The EU’s drug regulator has backed the emergency use of Merck’s pill for the treatment for clinically vulnerable Covid-19 patients as cases surge across the continent.

On Friday, the European Medicines Agency (EMA) “issued advice” backing the emergency use of the drug developed by Merck in collaboration with Ridgeback Biotherapeutics, although it has not yet been authorized by national authorities.

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© Reuters / Piroschka van de Wouw
EMA green lights new Covid treatments

In a statement, the drug regulator said the medicine called Lagevrio – also known as molnupiravir or MK 4482 – “can be used to treat adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of developing severe Covid-19.

It said the treatment should be administered as soon as possible after Covid-19 is diagnosed and within five days of the start of symptoms. The medicine should be taken twice a day for a period of five days.

The EMA listed the potential side effects of the capsules, including mild or moderate diarrhea, nausea, dizziness and headache. The treatment is not recommended for pregnant women.

The watchdog announced earlier on Friday that it had begun reviewing Pfizer’s medicine Paxlovid for Covid-19 with the same goal “to support national authorities” who may decide on its early use prior to marketing authorization in light of rising cases and deaths in Europe.

On Friday, Austria announced it would enter a new nationwide lockdown from Monday and make vaccination mandatory, while Germany’s health authorities claimed the country had turned into “one big outbreak.”

Both Pfizer and Merck have requested approval for their coronavirus medicines from the US Food and Drug Administration, but it is unclear when it might be granted.

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At least ten people have been killed and several wounded by security forces during mass demonstrations in Sudan against the recent military coup, a medics organization has said.

“The coup forces used live bullets heavily in different areas of the capital and there are tens of gunshot injuries, some of them in serious condition,” the Central Committee of Sudanese Doctors (CCSD) said in a statement.

The group of medics, which supports the protest movement, said several of the injured were in critical condition. It reported ten deaths across Bahri, Omdurman and the capital Khartoum.

According to AFP, citing witnesses, security forces also fired tear gas at protesters in the capital.

Although internet services have been disrupted and telephone lines cut since the military coup on October 25, thousands of people made it to the streets of major cities. 

The Sudanese Professionals Association, which also supports the demonstrators, said people were witnessing “excessive repression” and that there was a “deliberate interruption of voice and internet communications services.”

READ MORE: Protests in Sudan escalate amid reports of victims, videos claim to show military opening fire

Videos posted on social media show protesters wrapping up in national flags, chanting anti-military mottos and demanding the release of activists detained by the military since the takeover. Resistance committees across Sudan adopted the Liverpool Football Club’s chant ‘You Will Never Walk Alone’ as their slogan, which has already become a popular hashtag on Twitter.

On October 25, following a long period of tensions between Sudan’s military and civilian-led government, General Abdel Fattah al-Burhan announced the dissolution of both the Sovereign Council and the transitional government, declaring a state of emergency. The apparent military coup immediately prompted mass protests across the country.

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China has accused the Philippines of breaching its territory, saying two supply ships were blocked by Beijing’s coast guard as they approached a disputed shoal. Manila protested over the run-in, citing its own claim to the area.

The two Philippines vessels “trespassed” into waters near the Nansha island chain – also known as the Spratly Islands – on November 16, Foreign Ministry spokesman Zhao Lijan told reporters on Friday, noting that they entered the area “without China’s consent.”

“Chinese coast guard vessels performed official duties in accordance with law and upheld China’s territorial sovereignty and maritime order,” Zhao said, adding that the area is now “generally tranquil” and that the two countries are in communication about the encounter.

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FILE PHOTO: Chinese Coast Guard vessels patrol near a fishing boat in a disputed area of the South China Sea.
Philippines accuses China of using water cannon against its ships

The comments from Beijing come just one day after Manila first publicized the incident, with the Philippines Foreign Affairs Secretary Teodoro Locsin claiming Chinese vessels fired water cannon on the two supply boats and forced them to abandon their mission near a disputed shoal in the Spratlys. He called on China to “back off” and “take heed” of Philippines claims to the region. 

