Under Priority Review status, the FDA accepts Bristol-Myers Squibb’s (NYSE:BMY)
marketing application for lisocabtagene maraleucel (liso-cel), its
autologous anti-CD19 chimeric antigen receptor (CAR) T-cell
immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T
cells for the treatment of adult patients with relapsed or refractory
large B-cell lymphoma who have received at least two prior lines of
therapy.
The agency’s action date is August 17.
Holders of BMY Contingent Value Rights (CVR) (NYSE:BMY.RT) may see a rally today. Yesterday’s close was $3.36.
Reuters reports
that the COVID-19 death toll in China spiked to 1,367 yesterday
compared to 254 the day before with a concomitant jump in confirmed
infections (59,805 vs. 15,152) due to the use of computerized tomography
(CT), a new approach. Previously, infections were confirmed via RNA
tests.
The jump came a day after Chinese authorities
reported the lowest number of new cases in two weeks, bolstering a
forecast by Beijing’s senior medical advisor that the epidemic will end
by April.
Asian stock markets are under pressure while gold and bonds have rallied.
44 new cases have been detected on a Diamond Princess cruise ship quarantined off the coast of Japan.
Hong Kong has extended its suspension of schools until at least March 16.
Selected tickers and premarket moves: Co-Diagnostics (NASDAQ:CODX) (+10%), Novavax (NASDAQ:NVAX) (+4%), NanoViricides (NYSEMKT:NNVC) (+16%), Inovio Pharmaceuticals (NASDAQ:INO) (+11%), Alpha Pro Tech (NYSEMKT:APT) (+12%), Lakeland Industries (NASDAQ:LAKE) (+4%), Gilead Sciences (NASDAQ:GILD) (+0.3%), Regeneron Pharmaceuticals (NASDAQ:REGN) (+2%), Health Care Select Sector SPDR Fund (NYSEARCA:XLV) (-1%), Allied Health Products (NASDAQ:AHPI) (+19%).
Revolution Medicines, a Phase 1/2 oncology biotech
developing RAS pathway inhibitors, raised the proposed deal size for
its upcoming IPO on Tuesday.
The Redwood City, CA-based company now plans to raise $231 million by
offering 14 million shares at a price range of $16 to $17. The company
had previously filed to offer 10 million shares at a range of $14 to
$16. At the midpoint of the revised range, Revolution Medicines will
raise 54% more in proceeds than previously anticipated at a fully
diluted market cap of $1 billion.
Revolution Medicines was founded in 2015 And booked $48 million in
collaboration revenue for the 12 months ended September 30, 2019. It
plans to list on the Nasdaq under the symbol RVMD.
J.P. Morgan, Cowen, SVB Leerink and Guggenheim Securities are the joint
bookrunners on the deal. It is expected to price during the week of
February 10, 2020.
The word “pandemic” is not a comforting one.
And yet it is increasingly being bandied about in connection with the spread of the novel coronavirus that emerged from China.
U.S. health officials have been signaling for nearly two weeks now
that a coronavirus pandemic may be on the horizon. While stressing that
the virus presents only a “low risk” to Americans right now, the
director of the National Institute of Allergy and Infectious Diseases,
Dr. Anthony Fauci, acknowledged Tuesday that that might not remain the
case for long.
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“Is there a risk that this is going to turn into a global pandemic? Absolutely, yes,” Fauci said.
But what is a pandemic? And if efforts like the quarantining of
returning travelers cannot stop spread of the virus, what will? We’re
peering into the unknown here, but given the ease with which this
coronavirus seems to transmit from person to person, the world is likely
to see much broader international spread of the virus, now known as
SARS-CoV-2. (The disease the virus causes has been named Covid-19.)
Here’s what you need to know about pandemics. What is a pandemic?
A disease doesn’t have to infect all of the globe to be a pandemic.
Lots of people, over broad swaths of territory, will suffice.
The World Health Organization defines pandemic
as the worldwide spread of a new disease. The Centers for Disease
Control and Prevention offers a definition that is a bit more elastic,
describing it as a disease that spreads across regions.
The word is most commonly used in the context of influenza. Flu
pandemics occur when new flu strains emerge from nature — say a swine
flu virus or a flu strain circulating among chickens — and start
infecting people. But other diseases can and have been declared
pandemics.
It’s important to know that calling a disease outbreak a pandemic
doesn’t connote severity. The term relates solely to the amount of
ground the outbreak covers.
There can be mild pandemics, such as the 2009 H1N1 flu pandemic; it
killed roughly as many people as regular flu, though many were younger
than those who succumb to seasonal flu.
At the opposite end of the severity spectrum from the 2009 pandemic
was the 1918 Spanish flu. The poster child for a bad pandemic, it killed
between 50 million and 100 million around the globe in 1918-1919.
