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Pfizer proposes expansion of late-stage coronavirus vaccine trial



The Pfizer world headquarters stands in Midtown Manhattan in New York City.

Drew Angerer | Getty Images

Pfizer and German biotech firm BioNTech announced Saturday that they have submitted a proposal to the U.S. Food and Drug Administration to expand the phase-three trial of its coronavirus vaccine to include up to 44,000 participants, a significant increase from its previous target of 30,000. 

The companies, which are developing the vaccine together, said in a statement that the trial is proceeding as planned and they expect to have enrolled 30,000 participants by next week. 

“The proposed expansion would allow the companies to further increase trial population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data,” the companies said. 

Representatives of the Food and Drug Administration and of the Department of Health and Human Services did not immediately return CNBC’s request for comment.

Public health specialists have emphasized the need for participants in vaccine trials to reflect a diverse population, including the elderly, communities of color and people with underlying health conditions, all of whom have been disproportionately impacted by the virus. Including diverse participants helps ensure that the vaccine candidate is truly safe and effective across a variety of populations. 

Moderna, another company developing a Covid-19 vaccine, told CNBC earlier this month that they were slowing enrollment slightly in its trial to ensure it has sufficient representation of minorities most at risk for the disease.

Pfizer CEO Albert Bourla said earlier this month that the pharmaceutical company could have results from its late-stage trial as soon as October. On Saturday, the companies reiterated the possibility that they could have data reflecting whether the vaccine is effective or not by the end of October. However, it could take longer to collect enough data to determine whether the vaccine is safe, because it will take months of follow-up work to determine what kind of side effects, if any, the vaccine may cause.

“The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing,” the companies said. “As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October.”

Through Operation Warp Speed, the Trump administration’s effort to quickly bring a Covid-19 vaccine and therapeutics to market, the U.S. has now invested more than $10 billion in six candidates, including Pfizer’s. The U.S. announced in July that it agreed to pay nearly $2 billion to Pfizer and BioNTech for at least 100 million doses. 

In July, Pfizer announced that early-stage clinical trial showed the vaccine produced some neutralizing antibodies, which researchers believe is necessary to build immunity to the virus. 

—CNBC’s Meg Tirrell contributed to this report.

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Cell-based seafood producer BlueNalu raises $60 million




BlueNalu’s whole-muscle, cell-based yellowtail amberjack.

Source: BlueNalu

First, it was lab-grown chicken. Now, it’s seafood.

San Diego-based food startup BlueNalu said Tuesday that it raised $60 million in convertible note financing, as it prepares for a possible market launch later this year.

“This recent financing will allow us to continue advancing our mission and the next phase of our commercialization plans, while we continue to develop strategic partnerships that we expect will provide us with global market reach during the coming years,” says Lou Cooperhouse, BlueNalu’s president and CEO, in a statement.

BlueNalu intends to use the funds to complete its regulatory review with the Food and Drug Administration and begin testing its products in a variety of foodservice establishments across the U.S. The company didn’t disclose the names of any foodservice partners.

Plans are also underway to open a nearly 40,000-square-foot pilot production facility.

Rage Capital led this funding round. Agronomics, Lewis & Clark AgriFood, McWin, KBW Ventures, and Siddhi Capital also participated.

Cell-based, or cultured, seafood is created by extracting cells from fish and growing the samples in large bioreactors. The company plans on introducing mahi mahi as its first cultured seafood item, followed by bluefin tuna.

Late last year, the Singapore Food Agency approved cell-cultured chicken made by Eat Just. This was the first lab-grown chicken to receive regulatory approval, and the company is seeking to gain additional approvals to sell its products in other markets, including the U.S.

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Virtual vet service inspired by customer service calls




Chewy CEO Sumit Singh is seen outside the New York Stock Exchange (NYSE) ahead of the Chewy Inc. IPO in New York, June 14, 2019.

Andrew Kelly | Reuters

Chewy CEO Sumit Singh said Tuesday that calls to its customer service line prompted the online pet supplies retailer to accelerate its plans to launch a virtual vet service — even though that had been years away on the company’s roadmap.