While both countries regard the Ayungin shoal – alternatively referred to as the Second Thomas or Renai Jiao shoal – as their own territory, The Hague’s Permanent Court of Arbitration settled the dispute in the Philippines’ favor in 2016. However, despite that ruling, as well as the fact that Manila has maintained a presence on the shoal since 1999, Beijing has not abandoned its claims to the area.

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A large settlement of migrants in the suburbs of Dunkirk in northern France has been dismantled, in the wake of yet another wave of tensions with the UK over the growing number of illegal crossings.

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FILE PHOTO. ©REUTERS/Peter Cziborra
London & Paris trade barbs over Channel crossings

At my instruction, the security forces are evacuating the illegal migrant camp in Grande-Synthe this morning,” French Interior Minister Gerald Darmanin said on Twitter on Tuesday. He added that state services in the region would provide shelter for the group.

Government spokesman Gabriel Attal said the decision to dismantle the camp was primarily based on the intention to put people into shelters ahead of the winter season.

Around 1,500 migrants were evacuated from the site via buses and their tents removed. According to Utopia 56, one of the charities monitoring the process of dismantling the camp, people “were forced to board buses, without being informed of their destination, and some of their personal belongings have been destroyed.” 

In a separate tweet, Darmanin announced the arrest of 13 alleged migrant smugglers, “bringing the total to 1,308 since January.

These smugglers are criminals who exploit human misery, responsible for irregular immigration,” the minister wrote.

Tuesday’s actions by French authorities came in the wake of a phone call between Darmanin and his British counterpart Priti Patel. The two discussed the increasing number of illegal migrants attempting to cross the English Channel, and reiterated the importance of cooperation in making this route “unviable,” Patel said afterwards. 

The UK and France have a history of mutual accusations when it comes to illegal migration. While British officials have claimed that French authorities do not do enough to prevent migrants from embarking for the dangerous trip, France’s government has said that the UK should reform its labor market rules in order to become less attractive to migrants.

More than 23,000 people have crossed the Channel by boat this year, compared to 8,404 in 2020, according to Press Association figures.

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An American nonprofit behind the US-funded bat virus research in China has denied ever sending virus samples from Laos – a place where SARS-CoV-2 closest natural relative was found – to Wuhan in response to fresh allegations.

“No work was ever conducted in Laos as a part of this collaborative research project,” EcoHealth Alliance – a group that conducted experiments on coronaviruses while receiving funding from the National Institutes of Health (NIH) – said in a series of tweets on Sunday, responding to media reports alleging that the group might have transported a potentially dangerous virus from Laos to the laboratory in Wuhan.

The group’s name surfaced in October when the NIH principal deputy director, Lawrence Tabak, revealed EcoHealth Alliance did experiment on the viruses with the agency’s financial help. At that time, White House Medical Advisor Dr. Anthony Fauci stated that the viruses studied as part of the project “were distant enough molecularly that no matter what you did to them, they could never, ever become SARS-CoV-2.”

EcoHealth has come under renewed scrutiny after its emails, obtained through a Freedom of Information request, appeared to suggest that the group was discussing the prospect of collecting viral samples from bats in Laos and sending them to the Wuhan Institute of Virology. The emails were initially obtained by the White Coat Waste Project and sparked a flurry of reports over the weekend, including in the Spectator by British science writer Matt Ridley.

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FILE PHOTOS.
Fauci DID fund Wuhan virus experiments, but officials insist virus involved ‘could not have been’ cause of Covid-19 pandemic

The emails shared between EcoHealth Alliance and its US government funders reportedly reveal that the scientists discussed collecting viral samples from bats in eight countries, including in Laos, between 2016 and 2019, and toyed with the idea of transporting them to Wuhan, ostensibly, to avoid red tape. One email from 2016 cited by the Spectator reportedly reads: “All samples collected would be tested at the Wuhan Institute of Virology.”

Laos is the birthplace of at least one virus that seems to be very close to SARS-Cov-2. A bat viral strain called Banal-52 discovered in Laos in September shares 96.8 percent of its genome with the virus behind the Covid-19 pandemic

On Sunday, EcoHealth Alliance claimed that the emails cited by Ridley “do not show…that we were sampling bats in Laos and sending the results to Wuhan.”

