British Prime Minister Boris Johnson was admitted to the hospital
Sunday night due to ongoing coronavirus symptoms, a statement from his
office said.
Johnson was hospitalized “on the advice of his doctor” after
experiencing symptoms for more than 10 days after being diagnosed with
COVID-19, according to the statement, which was obtained by the BBC.
“The Prime Minister thanks NHS staff for all of their incredible hard
work and urges the public to continue to follow the Government’s advice
to stay at home, protect the NHS and save lives,” Johnson’s office
added, referring to the U.K.’s National Health Service.
Johnson announced that he had tested positives for the coronavirus
two weeks ago, saying at the time that he would continue to lead his
deputies in the government by video conference.
“Over the last 24 hours I have developed mild symptoms and tested
positive for coronavirus,” Johnson tweeted on March 26. “I am now
self-isolating, but I will continue to lead the government’s response
via video-conference as we fight this virus.”
Johnson is one of the only heads of state to test positive for the virus so far, with Monaco’s Prince Albert another example.
According to Johns Hopkins University, the U.K. has confirmed more than 48,000 cases of the virus and nearly 5,000 deaths.
https://thehill.com/policy/international/491256-boris-johnson-hospitalized-over-coronavirus-symptoms
Sunday, April 5, 2020
Tiger at Bronx Zoo tests positive for coronavirus
A tiger at the Bronx Zoo in New York City has tested positive for the
coronavirus, while several other animals are reportedly being monitored
for similar symptoms.
In a press release, the Wildlife Conservation Society (WCS), which operates the zoo, said that the animals were likely infected by an asymptomatic carrier of the disease. It’s the first known case of the virus being detected in an animal in the U.S., as well as the first confirmed case in a tiger anywhere in the world.
“Nadia, a 4-year-old female Malayan tiger at the Bronx Zoo, has tested positive for COVID-19. She, her sister Azul, two Amur tigers, and three African lions had developed a dry cough and all are expected to recover,” the WCS said in a statement.
“Our cats were infected by a person caring for them who was asymptomatically infected with the virus or before that person developed symptoms,” the release continued.
https://thehill.com/homenews/state-watch/491262-tiger-at-bronx-zoo-tests-positive-for-coronavirus
In a press release, the Wildlife Conservation Society (WCS), which operates the zoo, said that the animals were likely infected by an asymptomatic carrier of the disease. It’s the first known case of the virus being detected in an animal in the U.S., as well as the first confirmed case in a tiger anywhere in the world.
“Nadia, a 4-year-old female Malayan tiger at the Bronx Zoo, has tested positive for COVID-19. She, her sister Azul, two Amur tigers, and three African lions had developed a dry cough and all are expected to recover,” the WCS said in a statement.
“Our cats were infected by a person caring for them who was asymptomatically infected with the virus or before that person developed symptoms,” the release continued.
https://thehill.com/homenews/state-watch/491262-tiger-at-bronx-zoo-tests-positive-for-coronavirus
Pentagon chief says military moving toward face coverings
Defense Secretary Mark Esper
said Sunday that the military will issue guidance on face coverings for
troops after the Centers for Disease Control and Prevention (CDC)
recommended people cover their faces when out in public to stem the
spread of coronavirus.
ABC’s George Stephanopoulos asked Esper on “This Week” whether he expects all service members to follow the new CDC guidelines.
“We will have a directive on that coming out today,” he said, adding “We are going to move toward face coverings.”
The Pentagon chief also said another priority, in addition to the protection of troops, is to continue to conduct the country’s national security missions.
“And to do that, we can’t always do six feet distancing whether you’re in an attack submarine, a bomber, in a tank, so we have to take other measures,” he said.
“But we ought to provide them all the guidance they need to adjust it
in whatever’s unique to their situation, their circumstance or the
mission set,” he added.
President Trump announced the new CDC recommendations Friday, repeatedly saying it is “voluntary.”
