The FDA grants Emergency Use Authorization for Luminex’s (NASDAQ:LMNX)
ARIES SARS-CoV-2 Assay that detects the COVID-19 coronavirus. The
company says ARIES can process up to 144 tests per day with no special
training required and minimal human interaction.
https://seekingalpha.com/news/3558537-fda-oks-emergency-use-of-luminex-covidminus-19-test
Monday, April 6, 2020
Vir Biotech up 34% premarket on GSK COVID-19 deal
Vir Biotechnology (NASDAQ:VIR) jumps 34% premarket on modest volume in reaction to its collaboration with GlaxoSmithKline (NYSE:GSK) to research and develop treatments for COVID-19.
The partnership will leverage Vir’s proprietary
monoclonal antibody platform with GSK’s know-how in functional genomics
while combining their respective competencies in CRISPR screening and
artificial intelligence (AI) to identify anti-coronavirus compounds that
target cellular host genes. They will also apply their combined
expertise to research coronavirus vaccines, including SARS-CoV-2.
In addition to gaining access to Vir’s technology,
GSK will invest $250M in Vir via the purchase of its common stock at
$37.73 per share, a 30% premium to Friday’s close of $29.00.
https://seekingalpha.com/news/3558545-vir-biotech-up-34-premarket-on-gsk-covidminus-19-dealGW Pharma’s Epidiolex descheduled by DEA
The U.S. Drug Enforcement Agency (DEA) has notified GW Pharmaceuticals (NASDAQ:GWPH) that it no longer considers Epidiolex (cannabidiol) a controlled substance. The change is effective immediately.
The move was expected. In September 2018, the DEA took the intermediate step of categorizing the
product as a Schedule 5 drug (includes cough suppressants that contain
modest amounts of codeine, Lyrica and Motofen) that have lower abuse
potential than Schedule 4 substances (i.e., Xanax, Darvon, Ambien).
Shares up 4% premarket on light volume.
https://seekingalpha.com/news/3558584-gw-pharmas-epidiolex-descheduled-deaImmunomedics halts trial on positive data in breast cancer
Immunomedics’ (NASDAQ:IMMU) has halted its Phase 3 confirmatory ASCENT study due to compelling evidence of efficacy.
The remarkable results observed across multiple endpoints warranted early discontinuation of the trial.
The study evaluated sacituzumab govitecan in triple-negative breast cancer.
On another note, the company has appointed Harout
Semerjian as President and Chief Executive Officer, effective April 16.
Most recently, he served as Executive Vice President, Chief Commercial
Officer at Ipsen.
Shares are up 118% premarket.
https://seekingalpha.com/news/3558562-immunomedics-rockets-118-premarket-on-positive-adc-data-in-breast-cancerWalmart limits store traffic
As a safety precaution amid the pandemic, Walmart (NYSE:WMT) is metering the number of people allowed inside its stores.
Some of the measures being taken by the retail
giant include admitting customers one by one at a single entrance to
allow for a rate of five customers inside per 1K square feet of store
space.
The level of store traffic will be about 20% of a store’s usual capacity.
Customers waiting outside to get in will be asked
to stand in line at a distance of six feet apart from each other. Once
inside the store, customers will be directed to one-way lanes to create
separation.
https://seekingalpha.com/news/3558556-walmart-limits-store-traffic
Does COVID-19 Require Different Ventilator Protocols?
As New York health officials race to secure ventilators, some
physicians are starting to ask whether it’s time to change the way this
equipment is used in patients with COVID-19.
Cameron Kyle-Sidell, MD, a critical care physician working in New York City, has been sounding the alarm on Twitter, urging healthcare professionals to consider that COVID-19 acts less like typical acute respiratory distress syndrome (ARDS) and more like high-altitude pulmonary edema (HAPE). The bottom line, Kyle-Sidell said,
is that the current use of ventilators may be causing lung injury in
COVID-19 patients and that it may be time to consider lung-protective
strategies that utilize lower pressure settings.