The group acknowledged, however, that it requested NIH permission to work in Southeast Asian countries, including in Laos, and that this permission was granted. 

However, the nonprofit claimed it ended focusing on China instead.

 The response failed to satisfy Ridley, who is also a co-author of a book on Covid’s origin, who demanded “evidence” proving that  his report was not “fully accurate.”

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Greece will soon prohibit unvaccinated residents from entering a litany of public spaces, the country’s prime minister has announced, claiming its current Covid outbreak is largely fueled by those who haven’t received the jab.

Starting next week, the unvaccinated will be barred from entry to restaurants, cafes, theaters, bars, gyms and museums, among other indoor public places, PM Kyriakos Mitsotakis said on Thursday, noting that a negative Covid-19 test will no longer be accepted as an alternative to proof of vaccination.

“This is indeed a pandemic of the unvaccinated,” he said as he announced the move in a televised address, adding “Greece is mourning unnecessary losses because it simply does not have the vaccination rates of other European countries.”

The new rules are set to take effect on Monday, and will require Greeks to present vaccine certificates to businesses and other indoor establishments to be allowed inside. Those attending religious services mark a rare exception, however, as they will only be asked to present a negative test in order to enter a church or other place of worship.

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People wait in front of a vaccination after Austria's government has imposed a lockdown on people who are not fully vaccinated, in Vienna, Austria, November 18, 2021. © Reuters /Leonhard Foeger
Austria may lock down the vaccinated too

In a bid to encourage booster vaccinations among the elderly – a population much more vulnerable to Covid-19 – citizens over the age of 60 will be made to renew their certificate after a period of seven months.

While officials had hoped to hit a full vaccination figure of 70% for Greece’s population of 11 million by autumn, the number currently stands at about 62%, according to Reuters. As its weekly case counts continue to soar to record highs, the country reported 7,317 new Covid-19 infections and 63 deaths on Thursday, bringing the totals to more than 860,000 cases and some 17,000 fatalities since the pandemic kicked off in late 2019.

The new restrictions in Greece mirror similar policies implemented elsewhere in Europe, with Austria, Germany, Italy, France, the Czech Republic and Slovakia each imposing limits on public life for the unvaccinated. Though the Austrian government recently imposed a full lockdown for millions of residents who have not received the shot, some officials in that country are pushing for even harsher policies, including a national stay-at-home order on the jabbed and non-jabbed alike.

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Chris Inglis’ new White House office has a startup feel to it. There are desks, a few chairs, a coffee maker and a poster hanging on the wall.  But as the head of the newly established Office of the National Cyber Director, Inglis has to make due with what he has while still advising President Joe Biden on the smartest ways for the US to prevent and respond to cyberattacks.

Inglis has already had numerous conversations with the president, who has made clear that the government has a role to play in the defense of the private sector and in assisting the private sector in defending critical infrastructure.  And the president knows, says Inglis, that means the government needs to get its own cyber house in order. 

But like any real startup, Inglis’ resources are scarce.  More than three months after being confirmed by the Senate, he still doesn’t have the full staff he needs to take on his timely and critical mission.  That’s because the funding for his office – some $21 million, part of the $1 trillion infrastructure bill making its way through Congress – is still stuck in the political spin cycle.  Why does it matter?

“The threat is greater than I can ever remember,” Inglis told me during last month’s AFCEA and INSA Intelligence & National Security Summit in National Harbor, Maryland. “The audacity, the brazenness, the thresholds that have been crossed at every turn; we’re in a difficult place.”

While he’s waiting for Congress to act, he says he’s spending about fifty percent of his time defining his role, being careful not to duplicate the work already being done by other agencies and departments, while spending another fifty percent building relationships that will be important later.  Eventually, he’s expected to have a staff of some 75 people who will be expected to work hand in glove with CISA, the National Security Council’s cyber staff, the OMB and others.  The remaining fifty percent of his time, Inglis jokes, is spent figuring out how to attract the country’s best talent.   

