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Monday, June 15, 2020

FDA warns on use of malaria drugs with remdesivir

The FDA has issued a warning to healthcare providers that it does not recommend co-administering malaria meds chloroquine or hydroxychloroquine with Gilead Sciences’ (NASDAQ:GILD) remdesivir for COVID-19 patients since they may compromise the antiviral effect of the latter.
The agency says it is not aware of any instances in the field of this reduced activity but is continuing to “evaluate all data” related to remdesivir.
Earlier today, the FDA rescinded emergency use authorization of the malaria drugs for COVID-19.

Vir Biotech inks broad coronavirus partnership with Glaxo

Vir Biotechnology (NASDAQ:VIR) discloses that, on June 9, it inked a collaboration agreement with GlaxoSmithKline (NYSE:GSK) aimed at developing and commercializing products for the prevention, treatment and prophylaxis of SARS-CoV-2-related diseases.
The partnership will focus on three principal programs: antibodies targeting the virus, vaccines and products based on CRISPR screening of host targets expressed in connection to exposure to SARS-CoV-2. All three include the possibility of including other coronaviruses.
For the next four years, the companies will conduct R&D activities under mutually agreed plans and budgets for each of the three programs. Subject to an opt-out mechanism, the parties will share development, manufacturing and commercialization costs. Specifically, VIR will be responsible for 72.5% of the costs of the antibody program, 27.5% of the costs of the vaccine program and 50% of the costs of the functional genomics program.
GSK will lead commercialization globally. VIR has the right to co-promote antibody products in the U.S. on a case-by-case basis.
The agreement will remain in place as long as a collaboration product is being developed or commercialized by the lead party.
https://seekingalpha.com/news/3583210-vir-biotech-inks-broad-coronavirus-partnership-glaxo

New kid on the block in race for NASH drug

French biopharma Inventiva (OTCPK:IVEVF) has emerged as a new player in the pursuit of a treatment for nonalcoholic steatohepatitis (NASH).
Today, it announced positive results from a Phase 2 clinical trial, NATIVE, evaluating lanifibranor in adult NASH patients with liver steatosis and moderate-to-severe necroinflammation without cirrhosis.
The trial met the primary endpoint in the intent-to-treat population (1200 mg/day) demonstrating a statistically significant proportion of patients experiencing a decrease of at least two points in SAF (combines hepatocellular inflammation and ballooning) activity score at week 24 with no worsening of fibrosis. Specifically, 49% of treated participants achieved the endpoint compared to 27% in the placebo arm.
Key secondary endpoints were also met.
The company says lanifibranor, a pan-PPAR (peroxisome proliferator-activated receptors) agonist, is the first drug candidate to show statistically significant results on the two FDA and EMA primary efficacy endpoints relevant to potential accelerated approval during Phase 3 development.
The company’s current cash runway extends into Q3 2021 but the company is “open to all options” related to raising additional capital.
Next up are meetings with regulators before advancing into late-stage studies.
PPARs have stuck out so far in treating NASH. Genfit’s (NASDAQ:GNFT) elafibranor flopped in a Phase 3 study while CymaBay Therapeutics (NASDAQ:CBAY) terminated a Phase 2b trial of seladelpar on a potential safety signal, although shares rallied a month ago after the company announced that further analyses support a restart.
Inventiva says lanifibranor is different since it targets all three types of PPAR instead of just one.
NASH-related tickers: MDGL, VKTX, ICPT, ABBV
https://seekingalpha.com/news/3583247-new-kid-on-block-in-race-for-nash-drug

24% of workers at high risk of severe Illness from COVID-19

Nearly a quarter of U.S. workers are considered at high risk of severe illness from COVID-19 due to underlying health conditions or age, a consideration for employers as they reopen and try to protect these workers, according to a new Kaiser Family Foundation study.
The analysis estimates 37.7 million workers (based on their work status in 2018), including 10 million people age 65 and older and27.7 million who have preexisting medical conditions, are at greater risk for severe illness from COVID-19. They make up 24 percent of all adult workers, according to the study.
For the analysis, KFF examined data from the CDC’s 2018 National Health Interview Survey. Analysts looked at the number of workers at high risk of serious illness based on the CDC’s risk factors. People 65 and older are considered higher-risk, as are those who have diabetes, chronic obstructive pulmonary disease, heart disease, a body mass index above 40, moderate to severe asthma or a functional limitation because of cancer.
The analysis also estimates there are 12 million at-risk adults who do not work, including 6.5 million people age 65 and older who live with at least one full-time worker.
“This is a conservative estimate because additional nonworking at-risk adults live with people who work part time or who are in and out of the workforce,” researchers wrote. “The safety of these family members will need to be part of the considerations for employees and employers as businesses continue to refine safety protocols and others reopen their workplaces.”
Read more about the study here.
https://www.beckershospitalreview.com/workforce/24-of-workers-at-high-risk-of-severe-illness-from-covid-19-study-finds.html

