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Health Canada still reviewing Merck COVID-19 drug – CTV News

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Health Canada says it’s still reviewing data on an antiviral COVID-19 drug that was authorized Thursday in the United Kingdom.

The federal regulator said it continues to receive data “as new information becomes available” from pharmaceutical company Merck on their drug molnupiravir, considered the first pill to successfully treat COVID-19.

It offered no timeline for completion of the review process.

“As the review is still ongoing, it is not possible to predict when a regulatory decision will be made,” Health Canada stated by email.

While molnupiravir was granted conditional authorization for use in Britain, it wasn’t immediately clear how quickly the pill would be available there.

Merck has been supplying data to Health Canada on a rolling basis since August, when the product was still undergoing clinical trials.

Health Canada said earlier Thursday by email that it was “awaiting the final package of manufacturing data” from Merck, but said later in the day that statement was issued in error, however did not immediately elaborate.

The regulator said its review will determine whether benefits of using the drug outweigh risks and ensure it meets “stringent safety, efficacy and quality requirements.”

Merck announced preliminary results in September showing its drug cut hospitalizations and deaths by half among patients with early COVID-19 symptoms. The results haven’t yet been peer reviewed or published in a scientific journal.

The company also didn’t disclose details on molnupiravir’s side effects, except to say that rates of those problems were similar between people who got the drug and those who received dummy pills.

Molnupiravir was initially studied as a potential flu therapy with funding from the U.S. government. Last year, researchers at Emory University in Atlanta, Ga., decided to repurpose the drug as a potential COVID-19 treatment. They then licensed the drug to Ridgeback and partner Merck.

The drug targets an enzyme the coronavirus uses to reproduce itself, inserting errors into its genetic code that slow its ability to spread and take over human cells. That genetic activity has led some independent experts to question whether the drug could potentially cause mutations leading to birth defects or tumours.

Britain’s Medicines and Healthcare products Regulatory Agency said molnupiravir’s ability to interact with DNA and cause mutations had been studied “extensively” and that it wasn’t found to pose a risk to humans.

Dr. Sumon Chakrabarti, an infectious disease expert in Mississauga, Ont., said molnupiravir is intriguing because the errors it inserts into the genetic code aren’t recognized as errors by the SARS-CoV-2 virus.

“So that lead to massive mutations and the virus dies,” he said. “It’s kind of cool, actually.”

Merck Canada said Thursday that Health Canada will decide on authorization after reviewing “all necessary evidence.”

The company added that a supply agreement was not yet in place but that conversations with the Canadian government were ongoing.

“We remain committed to working with the government to ensure Canadians will have access to our medicine should it receive market authorization by Health Canada,” Merck said in an email from its media centre.

Chakrabarti said the current context of COVID-19’s circulation in the United Kingdom, where there’s been a “slow burn of a ton of hospitalizations,” may have provided more urgency for regulators there to authorize the drug on a conditional basis.

He said Health Canada will consider use of the drug “in the Canadian context.”

“They’ve been pretty good about not rushing things,” he said of the Canadian regulator. “They look at the data and when they make a recommendation, you can trust it.”

Molnupiravir is also pending review with regulators in the United States, the European Union and elsewhere. The U.S. Food and Drug Administration announced last month it would convene a panel of independent experts to scrutinize the pill’s safety and effectiveness in late November.

Merck and partner Ridgeback Biotherapeutic have requested clearance for the drug for adults with early cases of COVID-19 who are at risk for severe disease or hospitalization.

The pill, a take-home treatment, was licensed in Britain for adults 18 and older who have tested positive for COVID-19 and have at least one risk factor for developing severe disease, such as obesity or heart disease. Patients with mild-to-moderate COVID-19 would take four pills of the drug twice a day for five days.

Chakrabarti, who hasn’t seen the clinical trial data, said the caveat with the drug is that it has to be taken early — either shortly after exposure or in the first days of infection.

“The absolute risk reduction doesn’t seem to be that high, but at least it’s another tool in the box,” he said. “Anything we can use to to prevent hospitalization is good.”

With files from The Associated Press

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Alaska man charged with sending graphic threats to kill Supreme Court justices

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WASHINGTON (AP) — An Alaska man accused of sending graphic threats to injure and kill six Supreme Court justices and some of their family members has been indicted on federal charges, authorities said Thursday.

