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AstraZeneca’s COVID-19 vaccine on track despite suspension of trial, CEO says

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The chief executive of AstraZeneca says it is not uncommon for vaccine trials to be paused because of an adverse event and he believes the company can still deliver a safe COVID-19 vaccine by the end of the year.

“If you have an event that you didn’t expect, then you stop to look at it and explore it and study it,” Pascal Soriot said Thursday during a conference sponsored by British news outlet Tortois Media. “And that’s what happened in our case, but it’s really common.”

AstraZeneca announced this week that it had halted the Phase 3 trial of a COVID-19 vaccine the company is developing with researchers at Oxford University. It is considered one of the best candidates for a viable vaccine, but the trial was stopped after a female volunteer in Britain fell ill. She developed symptoms consistent with a rare disorder called transverse myelitis, which causes inflammation of the spinal cord. The woman’s condition has been improving, and she was expected to leave hospital this week.

Mr. Soriot said an independent safety committee was reviewing the case and it had yet to determine if the volunteer had actually developed transverse myelitis. He added that the trial won’t restart until the review is completed. The committee can either allow the trial to continue or stop the project altogether.

This was the second time the trial for the vaccine, known as AZD1222, has been halted. Mr. Soriot confirmed that another pause happened in July when a participant experienced neurological symptoms. Further examination found the participant had multiple sclerosis, which was deemed unrelated to the vaccine.

Mr. Soriot said that although transverse myelitis is rare, it had surfaced in other vaccine projects. “What is true is that you will see transverse myelitis mentioned in the product information of several other vaccines,” he said. “And the issue with vaccines is you actually vaccinate thousands and thousands of people, so you will see all sorts of issues come up that are often not related to the vaccine.”

He added that many other vaccine trials have had to stop but such developments rarely get much public attention. “The difference with other vaccine trials is the whole world is not watching them, of course, so they stop, they study and they restart. What happened here is not uncommon,” he said. “What we have here is a very special set of circumstances where the entire world becomes involved in the conduct of the clinical trial and wants to know every step of the way.”

The Phase 3 trial of AZD1222 involves 30,000 participants in Britain, the United States, Brazil and South Africa. Such trials often last several years, but AstraZeneca has been able to speed up the process by working in parallel with regulators. Usually drug companies complete their trials and then submit the data to regulators, who spend months analyzing the information. AstraZeneca has been handing over data as the trials proceed.

“We could not do this for every single vaccine or drug because the system would not be supporting it – the regulator would not have the resources,” Mr. Soriot said. He added that the vaccine will ultimately be tested on as many as 60,000 people before it is approved.

Despite the setback, Mr. Soriot said that if the trial can restart soon the company is on track to deliver the vaccine in a few months. “We could still have a vaccine by the end of this year, maybe early next year, but by the end of this year is still possible.”

Two other vaccines in development – by Pfizer Inc. and Moderna Therapeutics – are also in Phase 3 testing and could be ready by early 2021, he said.

AstraZeneca is producing the vaccine on a non-profit basis and has lined up manufacturing partners around the world to ensure it can be delivered in all regions at roughly the same time. The company and Oxford are also working with non-profit organizations to co-ordinate distribution among developing countries and to people in refugee camps.

Medical experts said it was not uncommon for trials to stop because a participant fell ill. “A suspension such as this is not unusual for Phase 3 trials, which have tens of thousands of participants,” said Ohid Yaqub, a senior lecturer at the science policy research unit at the University of Sussex.

“Suspending the trial gives time to investigate whether the incident is related to the vaccine or is happening by coincidence. If the data and safety monitoring board decides it’s the latter, the trial will resume. Other trials will also investigate their data, too.”

U.S. top infectious disease expert, Dr. Anthony Fauci, in an online forum moderated by PBS NewsHour’s Judy Woodruff on Tuesday, said while he thinks it’s “unlikely” there will be a coronavirus vaccine by Election Day, it’s not “impossible.” Reuters

Source: – The Globe and Mail

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Japan’s SoftBank returns to profit after gains at Vision Fund and other investments

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TOKYO (AP) — Japanese technology group SoftBank swung back to profitability in the July-September quarter, boosted by positive results in its Vision Fund investments.

Tokyo-based SoftBank Group Corp. reported Tuesday a fiscal second quarter profit of nearly 1.18 trillion yen ($7.7 billion), compared with a 931 billion yen loss in the year-earlier period.

Quarterly sales edged up about 6% to nearly 1.77 trillion yen ($11.5 billion).

SoftBank credited income from royalties and licensing related to its holdings in Arm, a computer chip-designing company, whose business spans smartphones, data centers, networking equipment, automotive, consumer electronic devices, and AI applications.

The results were also helped by the absence of losses related to SoftBank’s investment in office-space sharing venture WeWork, which hit the previous fiscal year.

