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Saturday, June 27, 2020

EU holds off decision on borders, Americans set to be excluded

European Union countries failed to settle on Friday on a final “safe list” of countries whose residents could travel to the bloc from July, with the United States, Brazil and Russia set to be excluded.
Ambassadors from the 27 EU members convened from Friday afternoon to establish criteria for granting quarantine-free access from next Wednesday.
A redrawn text of 10-20 countries was put to them, but many said they needed to consult first with their governments, diplomats said. The list did not include the United States, Brazil or Russia, one diplomat said.
Discussions were continuing overnight, with the EU countries expected to give informal replies by Saturday evening, people familiar with the matter said.
U.S. passengers may be allowed to travel if they meet certain conditions such as passing temperature checks, two U.S. officials said.
The European Commission had advised that the bloc first lift internal border controls and then gradually open up to outsiders. However, the first step has not gone according to plan.
Greece is mandating COVID-19 tests for arrivals from a range of EU countries, including France, Italy, the Netherlands and Spain, with self-isolation until results are known.
The Czech Republic has said it will not allow in tourists from Portugal, Sweden and part of Poland.
There is broad agreement that the bloc should only open up to those with a similar or better epidemiological situation, but there are questions about how to assess a country’s handling of the epidemic and the reliability of data.
A number of countries, such as Tanzania, Turkmenistan and Laos have no reported cases in the past two weeks, according to EU agency, the European Centre for Disease Prevention and Control (ECDC).
Based on ECDC data for the two weeks to Thursday, a range of countries are clearly in a worse situation than the European Union.
They include the United States, Mexico, Brazil and much of Latin America, Russia, South Africa and Saudi Arabia.
Despite pressure from U.S. airlines and unions, the White House has not committed to mandating fresh air travel safety measures in the wake of the pandemic. Discussions between airlines and government officials including Vice President Mike Pence on Friday over temperature checks ended without an agreement.
In a statement, Pence’s office said the parties also discussed “the best path forward for allowing Americans to safely travel internationally again.”
The Commission has suggested the western Balkans countries – Albania, Bosnia and Herzegovina, Kosovo, Montenegro, North Macedonia and Serbia – should be admitted.
However, according to the ECDC data, the number of cases in Bosnia and North Macedonia could be too high.

Friday, June 26, 2020

U.S. to ship remdesivir to states including Calif., Texas with rising COVID-19 cases

The U.S. government will ship more of Gilead Sciences Inc’s (GILD.O) antiviral treatment remdesivir to states experiencing an increase in COVID-19 cases including California, Texas, Florida and Arizona, according to the Department of Health and Human Services’ website.
The government reallocated remdesivir to states with increasing cases, White House task force coordinator Deborah Birx said during a briefing on Friday.
HHS said on its website that the doses will ship starting Monday and extinguish the full amount of Gilead’s donation of 120,647 treatment courses. It said it would continue to work with Gilead to determine how the company’s anticipated inventory of 2 million doses by year’s end will be allocated.
California will receive 464 cases of 40 vials each, Texas will receive 448 cases of 40 vials, Florida will receive 360 cases of 40 vials and Arizona will receive 356 cases of 40 vials, according to the website.
Gilead donated the courses after the treatment received emergency use authorization from the U.S. Food and Drug Administration last month.
New York, which was one of the hardest hit states initially, was allocated 2,714 cases in total.

