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Coronavirus update: Pfizer starts Phase 3 trial as Fauci voices optimism on vaccine timeline – Yahoo Canada Finance

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<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="The global search for a coronavirus vaccine appears to be taking flight, with a number of drug companies pressing ahead with clinical trials — including a late announcement from Pfizer (PFE) entering Phase 3 with one of its candidates developed with BioNTech (BNTX).” data-reactid=”16″>The global search for a coronavirus vaccine appears to be taking flight, with a number of drug companies pressing ahead with clinical trials — including a late announcement from Pfizer (PFE) entering Phase 3 with one of its candidates developed with BioNTech (BNTX).

Progress on an effective COVID-19 inoculation comes as the virus continues to claim new victims worldwide, while the U.S. fights an uphill battle to contain a surge in confirmed cases. Vaccines remain a key to ending the severe restrictions on public life, which include public mask-wearing and social distancing — all of which have become flashpoints in U.S. political discourse.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Yet the headway on vaccines has made Anthony Fauci, the federal government’s top infectious disease expert,&nbsp;“cautiously optimistic” that a potential vaccine candidate could emerge by late fall, he said on Tuesday. In a recent Yahoo Finance interview, Fauci said the accelerated push was “worth it” despite the inherent risks.” data-reactid=”18″>Yet the headway on vaccines has made Anthony Fauci, the federal government’s top infectious disease expert, “cautiously optimistic” that a potential vaccine candidate could emerge by late fall, he said on Tuesday. In a recent Yahoo Finance interview, Fauci said the accelerated push was “worth it” despite the inherent risks.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="On an earlings call Tuesday, Pfizer’s (PFE) CEO Albert Bourla said they company expects to have some sort of news and completed regulatory review by October 2020. The company had four potential candidates and has advanced one of those — a two-shot 30-microgram dose — into the final phase.” data-reactid=”19″>On an earlings call Tuesday, Pfizer’s (PFE) CEO Albert Bourla said they company expects to have some sort of news and completed regulatory review by October 2020. The company had four potential candidates and has advanced one of those — a two-shot 30-microgram dose — into the final phase.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Moderna (MRNA) also announced its Phase 3 trial yesterday, which it is doing with significant funding and support from the federal government. Johnson &amp; Johnson (JNJ) also announced entering phase 1 of its candidate Monday.” data-reactid=”20″>Moderna (MRNA) also announced its Phase 3 trial yesterday, which it is doing with significant funding and support from the federal government. Johnson & Johnson (JNJ) also announced entering phase 1 of its candidate Monday.

Pfizer executives told investors Tuesday they see the pandemic as a source of recurring revenue with the vaccine becoming a seasonal need, like the flu, and pricing adjusting accordingly. The current price of $19.50 is based on 100 million doses bought at $1.95 billion by the federal government, and is lower than the value the company believes the drug has for society, according to Bourla.

Pricing has been a point of concern for some patient advocacy groups, who believe companies should be providing the vaccine at no-profit costs.

Angela Hwang, global president of biopharmaceuticals at Pfizer, said on Tuesday the company would not offer other countries a lesser price than the U.S., except for poorer countries.

“No country in the developed world will receive (COVID-19 vaccine) doses at a lower price than the U..S.” for similar volume commitments, Hwang added.

Moving to end a ‘dangerous’ dependency

Manufacturing and logistics are proving to be the biggest hurdles the U.S. has to overcome to respond to the coronavirus outbreak.

It’s why the U.S. Health and Human Services Department, through Operation Warp Speed, and the Department of Defense (DoD) have all invested in various strategies to help boost U.S. output.