“People are starting to flow into the organization. I’m confident that we’re coming up to a breakout moment, not for the National Cyber Director, but the contribution that we can and should make. I’m sobered by the nature of the challenge, I’m optimistic we can make a difference.”

Optimistic he is.  And he’s not even complaining about being given a critical task for US national security and then having to wait for politics to play out before being able to act on it.

“It has been a semi-silver lining in that we would not have had time to think about how we want to apply the resources coming our way.”

While Inglis has been waiting, he and his small team have had time to think about the four things they’d like to focus on right away. 

First, is streamlining the roles and responsibilities in government of who handles what when it comes to protecting the public and private sectors from cyberattacks.  He also spoke during his confirmation hearing about the importance of allocation of resources and while the Office of the National Cyber Director doesn’t have the authority to move money, it does have what Inglis calls the responsibility to account for cyber money.

“One of the most critical gaps in cyber is that the physical digital infrastructure is not built to a common standard. The executive order related to this requires that within a certain amount of time we have to install basic procedures like multifactor authentication and encryption of stored material. That is a challenge and a potential vulnerability for us. We need to make sure that we make these investments necessary to buy down the lack of investment for years.

The second gap is in talent related to number of people required to occupy these jobs. It’s not simply the folks with IT or cyber in their name, but general cyber awareness. There is some expenditure of resources of time, attention, and money to get awareness right on the part of the truly accountable parties like agency and department heads. We have to make sure they don’t see cyber as a cost center, but an enabler on the part of all the users as they understand what their roles are and what the accountability is.

He admits there is still a level of education needed within government to get there.

That is usually the case in both the government and the private sector,” he said.  “We need to think this way about cyber and invest in cyber so that we can enable the mission, not hold it back. I think that education is the most important and effective way to handle this. Then, it is to make sure that the accountability is aligned and harmonized. We tend to take risk in one place and expect someone in another place to be the mitigator of a risk they don’t understand was taken in the first place. We need to operate in a collaborative fashion and get away from divisions of effort which are an agreement not to collaborate and allow adversaries to pick us off one at a time.”

Inglis says that unity of effort must start at home.  “The executive order issued in May has begun to lay out common expectations about the hardware, software, and practices that we need to begin in those spaces,” he said.  “Externally, if we have sector risk management agencies who engage the private sector for the purposes of supporting and engaging the critical components of that infrastructure, we need to make sure you don’t need a Ph.D. in government to know who to deal with and what you’re going to get from them.”

He is arguing for the government to also put ‘valuable material’ on the table.  “That could be our convening power,” said Inglis. “We could perhaps address and reduce liability or give companies a clue as to what might be around the corner because the government has access to exquisite intelligence. If that setup is possible, we also need a venue where collaboration takes place. Information doesn’t collaborate, people do.”

Inglis likes to point to the example of CISA and the Joint Cyber Collaborative.  “They put people from the private sector and the public sector side by side to co-discover threats that hold us at common risk. That project sets up the possibility of implicit collaboration in what we then do with that common operational picture. The government could take ideas that private sector companies turn into proprietary systems and enrich and classify them to deal with it in their system.”

Using what he calls “all the tools in the toolkit,” Inglis also notes the importance of international relationships, which fits nicely into the White House’s International Summit on Ransomware last week in Washington, which zeroed in on tighter cryptocurrency standards, among other things. “Beyond the Five Eyes, what do other like-minded nations think about what is expected behavior in this? What are governmental actions that are appropriate,” he asked.  

Inglis has been an active participant in the president’s recent actions in cyber.  He took part in a White House meeting with tech leaders in August that was hosted by President Biden, who Inglis says, spent the first hour sharing his vision about how the country should focus on collaborative integration.  “The companies represented weren’t only companies like Microsoft and Apple, but people who operate in the critical infrastructure space,” said Inglis.  “The people component, educators, were represented reflecting the president’s view that cyberspace is not just technology, it is also the people component. They are a major link in the chain, and we need to get the roles and responsibilities right.”

