 for similar reasons. France's ban on using HCQ for COVID-19 patients has not been lifted.

Yet Dr. Raoult persisted in treating COVID-19 patients with HCQ and azithromycin, an antibiotic. On April 4, 2023, he published preliminary results of treating over 30,000 patients between March 2020 and December 2021 at the institute he led until August 2022, the Institut Hospitalo-Universitaire Méditerranée Infection (IHU). He said the fatality rate of those treated with HCQ was at 7 percent, “half of the fatality rate of the deaths of any series of hospitalized patients [who] needed oxygen.” “So it's very efficient,” he added.

In May, French medical bodies called for sanctions against Dr. Raoult for “the largest 'unauthorised' clinical trial ever seen.” Dr. Raoult responded, "There's no trial, only the therapeutical choice by the doctors."

Over the years, HCQ has remained a contentious topic. Because he stood by his statement of HCQ’s effectiveness on COVID-19, Dr. Raoult, an accomplished scientist who received one of the highest honors in France—the prestigious Grand Prix Inserm—in 2010, has been labeled an anti-vaccine conspiracy theorist.

In response, he has maintained that he is not against vaccines, but to him, the equation of risks and benefits doesn’t hold for COVID-19 patients under 50 with low risk, especially children, to elect to take the injections.

He spoke to The Epoch Times while promoting his autobiography at a conference in Saint-Hyacinthe, a small city east of Montreal. The autobiography was published in France in April and in Canada in October. “Being a doctor and courageous runs in my family,” he said.

His father was a military doctor, and his great-grandfather an infectious disease doctor. He was born in French Dakar, today’s Senegal in West Africa, while his father was posted there working on malnutrition. His grandmother ran a resistance network against the Nazis and survived from Ravensbrück, a women’s concentration camp in northern Germany, 50 miles north of Berlin.

“I don’t want to be ashamed to be less courageous. She was deported to Ravensbrück, my God,” he said. “It’s in my family. Sometimes you need to disobey because you think it’s not good to obey some things incompatible with your moral sense.”

He said patients were told not to see doctors and doctors not to see patients during the COVID lockdown. That was “completely stupid” to him. In March 2020, he opened IHU to COVID-19 patients who were willing to receive HCQ treatments, and people queued in winding single-file lines outside his institute to wait for their turns.

French microbiologist Didier Raoult signs his autobiography in Saint-Hyacinthe near Montreal, Canada, on Oct. 8, 2023. (Tanya Du/The Epoch Times)

To him, countering the mainstream recommendation that HCQ was dangerous for COVID-19 patients was just an outcome of doing his job. “I don’t care about what the others say. I’m just talking about what I’m seeing. It’s not a Christian opinion; I don’t get any opinion.”

He said he was encouraged by a recent U.S. appeals court decision allowing a lawsuit from three doctors against the FDA to proceed. On Sept. 1, a panel of three judges on the 5th U.S. Circuit Court of Appeal in New Orleans revived the case, which alleges the FDA overstepping its authority by running a campaign against ivermectin’s effectiveness in treating COVID-19 patients.

It was very interesting because I hope it will happen sometime in France—the doctor is in charge of treating the patient. This is his role and his duty. So you can have recommendation information from the government or from the agency, but it cannot replace the responsibility of the doctor who prescribes the treatment,” Dr. Raoult said.

He added that patients should hold the doctor accountable if he didn’t do his job. “But it’s not an agency that should determine what the doctor [should] do.”

The maverick scientist, now 71, said he wasn't aware of any complaints from the 30,000 COVID-19 patients treated at IHU under his leadership. “This means that the people who have never seen the patient in the Ministry of Health don’t know better than we who treated 30,000 people. And I’ve been practicing medicine for 42 years, so I know what I’m doing.”

“Self-esteem is more important than the esteem of others,” he said about one of the themes of his autobiography. “I need to be agreed with myself. This is critical.”

Tanya Du contributed to this report.

Tyler Durden Thu, 10/12/2023 - 02:45

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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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