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CDC Walks Back Change To Testing Guidance, Caving To Pressure From Democrats: Live Updates

CDC Walks Back Change To Testing Guidance, Caving To Pressure From Democrats: Live Updates

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CDC Walks Back Change To Testing Guidance, Caving To Pressure From Democrats: Live Updates Tyler Durden Thu, 08/27/2020 - 11:39

Summary:

  • CDC walks back testing guidance change
  • Florida hospitalizations decline, cases roughly even with yesterday
  • Germany extending some restrictions on public events until Dec. 31
  • France tightens mask rules in Paris as cases spike
  • Abbott wins FDA approval for rapid COVID test
  • US, Brazil, Africa see infections slow
  • South Korea sees most new cases since March
  • Argentina outbreak passes Iran
  • SK parliament closes temporarily after outbreak scare
  • Kushner says US on track to keep promise of 100MN vax doses by year end

* * *

Update (1130ET): Where we left off last night, Dr. Fauci was expressing his dismay that a recent guidance change from the CDC (which he said had been "finalized" without his input while he was under general anesthesia) might send the wrong message - ie that asymptomatic cases aren't a major cause for concern.

Dr. Fauci's statement followed stronger condemnations from governors around the country (all of them Democrats of course), and now on Thursday, the CDC has already buckled and issued a clarification that mostly walks back the guidance.

The walk-back was leaked to the NYT and some other reporters late last night before being released "more broadly" Thursday morning.

The director of the Centers for Disease Control and Prevention has scaled back the agency’s recommendation advising some people not to get tested after exposure to the novel coronavirus, now saying “testing may be considered for all close contacts of confirmed or probable Covid-19 patients."

The statement by Dr. Robert R. Redfield was issued to some news outlets late Wednesday, and more broadly Thursday morning, after a storm of criticism over the new C.D.C. guidelines — involving potentially asymptomatic people — which were the product of the White House Coronavirus Task Force and not C.D.C.’s own scientists. Dr. Redfield made the statement in an effort to clarify the new policy, an official said. However, the guidelines issued earlier this week remained on the C.D.C.’s website as of Thursday morning, and it appears unlikely that the agency will change them.

"Testing is meant to drive actions and achieve specific public health objectives,” Dr. Redfield wrote. “Everyone who needs a Covid-19 test, can get a test. Everyone who wants a test does not necessarily need a test; the key is to engage the needed public health community in the decision with the appropriate follow-up action."

In guidelines posted on Monday, the agency said close contacts of Covid-19 patients “do not necessarily need a test” unless they are vulnerable or their doctor or a state or local public heath official recommended it. On a conference call with reporters Wednesday, Admiral Brett M. Giroir, the administration’s coronavirus testing czar, said the new policy mirrored the existing recommendation for health care and other front line workers, and the task force had simply decided to extend it to the general population.

Democratic governors will ultimately cry victory, but it's all roughly semantics. With the approval of the new Abbott rapid test, we suspect the number of tests run each day will soon skyrocket, especially as more students return to classrooms.

* * *

Update (1030ET): Florida just released the first major piece of US COVID-19 data for the day by revealing that the number of occupied hospital beds across the state declined by 147 over the last day, compared with 102 the day prior as the dramatic decline in hospitalizations in the Sunshine State continues.

Florida reported 3,269 new cases, slightly more than yesterday's 3,220, bringing the statewide total to nearly 612,000. The state reported 141 deaths, vs 153 yesterday, bringing the death toll to 11,011 statewide.

Meanwhile, the Paris mandatory mask order mentioned below will take effect at 8 am local time on Friday morning in the City of Lights. Meanwhile Angela Merkel once again called on Germans not to travel to high-risk areas.

* * *

Update (1025ET): Germany is barring more public events until Dec. 31.

  • GERMAN GOVT, STATES BAN SOME MASS PUBLIC EVENTS UNTIL DEC31:DPA

* * *

Update (0930ET): France is planning to extend its mandatory mask-wearing restrictions across all of Paris to try and quell an upsurge in new cases.

Infections are surging across France at the end of the summer holidays, with 5,429 new infections reported on Wednesday, the highest daily number since the end of the lockdown in mid-May. Each week, 830,000 people are being tested for the virus, a number expected to reach 1m next month.

 

* * *

Abbott Labs has become the focus of Thursday's rolling coronavirus coverage, as the FDA's approval - coming just days after the whole patient plasma approval controversy - of Abbott's 15-minute rapid COVID-19 test - which will be priced at just $5 a pop - has quelled fears about falling testing numbers along the sun belt. Now, parts of the country where test turnaround times still lag finally have a solid chance of getting up to speed.

What's more, testing that's rapid, plentiful and cheap is the centerpiece of what many experts have embraced as a "sustainable" alternative to lockdowns: Regular testing. Even if the rapid tests aren't as accurate, the logic goes, teachers and students and co-workers will be tested so regularly that nearly all positive cases should be caught before becoming contagious.

Abbott shares are soaring on the triumph, though the FDA has approved other testing innovations like at-home testing kits.

Abbott's product, BinaxNOW, works without laboratory equipment, and involves using a nasal swab and a small reactive card, which will deliver the result within minutes akin to an at-home drug test. The test can be administered by a range of health-care workers, including, crucially, pharmacists, at almost any location.

Moving on, experts rejoiced on Thursday as the latest batch of global data showed outbreaks in the US and Brazil continuing to slow, while new hotspots in Argentina and elsewhere simply aren't spreading fast enough to make up for the falling case numbers in the world's biggest outbreak zones.

Deaths have been declining, too, with some experts proclaiming that the downward trend seen over the past two weeks is likely to hold.

In the US, the average number of new deaths over the past week dipped below 1,000. Perhaps the irony is that the US is now technically worse than Brazil in terms of cases/population.

The US remains no. 1 in practically every other aspect.

Jared Kushner spoke to the press Thursday morning following news of a new deal with AstraZeneca for the Oxford/Astrazeneca vaccine that the US is on track to keep its promise of having 100 million doses of a vaccine by the end of the year.

But perhaps the biggest news in the Americas is that Argentina's outbreak has now overtaken Iran's.

Across the US, the outbreak is solidly in decline.

Africa Centers for Disease Control and Prevention's John Nkengasong reported some optimistic news on Thursday. Fears that Africa's outbreak was on the cusp of a major escalation have abated as 23 of Africa's 54 countries have reported a sustained decrease in new confirmed coronavirus cases over the past two weeks.

Meanwhile, in the latest testament to just how difficult COVID-19 can be to stamp out, South Korea's parliament has closed after a photojournalist covering the governing party tested positive on Wednesday. The closure comes as the country reported 441 additional coronavirus cases (prev. +320). Health officials urged businesses to ask employees to work from home as the new cases were the largest single-day tally since March, the latest in a series of multimonth highs recorded in recent days.

Finally, India recorded another single-day record of new coronavirus cases with 75,760 new infections reported over the past 24 hours. The Indian health ministry also reported 1,023 deaths, pushing the country's death toll from the pandemic to 60,472.

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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.

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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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