Panos Anastasiou, 76, is accused of sending more than 465 messages through a public court website, including graphic threats of assassination and torture coupled with racist and homophobic rhetoric.

The indictment does not specify which justices Anastasiou targeted, but Attorney General Merrick Garland said he made the graphic threats as retaliation for decisions he disagreed with.

“Our democracy depends on the ability of public officials to do their jobs without fearing for their lives or the safety of their families,” he said.

Anastasiou has been indicted on 22 counts, including nine counts of making threats against a federal judge and 13 counts of making threats in interstate commerce.

He was released from detention late Thursday by a federal magistrate in Anchorage with a a list of conditions, including that he not directly or indirectly contact any of the six Supreme Court justices he allegedly threatened or any of their family members.

During the hearing that lasted more than hour, Magistrate Kyle Reardon noted some of the messages Anastasiou allegedly sent between March 2023 and mid-July 2024, including calling for the assassination of two of the Republican-appointed Supreme Court justices so the current Democratic president could appoint their successors.

Instead of toning down his rhetoric after receiving a visit from FBI agents last year, Anastasiou increased the frequency of his messages and their vitriolic language, Reardon said.

Gray-haired and shackled at the ankles above his salmon-colored plastic slippers, Anastasiou wore a yellow prison outfit with ACC printed in black on the back, the initials for the Anchorage Correctional Facility, at the hearing. Born in Greece, he moved to Anchorage 67 years ago. Reardon allowed him to contact his elected officials on other matters like global warming, but said the messages must be reviewed by his lawyers.

Defense attorney Jane Imholte noted Anastasiou is a Vietnam veteran who is undergoing treatment for throat cancer and has no financial means other than his Social Security benefits.

She told the judge that Anastaiou, who signed his own name to the emails, worried about his pets while being detained. She said he only wanted to return home to care for his dogs, Freddie, Buddy and Cutie Pie.

He faces a maximum of 10 years in prison for each count of making threats against a federal judge and up to five years for each count of making threats in interstate commerce if convicted.

Threats targeting federal judges overall have more than doubled in recent years amid a surge of similar violent messages directed at public officials around the country, the U.S. Marshals Service previously said.

In 2022, shortly after the leak of a draft opinion overturning Roe v. Wade, a man was stopped near the home of Justice Brett Kavanaugh with weapons and zip ties.

___

Thiessen reported from Anchorage, Alaska.

The Canadian Press. All rights reserved.



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An iconic Churchill photo stolen in Canada and found in Italy is ready to return

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ROME (AP) — Canadian and Italian dignitaries on Thursday marked the successful recovery of a photo portrait of Winston Churchill known as “The Roaring Lion,” stolen in Canada and recovered in Italy after a two-year search by police.

At a ceremony at the Canadian Embassy in Rome, Italian carabinieri police handed over the portrait to the Canadian ambassador to Italy, Elissa Goldberg, who praised the cooperation between Italian and Canadian investigators that led to the recovery.

The 1941 portrait of the British leader taken by Ottawa photographer Yousuf Karsh is now ready for the last step of its journey home to the Fairmont Château Laurier, the hotel in Ottawa where it was stolen and will once again be displayed as a notable historic portrait.

Canadian police said the portrait was stolen from the hotel sometime between Christmas 2021 and Jan. 6, 2022, and replaced with a forgery. The swap was only uncovered months later, in August, when a hotel worker noticed the frame was not hung properly and looked different than the others.

Nicola Cassinelli, a lawyer in Genoa, Italy, purchased the portrait in May 2022 at an online Sotheby’s auction for 5,292 British pounds. He says he got a phone call from the auction house that October advising him not to sell or otherwise transfer the portrait due to an investigation into the Ottawa theft.

Cassinelli, who attended Thursday’s ceremony, said he thought he was buying a regular print and quickly agreed to send the iconic Churchill photograph home when he learned its true story.

“I immediately decided to return it to the Chateau Laurier, because I think that if Karsh donated it to the hotel, it means he really wanted it to stay there, for the particular significance this hotel had for him, and for his wife too,” Cassinelli told The Associated Press.

The famous image was taken by Karsh during Churchill’s wartime visit to the Canadian Parliament in December 1941. It helped launch Karsh’s career, who photographed some of the 20th century’s most famed icons, including Nelson Mandela, Albert Einstein and Queen Elizabeth.