Kyle-Sidell is not the only one raising questions about the use of the ARDS paradigm in COVID-19 patients. In a letter to the editor published in the American Journal of Respiratory and Critical Care Medicine on March 30, Luciano Gattinoni, MD, of the Medical University of Göttingen in Germany, and colleagues noted that COVID-19 patients in intensive care units in northern Italy had an atypical ARDS presentation, namely well-preserved lung gas volume and severe hypoxemia. Gattinoni and colleagues suggest in the letter that instead of high positive end-expiratory pressure (PEEP), physicians should consider the lowest possible PEEP and gentle ventilation.
https://www.medscape.com/viewarticle/928160
Kyle-Sidell is not the only one raising questions about the use of the ARDS paradigm in COVID-19 patients. In a letter to the editor published in the American Journal of Respiratory and Critical Care Medicine on March 30, Luciano Gattinoni, MD, of the Medical University of Göttingen in Germany, and colleagues noted that COVID-19 patients in intensive care units in northern Italy had an atypical ARDS presentation, namely well-preserved lung gas volume and severe hypoxemia. Gattinoni and colleagues suggest in the letter that instead of high positive end-expiratory pressure (PEEP), physicians should consider the lowest possible PEEP and gentle ventilation.
https://www.medscape.com/viewarticle/928160
Italian Doctor With COVID-19 Recovering After Immunosuppressant Treatment
Dr Alberto Bassi, a 62-year-old Italian dermatologist, was still
hospitalized in the town of Castel San Giovanni in Piacenza, Italy, and
on oxygen when he decided to send a message to all his fellow
physicians: “I’m now in the hospital with COVID-19 pneumonia. Tocilizumab changed everything.”
He posted to Medscape Consult, a crowdsourced social media platform in which clinicians share and discuss real cases, and a frenzy of questions from healthcare providers tackling COVID-19 ensued.
Bassi’s case is one of several confirmed and suspected cases of COVID-19 being discussed on Consult. One confirmed case showed classic respiratory symptoms that progressed rapidly in a 43-year-old Italian man. Another showed gastrointestinal symptoms — vomiting and diarrhea — that were resistant to therapy and no pulmonary symptoms. In more than 40 other threads, doctors from around the world are discussing epidemiology, comorbidities, and investigative treatments.
Bassi’s symptoms started on March 8: fever, cough, and muscle aches.
He suspects he was exposed at a hospital in Correggio, Italy where he
underwent retinal surgery 2 weeks before.
Initially, he took acetaminophen and rested, but 2 days later his oxygen saturation “had dropped from 98% to 88% with progressive respiratory failure,” he told Medscape by email. On the recommendation of the chief of the local ICU, a close friend, Bassi was hospitalized, and clinicians took a nasal swab to confirm COVID-19. Over the following days he received a treatment regimen of Plaquenil (hydroxychloroquine), lansoprazole, antiretroviral therapy, enoxaparin, and methylprednisolone (intravenous).
Then, after one dose of tocilizumab, an immunosuppressant used to treat rheumatoid arthritis, Bassi’s breathing improved almost immediately, he said in an email interview. Tocilizumab is an interleukin-6 receptor antagonist, blocking the proinflammatory IL-6 from its binding site and stopping the uncontrolled inflammatory response that may be a cause of mortality in some COVID-19 patients. A recent retrospective study of 150 patients in China suggested virally activated hyperinflammation may be a major cause of COVID-19 mortality.
As one physician commented on Bassi’s Consult post, “The second phase of [COVID-19] appears to be immunological. The virus may not even be present anymore and people die from the cytokine storm.”
Pranatharthi Chandrasekar, MD, division chief of infectious diseases
at Wayne State University in Detroit, Michigan, says that it is still
unclear if the virus or host inflammatory response are to blame. But if
hydroxychloroquine isn’t effective, anti-inflammatories are the next
course of action. And when prescribing anti-inflammatory drugs, such as
tocilizumab or corticosteroids, for COVID-19, “timing seems to be most
critical,” he told Medscape.
Cytokine storms, the uncontrollable pro-inflammatory reaction that can cause sepsis and organ failure, are also a key factor in cytokine release syndrome (CRS), which tocilizumab is FDA-approved to treat. Immunosuppressive therapies like tocilizumab may be an especially important treatment option, since corticosteroids can exacerbate lung injuries caused by COVID-19, according to a recent study published in The Lancet.
If caught in time, steroids may be enough to dampen the inflammatory reaction and prevent further deterioration, Chandrasekar said. “If conditions worsen further, tocilizumab as another, more potent anti-inflammatory drug may be useful.”
Bassi was given both — tocilizumab and intravenous corticosteroids. Many physicians responded to his message asking if the two were synergistic. “Of course, methylprednisolone was stopped when [they started] tocilizumab and reintroduced again the day after,” he said. But he has no way to be sure there was not a combined effect.
