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Biogen, Eisai Alzheimer’s drug lecanemab gets ‘fast track’ designation from FDA

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Biogen Inc and Japanese partner Eisai Co said on Thursday the U.S. Food and Drug Administration (FDA) had granted “fast track” designation to their experimental therapy lecanemab for the treatment of early Alzheimer’s disease.

The FDA had granted “breakthrough” therapy designation to the drug earlier this year.

The drug works in a similar manner to Biogen’s Aduhelm and gets rid of sticky deposits of a protein called amyloid beta from brains of patients in the initial stages of the disease to mitigate its impact.

The fast track status is designed to expedite the review of treatments and vaccines meant for serious conditions. A vaccine or treatment that gets the status is eligible for more frequent meetings with the FDA.

Biogen and Eisai have jointly developed three experimental drugs for the brain-wasting disease, which affects millions around the world.

Adulhelm’s development was nearly abandoned after disappointing trial results in 2019, but Biogen revived it after reviewing data that showed higher doses of the drug could slow disease progression.

Adulhelm, known scientifically as aducanumab, was dealt a setback in Japan on Wednesday when a health ministry panel said that inconsistent trial results made it difficult to determine its efficacy.

 

(Corrects to remove incorrect reference to unproven clinical benefit from 2nd paragraph and clarifies drug name in 6th para to be Aduhelm, not lecanemab)

 

(Reporting by Vishal Vivek in Bengaluru, Rocky Swift in Tokyo; Editing by Vinay Dwivedi)

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Ontario to start lifting COVID-related curbs, Quebec more cautious

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Canada’s most populous province of Ontario has blunted transmission of the Omicron coronavirus variant and will gradually ease restrictions on businesses from end-January, Premier Doug Ford said on Thursday.

The health care system is starting to stabilize in the wake of limitations imposed on Jan. 5, Ford told a news conference, saying Omicron cases should peak later this month.

“We can be confident that the worst is behind us and that we are now in a position to cautiously and gradually ease public health measures,” Ford said.

The province will allow restaurants, malls, and cinemas to operate with a 50% capacity limit from Jan. 31, before removing more curbs in February and March.

“While February will continue to present its own challenges, given current trends these are challenges we are confident we can manage,” Ford said.

In neighbouring Quebec, premier Francois Legault said he would maintain restrictions to help protect the health care system even though Omicron cases had peaked.

“I understand we are all tired, but lives are at stake. I’m currently under a lot of pressure to remove measures, but my duty is to be responsible to protect the lives of Quebecers,” he told a news conference.

Ontario and Quebec together account for around 61% of Canada’s population of 38.2 million people.

 

(Reporting by Ismail Shakil in Bengaluru and David Ljunggren in Ottawa; Editing by Tomasz Janowski and Grant McCool)

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Canadian vaccine mandate to lead to inflation, empty shelves, trucking executives say

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Canadian consumers should soon see higher prices and some empty shelves in supermarkets and other retail outlets because of disruptions stemming from a COVID-19 vaccine mandate for cross-border truckers, top trucking executives warned this week.

The mandate, imposed by Ottawa to help curb the spread of the virus, has cost six Canadian trucking companies about 10% of their international drivers, and many are hiking wages to lure new operators during what they said is the worst labor shortage they have experienced.

Within the next two weeks, consumers will see “there’s not as many choices on the shelves,” said Dan Einwechter, chairman and chief executive officer of Challenger Motor Freight Inc in Cambridge, Ontario.

“Eventually the prices will be passed on from the sellers of those products, because we’re passing on our increases to them,” he said.

Canada’s inflation rate https://www.reuters.com/business/canadas-annual-inflation-rate-hits-48-dec-highest-since-sept-1991-2022-01-19 hit a 30-year high of 4.8% in December and economists said the vaccine mandate may contribute to keeping prices higher for longer. In the United States, inflation surged https://www.reuters.com/world/us/us-consumer-prices-increase-strongly-december-2022-01-12 7% on a year-on-year basis in December, the largest rise in nearly four decades.

Prime Minister Justin Trudeau, who has championed vaccine requirements for federal employees, has resisted pressure from industry to delay or drop the mandate that was announced in November.

The vaccine requirement to enter Canada started on Jan. 15, and the one to enter the United States begins on Saturday.

Since more than two-thirds of the C$650 billion ($521 billion) in goods traded annually between Canada and the United States travels on roads, truckers were deemed essential workers until now and traveled freely even when the border was closed for 20 months.

