The European Medicines Agency has granted PRIME status to PhaseBio Pharmaceuticals’ (PHAS-2.1%) PB2452 as a reversal agent of AstraZeneca’s (AZN) anticoagulant Brilinta (ticagrelor).
PRIME, akin to Breakthrough Therapy status in the
U.S., provides for more intensive guidance on development and
accelerated review of the market application.
The company says the advisory group CHMP has
generally agreed to its proposed development plan for a non-randomized
open-label Phase 3 study in major bleeding and urgent surgical
populations, adding that positive results should be sufficient to
support marketing applications in Europe and the U.S.
It’s past 11 a.m. on Monday morning, and Haoran and Sisi, both in
their mid-20s, are still in their bedroom, in the Chinese megacity of
Chengdu. Haoran is under the covers, fiddling with his Huawei phone. His
girlfriend Sisi, in slippers and a robe, is sitting crosslegged on the
floor, focused on her laptop.
When asked what they are doing, they reply in unison: “Working.”
Chinese companies were supposed to be back to business this week. In
fact, the original plan was to return to work after the weeklong Lunar
New Year break — China’s biggest holiday — which ended Jan. 30. But the
coronavirus has changed all that.
Authorities now face a dilemma, with the need to tame the explosive epidemic, which has infected more than 40,000 people and killed nearly 1,000, versus getting the tiring engines of its economy revving again. China’s economy grew at 6.1% last year, its lowest rate in 30 years.
No country wants slowing growth, particularly not one whose unelected
government maintains legitimacy based largely on decades of rapid
economic development.
Its solution: to urge, and in some cities require, companies to advise their employees to work from home.
Whether this nationwide telecommuting experiment works may not be known from first-quarter economic data, which are expected to be disastrous for China. Nor from the fact that downloads of the country’s leading workplace messaging apps have skyrocketed.
Rather, the compelling evidence is likely to lie in how much company
leaders and managers change their minds about the idea, and either trust
their teams to work from home going forward, or see that it hurt
productivity.
Though not unheard of in the country, China lags much of the developed world in allowing telecommuting. Nearly half of Americans report having done some degree of working remotely, with more than 5% — or 8 million people — working full-time from home in 2017. Over half of Japanese companies offer some form of telecommuting.
“In China, if the boss is paying you money, he wants to see you
working in front of him,” said Li Min, a self-employed writer in Chengdu
who left an office job five years ago in part because of the lack of
flexibility offered by management. “If they pay you money, they buy
you,” she said.
Associated Press
A nearly empty restaurant in Beijing.
Had this epidemic disrupted China’s economy for a few days or even a
week, there may have been too little time for companies to observe how
they function as a team while dispersed and out of the office. But this
week marks the second week of government-advised telecommuting, and with
the coronavirus death rate still rising, a third or more week is not
unlikely.
In fact, many companies remained completely closed this week.
We surveyed 20 Chinese white-collar employees, and found that most
had either been asked to work from home or had the entire week of work
canceled (most with pay). Two of the 20 said they had the option to go
in to their office but felt there was an implicit nudge from management
to work from home. One said that management encouraged staff to work
from home, but told them, “If you want to work in the office this week
then you must wear a mask while you’re there.”
Years ago, as the internet gradually began taking a central role in
white-collar jobs, there was debate over whether working from home was
good or bad for productivity, morale and turnover. That debate seems
settled, as mounting data point to fewer distractions, more comfort and less commuting time for at-home employees.
But China may have a few years to go. For instance, in northern
cities like Beijing, the government turns on public heating across the
city in the winter. In Chengdu — a city of 18 million — with an average
January low of 37 degrees, it doesn’t quite make the cut for
city-provided heating, and many residents are reluctant to spend money
heating their homes themselves.
Thus Haoran and Sisi stay cooped up in their bedroom, with a small
portable heater buzzing, while the rest of their apartment remains
chilly. Their predicament is not unusual in the west and south of China.
And it doesn’t make for the coziest work experience in the winter
months.
