The Food and Drug Administration has issued an Emergency Use
Authorization (EUA) for the VentFree Respiratory Muscle Stimulator in
order to potentially reduce the number of days adult patients, including
those with COVID-19, require mechanical ventilation, according to a press release from Liberate Medical.
In comparison with mechanical ventilation, which is invasive and commonly weakens the breathing muscles, the VentFree system uses
noninvasive neuromuscular electrical stimulation to contract the
abdominal wall muscles in synchrony with exhalation during mechanical
ventilation, according to the press release. This allows patients to
begin treatment during the early stages of ventilation while they are
sedated and to continue until they are weaned off of ventilation.
A pair of pilot randomized, controlled studies, completed in Europe
and Australia, showed that VentFree helped to reduce ventilation
duration and ICU length of stay, compared with placebo stimulation. The
FDA granted VentFree Breakthrough Device status in 2019.
VentFree has been authorized for use only for the duration of the
current COVID-19 emergency, as it has not yet been approved or cleared
for usage by primary care providers.
https://www.medscape.com/viewarticle/930006
Tuesday, May 5, 2020
State data show coronavirus cases as early as January in Florida
Florida Health Department data shows that 171 people had coronavirus
symptoms or had tested positive for COVID-19 in the months before cases
were publicly announced, according to a Palm Beach Post report.
The Post analyzed state data, which was removed from the health department’s website May 4 without explanation. The newspaper had previously downloaded and retained the data.
The data showed that 171 people were either showing symptoms or had tested positive for the new virus in January and February. Florida officially announced its first presumed cases of coronavirus March 1.
It is unclear whether the patients reported their coronavirus symptoms to the state later or if the health department’s local offices were actively investigating COVID-19 at the time, or both, according to the Post.
Of the 171 people, 105 were women and 66 were men. Most of these early patients hadn’t traveled, and none reported going to China, the Post reports.
https://www.beckershospitalreview.com/public-health/state-data-shows-coronavirus-cases-as-early-as-january-in-florida.html
The Post analyzed state data, which was removed from the health department’s website May 4 without explanation. The newspaper had previously downloaded and retained the data.
The data showed that 171 people were either showing symptoms or had tested positive for the new virus in January and February. Florida officially announced its first presumed cases of coronavirus March 1.
It is unclear whether the patients reported their coronavirus symptoms to the state later or if the health department’s local offices were actively investigating COVID-19 at the time, or both, according to the Post.
Of the 171 people, 105 were women and 66 were men. Most of these early patients hadn’t traveled, and none reported going to China, the Post reports.
https://www.beckershospitalreview.com/public-health/state-data-shows-coronavirus-cases-as-early-as-january-in-florida.html
Seattle Genetics’ bladder cancer med Padcev blows early expectations away
Even a pandemic can’t slow Seattle Genetics’ new bladder cancer
treatment Padcev down—and analysts are jacking up their sales estimates
for the drug as a result.
In its first quarter on the market after a mid-December FDA approval, the therapy “blew out expectations … exceeding consensus estimates” by four- to fivefold with $34.5 million in sales, J.P. Morgan analyst Cory Kasimov wrote in a note to clients.
Even SVB Leerink’s Andrew Berens, whose Padcev sales projection was twice as high as Kasimov’s, noted that the drug “handily beat our estimate of $10 million for the quarter, even in the midst of the pandemic.”
And the performance was no fluke, either. While other drugmakers have seen their Q1 sales boosted by some stockpiling early in the pandemic, that’s likely not what happened to Padcev, which “follows a ‘just in time’ delivery model” that sees the drug delivered as-needed, Kasimov wrote.
Berens also cited assurances from SeaGen’s leaders that many of the patients who received Padcev in Q1 are still alive and receiving therapy. Management said it “had no reason to believe this early adoption was driven primarily by a warehouse of end-stage patients which might have truncated duration of usage as has been seen with several other oncology drug launches.”
If that’s the case, “many of these Q1 patients are likely to be on the drug in Q2 given the expected duration of treatment of about 4.5 months in this setting,” Berens wrote, upping his 2020 target for the drug to $221 million and peak sales prediction in relapsed or refractory bladder cancer to $2 billion.