Only 26% of parents believe flu vaccine is effective

Only 1 in 4 parents believe the flu shot is effective, and 1 in 8 parents worry about vaccine safety for both flu shots and routine childhood vaccines, according to a new article published in the journal Pediatrics.
U.S. families with children were surveyed online in February 2019, with a total of 2,176 parents responding.
Five key takeaways:
1. Of all respondents, 6.1 percent were hesitant about routine childhood vaccines, with 25.8 percent of parents hesitant about flu shots.
2. Seventy percent of respondents strongly agreed that routine childhood vaccines are effective, compared to 26 percent for flu shots.
3. Almost 1 in 15 parents are hesitant about routine childhood vaccines, and more than 1 in 4 are hesitant about the flu vaccine.
4. For both routine childhood and flu shots, 1 in 8 parents are concerned about vaccine safety.
5. Parents with less than a bachelor’s degree and a household income 400 percent greater than the federal poverty level were more hesitant about both routine childhood vaccines and flu shots.
https://www.beckershospitalreview.com/public-health/only-26-of-parents-believe-flu-vaccine-is-effective.html

U of Illinois to test Moderna’s COVID-19 vaccine in older, minority populations

The University of Illinois at Chicago will conduct a study of Moderna’s experimental COVID-19 vaccine, focusing on older patients and minority groups, which are at high risk of infection, the Chicago Sun-Times reported.
The trial, part of the federal government’s Operation Warp Speed, will include at least 1,000 people and is set to begin July 9. At least 400 people will be 65 or older, and researchers are hoping to test a large number of African American and Latino residents, both groups that are at a high risk of infection and death. They’re also hoping to test people working in warehouses and manufacturing sites, places with high risk of the virus spreading.
Researchers aim to determine if the vaccine is effective in preventing COVID-19 and severe COVID-19 illness, according to the Sun-Times.
The trial is scheduled to last two years, but researchers said that if the vaccine proves to be effective by the end of this year or in early next year, it could be approved for use in 2021.
Study participants will be given a shot at the beginning of the trial and another a month later, with half receiving the vaccine and half receiving a placebo.
UIC is one of several sites in the U.S. that will test Moderena’s vaccine, and more than 30,000 people are expected to enroll in the trials, the Sun-Times reported.
https://www.beckershospitalreview.com/pharmacy/u-of-illinois-to-test-moderna-s-covid-19-vaccine-in-older-and-minority-populations.html

Stocks rise after Fed expands stimulus

Stocks erased earlier losses and rose Monday, after the Federal Reserve said it would begin purchasing individual corporate bonds as part of its emerging lending program to inject liquidity into the virus-stricken economy.
Earlier in the session, the Dow was off as many as 762 points, or 3%, as investor jitters over rising coronavirus cases in key parts of the country stirred up an extension of last week’s pullback in equities.
Last week, stocks posted their first weekly loss in a month, with a steep selloff on Thursday comprising much of the weekly decline. The plunge, which came on the heels of a more than 40% run-up in the S&P 500 since March, came after new data showed rising coronavirus case and hospitalization counts in states that were among the first to reopen businesses, and after the Federal Reserve last week delivered a grim forecast for near-term economic activity.
Market participants continued to eye coronavirus cases across the country for signs of resurgences. New cases in the densely populated state of Florida grew faster than the past week’s average as of Sunday’s tally, according to Bloomberg data, and Washington State Department of Health issued a report warning of statewide increases in the virus.
In New York, the daily coronavirus death toll came in at 23 as of Sunday, or the lowest since the pandemic began and well below the near 800 per day at the outbreak’s peak in early April. Governor Andrew Cuomo, however, flagged that more than 25,000 complaints had been filed over violations of social distancing standards, and Cuomo warned he would tighten restrictions if businesses and individuals did not comply with the phased reopening process.
Still, some analysts maintained that geographies that have been slower to reopen including the Northeast, were less at risk of a renewed flare-up in cases, given their more protracted original lockdowns.
“We are not worried that the renewed lockdowns we expect in parts of Arizona, Texas, the Carolinas, Arkansas, and perhaps others, will be required elsewhere,” Ian Shepherdson, chief economist for Pantheon Macroeconomics, said in a note. “Far more people have been sick in the densely populated Northeast and Midwest than in most of the South, and lockdowns in major cities have been very long and painful.”
“Accordingly, we’re expecting people in the Northeast and Midwest to be much more cautious about maintaining social distancing, and to be more willing to wear masks in stores, on public transportation and at leisure facilities,” he added.
Meanwhile, White House economic director Larry Kudlow during CNN’s “State of the Union” on Sunday downplayed economic concerns posed by potential new waves of the coronavirus, saying, “There’s a very good chance you are going to get the V-shaped recovery,” and asserting growth would pick back up in the second half of the year. The remarks contrasted with some of the more cautionary outlooks from officials including Federal Reserve Chair Jerome Powell, who last week underscored the ongoing uncertainty created by the pandemic.
Kudlow also said the current $600-per-week unemployment payment paid out to some Americans who had lost their jobs during the pandemic as part of Washington’s sweeping coronavirus relief plan would end on schedule at the end of July, calling the program “a disincentive” for people to return to work.
Later this week, market participants are poised to receive new economic data on the retail trade and manufacturing sectors, which many economists believe will affirm an at least slight pick-up in activity from the doldrums of April.
Stocks rose and the Dow added more than 200 points, after the Federal Reserve said it will purchase individual corporate bonds that meet their criteria under the central bank’s Secondary Market Corporate Credit Facility. Previously, the Fed had been purchasing just exchange-traded funds under this facility.
The new program will include an index “made up of all the bonds in the secondary market that have been issued by U.S. companies that satisfy the facility’s minimum rating, maximum maturity, and other criteria. This indexing approach will complement the facility’s current purchases of exchange-traded funds,” the Fed said in a statement.
https://finance.yahoo.com/news/stock-market-news-live-june-15-2020-222141593.html