While he’s waiting for the funding he needs to get his office fully staffed, Inglis said he’s also putting thought into reconciling resources with aspirations.  Managing expectations is going to be important.  Frustration has been growing for years over what some see as a lack of government response to some of the largest hacks in history.  The phrase ‘time and place of our choosing’ as a definition of response has grown old and some Americans are weary of a government that isn’t responding in a more public way to the beating it sees the US taking in cyberspace.

So, I asked Inglis whether there should be red lines in cyber.

“Red lines are both good and bad,” he answered.  “They are clear and crisp, and everybody knows what they are. The downside is that because of that, an adversary knows exactly how far they can go. It means that you set up a somewhat permissive environment. Red lines also don’t have context; sometimes there is a reason that a defender would make the ransomware payment. As a matter of policy, the U.S. government does not pay ransomware, but I imagine there will be a situation at some point where a hospital is against the Russian state and actual life and safety is at risk. If there is no other way to get the material back, in order to get back in the business of saving lives, they would want to rethink if a red line is a red line in that particular situation. I think the right thing to do here is not to establish hard thresholds of things with scripted responses, but outline what we are prepared to defend and what principles we will exercise in defense of those things. We commit to defending the private sector when it is held at risk by a nation state in cyberspace as much as in the kinetic space and make that clear to adversaries. I think that would be more helpful in changing decision calculus and creating a useful ambiguity about when and where we will come in.”

Inglis said he’s also thinking a lot about present and future resilience.  It’s a worthwhile focus, given that the White House estimates that nearly half a million public and private sector cybersecurity jobs are currently unfilled. 

“That is a massive problem,” said Inglis. “However, the more insidious problem is that the 320 million people in the United States who use the internet who have no idea how to properly take their place on the front lines of this issue. There is an awareness issue that requires us not to make Python programmers out of them but to make sure they understand the nature of this space.”

Everyone has heard the old saying that time is money, but in Inglis’ case, time is security so I asked him point blank whether he thought government was moving has quickly as it should on the cyber problem.

“Government is moving at speed; the question is if it is at the necessary speed. I don’t think anyone is moving at the necessary speed. Some are moving at light speed, but at the end of the day, we need an integrated, collaborative approach. While we won’t have unity of command, I think there needs to be a universally felt sense of urgency so that we will all get our heads in the game.”

Congress, are you listening?  Oh, and by the way, that poster in Inglis’ office? It reads, ‘Hours Since the Last Surprise.”

As a startup with maybe too few resources at the start and who often didn’t understand how all the wickets are run, we have our occasional surprise,” said Inglis.  “When we encounter those surprises and go to someone with the deep and sharp expertise to help us navigate that, we get what we need. However, we are not a full functioning, full featured, fully capable organization yet. We’re trying to build somebody else’s airplane while we’re free falling from our own. We have a parachute, and we can land safely, but it is a bit of a challenge at times.”

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Hospitals in the Netherlands have begun delaying certain operations to free-up ICU beds during a record wave of Covid-19 infections, while an infectious diseases researcher has warned of an impending ‘Code Black’ in the sector.

The country set a daily national record for new Covid infections on Thursday, registering around 23,600 cases. It was the third day in a row of the figure topping 20,000.

To make more staff available for Covid wards, a number of operations, including those for cancer and heart patients, are being canceled from this week on, Dutch healthcare officials have said. Fewer than 200 beds remained available in Dutch ICUs as of Thursday, while Friday figures show almost half (47.8%) of occupied ICU beds were being used by Covid patients.

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FILE PHOTO. A woman wearing a protective mask walks past a store in Amsterdam, Netherlands.
Netherlands re-introduces facemasks & other restrictions as Covid-19 cases surge

“These are cancer patients that should actually be operated-on within six weeks of diagnosis, and that won’t be met in all cases. It’s also heart patients,” said a spokesperson for the National Coordination Center for Patient Distribution (LCPS).