The thing is, SeaGen isn’t stopping there. It’s currently trying for a nod in previously untreated patients, an opportunity Berens pegs at $5.8 billion. And those SVB Leerink estimates don’t even factor in potential revenue from earlier stages of the disease, such as muscle-invasive bladder cancer (MIBC), a “sizable” market the company is pursuing with a phase 3 trial testing Padcev alongside Merck immuno-oncology powerhouse Keytruda.
“We estimate there are about 10,000 MIBC patients in the U.S., and the expected duration of therapy could be significant in these less advanced patients,” Berens wrote.
But it wasn’t all rosy news for Seattle Genetics in Q1, with Adcetris—until December its only approved drug, and a powerhouse with several indications—narrowly missing consensus estimates at $164.1 million.
https://www.fiercepharma.com/marketing/seattle-genetics-padcev-blows-early-sales-expectations-out-water
In its first quarter on the market after a mid-December FDA approval, the therapy “blew out expectations … exceeding consensus estimates” by four- to fivefold with $34.5 million in sales, J.P. Morgan analyst Cory Kasimov wrote in a note to clients.
Even SVB Leerink’s Andrew Berens, whose Padcev sales projection was twice as high as Kasimov’s, noted that the drug “handily beat our estimate of $10 million for the quarter, even in the midst of the pandemic.”
And the performance was no fluke, either. While other drugmakers have seen their Q1 sales boosted by some stockpiling early in the pandemic, that’s likely not what happened to Padcev, which “follows a ‘just in time’ delivery model” that sees the drug delivered as-needed, Kasimov wrote.
Berens also cited assurances from SeaGen’s leaders that many of the patients who received Padcev in Q1 are still alive and receiving therapy. Management said it “had no reason to believe this early adoption was driven primarily by a warehouse of end-stage patients which might have truncated duration of usage as has been seen with several other oncology drug launches.”
If that’s the case, “many of these Q1 patients are likely to be on the drug in Q2 given the expected duration of treatment of about 4.5 months in this setting,” Berens wrote, upping his 2020 target for the drug to $221 million and peak sales prediction in relapsed or refractory bladder cancer to $2 billion.
The thing is, SeaGen isn’t stopping there. It’s currently trying for a nod in previously untreated patients, an opportunity Berens pegs at $5.8 billion. And those SVB Leerink estimates don’t even factor in potential revenue from earlier stages of the disease, such as muscle-invasive bladder cancer (MIBC), a “sizable” market the company is pursuing with a phase 3 trial testing Padcev alongside Merck immuno-oncology powerhouse Keytruda.
“We estimate there are about 10,000 MIBC patients in the U.S., and the expected duration of therapy could be significant in these less advanced patients,” Berens wrote.
But it wasn’t all rosy news for Seattle Genetics in Q1, with Adcetris—until December its only approved drug, and a powerhouse with several indications—narrowly missing consensus estimates at $164.1 million.
https://www.fiercepharma.com/marketing/seattle-genetics-padcev-blows-early-sales-expectations-out-water
Gilead Sciences in talks to expand global supply of COVID-19 drug remdesivir
Gilead Sciences Inc
said on Tuesday it was in discussions with chemical and drug
manufacturers to produce its antiviral drug remdesivir for Europe, Asia
and the developing world through at least 2022.
The drugmaker last week received the U.S. Food and Drug Administration’s emergency use authorisation for using remdesivir as a treatment against COVID-19, the respiratory illness caused by the new coronavirus.
Gilead also said on Tuesday it was negotiating long-term voluntary licenses with several generic drugmakers in India and Pakistan to produce remdesivir for developing countries.
https://www.marketscreener.com/GILEAD-SCIENCES-4876/news/Gilead-Sciences-in-talks-to-expand-global-supply-of-COVID-19-drug-remdesivir-30545153/
The drugmaker last week received the U.S. Food and Drug Administration’s emergency use authorisation for using remdesivir as a treatment against COVID-19, the respiratory illness caused by the new coronavirus.
