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Novartis' Heart Drug Gets Accelerated Review in Britain for High-Risk Patients – Nasdaq

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Britain’s National Health Service (NHS) announced an agreement with pharmaceutical giant Novartis (NYSE: NVS) to help accelerate the review process for its heart drug inclisiran. The agreement would see inclisiran provided to patients who are at high risk of cardiovascular incidents (heart attacks and strokes) once a separate U.K.-based clinical trial yields its results.

The drug has already been submitted for approval from U.S. regulators back in 2019 and is currently pending approval. Inclisiran goes after a specific protein called PCSK9, which plays a role in producing LDL cholesterol (also known as the “bad” cholesterol) and is intended to be used alongside conventional cholesterol-lowering medications such as statins.

Image source: Getty Images.

Heart disease is the leading cause of death in the U.K., causing twice as many deaths in comparison to the second biggest killer, lung cancer. However, the overall number of deaths in the U.K. has fallen by almost 50% over the past decade, although national healthcare agencies are far from satisfied with leaving it at that.

What this means for Novartis

Novartis is expecting that future sales for its drug will shoot up significantly thanks to this deal. The company ended up buying the rights for inclisiran for $9.7 billion back in 2019 and expects the drug to be a major blockbuster in the years to come.

If inclisiran ends up winning approval from U.K. health regulators, the deal also stipulates that the NHS will subsidize the price of the drug and offer it as an add-on therapy for patients that don’t respond well to statins. While an official price wasn’t agreed upon, inclisiran is intended to be competitively priced alongside competitor drugs such as Sanofi’s Praluent and Amgen’s Repatha. 

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3 more COVID-19 deaths linked to Edmonton hospital outbreak – CTV News Edmonton

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EDMONTON —
Three new deaths are being linked to the COVID-19 outbreak at the Misericordia hospital on Thursday.

The three patients were men in their 70s, 80s, and 90s respectively, according to the province. 

An additional staff member at the hospital has also tested positive.

There have now been 16 patients who have tested positive and 16 staff members. A total of six people have died from COVID-19 in connection with the outbreak at the hospital.

Admissions at the hospital are still closed, and day procedures and visitors are still being postponed or rescheduled at other hospitals.

Anyone who needs emergency care is urged to visit another hospital or to call 911 if needed.

Expectant mothers will be moved to the Grey Nuns Community Hospital to deliver.

Hospital staff is continuing to follow cleaning protocols to minimize the risk of spreading.  

Also on Thursday, the province confirmed 37 new cases of COVID-19 across Alberta. The number of active cases fell by 24 to 584 while the number of recoveries grew by 58 to 7,774. 

A total of 161 Albertans have now died due to COVID-19.

On Wednesday, officials confirmed that cases connected to the Misericordia hospital had risen to 35: 20 patients and 15 staff members.

As a result, the facility stopped taking new patient admissions.

Chief Medical Officer of Health Dr. Deena Hinshaw has taken the week off from delivering live COVID-19 updates, citing the need to spend some time with her family.

Check back for live updates once numbers are released at around 3:30 p.m.

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WHO experts to visit China to plan COVID-19 investigation – WellandTribune.ca

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BEIJING – Two World Health Organization experts were heading to the Chinese capital on Friday to lay the groundwork for an investigation into the origins of the coronavirus pandemic.

An animal health expert and an epidemiologist will meet Chinese counterparts in Beijing to work out logistics, places to visit and the participants for a WHO-led international mission, the U.N. organization said.

A major issue will be to “look at whether or not it jumped from species to human, and what species it jumped from,” WHO spokesperson Dr. Margaret Harris said at a briefing in Geneva.

Scientists believe the virus may have originated in bats and was transmitted to another mammal such as a civet cat or an armadillo-like pangolin before being passed on to people.

A cluster of infections late last year focused initial attention on a fresh food market in the central Chinese city of Wuhan, but the discovery of earlier cases suggests the animal-to-human jump may have happened elsewhere.

In an effort to block future outbreaks, China has cracked down on the trade in wildlife and closed some markets, while enforcing strict containment measures that appear to have virtually stopped new local infections.

