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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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With grief lingering, Blue Jackets GM Waddell places focus on hockey in wake of Gaudreau’s death

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BUFFALO, N.Y. (AP) — Hearing the familiar sounds of clacking sticks and pucks banging off the boards and glass while watching Columbus Blue Jackets prospects from the stands of a cold rink on a warm late-summer afternoon was not enough to wash away the lingering residuals of grief for Don Waddell on Saturday.

That, the Blue Jackets’ general manager acknowledged, will take more time than anyone can guess — weeks, months, perhaps an entire season and beyond.

What mattered is how spending the weekend attending the Sabres Prospects Challenge represented a start to what Waddell called among the first steps in refocusing on hockey and the future in the aftermath of the deaths of Columbus star Johnny Gaudreau and his brother, Matthew, who were struck by a suspected drunken driver while riding bicycles on Aug 29.

“We got to play hockey,” Waddell said. “We’re not going to forget about Johnny and his family, the Gaudreau family.”

He then reflected on the speech Johnny Gaudreau’s wife, Meredith, made during the brothers’ funeral on Monday, by urging those in mourning to move forward as she will while focusing on raising their children.

“Everybody knows that Johnny wants them to play hockey,” Waddell said. “And everybody’s rallying around that.”

The resumption of hockey in Columbus began last week, when most Blue Jackets players returned to their facility to be together and lean on each other at the urging of Waddell and team captain Boone Jenner. And it will continue on Thursday, when the team opens training camp, exactly three weeks since the Gaudreaus were killed.

“Tragic. Senseless. But now we got to focus on trying to get our team ready to play hockey this year,” Waddell said. “We all mourn and heal differently, but I think as a team being together like that is going to be critical for them to get moving forward.”

Tragedy is no stranger to Waddell or the Blue Jackets.

Waddell was general manager of the then-Atlanta Thrashers in 2003 when Dany Heatley lost control of his car and struck a wall, with the crash killing passenger and teammate Dan Snyder. In 2021, Blue Jackets goalie Matiss Kivlenieks died during a July Fourth fireworks accident.

Waddell placed the emphasis on himself and coach Dean Evason — both newcomers to Columbus this offseason — to guide the team through what will be an emotional season.

“Now, do I think there’s going to be some dark days? I won’t be surprised,” Waddell said.

Reminders of the Gaudreaus’ deaths remain apparent, and reflected in Buffalo on Friday night. A moment of silence was held in tribute to the brothers before the opening faceoff of a game between the Blue Jackets and Sabres.

Afterward, Columbus prospect Gavin Brindley recalled the times he spent with Johnny Gaudreau in Columbus and as teammates representing the United States at the world hockey championships in the Czech Republic in May.

“He was one of the biggest mentors for me at the world championships,” Brindley said. “I couldn’t tell you how many times we hung out with Meredith, pictures on my phone. It’s just so hard to look back and see that kind of stuff.”

The NHL and NHL Players’ Association are providing the Blue Jackets help in the form of grief counseling, crowd security at vigils and addressing hockey issues, such as potentially altering the league’s salary cap rules to provide Columbus relief from having to reach the NHL minimum payroll because of the void left by Gaudreau’s contract.

“The Blue Jackets, I don’t think anybody’s focused from an organizational standpoint, from a hockey standpoint as to what comes next, because I think everybody’s still in shock,” NHL Commissioner Gary Bettman told The Associated Press last week. “I don’t think anybody’s focused right now other than on the grieving part, which is understandable.”

Much of the burden has fallen to Waddell, who has been in discussions with the NHL and the NHLPA and dealing with outreach programs with the Blue Jackets’ partner OhioHealth, while also overseeing preparations for training camp and gauging his prospects in Buffalo.

There’s also his roster to attend to, which he said has two openings at forward, one involving Justin Danforth, who may miss the start of the season because of a wrist injury. Waddell didn’t have to mention the second opening.

Tiring and emotional as it’s been, Waddell found comfort being in his element, a rink, and looking ahead to the start of training camp.

“The guys are in really good shape. We’ve done a lot of testing already and they’re eager to get going,” Waddell said. “We have a reason to play for. And we’ll make the best of it.”

The Blue Jackets later Sunday signed veteran winger James van Riemsdyk to a one-year contract worth $900,000.

“James van Riemsdyk has been a very consistent, productive player throughout his career,” Waddell said. “Bringing him to Columbus will not only provide depth to our group up front, but also valuable leadership and another veteran presence in our dressing room.”

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AP Hockey Writer Stephen Whyno in New York contributed to this report.

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PSG says defender Nuno Mendes target of racial abuse after a French league game

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PARIS (AP) — Paris Saint-Germain defender Nuno Mendes was the target of abusive and racist comments on social media after a French league game.

