Connect with us

Business

HHS Funds Phase 2/3 Clinical Trial for Potential Treatment for COVID-19

Avatar

Published

on

HHS Funds Phase 2/3 Clinical Trial for Potential Treatment for COVID-19

An antibody medicine being evaluated to treat severe cases of coronavirus disease 2019 (COVID-19) will receive additional support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) under an existing partnership with Regeneron Pharmaceuticals of Tarrytown, New York.

The Biomedical Advanced Research and Development Authority (BARDA) within ASPR will provide support for a U.S. Phase 2/3 clinical trial to evaluate Kevzara as a potential treatment for severely ill COVID-19 patients. Currently, Kevzara is approved by the U.S. Food and Drug Administration for the treatment of rheumatoid arthritis. Kevzara was developed under a collaboration between Regeneron and Sanofi; the companies continue to collaborate on studying Kevzara for COVID-19, with Regeneron leading U.S.-based trials and Sanofi leading trials outside the U.S.

‘We are working at a record pace with our private sector partners to speed development of therapeutic treatments for people with COVID-19,’ said BARDA Director Rick A. Bright, PhD. ‘By repurposing a currently approved product, we may be able to expedite development and make treatments available quickly.’

Patients with COVID-19 are at risk of developing life-threatening respiratory failure, which may be mediated in part by elevated levels of a series of pro-inflammatory molecules, including interleukin-6 (IL-6). Kevzara is a fully-human monoclonal antibody that binds to the IL-6 receptor on normal cells and may improve patient outcomes by decreasing the severe inflammatory response.

The role of IL-6 is supported by preliminary uncontrolled data from a Chinese trial of a different IL-6 agent, which showed rapid reductions in fever in all patients and improvements in oxygenation. The Phase 2/3 clinical trial will determine if Kevzara can be used as a safe and effective therapy to reduce the amount of time that a person infected with the novel coronavirus remains ill. The first part of the trial will evaluate the impact of Kevzara on fever and patients’ need for supplemental oxygen. The second, larger part of the trial will evaluate the improvement in longer-term outcomes, including whether it can prevent death and reduce the need for mechanical ventilation, supplemental oxygen, and/or hospitalization.

This partnership with Regeneron is among the first to be issued by BARDA with funding from the H.R.6074 – Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 that was passed by the U.S. Congress and signed by President Trump on March 6, 2020.

HHS continues to work across the U.S. government, including with the Department of Defense, to review potential products from public and private sectors to identify promising candidates that could detect, protect against, or treat COVID-19 for development and FDA approval/clearance.

In addition to this adaptive Phase 2/3 clinical trial with Kevzara, one other HHS-funded trial of an investigational COVID-19 treatment is ongoing. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is sponsoring a randomized controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults.

‘Proven treatment options for COVID-19 are urgently needed. This trial of Kevzara is critical to inform doctors on treatment options for COVID-19,’ said HHS Secretary Alex Azar. ‘The close collaboration between BARDA, the FDA, and Regeneron to initiate this trial as soon as possible again demonstrates the speed at which we are responding to this pandemic.’

HHS divisions, including NIH and ASPR, are supporting the development of multiple diagnostic tests, vaccines, and potential therapeutic treatments for COVID-19. BARDA continues to seek partners for COVID-19 medical countermeasures, and offers multiple ways to submit proposals for potential new products or technologies.

About HHS, ASPR, and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance.

Contact:

Tel: 202-690-6343

Business

Stocks Close In the Red After Massive 900-Point Rally Falls Apart

Avatar

Published

on

Stocks Close In the Red After Massive 900-Point Rally Falls Apart

In what could be an ominous sign of things to come, the stock market couldn’t hold on to a massive rally yesterday. Stocks closed the day in the red.

The Dow Jones Industrial Average climbed as much as 937 points intraday. This was before it gave back all the gains and closed the day down 26 points.

It could turn out to be a turning point that many experienced investors have been predicting.

Their belief is that the rapid 20% rebound in stock prices couldn’t last. They also believe that we may eventually re-test the March 23 lows.

900-Point Rally Fails

Jim Cramer, host of ‘Mad Money’ on CNBC seems to be slowly coming around to the idea.

“Just think about the last 500 Dow points [Monday]. I don’t know. They were done in, what, about 30 minutes. That’s not sustainable. There are people who are just anxious about taking something off the table because they’ve just seen a remarkable two-day bull market, and now they’re ready to find out about … the various stages that we need to get out.”

David Kostin, the chief U.S. equity strategist at Goldman Sachs, believes that stocks are poised to fall again. He mentioned that it’s likely, if you compare it to how the market behaved during the 2008 financial crisis.

