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J&J halts COVID-19 vaccine trial due to unexplained illness – BNN

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Johnson & Johnson shares fell after the drugmaker was forced to pause its late-stage study of a coronavirus vaccine, overshadowing an improved financial outlook for the year.

The temporary halt in the trial after one participant became ill unnerved investors in spite of the company’s sound business performance and could add to concern about the rapid pace of coronavirus vaccine research. J&J said adverse events are an expected part of drug studies and that it’s investigating. The shares fell 1.9 per cent at 11:15 a.m. in New York.

J&J was notified about the person’s illness 36 hours ago and immediately approached the independent Data Safety Monitoring Board to conduct an analysis, Chief Financial Officer Joseph Wolk said. The company also paused dosing other participants.

J&J doesn’t know whether the person received the vaccine or a placebo, as patient information remains blinded to the company at this time, Wolk said in an interview. “We need to let the independent board do their research,” he added.

Based on what is known about the trial, some information about the person who became sick could be outlined, according to analysts.

“Although we can’t pin down the age group, we can safely conclude from trial design that the participant with illness was healthy coming into the trial, and did not have comorbidities,” Evercore ISI analyst Umer Raffat said in a note.

The company is sticking to its plan to expand manufacturing capability to producing 1 billion doses a year of the adenovirus-based vaccine, Wolk said. It expects to have data about the drug’s safety and effectiveness from the 60,000-subject study before the end of the year, with potential for an emergency-use authorization in the U.S. at the outset of 2021.

J&J notified Operation Warp Speed, the White House-led effort to accelerate Covid vaccine development, and also contacted regulators in the U.S. and international markets of its plan to pause the trial. “It’s simply a notification at this point until we find out more from the independent board,” Wolk said.

The company said it had paused the trial on its own, and that it wasn’t on a regulatory hold ordered by the U.S. Food and Drug Administration.

Virus Headwinds

The rosy forecast alongside the research setback underscored the health-care conglomerate’s reliance on blockbuster cancer drugs and consumer products even as the pandemic creates upheaval in other areas.

Multiple myeloma therapy Darzalex brought in US$1.1 billion in third-quarter revenue, the company said Tuesday in a statement, beating analysts’ expectation of US$1 billion. U.S. sales of Tylenol, the over-the-counter pain reliever and fever fighter, rose as Americans restocked their medicine cabinets for the pandemic.

The outbreak continued to take a toll on J&J’s medical-device unit, as persistent delays in elective procedures eroded sales in its surgery, orthopedics and vision businesses. The unit reported third-quarter revenue of US$6.2 billion, a 3.9 per cent decline year-over-year. The results were still better than analysts expected, and the company said it sees a strong recovery in the business this year.

“I think everybody kind of feared the worst back in April,” Wolk said. “We’ve seen the hospital systems react remarkably well.”

Guidance Boost

J&J boosted its full-year adjusted earnings forecast by 10 cents to US$7.95 to US$8.05 a share and increased its sales outlook. It’s the second time this year J&J has raised its financial guidance. Wolk said the raise reflected the company’s “balanced optimism.”

“Even if a second wave or re-emergence of Covid happened selectively, we think in pockets and hotspots, hospital systems and the health-care system overall is in a better position to manage that,” Wolk said.

Third-quarter sales at the News Brunswick, New Jersey-based company beat Wall Street expectations at US$21.08 billion.

J&J also announced Tuesday that it will contribute up to an additional US$1 billion to an all-in settlement amount to resolve opioid lawsuits filed and future claims by states, cities, counties and tribal governments. That’s on top of an earlier US$4 billion agreement announced by a committee of state attorneys general a year ago.

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BCCDC flags 8 Vancouver flights for possible COVID-19 exposure – BC News – Castanet.net

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The BC Centre for Disease Control is warning airline passengers they may have been exposed to COVID-19 on multiple recent Vancouver flights. 