In Italy, current guidelines only allow tocilizumab after the high
viral load phase of COVID-19 has passed. Patients must be without fever
for 72 hours or have been showing symptoms for at least 7 days. China
approved its own tocilizumab clinical trial in mid-February, but the trial is still recruiting. However, a preprint from ChinaXiv
that followed 20 patients given tocilizumab in early February found
that the drug could reduce fever, need for oxygen therapy, blood
lymphocytes, C-reactive protein, and lung abnormalities on the CT scan.
The drug is not yet approved by the FDA for treating COVID-19. But Bassi’s testimony on Consult came just days after the FDA green-lighted phase 3 trials of tocilizumab (Actemra, Genentech) for COVID-19 pneumonia treatment. Genentech, a subsidiary of Roche, will move forward with the double-blind, placebo-controlled trial evaluating intravenous tocilizumab combined with the standard of care in patients with COVID-19 pneumonia.
Bassi remains in the hospital on oxygen therapy, but is “getting better every day.” He’s no longer on Plaquenil or the retroviral. “This is a very dangerous illness,” he wrote to Medscape, “It certainly requires admittance in special intensive critical care units, close follow up is essential, and — as usual — so is a lot of luck.”
https://www.medscape.com/viewarticle/928152#vp_1
He posted to Medscape Consult, a crowdsourced social media platform in which clinicians share and discuss real cases, and a frenzy of questions from healthcare providers tackling COVID-19 ensued.
Bassi’s case is one of several confirmed and suspected cases of COVID-19 being discussed on Consult. One confirmed case showed classic respiratory symptoms that progressed rapidly in a 43-year-old Italian man. Another showed gastrointestinal symptoms — vomiting and diarrhea — that were resistant to therapy and no pulmonary symptoms. In more than 40 other threads, doctors from around the world are discussing epidemiology, comorbidities, and investigative treatments.
Initially, he took acetaminophen and rested, but 2 days later his oxygen saturation “had dropped from 98% to 88% with progressive respiratory failure,” he told Medscape by email. On the recommendation of the chief of the local ICU, a close friend, Bassi was hospitalized, and clinicians took a nasal swab to confirm COVID-19. Over the following days he received a treatment regimen of Plaquenil (hydroxychloroquine), lansoprazole, antiretroviral therapy, enoxaparin, and methylprednisolone (intravenous).
Then, after one dose of tocilizumab, an immunosuppressant used to treat rheumatoid arthritis, Bassi’s breathing improved almost immediately, he said in an email interview. Tocilizumab is an interleukin-6 receptor antagonist, blocking the proinflammatory IL-6 from its binding site and stopping the uncontrolled inflammatory response that may be a cause of mortality in some COVID-19 patients. A recent retrospective study of 150 patients in China suggested virally activated hyperinflammation may be a major cause of COVID-19 mortality.
As one physician commented on Bassi’s Consult post, “The second phase of [COVID-19] appears to be immunological. The virus may not even be present anymore and people die from the cytokine storm.”
Cytokine storms, the uncontrollable pro-inflammatory reaction that can cause sepsis and organ failure, are also a key factor in cytokine release syndrome (CRS), which tocilizumab is FDA-approved to treat. Immunosuppressive therapies like tocilizumab may be an especially important treatment option, since corticosteroids can exacerbate lung injuries caused by COVID-19, according to a recent study published in The Lancet.
If caught in time, steroids may be enough to dampen the inflammatory reaction and prevent further deterioration, Chandrasekar said. “If conditions worsen further, tocilizumab as another, more potent anti-inflammatory drug may be useful.”
Bassi was given both — tocilizumab and intravenous corticosteroids. Many physicians responded to his message asking if the two were synergistic. “Of course, methylprednisolone was stopped when [they started] tocilizumab and reintroduced again the day after,” he said. But he has no way to be sure there was not a combined effect.
The drug is not yet approved by the FDA for treating COVID-19. But Bassi’s testimony on Consult came just days after the FDA green-lighted phase 3 trials of tocilizumab (Actemra, Genentech) for COVID-19 pneumonia treatment. Genentech, a subsidiary of Roche, will move forward with the double-blind, placebo-controlled trial evaluating intravenous tocilizumab combined with the standard of care in patients with COVID-19 pneumonia.
Bassi remains in the hospital on oxygen therapy, but is “getting better every day.” He’s no longer on Plaquenil or the retroviral. “This is a very dangerous illness,” he wrote to Medscape, “It certainly requires admittance in special intensive critical care units, close follow up is essential, and — as usual — so is a lot of luck.”
https://www.medscape.com/viewarticle/928152#vp_1
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