“The way I think about this is [there’s an asymmetry] in terms of downside risk towards a level in the S&P 500 of around 2,000, which is about 25%, and an upside of around 10% to a target at the end of the year of around 3,000. [That’s not symmetrical] in terms of timing. I think the risk is a lot further towards the downside,” Kostin said. He then added: “I would just remind you that in [Q4 2008], there were many different rallies, they’re called bear market rallies, some of which were almost 20% a couple of times, but the market did not bottom until March of 2009.”

“I wouldn’t be surprised if we hit 2,000 on the S&P 500 ”said Alex Chalekian, the CEO of Lake Avenue Financial.

He added “We’re going to see opportunities and we’re going to take advantage of them,” he said. “But in the meantime, there’s no rush to jump back into the market right now.”

Economic Strategists React

Peter van der Welle, a multi-asset strategist at Robeco says “From a sentiment angle, recent exceptional bounces suggest that investor sentiment is still in the denial phase, rather than in the phase of capitulation that paves the way for a new bull market.”.

In addition, Albert Edwards, a global strategist at Société Générale, said that investors hoping that monetary and fiscal stimulus can save the market through this rally have made a mistake. “This optimism is the legacy of a long bull market. Investors can’t conceive that the Fed will ‘allow’ the stock market to collapse. Think again. That was the view in 2007 too,” he said.

Finally, Goldman Sachs conducted a poll with more than 1,800 of its institutional clients as respondents. It found out that 50% believe the lows have not yet been set. The survey also revealed that 75% believe equities remain in a bear market.

Up Next:

Continue Reading

Business

With Survival at Stake, Small Business Owners Frustrated by Aid Delays

Avatar

Published

on

With survival at stake, small business owners frustrated by aid delays

Greg Hunnicutt has almost entirely shut down his Houston-based construction business. At his one remaining job site, he’s being careful to minimize the risk of anyone being exposed to the coronavirus. So he keeps fewer workers on the job.

“My electrician is there now doing some work,” he said. “It’s just him and his helper. So what I’m trying to accomplish here is reducing how people interact.”

With his income sharply reduced, Hunnicutt needs more funds, and fast. He reached out to NPR on Friday, when the Small Business Administration’s coronavirus crisis lending program opened. At the time, he was having trouble getting through online to apply for an SBA loan through his bank, Wells Fargo. I asked him this week how it was going.

“Well, it’s not,” he said, laughing. He says he filled out a form on the bank’s website over the weekend, but he hasn’t heard back yet.

But he says he needs that money soon to keep his business alive.

“I paid my guys two weeks,” he said. “Well, that was two weeks ago. Starting today, this week, they haven’t been paid.”

If the process doesn’t move quickly, he said his business will be in serious trouble.

Business problems with banks

Hunnicutt is one of dozens of small business owners that contacted NPR, describing obstacles in applying for loans. The $350 billion SBA initiative, called the Paycheck Protection Program, is designed to keep workers at small companies on the payroll during the crisis.

The Trump administration had said it hoped the program could give some businesses immediate financial assistance. And administration officials have bragged that hundreds of millions of dollars were disbursed through banks on the first day.

Some small business owners, like Hunnicutt, are waiting to hear from their banks. Others have said they haven’t been able to get through to their banks, due to crashing websites.

Several business owners cited restrictions from Bank of America as a major hurdle. On Friday, Bank of America said a deposit account with the bank was not enough to qualify for loans. Applicants would need loan or credit card accounts with the bank. That left out the many businesses without lending relationships with the bank and sparked an online backlash. Bank of America loosened its requirements over the weekend.

The SBA program reflects the difficulties of quickly setting up a massive new emergency lending effort, and running it through myriad banking institutions.

And it comes at a time when businesses desperately need money. A recent survey from the U.S. Chamber of Commerce found that one in four businesses say they are two months or less from closing permanently, and one in 10 say it’s one month or less.

Bigger problems than banks

Small businesses’ difficulties with the new program go beyond their banks, however. New rules written after Congress created the program are tripping up some businesses, according to Stephanie O’Rourk, a partner at accounting firm CohnReznick.

“The problem with the program is that it doesn’t align with the reality of the situation that a lot of businesses are going through right now,” she said.

For example, she says, the new rules now say that the loans must be paid back in two years instead of the 10 that the CARES Act says. In addition, Treasury added a rule saying three-quarters of the money must be used on payrolls in order for it to be forgiven.

For some businesses, non-payroll expenses are just too high to spend that much on employees.

Chelsea Altman, co-owner of five restaurants in New York City, says that rule will be bad for her and other businesses in high-cost cities.

“In New York state or New York City, your rent is very high,” she said. “So there is a chance that even with this 75 percent going to labor and then the other 25 percent is supposed to go to your rent, there’s times when that won’t” cover the rent.

Some banks displeased

Many banks opened the program up only to their own customers. As NPR has reported, that worried some small business advocates because it threatens to leave out smaller, and particularly, minority-owned businesses.

Banks, meanwhile, had their reasons for wanting to limit their applications, according to Aaron Klein, policy director of the Center on Regulation and Markets at the Brookings Institution.