Eight new flights have been added to the BCCDC’s list of affected flights:

  • Oct. 15: Air Canada 8187, Vancouver to Fort St. John (Rows 2 – 6)
  • Oct. 19, Air Canada 8484, Vancouver to Edmonton (Rows 7 – 13)
  • Oct. 14: Air Canada 299, Winnipeg to Vancouver (Rows 21 – 27)
  • Oct. 16: WestJet 714, Vancouver to Toronto (Rows 17 – 23)
  • Oct. 17: WestJet 139, Calgary to Vancouver (Rows 1 – 7)
  • Oct. 11: WestJet 141, Edmonton to Vancouver (Rows 1 – 6)
  • Oct.14: Aeromexico 696, Mexico City to Vancouver (Not reported) 
  • Oct. 16: WestJet 725, Toronto to Vancouver (Rows 2 – 8)

Any travellers returning to B.C. are encouraged to check the public health agency’s website for updates about flights identified for the risk of exposure. Those travelling from outside of Canada, meanwhile, must arrive prepared with a 14-day self-isolation plan. 

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Another store in Orchard Park Mall calls it quits – KelownaNow

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Yet another Canadian retailer has called it quits in 2020.

This time it’s Montreal-based fashion retailer Le Chateau, which has occupied a storefront in Orchard Park Mall for decades.

On Friday, the company announced it will be closing 123 stores and cutting 1,400 employees who work in stores and at the company’s head office.

After 60 years in operation, Le Chateau Inc. is seeking court protection from creditors to allow it to liquidate its assets and close its stores.

The company said it has spent much of the COVID-19 pandemic trying to refinance or sell the business to a third party that would keep it in operation, but was unsuccessful.

“Its already evident impact on consumer demand for Le Chateau’s holiday party and occasion wear, which represents the core of our offering, has diminished Le Chateau’s ability to pursue its activities,” the company said.

“Regrettably, these circumstances leave the company with no option other than to commence the liquidation process.”

The company’s application comes after several other Canadian retailers have shuttered or downsized operations in the wake of the pandemic.

Reitmans Canada Ltd., Aldo Group Inc., DavidsTea Inc., Mountain Equipment Co-operative, Moores the Suit People Corp. and Laura’s Shoppe Inc. are among the dozens of retailers that have all filed for CCAA.

With files from the Canadian Press.

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Protesting COVID-19 measures 'just nonsense' — Windsor-Essex's top doc – Windsor Star

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Article content continued

“They think, ‘I know more than them — but I never went to any university or any school. I read something on the Facebook or I heard someone say that,’” Ahmed said. “It’s just nonsense.”

Ahmed said he is disturbed by the spread of misinformation, and lamented the “confusion and chaos” that lead to large numbers of people ignoring COVID-19 guidelines.

“Not following those measures results in what we are seeing right now in the U.S., what we are seeing right now in other areas of the country,” Ahmed said.

“I really worry about these people. They are doing a complete disservice to the entire community.”

Expressing his exasperation with anti-mask protesters, however, wasn’t Ahmed’s purpose for speaking with media on Friday.

In an update on the region’s COVID-19 situation, Ahmed noted that — in recent contrast to parts of the province like Toronto, Peel Region, and Ottawa — Windsor-Essex is doing well on most metrics.

For example, a new graph by the health unit shows that the percentage of local COVID-19 cases resulting from community transmission has not increased. Indeed, the figure dropped this month: as of Oct. 22, the proportion of new cases in Windsor-Essex that were acquired in the community is 25 per cent, going by a seven-day average.

A graph presented by the Windsor-Essex County Health Unit in an update on the region’s COVID-19 situation on Oct. 23, 2020. Photo by Windsor-Essex County Health Unit /Windsor Star

“It’s not bad compared to some of the other regions, and what it could be,” Ahmed said.

Local hospitalizations resulting from COVID-19, going by a 14-day moving average, have remained in the single digits since the beginning of September — a trend the health unit considers “low and stable.”

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