Karsh and his wife Estrellita gifted an original signed print to the Fairmont Chateau Laurier in 1998. The couple had lived and operated a studio inside the hotel for nearly two decades.

Geneviève Dumas, general manager of the Fairmont Château Laurier, said on Thursday she felt immensely grateful.

“I would like to extend my deepest gratitude to everybody involved in solving this case, and ensuring the safe return of this priceless piece of history.”

Police arrested a 43-year-old man from Powassan, Ontario, in April and have charged him with stealing and trafficking the portrait. The man, whose name is protected by a publication ban, faces charges that include forgery, theft over $5,000 and trafficking in property obtained by crime exceeding $5,000.

The Canadian Press. All rights reserved.



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Mexican president blames the US for bloodshed in Sinaloa as cartel violence surges

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CULIACAN, Mexico (AP) — Mexican President Andrés Manuel López Obrador blamed the United States in part on Thursday for the surge in cartel violence terrorizing the northern state of Sinaloa which has left at least 30 people dead in the past week.

Two warring factions of the Sinaloa cartel have clashed in the state capital of Culiacan in what appears to be a fight for power since two of its leaders were arrested in the United States in late July. Teams of gunmen have shot at each other and the security forces.

Meanwhile, dead bodies continued to pop up around the city. On one busy street corner, cars drove by pools of the blood leading to a body in a car mechanic shop, while heavily armed police in black masks loaded up another body stretched out on a side street of the Sinaloan city.

Asked at his morning briefing if the U.S. government was “jointly responsible” for this violence in Sinaloa, the president said, “Yes, of course … for having carried out this operation.”

The recent surge in cartel warfare had been expected after Joaquín Guzmán López, a son of former Sinaloa cartel leader Joaquín “El Chapo” Guzmán, landed near El Paso, Texas on July 25 in a small plane with Ismael “El Mayo” Zambada.

Zambada was the cartel’s elder figure and reclusive leader. After his arrest, he said in a letter circulated by his lawyer that he had been abducted by the younger Guzmán and taken to the U.S. against his will.

On Thursday afternoon, another military operation covered the north of Culiacan with military and circling helicopters.

Traffic was heavy in Culiacan and most schools were open, even though parents were still not sending their children to classes. Businesses continue to close early and few people venture out after dark. While the city has slowly reopened and soldiers patrol the streets, many families continue to hide away, with parents and teachers fearing they’ll be caught in the crossfire.

“Where is the security for our children, for ourselves too, for all citizens? It’s so dangerous here, you don’t want to go outside,” one Culiacan mother told the Associated Press.

The mother, who didn’t want to share her name out of fear of the cartels, said that while some schools have recently reopened, she hasn’t allowed her daughter to go for two weeks. She said she was scared to do so after armed men stopped a taxi they were traveling in on their way home, terrifying her child.

During his morning press briefing, López Obrador had claimed American authorities “carried out that operation” to capture Zambada and that “it was totally illegal, and agents from the Department of Justice were waiting for Mr. Mayo.”

“If we are now facing instability and clashes in Sinaloa, it is because they (the American government) made that decision,” he said.

He added that there “cannot be a cooperative relationship if they take unilateral decisions” like this. Mexican prosecutors have said they were considering bringing treason charges against those involved in the plan to nab Zambada.

He was echoed by President-elect Claudia Sheinbaum, who said later in the day that “we can never accept that there is no communication or collaboration.”

It’s the latest escalation of tensions in the U.S.-Mexico relationship. Last month, the Mexican president said he was putting relations with the U.S. and Canadian embassies “on pause” after ambassadors criticized his controversial plan to overhaul Mexico’s judiciary by requiring all judges to stand for election.

Still, the Zambada capture has fueled criticisms of López Obrador, who has throughout his administration refused to confront cartels in a strategy he refers to as “hugs not bullets.” On previous occasions, he falsely stated that cartels respect Mexican citizens and largely fight amongst themselves.

While the president, who is set to leave office at the end of the month, has promised his plan would reduce cartel violence, such clashes continue to plague Mexico. Cartels employ an increasing array of tactics, including roadside bombs or IEDs, trenches, home-made armored vehicles and bomb-dropping drones.

Last week, López Obrador publicly asked Sinaloa’s warring factions to act “responsibly” and noted that he believed the cartels would listen to him.

But the bloodshed has only continued.

The Canadian Press. All rights reserved.



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