The WHO mission is politically sensitive, with the U.S. — the top funder of the U.N. body — moving to cut ties with it over allegations it mishandled the outbreak and is biased toward China.

“China took the lead in inviting WHO experts to investigate and discuss scientific virus tracing,” Chinese foreign ministry spokesperson Zhao Lijian said Friday.

In contrast, he said, the U.S. “not only announced its withdrawal from the World Health Organization, but also politicized the anti-epidemic issue and played a buck-passing game to shift responsibilities.”

More than 120 nations called for an investigation into the origins of the virus at the World Health Assembly in May. China has insisted that WHO lead the investigation and for it to wait until the pandemic is brought under control. The U.S., Brazil and India are continuing to see an increasing number of cases.

The last WHO coronavirus-specific mission to China was in February, after which the team’s leader, Canadian doctor Bruce Aylward, praised China’s containment efforts and information sharing. Canadian and American officials have since criticized him as being too lenient on China.

An Associated Press investigation showed that in January, WHO officials were privately frustrated over the lack of transparency and access in China, according to internal audio recordings. Their complaints included that China delayed releasing the genetic map, or genome, of the virus for more than a week after three different government labs had fully decoded the information.

Privately, top WHO leaders complained in meetings in the week of Jan. 6 that China was not sharing enough data to assess how effectively the virus spread between people or what risk it posed to the rest of the world, costing valuable time.

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Associated Press journalist Jamey Keaten in Geneva contributed to this report.

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Coronavirus: What's happening around the world on Friday – CBC.ca

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The latest:

  • WHO officials arrive in Beijing to investigate origins of the coronavirus pandemic.
  • United Kingdom quarantine measures for travellers ease.
  • Canada’s hardest-hit nursing homes lost 40% of residents in just 3 months of the pandemic.
  • Texas reports new high for hospitalizations for 10th consecutive day.

Two World Health Organization (WHO) experts headed to the Chinese capital on Friday to lay the groundwork for a larger mission to investigate the origins of the coronavirus pandemic.

An animal health expert and an epidemiologist will meet Chinese counterparts in Beijing to set the “scope and terms of reference” for a WHO-led international mission aimed at learning how the virus jumped from animals to humans, a WHO statement said.

Scientists believe the virus may have originated in bats and was transmitted to another mammal such as a civet cat or an armadillo-like pangolin before being passed on to people.

A cluster of infections late last year focused initial attention on a fresh food market in the central Chinese city of Wuhan, but the discovery of earlier cases suggests the animal-to-human jump may have happened elsewhere.

In an effort to block future outbreaks, China has cracked down on the trade in wildlife and closed some markets while enforcing strict containment measures that appear to have virtually stopped new local infections.

The WHO mission is politically sensitive, with the U.S. — the top funder of the UN body — moving to cut ties with it over allegations it mishandled the outbreak and is biased toward China.

“China took the lead in inviting WHO experts to investigate and discuss scientific virus tracing,” Chinese foreign ministry spokesperson Zhao Lijian said Friday.

More than 120 nations called for an investigation into the origins of the virus at the World Health Assembly in May. China has insisted that WHO lead the investigation and that it wait until the pandemic is brought under control. (Fabrice CoffriniAFP/Getty Images)

In contrast, he said, the U.S. “not only announced its withdrawal from the World Health Organization but also politicized the anti-epidemic issue and played a buck-passing game to shift responsibilities.”

More than 120 nations called for an investigation into the origins of the virus at the World Health Assembly in May. China has insisted that the WHO lead the investigation and that it wait until the pandemic is brought under control. The U.S., Brazil and India are continuing to see an increasing number of cases.

The last WHO coronavirus-specific mission to China was in February, after which the team’s leader, Canadian doctor Bruce Aylward, praised China’s containment efforts and information sharing. Canadian and American officials have since criticized him as being too lenient with regard to China’s role in helping stop the spread of the virus.

Privately, top WHO leaders complained in meetings in the week of Jan. 6 that China was not sharing enough data to assess how effectively the virus spread between people or what risk it posed to the rest of the world, costing valuable time.


What’s happening with coronavirus in Canada

As of 7 a.m. ET on Friday, Canada had 106,805 confirmed and presumptive coronavirus cases. Provinces and territories listed 70,574 of those as recovered or resolved. A CBC News tally of deaths based on provincial reports, regional health information and CBC’s reporting stood at 8,788.