WeWork, which filed for Chapter 11 bankruptcy protection in 2023, emerged from Chapter 11 in June.

SoftBank has benefitted in recent months from rising share prices in some investment, such as U.S.-based e-commerce company Coupang, Chinese mobility provider DiDi Global and Bytedance, the Chinese developer of TikTok.

SoftBank’s financial results tend to swing wildly, partly because of its sprawling investment portfolio that includes search engine Yahoo, Chinese retailer Alibaba, and artificial intelligence company Nvidia.

SoftBank makes investments in a variety of companies that it groups together in a series of Vision Funds.

The company’s founder, Masayoshi Son, is a pioneer in technology investment in Japan. SoftBank Group does not give earnings forecasts.

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Yuri Kageyama is on X:

The Canadian Press. All rights reserved.

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Trump campaign promises unlikely to harm entrepreneurship: Shopify CFO

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Shopify Inc. executives brushed off concerns that incoming U.S. President Donald Trump will be a major detriment to many of the company’s merchants.

“There’s nothing in what we’ve heard from Trump, nor would there have been anything from (Democratic candidate) Kamala (Harris), which we think impacts the overall state of new business formation and entrepreneurship,” Shopify’s chief financial officer Jeff Hoffmeister told analysts on a call Tuesday.

“We still feel really good about all the merchants out there, all the entrepreneurs that want to start new businesses and that’s obviously not going to change with the administration.”

Hoffmeister’s comments come a week after Trump, a Republican businessman, trounced Harris in an election that will soon return him to the Oval Office.

On the campaign trail, he threatened to impose tariffs of 60 per cent on imports from China and roughly 10 per cent to 20 per cent on goods from all other countries.

If the president-elect makes good on the promise, many worry the cost of operating will soar for companies, including customers of Shopify, which sells e-commerce software to small businesses but also brands as big as Kylie Cosmetics and Victoria’s Secret.

These merchants may feel they have no choice but to pass on the increases to customers, perhaps sparking more inflation.

If Trump’s tariffs do come to fruition, Shopify’s president Harley Finkelstein pointed out China is “not a huge area” for Shopify.

However, “we can’t anticipate what every presidential administration is going to do,” he cautioned.

He likened the uncertainty facing the business community to the COVID-19 pandemic where Shopify had to help companies migrate online.

“Our job is no matter what comes the way of our merchants, we provide them with tools and service and support for them to navigate it really well,” he said.

Finkelstein was questioned about the forthcoming U.S. leadership change on a call meant to delve into Shopify’s latest earnings, which sent shares soaring 27 per cent to $158.63 shortly after Tuesday’s market open.

The Ottawa-based company, which keeps its books in U.S. dollars, reported US$828 million in net income for its third quarter, up from US$718 million in the same quarter last year, as its revenue rose 26 per cent.

Revenue for the period ended Sept. 30 totalled US$2.16 billion, up from US$1.71 billion a year earlier.

Subscription solutions revenue reached US$610 million, up from US$486 million in the same quarter last year.

Merchant solutions revenue amounted to US$1.55 billion, up from US$1.23 billion.

Shopify’s net income excluding the impact of equity investments totalled US$344 million for the quarter, up from US$173 million in the same quarter last year.

Daniel Chan, a TD Cowen analyst, said the results show Shopify has a leadership position in the e-commerce world and “a continued ability to gain market share.”

In its outlook for its fourth quarter of 2024, the company said it expects revenue to grow at a mid-to-high-twenties percentage rate on a year-over-year basis.

“Q4 guidance suggests Shopify will finish the year strong, with better-than-expected revenue growth and operating margin,” Chan pointed out in a note to investors.

This report by The Canadian Press was first published Nov. 12, 2024.

Companies in this story: (TSX:SHOP)

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RioCan cuts nearly 10 per cent staff in efficiency push as condo market slows

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TORONTO – RioCan Real Estate Investment Trust says it has cut almost 10 per cent of its staff as it deals with a slowdown in the condo market and overall pushes for greater efficiency.

The company says the cuts, which amount to around 60 employees based on its last annual filing, will mean about $9 million in restructuring charges and should translate to about $8 million in annualized cash savings.

The job cuts come as RioCan and others scale back condo development plans as the market softens, but chief executive Jonathan Gitlin says the reductions were from a companywide efficiency effort.

RioCan says it doesn’t plan to start any new construction of mixed-use properties this year and well into 2025 as it adjusts to the shifting market demand.

The company reported a net income of $96.9 million in the third quarter, up from a loss of $73.5 million last year, as it saw a $159 million boost from a favourable change in the fair value of investment properties.

RioCan reported what it says is a record-breaking 97.8 per cent occupancy rate in the quarter including retail committed occupancy of 98.6 per cent.

This report by The Canadian Press was first published Nov. 12, 2024.

Companies in this story: (TSX:REI.UN)

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