Meanwhile, new calculations by an infectious disease modeller at Wageningen University & Research suggest that a so-called ‘Code Black’ in hospitals is looming. The emergency designation means that patient safety is at risk and, if declared, would mean many people with life-threatening illnesses cannot go to the ICU, while doctors have to prioritize who to treat.

According to recent estimates from the Dutch Healthcare Authority (NZa), up to 200,000 operations were not performed as a result of urgently needed Covid care since the start of the pandemic. On Thursday, the NZa revealed that almost a quarter of operating rooms across the country are not currently in use due to a combination of Covid patient pressures and rising staff absences due to illness.

It is not yet clear what impact the delayed care will have on public health. In December 2020, the Dutch National Institute for Public Health and the Environment (RIVM) calculated that an estimated 34,000 to 50,000 ‘healthy life years’ had been lost due to the first Covid-19 wave alone.

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An exoplanet some 70% the mass of Jupiter and about 1.4 times its size has been discovered by astronomers at India’s Physical Research Laboratory (PRL). The behemoth is 752 light years away from Earth, and has an incredible orbit.

The new discovery was revealed by the Indian Space Research Organization on Tuesday in a statement saying the country’s PRL Advanced Radial-velocity Abu-sky Search (PARAS) had measured the movements of the newly-discovered exoplanet between December 2020 and March 2021.

The planet, named either HD 82139 or TOI 1789 depending on which cataloguing method is used, is ultra-hot – with a surface temperature up to 2,000 degrees Kelvin.

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India’s PRL Advanced Radial-velocity Abu-sky Search (PARAS), an optical fiber-fed spectrograph, observed t he exoplanet and its movements from the Mt. Abu Observatory, according to the space agency. Not only is the planet ultra-hot, but it is also one of the closest to an orbiting star yet discovered.

The measurements obtained via PARAS were confirmed by Germany’s TCES spectrograph in April, and further verified by independent photometric observations from the PRL’s 43cm telescope, also located at Mt. Abu.

The exoplanet has an unusually quick orbit – a mere 3.2 days. The pace indicates that its distance from its host star is one-tenth the distance between Mercury and the Sun. This makes the exoplanet one of fewer than 10 such solar systems discovered thus far. Given the closeness to its host star – an aging orb 1.5 times the mass of the Sun – the new planet is also one of the lowest density planets yet discovered.

Planets so close to their host stars, with a distance less than 0.1 AU and masses between 0.25 to several times the mass of Jupiter, are known as “hot-Jupiters.”

The Indian space agency hailed the detection of the new planet as an opportunity to “enhance our understanding of various mechanisms responsible for inflation in hot-Jupiters and the formation and evolution of planetary systems around evolving and aging stars.” It is the second planet to be discovered by PARAS, with a previous discovery taking place in 2018.

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New research has found that legalizing the sale and use of recreational cannabis could bring a €5 billion ($5.67 billion) boost to the German economy via annual tax revenues and cost savings within the police.

Should Germany proceed with legalization, the research estimates that it could bring in tax revenues of €3.4 billion ($3.86 billion) per year and save some €1.3 billion ($1.48 billion) in costs within the police and judicial system, alongside creating 27,000 new jobs. 

The report, carried out by the Institute for Competition Economics (DICE) at the Heinrich Heine University in Düsseldorf and commissioned by the German Cannabis Association, comes amid ongoing discussions for the formation of a coalition federal government. 

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FILE PHOTO.
‘Start of dim future?’ German police unions sound alarm over potential weed legalization amid ongoing govt coalition talks

One of the areas under consideration in the three-way talks between the Social Democrats (SPD), the Greens, and the Free Democrats (FDP) is the potential regulation of the sale and use of recreational cannabis.

Using cannabis for medicinal purposes has been legal in Germany since 2017. However, its possession or distribution for recreational use remains illegal and can result in fines as well as time behind bars.

Earlier this year, research on the legalization of cannabis across Europe by market intel firm Prohibition Partners said that if Germany legalized its use by adults, the move would see that country alone constituting “over half of the European market until 2024.” It would also help propel the European cannabis market from its 2021 valuation of €400 million ($454 million) to some €3 billion ($3.4 billion) by 2025. 

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