South Korea backs remdesivir for COVID-19, urges caution with dexamethasone

South Korea has added Gilead’s anti-viral drug remdesivir to its coronavirus treatment guidelines in its first revision of recommendations since the outbreak began and urged caution in the use of the steroid therapy dexamethasone.
South Korea, widely praised around the world for its handling of the pandemic without a full lockdown, has reported 12,602 coronavirus cases as of Thursday midnight, with 282 deaths.
Remdesivir is designed to hinder certain viruses, including the new coronavirus, from making copies of themselves and potentially overwhelming the body’s immune system. The drug previously failed trials as an Ebola treatment.
South Korea’s updated guidelines come after a study showed that the cheap and widely used dexamethasone reduced deaths in very sick COVID-19 patients. They advised doctors to take caution until a full study is published.
“It seems appropriate to administer (dexamethasone), limited to severe cases with acute respiratory syndrome, as the doctor monitors the patient’s condition,” Kim Young-ok, director general of pharmaceutical safety bureau at the Ministry of Food and Drug Safety, told a briefing on Friday.
There was enough domestic supply of the dexamethasone, widely used since the 1960s, with the production of approximately 43 million tablets and 60 million injection ampoules a year, said Kim.
Doctors in Europe will soon be able to treat patients with the drug after the healthcare regulator’s endorsement put it on track to become the first therapy for the disease on the continent.
“An excessive use of dexamethasone can trigger different side effects as it tamps down the immune system along with inflammation, possibly leading to even cataract or glaucoma,” said Dr. Song Dae-sub, professor of pharmacy at Korea University.
Korean health authorities also advised the dropping of hydroxychloroquine after a study found the decades-old malaria drug, which U.S. President Donald Trump touted a possible treatment, did not provide any benefit.
There are currently no approved vaccines or treatments for the coronavirus, which has killed more than 488,467​ people globally, but about a dozen vaccines from more than 100 candidates globally are being tested on humans.

Pence pins COVID-19 spikes on testing rise, younger, asymptomatic infections

The White House’s novel coronavirus task force pegged a massive spike in COVID-19 in 16 states on more infections among younger people as well as increased testing.
Speaking at the White House on Friday, Vice President Mike Pence pushed back on whether the record-high numbers in states like Texas and Arizona are due to reopening state economies too soon, even as states pull back their reopening plans.
So far, hospitals have not reached surge capacity, and supplies are still available, he said.
“I think there will be a temptation for people to look at the sunbelt states reopening and putting people back to work and then suggest the reopening has to do with what we are seeing in the last week or so,” Pence told reporters Friday. “They reopened almost two months ago.”
Pence said that what federal officials are observing in Florida, Texas and some other states is more people under 35 years old testing positive.

“In many cases, they have no symptoms but they are coming forward and confirming they have contracted the coronavirus,” he said.
The task force identified 16 states that are seeing major spikes in cases. Florida, for example, reported that nearly 9,000 people tested positive for the virus, a record high.
Pence’s comments that reopening isn’t to blame comes as the states heavily impacted by the spikes pull back on some of their reopening measures.
Florida, for example, announced Friday that bars can no longer serve liquor. Texas told hospitals they had to suspend elective procedures that systems have been slowly restarting.
There could also be more hot spots than the 16 the task force identifies. Kaiser Family Foundation reported Thursday that there are 26 states with upward 14-day trends in testing positivity rates from June 10-24.

Governors in the most impacted states have told the task force their hospital capacity “remains strong,” Pence said. “At this point in time, we are told that in all of the states most deeply impacted that hospital [capacity] remains broadly available.”
He said that two months ago they saw that 15% of new cases were being hospitalized, and “now that number is averaging 5% around the country.”

How Walgreens leveraged its Microsoft partnership to respond to COVID-19

Amid the surge in coronavirus cases in April, Walgreens leveraged its partnership with Microsoft to roll out a COVID-19 risk assessment tool on its website and mobile app.
That risk assessment tool, powered by Microsoft’s healthcare bot, runs on Microsoft Azure and helps users assess their risk of COVID-19, based on guidelines from the Centers for Disease Control and Prevention.
Walgreens announced its partnership with Microsoft last year to develop new healthcare delivery models, including technology and retail innovations to disrupt the healthcare delivery space.
It’s just one example of how the pharmacy and retail giant is using its tech collaborations to build digital health services and expand access to care.
Before the health crisis, Walgreens was making steady moves to expand its reach deeper into the U.S. healthcare market. It teamed up with Verily, Alphabet Inc.’s life sciences research arm, to work on solutions for patients with chronic conditions.