Trudeau defended the mandate on Wednesday, saying Canada was “aligned” with the United States, its largest trading partner.

“We will continue to make sure that we are getting what we need in Canada while, as always, putting the safety and health of Canadians as our top priority,” Trudeau said.

As many as 32,000, or 20%, of the 160,000 Canadian and American cross-border truck drivers may be taken off the roads by the mandate, the Canadian Trucking Alliance (CTA) estimates. The industry was short some 18,000 drivers even before the mandate, CTA said.

“We raised our base rate for cross-border drivers effective Jan. 1 by almost 20% … and it didn’t gain us any drivers,” said Rob Penner, president and CEO of Winnipeg, Manitoba-based Bison Transport. “There’s more freight than there is people right now.”

Canada’s transport ministry said in a statement the measure was not negatively affecting the supply of goods, while cross-border truck traffic had not varied significantly since the mandate came into effect.

BAD TIMING

The six executives who manage nearly 9,200 trucks between their companies and have a combined 173 years in the industry say strong demand for freight during a labor shortage will inevitably translate into higher prices for consumers.

“We’ve been oversold by 5% or 10%, depending on the day, for the last four or five months … The timing of all this couldn’t have been worse,” said Mark Seymour, CEO of Kriska Transportation Group in Prescott, Ontario.

Canadian firms see labor shortages intensifying and wage pressures increasing, according to a Bank of Canada survey https://www.reuters.com/world/americas/firms-see-increasing-labor-shortages-wage-pressures-bank-canada-survey-2022-01-17 released on Monday. Investors increasingly expect https://www.reuters.com/world/americas/even-omicron-slams-canada-bets-january-rate-hike-rise-2022-01-18 the central bank to raise interest rates next week for the first time since 2018.

Fresh foods are particularly sensitive to freight problems because they expire rapidly, though all imports from the United States could be affected, the trucking managers said.

“We have to move the milk, we have to move food. But the rates are going to be much higher,” said Doug Sutherland, president of Sutherland Group Enterprises in Salmo, British Columbia.

“Inflation is going to be the biggest impact of what’s going on here.”

($1 = 1.2478 Canadian dollars)

(Reporting by Steve Scherer; Additional reporting by David Ljunggren; Editing by Paul Simao)

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Natural immunity against COVID lowered risk more than vaccines against Delta variant, new study says – Euronews

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Unvaccinated people who had previously contracted COVID-19 were better protected against the Delta variant than those who were only vaccinated, a new study published on Wednesday by a US health authority said.

Despite this, “vaccination remains the safest strategy” against the disease, the Centers for Disease Control and Prevention (CDC) said when publishing the data.

It also pointed out that contracting the disease exposes you to serious complications, while vaccines have proven to be extremely safe and effective.

The study was conducted before booster doses were widely available, and before the emergence of the Omicron variant, which now accounts for more than 99 per cent of new cases in the US. It is therefore possible that the balance has shifted towards vaccination being more effective than immunity following infection.

However, the results published on Wednesday provide key insights into the differences between vaccine-acquired and post-infection immunity.

The health authorities studied cases in the states of New York and California from late May to November 2021. Delta became the majority disease in the US at the end of June.

During the entire period under analysis, the people with the least protection by far were those who had neither been vaccinated nor fallen ill in the past.

But before Delta, vaccinated people who had never contracted COVID-19 were better protected than unvaccinated people who had already fallen ill.

After the introduction of Delta, the ratio was reversed.

Less risk to infected but not vaccinated people

The study analysed the risk of getting Delta compared to the risk of those most likely to get it, in other words, people who had neither been vaccinated nor infected in the past by the beginning of October.

Those that had been vaccinated but never infected with COVID-19 were six times less likely to get it in California, and about five times less likely in New York.

But the risk was even lower for previously infected but not vaccinated individuals: by 29 in California, and by 15 in New York.

When analysing the risk of hospitalisation, this time in California only, the researchers found a similar reversal between the two periods.

“This could be due to different immune response stimuli” caused either by encountering the real virus or a vaccine, the CDC explained.

The reversal also “coincided with the onset of vaccine-induced immunity decline in many people” before booster doses, the study authors added.

The CDC noted too that work on Delta in other countries “has also demonstrated increased protection of previously infected individuals, both vaccinated and unvaccinated, compared with vaccination alone”.

They emphasised that further studies were needed to investigate the durability of protection conferred by infection with each of the variants, including Omicron.

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