Gilead also said on Tuesday it was negotiating long-term voluntary licenses with several generic drugmakers in India and Pakistan to produce remdesivir for developing countries.
https://www.marketscreener.com/GILEAD-SCIENCES-4876/news/Gilead-Sciences-in-talks-to-expand-global-supply-of-COVID-19-drug-remdesivir-30545153/
CVS Health Q1 2020 Earnings Preview
CVS Health (NYSE:CVS) is scheduled to announce Q1 earnings results on Wednesday, May 6th, before market open.
The consensus EPS Estimate is $1.63 (+0.6% Y/Y) and the consensus Revenue Estimate is $64.14B (+4.0% Y/Y).
Over the last 2 years, CVS has beaten EPS estimates 100% of the time and has beaten revenue estimates 75% of the time.
Over the last 3 months, EPS estimates have seen 7 upward revisions and 10 downward. Revenue estimates have seen 8 upward revisions and 3 downward.
https://seekingalpha.com/news/3569210-cvs-health-q1-2020-earnings-preview
UK’s obese residents may be forced to stay home once lockdown ends
Obese Britons may be forced to work from home even as others return after the coronavirus lockdown, according to reports.
Leaked government documents show that the obese are being treated as “vulnerable” people — along with those over 70 and pregnant women — who will be told to stay home even when the general lockdown is lifted, the Sun said.
Companies may even have to find new roles for the workers who need to stay home, the report says.
Almost a third of adults in England are clinically obese — one of the highest rates in the Western world — and the stringent rules could be enforced for up to a year, the paper says.
Health Secretary Matt Hancock spoke Monday of the possible relationship between obesity and becoming critically ill if infected by the coronavirus.
“Emerging data from around the world suggests there could possibly be a relationship between obesity and the impact of COVID-19 on individuals,” he said, according to the report.
“It’s too early to say if obesity in itself is a factor or conditions associated with it — or there is not enough data yet to rule it out — so we need to approach any assumptions with caution.”
A study of coronavirus patients in New York state’s largest hospital system found 42 percent of them were obese.
https://nypost.com/2020/05/05/obese-brits-may-be-forced-to-stay-home-after-lockdown-lifted/
Leaked government documents show that the obese are being treated as “vulnerable” people — along with those over 70 and pregnant women — who will be told to stay home even when the general lockdown is lifted, the Sun said.
Companies may even have to find new roles for the workers who need to stay home, the report says.
Almost a third of adults in England are clinically obese — one of the highest rates in the Western world — and the stringent rules could be enforced for up to a year, the paper says.
Health Secretary Matt Hancock spoke Monday of the possible relationship between obesity and becoming critically ill if infected by the coronavirus.
“Emerging data from around the world suggests there could possibly be a relationship between obesity and the impact of COVID-19 on individuals,” he said, according to the report.
“It’s too early to say if obesity in itself is a factor or conditions associated with it — or there is not enough data yet to rule it out — so we need to approach any assumptions with caution.”
A study of coronavirus patients in New York state’s largest hospital system found 42 percent of them were obese.
https://nypost.com/2020/05/05/obese-brits-may-be-forced-to-stay-home-after-lockdown-lifted/
Jazz Pharma down 9% after hours on Q1 miss, guidance cut
Jazz Pharmaceuticals (NASDAQ:JAZZ) Q1 results:
Revenues: $534.7M (+5.2%); product sales: $530.2M (+5.3%).
Xyrem sales: $407.9M (+10.8%); Defitelio/defibrotide: $47.4M (+14.2%); Erwinaze: $37.7M (-38.1%).
Net loss: ($157.8M) (-285.2%); non-GAAP net
income: $25.8M (-84.3%); loss/share: ($2.82) (-291.8%); non-GAAP EPS:
$0.45 (-84.1%).
~1.1M ordinary shares repurchased at an average price of $122.91.
2020 guidance: Revenues: $2,120M –
2,260M from $2,320M – 2,400M; product sales: $2,105M – 2,240M from
$2,305M – 2,375M; sleep/neuroscience sales: $1,650M – 1,740M from
$1,740M – 1,810M; hematology/oncology sales: $420M – 510M from $500M –
580M.
Shares down 9% after hours.
https://seekingalpha.com/news/3569640-jazz-pharma-down-9-after-hours-on-q1-miss-guidance-cut
Subscribe to:
Comments (Atom)