“You can do it. You don’t have to do it. I’m choosing not to do it, but some people may want to do it, and that’s OK,” he said.
The recommendations are a backtrack from the CDC’s earlier suggestion that healthy people should not use masks because it would not protect them from contracting the coronavirus.
But now, the CDC says wearing a face covering can prevent asymptomatic people from unknowingly spreading the disease, adding that people should not purchase the surgical masks or N95 respirators needed by medical professionals. Officials also stressed the recommendation was to be used in addition to, not instead of, social distancing guidelines.
https://thehill.com/homenews/sunday-talk-shows/491218-pentagon-chief-says-military-moving-toward-face-coverings
ABC’s George Stephanopoulos asked Esper on “This Week” whether he expects all service members to follow the new CDC guidelines.
“We will have a directive on that coming out today,” he said, adding “We are going to move toward face coverings.”
The Pentagon chief also said another priority, in addition to the protection of troops, is to continue to conduct the country’s national security missions.
“And to do that, we can’t always do six feet distancing whether you’re in an attack submarine, a bomber, in a tank, so we have to take other measures,” he said.
President Trump announced the new CDC recommendations Friday, repeatedly saying it is “voluntary.”
“You can do it. You don’t have to do it. I’m choosing not to do it, but some people may want to do it, and that’s OK,” he said.
The recommendations are a backtrack from the CDC’s earlier suggestion that healthy people should not use masks because it would not protect them from contracting the coronavirus.
But now, the CDC says wearing a face covering can prevent asymptomatic people from unknowingly spreading the disease, adding that people should not purchase the surgical masks or N95 respirators needed by medical professionals. Officials also stressed the recommendation was to be used in addition to, not instead of, social distancing guidelines.
https://thehill.com/homenews/sunday-talk-shows/491218-pentagon-chief-says-military-moving-toward-face-coverings
Advancing COVID-19 Treatments
Scott Gottlieb and Mark McClellan Co-Author
Efficiently launching medical products to combat the current and future outbreaks of COVID-19 requires supporting the Food and Drug Administration’s (FDA) work with manufacturers that have high potential to develop and deliver needed diagnostics, therapeutics, and prophylactics, stated former FDA Commissioners Scott Gottlieb, MD and Mark McClellan, MD, PhD, in a working paper issued today by the Duke-Margolis Center for Health Policy.
The co-authors call for FDA to establish two task forces: one focused rapid development of point of care (POC) diagnostics; the second focused on rapid development of effective therapeutics and prophylaxis. In addition, the commissioners urge the White House to accelerate steps on a nationwide COVID-19 surveillance partnership to support these efforts and help target further interventions.
”We need these drugs and testing tools to help patients now. We also need them for the long term,” said Drs. Gottlieb and McClellan. “With the isolation and other steps we are taking now, it’s possible that the epidemic spread of coronavirus will wane in the coming weeks and months. But it’s also possible that there will be additional waves of viral spread with the risk of another epidemic in the future.”
To current and future needs, the co-authors contend that the FDA can support large scale access to different drugs that have shown they may be effective against the coronavirus in a framework can collect good information to determine which medicines are working best for patients, and ultimately merit full FDA approval. “At the same time, we can advance treatments that can help protect people from becoming infected with coronavirus in the first place,” said the co-authors.
The white paper details how the FDA could structure the recommended task forces as well as the goal of each entity. The paper also defines how establishing a public-private partnership can help to ensure more comprehensive national surveillance COVID-19 to prevent the current and possible future waves of infections.
Dr. Gottlieb is a resident fellow at the American Enterprise Institute and was Commissioner of the Food and Drug Administration from 2017-19. Dr. McClellan, who directs the Duke-Margolis Center for Health Policy, was Commissioner of the Food and Drug Administration from 2002-04.