Other flu pandemics from the era of modern virology — 1957, 1968 — looked a lot more like 2009 than 1918. When was the last pandemic? When was the last pandemic caused by a coronavirus?
The last pandemic was the aforementioned 2009 H1N1 outbreak. As for
when or whether there has been a coronavirus pandemic before, that’s not
known.
There are four coronaviruses that are endemic in people, meaning they
circulate in an ongoing manner. You likely don’t know their names
because they mostly cause colds; they’re among the multitude of viruses
that swarm around us during cold and flu season. (They’re known as OC43,
NL63, 229E, and HKU1.)
They were all formerly animal viruses but crossed over to infect
people before the existence of viruses was recognized. As a result,
there is no record of how rapidly they spread when they first started
infecting people and whether they caused severe disease before settling
down to become causes of the common cold.
Two other animal coronaviruses have crossed into people in the past
two decades, SARS and MERS. SARS spread to a number of countries around
the world but the virus was snuffed out after about 8,000 cases and
nearly 800 deaths. MERS, which still jumps to people from camels, has
mainly infected people on the Arabian Peninsula. Neither is considered
to have caused a pandemic. Who would declare a pandemic?
An official declaration would come from the WHO, though the agency may be reluctant to unleash this term anytime soon.
The WHO was harshly criticized when the 2009 flu pandemic turned out
to be much less severe than people had feared. Rather than feeling
relieved the pandemic wasn’t causing large numbers of deaths, people
felt aggrieved they’d been scared over something they later concluded
was far less scary than expected. And governments that had contacts to
buy pandemic vaccine — contracts that were triggered by the WHO’s
declaration — were left on the hook for vaccine many people didn’t want.
In other words, the term can be a loaded one. But if this virus is
discovered to be spreading in an unstoppable fashion in countries on
several continents, infectious disease experts will use the P word
— whether the WHO officially declares a pandemic or not. Should the outbreak be declared a pandemic now?
There currently isn’t evidence that the virus is spreading out of
control in many places outside of China. That said, it’s currently
challenging to know how much transmission is going on outside of China
because a lot of infections appear to be quite mild and thus easy to
miss.
Until recently only two laboratories in Africa — one in Senegal, the
other in South Africa — were able to test for the new coronavirus, known
provisionally as SARS-CoV-2, which was previously known as 2019-nCoV.
Late last week the WHO shipped testing reagents to labs in a number of
African countries. So far no African countries have reported cases; but
given the strong links between China and many African countries, they
may find cases soon. But aren’t there cases in a lot of places?
Roughly 24 countries have diagnosed infections, and the overall
numbers are growing. Most of the cases still are in tourists from China
or people who had recently been in China. But increasingly countries are
reporting cases of “secondary spread” — that is, cases in which a
person who hadn’t traveled to China contracted the virus from someone
who had. Some of those secondary cases are spreading the virus as well.
Take the case of a British businessman
who got infected at a conference in Singapore in late January. He later
traveled to the French Alps where he transmitted the virus to five
family members on a ski trip. Later he flew home to Britain and spent
some time in his local pub before realizing he was infected with the
virus.
There’s also a cluster of now 14 cases in Germany stemming from a
business trip a woman from China made to her company’s headquarters in
Bavaria. She infected at least a couple of colleagues, who infected
others. Several family members of infected colleagues have themselves
tested positive for the virus.
WHO Director-General Tedros Adhanom Ghebreyesus warned this week that
these types of cases could ignite more widespread transmission.
“The detection of this small number of cases could be the spark that
becomes a bigger fire. But for now it’s only a spark,” said Tedros, as
he is known. “Our objective remains containment. We call on all
countries to use the window that we have to prevent a bigger fire.” When will we know if that bigger fire has been ignited?
It’s worth watching Singapore. The city-state, which has a very
strong public health system, was among the places hit during the 2003
SARS outbreak and has since then substantially beefed up its outbreak
response capacity.
As of Tuesday, Singapore had diagnosed 47 cases, with an increasing
number of those infections in people who had been infected in the city.
Health authorities there have tried to trace how each case became
infected. They are starting to see infections in people who aren’t part
of known clusters of cases — which the government acknowledges could be a
sign that the virus is spreading undetected in parts of the city.
In an extraordinarily candid address to his country, Prime Minister
Lee Hsien Loong acknowledged the coronavirus “is probably already
circulating in our own population.” The address was posted on Facebook on Saturday.
“If the numbers keep growing, at some point we will have to
reconsider our strategy. If the virus is widespread, it’s futile to try
to trace every contact,” Lee said. “We are not at that point yet. It may
or may not happen. But we are thinking ahead and anticipating the next
few steps.”
Infectious diseases epidemiologist Marc Lipsitch predicted that if
Singapore is starting to find cases that can’t be connected to known
transmission chains, other places will start seeing them, too.