Some public health and infectious disease experts are pressing for governments in Canada to shift to minimizing, not eradicating, COVID-19 while allowing society to resume functioning.

WATCH | Union calls for more protective equipment as mask shortage sidelines paramedics:

Jason Fraser, chair of the Ambulance Committee of Ontario for CUPE, is calling on the provincial government to make sure there is an adequate supply of personal protective equipment available for paramedics. 0:48

The open letter to Prime Minister Justin Trudeau and all premiers, dated July 6, says aiming to prevent or contain every case is not sustainable at this stage in the pandemic.

“We need to accept that COVID-19 will be with us for some time and to find ways to deal with it,” the 18 experts wrote.

The aim of lockdowns and physical distancing was to flatten the epidemic curve so that health-care systems wouldn’t be overwhelmed with too many cases at once, Neil Rau, an infectious disease physician and medical microbiologist at the University of Toronto said. Stamping out the virus is a different goalpost.


Here’s what’s happening around the world

According to Johns Hopkins University in Baltimore, the global total of confirmed coronavirus cases was over 12.2 million as of 7 a.m. ET on Thursday. More than 555,000 people have died while almost 6.7 million have recovered. The U.S. and Brazil lead case numbers, with a combined total of more than 4.8 million.

Quarantine measures for those traveling to the United Kingdom from around 70 countries and overseas territories, including France and Italy, no longer apply from Friday in a boost to the ailing aviation and travel industries hit by COVID-19.

Those arriving from higher-risk countries will still have to self-quarantine for 14 days, but many popular destinations are now exempt, meaning millions of Britons are able to take summer holidays without having to stay at home when they return.

Kazakhstan’s president, Kassym-Jomart Tokayev, said on Friday he may sack his cabinet if its second, two-week lockdown fails to curb the coronavirus outbreak in the oil-rich Central Asian nation.

People wear face mask in Hanoi. Vietnam has reported just 369 coronavirus cases, with no deaths. It has been 81 days without domestic transmission. (Linh Pham/Getty Images)

Kazakhstan, which imposed a new lockdown on Sunday, has confirmed almost 55,000 COVID-19 infections, including 264 deaths. The number of new cases rose on Thursday to a daily record of 1,962 before declining to 1,726 on Friday.

The economic fallout from the COVID-19 pandemic has negatively impacted about 31 million workers in Vietnam, with 900,000 out of work and nearly 18 million people receiving less income than before, a government agency said on Friday.

If solutions to drive business activity were not immediately implemented, there could be five million more people out of work by the end the year, the General Statistics Office (GSO) said.

Vietnam has reported just 369 coronavirus cases, with no deaths. It has been 81 days without domestic transmission, owing to successful programs to contain the virus.

Hong Kong’s Education Bureau on Friday announced the suspension of all schools from Monday after a spike in locally transmitted coronavirus cases that has fuelled fears of a renewed community spread in the city.

Schools in the Asian financial hub have been mostly shut since February, with many having switched to online learning and lessons by conference call. Many international schools are already on summer break.

The city reported 42 new cases on Thursday, of which 34 were locally transmitted, marking the second consecutive day of rising local infections.

More than 60,000 new COVID-19 infections were reported across the United States on Wednesday, the greatest single-day tally by any country since the virus emerged late last year in China. U.S. deaths rose by more than 900 for the second straight day.

Florida on Thursday announced nearly 9,000 new cases and 120 new coronavirus deaths, a record daily increase in lives lost. California and Texas, the most populous states, announced record increases in COVID deaths on Wednesday.

Texas Gov. Greg Abbott says the numbers next week may be even worse. The 105 new deaths reported Thursday makes this the deadliest week of the pandemic in what has rapidly become one of America’s virus hot zones. Texas reported a new high for hospitalizations for the 10th consecutive day.

Health care workers move a patient in the COVID-19 Unit at United Memorial Medical Center in Houston. Texas hospitals are being overwhelmed with COVID-19 patients, as the state reported a new high for hospitalizations for the 10th consecutive day. (Mark Felix/AFP/Getty Images)

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