Shortages of protective gear, testing supplies, glass vials for vaccines and necessary refrigerated transportation for vaccines are all strained amid the pandemic. To date, the executive branch has either funded or used the Defense Protection Act (DPA) to produce N-95 masks and ventilators, and other critical equipment.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="It is also funding the production and research for COVID-19 vaccines. That includes announcements this week to tap Eastman Kodak (KODK) and FUJIFILM (FUJIY) with Texas A&amp;M University for manufacturing.” data-reactid=”29″>It is also funding the production and research for COVID-19 vaccines. That includes announcements this week to tap Eastman Kodak (KODK) and FUJIFILM (FUJIY) with Texas A&M University for manufacturing.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Under the DPA, Kodak has received a $765 million loan to pivot to producing generic drug active ingredients — a product that is largely produced in overseas facilities in India and China.” data-reactid=”30″>Under the DPA, Kodak has received a $765 million loan to pivot to producing generic drug active ingredients — a product that is largely produced in overseas facilities in India and China.

Previously, HHS awarded an up to $812 million grant to startup Phlow Corporation to do the same, in keeping with the Trump Administration’s position that the U.S. is over-reliant on overseas products.

“If we have learned anything from the global pandemic, it is that Americans are dangerously dependent on foreign supply chains for their essential medicines,” said Peter Navarro, White House advisor, in a statement announcing the Kodak loan.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Separately, HHS announced a $265 million contract with FUJIFILM and Texas A&amp;M to help increase the country’s vaccine production capabilities. That includes candidates like Novavax’s (NVAX), which recently announced a separate partnership with FUJIFILM.” data-reactid=”33″>Separately, HHS announced a $265 million contract with FUJIFILM and Texas A&M to help increase the country’s vaccine production capabilities. That includes candidates like Novavax’s (NVAX), which recently announced a separate partnership with FUJIFILM.

Warp Speed has previously given hundreds of millions for key medical material needs to companies like ApiJect, Corning and SiO2 Material. However, other companies are independently pursuing drug production without government money.

Quartic.ai, a startup like Phlow, also recognized the need for domestic production of drug ingredients and began addressing the issue prior to the global pandemic. The company partnered with Bright Path Labs earlier this year to focus on continuous manufacturing of drug ingredients.

Larry Taber, vice president of Life Sciences at Quartic, told Yahoo Finance that Bright Path had been in touch with the White House coronavirus task force about producing 25 ingredients.

“This technology, continuous flow, has been around for a decade and a half, but it has not been well-received by the pharma industry” until a couple of years ago, Taber said.

The technology requires a smaller footprint than traditional batch manufacturing, and would take just a few months to set up. An pharmaceutical veteran, Taber suggested the reason it hasn’t taken off, according to Taber, is because the existing, expensive infrastructure at those companies.

“I’ve taken products outside the U.S. and I know we can bring them back in…and can make them just as competitively,” he said.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Anjalee Khemlani is a&nbsp;reporter&nbsp;at Yahoo Finance. Follow her on Twitter:&nbsp;@AnjKhem” data-reactid=”44″>Anjalee Khemlani is a reporter at Yahoo Finance. Follow her on Twitter: @AnjKhem

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<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Read the latest financial and business news from Yahoo Finance” data-reactid=”50″>Read the latest financial and business news from Yahoo Finance

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Follow Yahoo Finance on&nbsp;Twitter,&nbsp;Facebook,&nbsp;Instagram,&nbsp;Flipboard,&nbsp;SmartNews,&nbsp;LinkedIn,&nbsp;YouTube.” data-reactid=”51″>Follow Yahoo Finance on TwitterFacebookInstagramFlipboardSmartNewsLinkedInYouTube.

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Federal $500M bailout for Muskrat Falls power delays to keep N.S. rate hikes in check

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HALIFAX – Ottawa is negotiating a $500-million bailout for Nova Scotia’s privately owned electric utility, saying the money will be used to prevent a big spike in electricity rates.

Federal Natural Resources Minister Jonathan Wilkinson made the announcement today in Halifax, saying Nova Scotia Power Inc. needs the money to cover higher costs resulting from the delayed delivery of electricity from the Muskrat Falls hydroelectric plant in Labrador.

Wilkinson says that without the money, the subsidiary of Emera Inc. would have had to increase rates by 19 per cent over “the short term.”