Lipsitch, a professor at Harvard’s T.H. Chan School of Public Health,
thinks the next couple of weeks will tell the tale. But he believes the
world is in the early stages of a coronavirus pandemic.
“My picture of the future is essentially it’s like 2009 flu but more
severe. The big question is how much more severe,” he told STAT. The
Covid-19 outbreak in China is quickly spreading worldwide, sparking
quick calculations on how deadly this new disease is. One measure is
called a case fatality rate. While the formula is simple, it’s difficult
to get a precise answer. Hyacinth Empinado/STATHow bad could this be?
The WHO says data from China suggests about 82% of confirmed cases
have only mild infection, about 15% are severe enough to require
hospital care, and about 3% need intensive care.
Preliminary data suggest roughly 2% of people who tested positive for
the virus have died. While lower than the SARS 10% fatality rate, that
number is not at all reassuring. But it’s also too soon to draw
conclusions.
To calculate the fatality rate you have to have a good idea of how
many people have actually been infected and how many have died. Because
so many people likely have mild infections and haven’t been counted,
it’s impossible at this stage to know the fatality rate for sure.
“If we’ve very fortunate, there are tons of mild cases being missed
and maybe it’s 0.4% or something … which is big,” said Lipsitch. “But
that would be a lot of mild cases missed.”
Four deaths per 1,000 people infected would amount to four times as
many deaths as influenza normally causes in an average year. Given that
this is a new virus to which most people will have no immunity, it’s
conceivable the attack rate — the number of people infected — will be
higher than the attack rate for seasonal flu. In the U.S., the CDC estimates that about 8% of people will contract influenza in any non-pandemic year.
The damage could be worse in low-income countries that don’t have the
capacity to support a lot of severely ill pneumonia patients who need
mechanical ventilation.
“This disease may appear relatively mild in the context of a
sophisticated health system. That may not be the case should this
disease reach a system that is not as capable as that of China,” said
Dr. Mike Ryan, WHO’s health emergencies director. Transmission of viruses that cause colds and flu typically
peters out in the Northern Hemisphere with the arrival of spring.
President Trump said this week that the virus might fade by April. Might
the advent of warmer temperatures stymie spread of this new virus?
Though this coronavirus isn’t related to influenza, it is acting a
lot like a new flu virus. One of the characteristics of pandemic flu
viruses is that they are able to circulate out of season; there are so
many people susceptible that the virus can keep transmitting.
In 2009, during the last flu pandemic, the fact that there was a new
flu virus circulating was only realized in late April — around the time
when flu typically subsides in this part of the world. Transmission
abated somewhat over the summer, but the big wave of infections in North
America began early in the fall. By the time vaccine started to become
available in November, the outbreak had peaked.
The temperatures this week in Singapore have been in the mid-to-high
80s. That suggests higher temperatures may slow, but probably won’t stop
transmission of the new virus, Lipsitch said.
“I think the fact that Singapore is seeing cases transmit is also
kind of evidence that it’s not a matter of yes or no,” he said. “It’s a
matter of degree.”
The U.S. Equal Employment Opportunity Commission is suing
Yale New Haven (Conn.) Hospital, alleging its policy mandating eye and
neuropsychological exams for employees age 70 or older who seek medical
privileges violates two federal antidiscrimination laws.
Yale New Haven implemented its late career practitioner policy about
four years ago. The policy requires employees 70 and older who apply for
or seek to renew staff privileges to take both medical exams. Employees
under age of 70 are not required to take the exam.
In the lawsuit, filed Feb. 11, EEOC claims that the individuals
required to be tested are singled out solely because of their age,
instead of a suspicion that their cognitive abilities may have declined.
As a result, Yale New Haven’s policy violates the Age Discrimination in Employment Act, the lawsuit says.
“While Yale New Haven Hospital may claim its policy is
well-intentioned, it violates antidiscrimination laws,” said Jeffrey
Burstein, a regional attorney for the EEOC’s New York District office.
“There are many other nondiscriminatory methods already in place to
ensure the competence of all of its physicians and other healthcare
providers, regardless of age.”
In addition, the EEOC charges that the policy also violates the
Americans with Disabilities Act because it subjects employees to medical
examinations that are not job-related.
“Yale New Haven Hospital’s late career practitioner policy is
designed to protect our patients from potential harm while including
safeguards to ensure that our physicians are treated fairly,” a Yale New
Haven spokesperson told Becker’s. “The policy is modeled on
similar standards in other industries and we are confident that no
discrimination has occurred and will vigorously defend ourselves in this
matter.” https://www.beckershospitalreview.com/legal-regulatory-issues/yale-new-haven-hospital-sued-over-exam-policy-for-employees-70-years.html