When asked if they were glad to have this opportunity to telecommute,
which they hadn’t been afforded before, or whether they preferred being
in the office, they again replied in unison: “The office.” https://www.marketwatch.com/story/coronavirus-plunges-china-into-massive-work-at-home-pilot-program-2020-02-10
The coronavirus outbreak, that has sickened 43,000 people and killed
at least 1,018, according to the latest numbers from the World Health
Organization, may be a smaller risk to Chinese manufacturing than
feared, according to JPMorgan.
Analysts included this map of China in a note published Tuesday with
the yellow dots indicating the location of manufacturing facilities in
China, and their position relative to Hubei province, home to Wuhan
City, viewed as the epicenter of the virus after the first cases emerged
there late last year.
The dispersion and severity of cases are indicated by the differing shades of pink.
Indicative map of manufacturing facilities in China relative to Hubei province: Bloomberg
As the map shows, manufacturing facilities in Hubei are limited, they
wrote. And the biggest industries, autos and health care, are not very
time-sensitive, they wrote.
“In this regard (time sensitive and complex supply chain), the tech
sector still needs to be monitored for idiosyncratic dislocations,” they
wrote. “So far, gradual supply resumption seems on track. Some new
products (like iPhone SE2 AAPL, +0.45%
) may get delayed but existing products appear to have sufficient
inventory. Thus, our analysts worry more about demand than supply.”
The potential damage to consumer sentiment is the key issue, they
wrote. Until the current outbreak, data globally was good with only bond
and commodity markets showing some skittishness.
“In a somewhat cyclical argument, it is important for the market to
hold up as, contrary to popular belief, we find price action shaping
narratives and sentiment as much as (if not more than) the other way
around,” said the note.
The outbreak has triggered three types of investor reaction, according to the note.
Most investors appear to have to have opted to just ride out the
storm, assuming the market response will be temporary and hard to time. A
second group is expecting the situation to suddenly take a turn for the
worse, and are calling views on the economic cycle into question, they
wrote in a note Tuesday.
A minority of investors are actually raising risk exposure, assuming
the infection spread is under control, after measures including the full
quarantine of Chinese cities in the region and restrictions on travel.
That group is assuming the supply disruption will be short-lived as
factories can go back to operating at 100% capacity as soon as the
infection risks are reduced, the analysts said.
JPMorgan isn’t expecting Asian markets to gain significantly past
their pre-virus levels, as they did after the severe acute respiratory
syndrome (SARS) outbreak, which led to the deaths of 774 people in 2002
and 2003. Asia was enjoying stronger growth after the SARS crisis and
emerging from a six-year downturn. This time around, growth is more
subdued and earnings are not off-trend to a wide degree.
“While there may be a temporary overshoot (as above), we believe
markets will remain rangebound for most of the year, reflecting the
modest cycle expansion,” said the note. https://www.marketwatch.com/story/coronavirus-may-be-smaller-risk-to-chinese-manufacturing-than-feared-says-jpmorgan-2020-02-11
Astellas Pharma (OTCPK:ALPMF) and collaboration partner Pfizer (NYSE:PFE) announce final overall survival (OS) data from a Phase 3 clinical trial, PROSPER,
evaluating Xtandi (enzalutamide) plus androgen deprivation therapy
(ADT) in men with non-metastatic castration-resistant prostate cancer.
Treatment with Xtandi + ADT resulted in a
statistically significant improvement in OS, a secondary endpoint,
compared to placebo + ADT.
In September 2017, the companies announced that the study met the primary endpoint of metastasis-free survival.
Thinly traded micro cap Marker Therapeutics (NASDAQ:MRKR) is up 8% premarket on average volume in reaction to its announcement that
the FDA has lifted the clinical hold on its planned clinical trial
evaluating its MultiTAA T cell therapy in patients with post-transplant
acute myeloid leukemia (AML).
The agency instituted the clinical hold in
November 2019 citing the need for additional information and technical
specifications for two legacy reagents supplied by third parties used in
the manufacturing process.
Associated Press