Nova Scotia Power CEO Peter Gregg says the deal, once approved by the province’s energy regulator, will keep rate increases limited “to be around the rate of inflation,” as costs are spread over a number of years.

The utility helped pay for construction of an underwater transmission link between Newfoundland and Nova Scotia, but the Muskrat Falls project has not been consistent in delivering electricity over the past five years.

Those delays forced Nova Scotia Power to spend more on generating its own electricity.

This report by The Canadian Press was first published Sept. 16, 2024.

The Canadian Press. All rights reserved.

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Roots sees room for expansion in activewear, reports $5.2M Q2 loss and sales drop

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TORONTO – Roots Corp. may have built its brand on all things comfy and cosy, but its CEO says activewear is now “really becoming a core part” of the brand.

The category, which at Roots spans leggings, tracksuits, sports bras and bike shorts, has seen such sustained double-digit growth that Meghan Roach plans to make it a key part of the business’ future.

“It’s an area … you will see us continue to expand upon,” she told analysts on a Friday call.

The Toronto-based retailer’s push into activewear has taken shape over many years and included several turns as the official designer and supplier of Team Canada’s Olympic uniform.

But consumers have had plenty of choice when it comes to workout gear and other apparel suited to their sporting needs. On top of the slew of athletic brands like Nike and Adidas, shoppers have also gravitated toward Lululemon Athletica Inc., Alo and Vuori, ramping up competition in the activewear category.

Roach feels Roots’ toehold in the category stems from the fit, feel and following its merchandise has cultivated.

“Our product really resonates with (shoppers) because you can wear it through multiple different use cases and occasions,” she said.

“We’ve been seeing customers come back again and again for some of these core products in our activewear collection.”

Her remarks came the same day as Roots revealed it lost $5.2 million in its latest quarter compared with a loss of $5.3 million in the same quarter last year.

The company said the second-quarter loss amounted to 13 cents per diluted share for the quarter ended Aug. 3, the same as a year earlier.

In presenting the results, Roach reminded analysts that the first half of the year is usually “seasonally small,” representing just 30 per cent of the company’s annual sales.

Sales for the second quarter totalled $47.7 million, down from $49.4 million in the same quarter last year.

The move lower came as direct-to-consumer sales amounted to $36.4 million, down from $37.1 million a year earlier, as comparable sales edged down 0.2 per cent.

The numbers reflect the fact that Roots continued to grapple with inventory challenges in the company’s Cooper fleece line that first cropped up in its previous quarter.

Roots recently began to use artificial intelligence to assist with daily inventory replenishments and said more tools helping with allocation will go live in the next quarter.

Beyond that time period, the company intends to keep exploring AI and renovate more of its stores.

It will also re-evaluate its design ranks.

Roots announced Friday that chief product officer Karuna Scheinfeld has stepped down.

Rather than fill the role, the company plans to hire senior level design talent with international experience in the outdoor and activewear sectors who will take on tasks previously done by the chief product officer.

This report by The Canadian Press was first published Sept. 13, 2024.

Companies in this story: (TSX:ROOT)

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Talks on today over HandyDART strike affecting vulnerable people in Metro Vancouver

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VANCOUVER – Mediated talks between the union representing HandyDART workers in Metro Vancouver and its employer, Transdev, are set to resume today as a strike that has stopped most services drags into a second week.

No timeline has been set for the length of the negotiations, but Joe McCann, president of the Amalgamated Transit Union Local 1724, says they are willing to stay there as long as it takes, even if talks drag on all night.

About 600 employees of the door-to-door transit service for people unable to navigate the conventional transit system have been on strike since last Tuesday, pausing service for all but essential medical trips.

Hundreds of drivers rallied outside TransLink’s head office earlier this week, calling for the transportation provider to intervene in the dispute with Transdev, which was contracted to oversee HandyDART service.

Transdev said earlier this week that it will provide a reply to the union’s latest proposal on Thursday.

A statement from the company said it “strongly believes” that their employees deserve fair wages, and that a fair contract “must balance the needs of their employees, clients and taxpayers.”

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

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