Read the paper:
https://healthpolicy.duke.edu/sites/default/files/atoms/files/covid-19_tx_working_paper.pdf
https://healthpolicy.duke.edu/news/advancing-treatments-save-lives-and-reduce-risk-covid-19
Efficiently launching medical products to combat the current and future outbreaks of COVID-19 requires supporting the Food and Drug Administration’s (FDA) work with manufacturers that have high potential to develop and deliver needed diagnostics, therapeutics, and prophylactics, stated former FDA Commissioners Scott Gottlieb, MD and Mark McClellan, MD, PhD, in a working paper issued today by the Duke-Margolis Center for Health Policy.
The co-authors call for FDA to establish two task forces: one focused rapid development of point of care (POC) diagnostics; the second focused on rapid development of effective therapeutics and prophylaxis. In addition, the commissioners urge the White House to accelerate steps on a nationwide COVID-19 surveillance partnership to support these efforts and help target further interventions.
”We need these drugs and testing tools to help patients now. We also need them for the long term,” said Drs. Gottlieb and McClellan. “With the isolation and other steps we are taking now, it’s possible that the epidemic spread of coronavirus will wane in the coming weeks and months. But it’s also possible that there will be additional waves of viral spread with the risk of another epidemic in the future.”
To current and future needs, the co-authors contend that the FDA can support large scale access to different drugs that have shown they may be effective against the coronavirus in a framework can collect good information to determine which medicines are working best for patients, and ultimately merit full FDA approval. “At the same time, we can advance treatments that can help protect people from becoming infected with coronavirus in the first place,” said the co-authors.
The white paper details how the FDA could structure the recommended task forces as well as the goal of each entity. The paper also defines how establishing a public-private partnership can help to ensure more comprehensive national surveillance COVID-19 to prevent the current and possible future waves of infections.
Dr. Gottlieb is a resident fellow at the American Enterprise Institute and was Commissioner of the Food and Drug Administration from 2017-19. Dr. McClellan, who directs the Duke-Margolis Center for Health Policy, was Commissioner of the Food and Drug Administration from 2002-04.
Read the paper:
https://healthpolicy.duke.edu/sites/default/files/atoms/files/covid-19_tx_working_paper.pdf
https://healthpolicy.duke.edu/news/advancing-treatments-save-lives-and-reduce-risk-covid-19
Incyte details late-stage data on ruxolitinib cream for atopic dermatitis
Following up on its initial announcements in January and February, Incyte (NASDAQ:INCY) reports detailed results from two successful Phase 3 clinical trials, TRuE-AD1 and TRuE-AD2,
evaluating a topical cream formulation of kinase inhibitor ruxolitinib
in adolescents and adults with atopic dermatitis (AD). The data were
presented at the Revolutionizing Atopic Dermatitis Virtual Symposium.
Both studies met the primary endpoint of a
statistically significant proportion of treated patients achieving clear
or almost clear skin at week 8 compared to vehicle cream (placebo).
Specifically, 50.0% of patients in AD1 and 39.0% in AD2 who received
twice daily applications of 0.75% ruxolitinib cream achieved
clear/almost clear skin compared to 15.1% and 7.6%, respectively, in the
vehicle arms. 53.8% and 51.3%, respectively, of patients receiving 1.5%
ruxolitinib cream achieved clear/almost clear skin.
Treated patients also experienced statistically significant reductions in itching as measured by a scale called NRS score.
No new safety signals were observed.
The company markets an oral formulation of ruxolitinib under the brand name Jakafi.
The standard-of-care topical treatment of AD is corticosteroid creams, lotions or ointments.
The FDA approved Pfizer’s (NYSE:PFE) non-steroidal Eucrisa (crisaborole)
ointment, which inhibits a pro-inflammatory enzyme called
phosphodiesterase 4 (PDE4), in December 2016. In two pivotal studies,
32.8% and 31.4%, respectively, of treated patients achieved clear/almost
clear skin at day 29.
The company plans to file a marketing application in the U.S. in Q4.