“The Treasury Department made a major unforced error, leaving anti-money laundering rules on autopilot,” he said.

To lend money, banks have to go through a procedure called Know Your Customer to prevent money laundering. It can be a cumbersome process, Klein explained, and stands to be a serious impediment to an effort that seeks to get tens of billions out the door in a matter of days.

Other banks have voiced their own issues, including forms that changed overnight, unclear guidance from the government, and difficulty with the Small Business Administration website.

For now, at least one concern with the program is being answered: that the initial $349 billion appropriated for it is too small to meet business demand. On Tuesday, the Treasury said it was preparing to ask Congress to spend another $200 billion on the program. Senate Majority Leader Mitch McConnell said on Tuesday that he plans to work with Democrats and Treasury to put more money into the program.

Copyright 2020 NPR. To see more, visit https://www.npr.org.

© KNOW Minnesota Public Radio, Copyright © 2020 APM. All rights reserved.

Continue Reading

Business

JPMorgan Predicts ‘Bad Recession’; Former Fed Chair Sees ‘Shocking’ Downturn

Avatar

Published

on

JPMorgan Predicts ‘Bad Recession’; Former Fed Chair Sees ‘Shocking’ Downturn

Jamie Dimon, the head of JPMorgan, says he expects the coronavirus pandemic to include a “bad recession” that could put the country into a situation similar to the 2008 financial crisis.

“We don’t know exactly what the future will hold,” Dimon started. “But at a minimum, we assume that it will include a bad recession combined with some kind of financial stress similar to the global financial crisis of 2008,” he added. “Our bank cannot be immune to the effects of this kind of stress.”

Dimon made the comments in the company’s annual shareholder letter.

The letter went on to say that while the bank came into the crisis well funded, the pandemic continues to progress in “dramatically different” ways compared to anything predicted by the Federal Reserve’s stress test for banks.

The Pandemic and the Economy

Perhaps attempting to ease the shareholders into bad news, Dimon stated that JPMorgan’s earnings “will be down meaningfully in 2020” due to the pandemic. He also warned that in an “extremely adverse” downturn in the U.S. economy, the bank would probably consider suspending its dividend in an effort to preserve capital.

Interestingly, Dimon says regulations placed after the 2008 financial crisis could hinder the bank’s ability to help in future crises.

“As we get closer to the extremely adverse scenario, current regulatory constraints will limit additional actions we can take to help clients,” Dimon said, “in spite of the extraordinary amount of capital and liquidity we could deploy.”

Others at Dimon’s bank are sounding the alarm bells as well.

Mislav Matejka, head of global equity strategy at JPMorgan, warned investors yesterday of a very high likelihood that we experience “a vicious spiral, which is typical of a recession, between weak final demand, weaker labor markets, falling profits, weak credits markets and low oil prices.”

JPMorgan economists are expecting “only a gradual bottoming out in activity” because of this. They predict it to be like the ones that took place after the Great Financial Crisis. These economists also believe that it’s “not a V-shaped one that we see, for example, after natural disasters.”

Recession and Prolonged Recovery

The bank also expects the unemployment rate will climb to 8.5% during the second half of the year. It also predicts that the U.S. GDP will decline by 10%. For comparison, the economy saw a 4% decline during the financial crisis.

“And this is all assuming that the virus is history by June, which might prove significantly optimistic,” Matejka wrote.

“While consensus view still appears to be a quick recovery, recessions tend to linger,” he added. “It took equities on average 18 months to record the final low in the past.”

Echoing JPMorgan’s worries about the potential for a prolonged recovery is former Federal Reserve Chair Janet Yellen.

In a recent CNBC interview, Yellen says the current state of the economy is worse than what the data shows.

She says we are already in an “absolutely shocking” downturn that is not reflected yet in the current data. Additionally, she mentioned that the unemployment rate probably sits closer to 13%.

She also says the economy has contracted “at least 30% and I’ve seen far higher numbers.”

Yellen says she is optimistic the country will experience a “V”-shaped recovery. She, however, acknowledges that the length of time a country remains shut down will dictate the speed of recovery.

“I think a ‘V’ is possible, but I am worried that the outcome will be worse,” she said. “It really depends to my mind on just how much damage is down during the time that the economy is shut down in the way it is now,” Yellen added.

Up Next:

Continue Reading
Advertisement

Facebook

Trending

Copyright © 2019 The Capitalist. his copyrighted material may not be republished without express permission. The information presented here is for general educational purposes only. MATERIAL CONNECTION DISCLOSURE: You should assume that this website has an affiliate relationship and/or another material connection to the persons or businesses mentioned in or linked to from this page and may receive commissions from purchases you make on subsequent web sites. You should not rely solely on information contained in this email to evaluate the product or service being endorsed. Always exercise due diligence before purchasing any product or service. This website contains advertisements.