“We started to get calls in our customer service/customer experience centers where customers would be sitting at home saying ‘Hey. My dog just ate chocolate and I can’t get a hold of my veterinarian,'” Singh said, at a virtual conference hosted by the National Retail Federation.

The executive said his weekend mornings are spent reading customer reviews.

“A healthy level of anxiety is actually good because it keeps you paranoid,” he said. “It keeps you on your toes and it keeps you anticipating.”

The virtual vet service, which launched in October, is one example of how the company is trying to continue to build on the momentum it’s seen during the pandemic.

He shook off the notion that pet owners will return to buying more of their dog food, cat litter or pet toys at the store after the pandemic, saying customers have formed new habits.

“We’ve been in lockdown for 10, 11 months now, the larger part of the year,” he said. “Customers have had the opportunity to try online models not just with pet, but across a plethora of services whether it’s home delivery, food delivery, grocery shopping or pet. That, in my opinion, really provides a bit of a mental shift for customers.”

Chewy’s shares have shot up by more than 265% in the past year as more Americans adopted pets and shopped online during the pandemic. The company’s market cap is more than $44 billion.

Yet its rapid rise during the global health crisis has caused some investors and analysts to wonder if it can keep up that pace of growth and hold on to customers for the long term. UBS downgraded Chewy and Peloton to sell on Tuesday. It said the online pet supply retailer and exercise equipment company have both been Covid-19 beneficiaries and could see those tailwinds fade.

UBS did not change its $75 price target for Chewy, a nearly 30% drop from where its shares are currently trading. Shares were down about 1% Tuesday afternoon.

Sumit said it’s monitoring trends that will shape its next three to five years, including the acceleration toward more online shopping, the reliance on tools and technology to improve customer service and whether people will return to offices, work from home or do both.

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MyPillow’s CEO says Bed Bath & Beyond, Kohl’s stopped selling his products




My Pillow CEO Michael Lindell is seen outside the door of the West Wing at the White House on Friday, Jan 15, 2021 in Washington, DC.

Jabin Botsford | The Washington Post | Getty Images

MyPillow CEO Mike Lindell, who has repeated false claims that President Donald Trump did not lose the election, said retailers including Bed Bath & Beyond and Kohl’s are removing his company’s products from their stores.

Trump’s supporters on social media platforms are now calling for boycotts of the retailers, while other consumers are urging people to not purchase MyPillow products.

“I just got off the phone with Bed Bath & Beyond,” Lindell said during an interview Monday evening with the Right Side Broadcasting Network. “They’re dropping MyPillow.”

“Just got off the phone — not five minutes ago. Kohl’s, all these different places. … These guys don’t understand,” he went on. “They’re scared. Like a Bed Bath & Beyond, they’re scared. They were good partners. In fact, I told them, ‘You guys come back anytime you want.'”

A search by CNBC on both of the retailer’s websites Tuesday morning still showed available MyPillow merchandise for sale. MyPillow is also still sold at J.C. Penney, Amazon, Belk and some other major retailers.

A representative from Kohl’s confirmed the decision to exit the MyPillow brand. “There has been decreased customer demand for MyPillow,” the spokeswoman said in an emailed statement. “We will sell our current inventory and not buy additional/future inventory in the brand.”

Bed Bath & Beyond did not immediately respond to CNBC’s request for comment.

Lindell has come under fire for spreading of conspiracy theories. Last year, for example, he promoted a fake cure for Covid. More recently, he has said there was widespread voter fraud during the 2020 election.

According to report by The New York Times, officials at Dominion Voting Systems have now sent Lindell a legal letter that warns of pending litigation over his baseless claims of widespread fraud involving their machines. Lindell was not immediately available to respond to CNBC’s request for comment about the letter.

Last week, Lindell was seen visiting the White House and carrying partially obscured notes that looked to tell Trump to invoke “martial law if necessary.”

Following Lindell’s interview where he referenced Bed Bath & Beyond and Kohl’s, users on Twitter are calling for other retailers, like Walmart, to drop MyPillow as well.

The country’s largest retailer recently halted donations from its political action committee to the campaigns of congressional Republicans who opposed certifying President-elect Joe Biden’s victory.

Lindell created his MyPillow empire from scratch in 2004, while struggling with a cocaine addiction. His memoir about his background was published in late 2019.

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