Management will host a conference call on Monday, April 6, at 8:00 am ET to discuss the data.
https://seekingalpha.com/news/3558456-incyte-details-late-stage-data-on-ruxolitinib-cream-for-atopic-dermatitisBiotech week ahead, April 6
Biotech stocks went along with the broader market flow in the week
ended April 3, with the COVID-19 pandemic dictating sentiment. The week
witnessed a host of clinical readouts and pre-announcements in light of the COVID-19 impact.
The stock that made headlines during the week was Amarin Corporation plc AMRN 8.43%, which slumped on an adverse court ruling.
The following are catalysts that could impact biotech stocks in the unfolding week.
The focus is likely to stay on pre-clinical and clinical updates from companies developing therapies and/or vaccines for SARS-CoV-2. More companies are expected to update investors with preliminary first-quarter results that factor in the COVID-19 impact.
Conferences
Oragenics Inc OGEN 2.11%: Results from the Phase 2 study of AG013 in oral mucositis (early 2020)
https://www.benzinga.com/general/biotech/20/04/15729886/the-week-ahead-in-biotech-spotlight-on-q1-pre-announcements-as-covid-19-continues-to-disrupt-oper
The stock that made headlines during the week was Amarin Corporation plc AMRN 8.43%, which slumped on an adverse court ruling.
The following are catalysts that could impact biotech stocks in the unfolding week.
The focus is likely to stay on pre-clinical and clinical updates from companies developing therapies and/or vaccines for SARS-CoV-2. More companies are expected to update investors with preliminary first-quarter results that factor in the COVID-19 impact.
Conferences
- Goldman Sachs Cell Therapy Day: April 6
- 2020 Wells Fargo Biotech Virtual Corporate Access Day: April 7 in Boston, Massachusetts
- Canaccord Genuity Horizons in Oncology Virtual Event: April 8 in Boston
- 2020 Wells Fargo Biotech Virtual Corporate Access Day: April 9 in San Francisco, California
Clinical Readouts
Menlo Therapeutics Inc MNLO 1.89%: top-line data from two ongoing serlopitant Phase 3 studies in pruritus associated with prurigo nodularis (late March/early April)Oragenics Inc OGEN 2.11%: Results from the Phase 2 study of AG013 in oral mucositis (early 2020)
Earnings
- AngioDynamics, Inc. ANGO 2.03% (Tuesday after the close)
- PAVmed Inc PAVM 5.21% (Thursday after the close)
IPOs
Keros Therapeutics, which develops therapies for hematological and neuromuscular disorders, plans to offer 5 million shares in an IPO priced between $14 and $16. The company has applied to list its shares on the Nasdaq under the ticker symbol “KROS.”IPO Quiet Period Expiry
Imara Inc IMRAhttps://www.benzinga.com/general/biotech/20/04/15729886/the-week-ahead-in-biotech-spotlight-on-q1-pre-announcements-as-covid-19-continues-to-disrupt-oper
Malaria drugs in high demand amid COVID-19
States across the U.S. are instituting measures
to prevent hoarding of malaria drugs hydroxychloroquine and chloroquine
in an effort to maintain supply amid acute demand from pharmacies and
COVID-19 patients.
At least 20 states have implemented emergency
restrictions or guidelines aimed at easing pressure on availability for
autoimmune patients. Some are limiting the size of prescriptions and/or
asking pharmacists to ensure that patients have tested positive for the
virus before filling scripts. Supplies of the drugs were already running
low last month.
Neither medicine has been proven to work against
COVID-19, but a number of studies are in process. Doctors are adding
them to standard-of-care treatment and have seen, in certain cases, some
effectiveness at shortening recovery time. Both work in the immune
system by preventing flare-ups, a condition seen in some severely ill
COVID-19 patients (cytokine storm).
Certain drug makers have donated millions of doses and others are ramping up production.
https://seekingalpha.com/news/3558453-malaria-drugs-in-high-demand-amid-covidminus-19
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