Walgreens also is collaborating with technology company Philips to offer sleep solutions and digital tools through its digital marketplace as part of its ongoing focus on chronic disease management.
In 2019, Walgreens announced a partnership with LabCorp to open at least 600 testing centers inside Walgreens retail locations over the next four years.
It’s also forged a series of partnerships with local health providers, insurance companies and digital health companies to offer in-store and online health services including AmWell, Heal, UnitedHealthcare, McLaren Health Care, Novant Health and Providence St. Joseph Health.
In a deal with Chicago-based VillageMD, a national provider of primary care, the company opened up several primary care clinics next to Walgreens stores in the Houston area, with plans to possibly expand there and in other markets.
These partnerships are part of Walgreens’ strategy to stay competitive in the healthcare retail market as it looks to outmaneuver rivals like CVS Health and Amazon.
The collaborations also will be valuable as Walgreens continues to innovate during the COVID-19 health crisis and after the crisis subsidies, said Rick Gates, Walgreens’ senior vice president of pharmacy and healthcare.
“The need to accelerate the pace of innovation is going to be very important. There is going to be a lot more collaboration to solve things quickly and it’s going to be less about building things yourself,” he told Fierce Healthcare.
The pandemic has proven that healthcare companies need to be fast to market with products and services to meet consumers’ evolving needs, and that pace of change will not slow down, he said.
In the past three months, Walgreens took steps to meet immediate needs driven by the pandemic with a focus on digital health. The company expanded telehealth services through its Find Care platform and doubled the number of virtual care providers available.
It also provides patients with information about COVID-19 clinical trials through the Find My Clinical Trial program on its mobile app.

Consumers have been clicking on the Walgreens mobile app quite frequently, with usage jumping 22% in April compared to the same time last year. Find Care visits increased 40%, to 2 million visits, in the second quarter of 2020 compared to the previous quarter, the company reported.
“The pandemic has upended healthcare delivery not only in terms of how it’s delivered today but how it will be delivered in the future,” Gates said.
During the health crisis, millions of Americans turned to telehealth and digital health services.
“Those changes are going to stick,” he said. “The question is going to be how will consumer behavior continue to evolve.”
He added, “Consumers’ expectations are changing and if you’re not with them, then you’re behind.”
With that in mind, Walgreens also is taking steps to get ahead of longer-term trends with new services and digital tools.
With many consumers facing unemployment and shifts in health coverage, affordability is now a major issue. “There is uncertainty for consumers on how to afford essentials in life, such as food and medications,” Gates said.
Walgreens lowered the prices on hundreds of medications available through the company’s subscription service, including drugs used to treat common chronic conditions such as diabetes, asthma, high blood pressure, high cholesterol and mental health. The pharmacy program also is open to Medicare and Medicaid members.
The pharmacy giant also is expanding the role of pharmacists as a part of the patient care team.
As a pharmacist by training, Gates spent the early part of his career working with patients face-to-face in Walgreens stores. He believes pharmacists will play a valuable role as local health providers in a post-pandemic world even as many of those interactions will likely be virtual rather than in-person.
Pharmacies have close ties to their communities, and, during the pandemic, pharmacists were often the most accessible health providers for patients seeking medical guidance and to ask questions about medications, Gates said.

Walgreens has seen a significant uptick in the use of its pharmacy chat tool which is available 24/7 through its website and mobile app.
“The pharmacy of the future will have a community presence with an omnichannel approach,” Gates said.
The company also wants its pharmacists to play a bigger role in providing mental health services, a critical need that has only grown since the onset of the COVID-19 pandemic.
Pharmacists at all Walgreens stores are being trained in “mental health first aid” to enhance mental health literacy, understanding risk factors and warning signs for mental health and addiction concerns and strategies for how to help someone in both crisis and non-crisis situations.
The training program was developed through a collaboration between Walgreens, the National Council for Behavioral Health and the American Pharmacists Association.
Efforts to address patients’ mental health needs also extend to Walgreen’s telehealth services, Gates said.
“What we’re seeing is that consumers and patients are looking at mental health services through telehealth differently than before and we want to make sure our pharmacists are trained to help consumers navigate these services,” he said.

Gilead terminates agreement with DURECT

DURECT announces Gilead Sciences will terminate the License Agreement in July 2019, effective December 22, for the development and commercialization of a long-acting injectable HIV investigational product utilizing DURECT’s SABER technology.
DURECT anticipates recognizing remaining deferred revenue of ~$23.1M Q2 of 2020, associated with the receipt of the upfront license and development milestone payment.
(NASDAQ:DRRX) is down ~1% in after hours.