The club condemned the abuse and expressed its “full support” Sunday for the Portugal left back, who was targeted following PSG’s 3-1 win against Brest on Saturday.

Mendes, who is Black, shared on his Instagram account a racist message he received.

During the match, Mendes brought down Ludovic Ajorque in the box for a penalty that Romain Del Castillo converted to give Brest the lead.

“Paris Saint-Germain doesn’t tolerate racism, antisemitism or any other form of discrimination,” the club said. “The racial insults directed at Nuno Mendes are totally unacceptable … we are working with the relevant authorities and associations to ensure those responsible are held accountable for their actions.”

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Slovenia’s Tadej Pogacar wins Grand Prix Cycliste de Montreal

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MONTREAL – Tadej Pogacar was so dominant on Sunday, Canada’s Michael Woods called it a race for second.

Pogacar, a three-time Tour de France champion from Slovenia, pedalled to a resounding victory at the Grand Prix Cycliste de Montreal.

The UAE Team Emirates leader crossed the finish line 24 seconds ahead of Spain’s Pello Bilbao of Bahrain — Victorious to win the demanding 209.1-kilometre race on a sunny, 28 C day in Montreal. France’s Julian Alaphilippe of Soudal Quick-Step was third.

“He’s the greatest rider of all time, he’s a formidable opponent,” said Woods, who finished 45 seconds behind the leader in eighth. “If you’re not at your very, very best, then you can forget racing with him, and today was kind of representative of that.

“He’s at such a different level that if you follow him, it can be lights out.”

Pogacar slowed down before the last turn to celebrate with the crowd, high-five fans on Avenue du Parc and cruise past the finish line with his arms in the air after more than five hours on the bike.

The 25-year-old joined Belgium’s Greg Van Avermaet as the only multi-time winners in Montreal after claiming the race in 2022. He also redeemed a seventh-place finish at the Quebec City Grand Prix on Friday.

“I was disappointed, because I had such good legs that I didn’t do better than seventh,” Pogacar said. “To bounce back after seventh to victory here, it’s just an incredible feeling.”

It’s Pogacar’s latest win in a dominant year that includes victories at the Tour de France and Giro d’Italia.

Ottawa’s Woods (Israel Premier-Tech) tied a career-best in front of the home crowd in Montreal, but hoped for more after claiming a stage at the Spanish Vuelta two weeks ago.

“I wanted a better result,” the 37-year-old rider said. “My goal was a podium, but at the same time I’m happy with the performance. In bike racing, you can’t always get the result you want and I felt like I raced really well, I animated the race, I felt like I was up there.”

Pogacar completed the 17 climbs up and down Mount Royal near downtown in five hours 28 minutes 15 seconds.

He made his move with 23.3 kilometres to go, leaving the peloton in his dust as he pedalled into the lead — one he never relinquished.

Bilbao, Alaphilippe, Alex Aranburu (Movistar Team) and Bart Lemmen (Visma–Lease) chased in a group behind him, with Bilbao ultimately separating himself from the pack. But he never came close to catching Pogacar, who built a 35-second lead with one lap left to go.

“It was still a really hard race today, but the team was on point,” Pogacar said. “We did really how we planned, and the race situation was good for us. We make it hard in the last final laps, and they set me up for a (takeover) two laps to go, and it was all perfect.”

Ottawa’s Derek Gee, who placed ninth in this year’s Tour de France, finished 48th in Montreal, and called it a “hard day” in the heat.

“I think everyone knows when you see Tadej on the start line that it’s just going to be full gas,” Gee said.

Israel Premier-Tech teammate Hugo Houle of Sainte-Perpétue, Que., was 51st.

Houle said he heard Pogacar inform his teammates on the radio that he was ready to attack with two laps left in the race.

“I said then, well, clearly it’s over for me,” Houle said. “You see, cycling isn’t that complicated.”

Australia’s Michael Matthews won the Quebec City GP for a record third time on Friday, but did not finish in Montreal. The two races are the only North American events on the UCI World Tour.

Michael Leonard of Oakville, Ont., and Gil Gelders and Dries De Bondt of Belgium broke away from the peloton during the second lap. Leonard led the majority of the race before losing pace with 45 kilometres to go.

Only 89 of 169 riders from 24 teams — including the Canadian national team — completed the gruelling race that features 4,573 metres in total altitude.

Next up, the riders will head to the world championships in Zurich, Switzerland from Sept. 21 to 29.

Pogacar will try to join Eddy Merckx (1974) and Stephen Roche (1987) as the only men to win three major titles in a season — known as the Triple Crown.

“Today gave me a lot of confidence, motivation,” Pogacar said. “I think we are ready for world championships.”

This report by The Canadian Press was first published Sept. 15, 2024.



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