New York City to end 24-hour subway services for overnight disinfecting

New York City will temporarily suspend subway service between 1 a.m. and 5 a.m. for daily cleaning and disinfecting, New York Gov. Andrew Cuomo (D) announced Thursday, one day after announcing he would institute cleaning requirements.
The Metropolitan Transit Authority (MTA) “can disinfect all trains and buses every night, it can best be done by stopping train service from 1 a.m. to 5 a.m. every night during the pandemic so they can actually perform this service,” Cuomo said at his daily press briefing on Thursday.
Cuomo added that the MTA will provide buses, “dollar vans” and other vehicles to replace the subway for essential workers who rely on public transportation during those hours.

The governor said the subway has been eyed as one of the potential key vectors of virus transmission in the city, which has been the epicenter of the pandemic in the state. The four-hour window, he said, is the period of lowest ridership for the subway system, saying an estimated 10,000 people use the system during those hours. Ridership overall is down 92 percent, he added.
Cuomo said the MTA also intends to disinfect the Metro North line and the Long Island Rail Road, but said no service disruptions would be necessary.
“This is going to be one of the most aggressive, creative, challenging undertakings that the MTA has done,” Cuomo said. “It’s going to require the MTA, the state, the city, the [New York City Police Department] NYPD to all work together. It’s not that easy to stop train service.”
The governor announced the cleaning efforts at his briefing Wednesday.
“Any essential worker who shows up and gets on a train should know that that train was disinfected the night before,” Cuomo said. “Letting them endanger their own life and endanger the lives of others is not helping anyone,”
https://thehill.com/policy/transportation/495475-new-york-to-end-24-hour-subway-services-so-public-transport-can-be

Maryland mandates universal COVID-19 testing at nursing homes

Nursing homes in Maryland are required to conduct COVID-19 testing of all residents and staff, regardless of whether they are showing symptoms, per an order issued April 29 by Gov. Larry Hogan.
Nursing homes now account for 19 percent of the state’s total number of positive coronavirus cases and 46 percent of the deaths in the state from the virus.
The governor and the state’s health department issued several other directives aimed at limiting the spread of the virus in nursing homes, including daily clinical evaluations of residents and developing surge staffing plans.
To bolster surge staffing plans at nursing homes, the state has created new bridge teams, which will provide emergency staffing to nursing homes that have staffing crises. Each bridge team includes a registered nurse and five to seven aides, who can provide care for up to 100 nursing home residents per shift.
The governor also ordered nursing homes to accept help from the state’s strike teams, which have provided medical help to more than 80 facilities, according to The Baltimore Sun. There had been reports that some nursing homes had rejected the assistance from the strike teams.
Maryland also expanded its testing capability, after acquiring 500,000 tests from South Korea, the governor said. The state’s new expanded testing strategy will focus on high-risk groups and clusters, such as nursing homes and healthcare workers.
https://www.beckershospitalreview.com/post-acute-care/maryland-mandates-universal-covid-19-testing-at-nursing-homes.html

NY Will Hire Contact Tracing ‘Army’ Of 17,000 To Battle Coronavirus – Cuomo

New York Gov. Andrew Cuomo said in a Thursday press conference that the state will hire thousands of contact tracers (who notify people who have been exposed to COVID-19) as part of the system being developed to help the state return to everyday life, as coronavirus hospitalizations and deaths continue to decline.

KEY FACTS

Between 6,400 and 17,000 tracers will be hired based on projected cases, Cuomo said.

The contract tracing system is being developed in partnership with former New York City Mayor Michael Bloomberg, who pledged $10 million to help fund the effort, and Johns Hopkins University.

Cuomo said New York is creating the contract tracing “playbook” that will be shared with New Jersey and Connecticut.

In order to become a contact tracer, people will need to go through training and pass an online exam, Cuomo said.

Contact tracing will be a three step process: after a person tests positive, they will be interviewed about contacts from the previous 14 days, and then those contacts will be isolated for 14 days, according to Cuomo.

New York City alone is hiring 1,000 contact tracers with a “healthcare background,” said Mayor Bill de Blasio, who joined Cuomo’s press conference via video call.

Crucial quote

“How can we begin to loosen these restrictions and begin reopening the economy?” asked Bloomberg during the press conference via video chat. “One of the most important steps we have to take to reopen the economy as safely as possible is to create a system of contact tracing. When social distancing is relaxed, contact tracing is our best hope for isolating the virus when it appears, and keeping it isolated.”

Big number

4,681. That’s how many people tested positive for coronavirus Wednesday, Cuomo said. “It’s not rocket science to do contact tracing on an individual basis, the problem is the scale,” said Cuomo, adding, “How do you communicate with 4,681 people, trace back everyone they’ve been in contact with for 14 days?”

Key background

New York is the hardest-hit by coronavirus in the United States. As of Thursday, over 305,000 cases have been confirmed and over 23,000 New Yorkers have died, and Cuomo said the hospitalization rate and number of deaths continues to decline. Cuomo has emerged on the national stage as a leader amid the crisis (he has been criticized, however, for his handling of nursing homes and prisons). Bloomberg has committed $10 million to developing New York’s tracing program. CDC guidelines state that a close contact of a person infected with coronavirus “was within 6 feet of an infected person for at least 30 minutes starting from 48 hours before illness onset until the time the patient is isolated.”
https://www.forbes.com/sites/lisettevoytko/2020/04/30/ny-will-hire-contact-tracing-army-of-17000-to-battle-coronavirus-cuomo-says/#25e0e7fe1bf3

Eiger Announces First COVID-19 Patients Dosed with Peginterferon Lambda

Eiger BioPharmaceuticals, Inc (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the first patients have been dosed in a Phase 2 study of peginterferon lambda (Lambda) in outpatients with mild COVID-19 at the Stanford University School of Medicine. 
Approximately 120 patients will be randomized 1:1 to a single subcutaneous dose of Lambda or normal saline placebo to evaluate the efficacy of Lambda in reducing the duration of viral shedding of SARS-CoV-2 virus and in reducing duration of symptoms and hospitalization in patients with mild COVID-19. Patients will be followed for 28 days.
The Stanford study is co-led by Upinder Singh, MD, Professor of Medicine and Infectious Diseases and Geographic Medicine and Microbiology and Immunology and Prasanna Jagannathan, MD, Assistant Professor of Medicine and Infectious Diseases.
Lambda interferon plays a key role in the targeted innate immune response against viral pathogens that infect the respiratory tract. Upon infection of airway epithelial cells, type III IFNs, like lambda interferon, are produced first and act as the initial line of defense to limit virus spread at the epithelial barrier without triggering inflammation. The study will investigate the hypothesis that Lambda may be most effective in patients who have confirmed infection with mild symptoms in order to reduce duration and severity of COVID-19.
“SARS-CoV-2 induces very weak expression of interferons in infected cells,” said Colin Hislop, MD, Senior Vice President of Clinical and Development Operations. “Absence of interferon production likely hampers the early innate immune response to SARS-CoV-2 infection and suggests stimulation of antiviral immunity with exogenous lambda interferon might be successful for treating SARS-CoV-2 infection.”
The Stanford study is one of six international, investigator sponsored studies evaluating Lambda in COVID-19. Other sites include Soroka University (Israel), Mount Sinai Hospital (New York), Massachusetts General Hospital (Boston), Johns Hopkins University (Baltimore), and University of Toronto (Toronto). Eiger has been involved in protocol development, regulatory interactions and is providing Lambda clinical drug supply. Collectively, up to 400 patients are expected be enrolled and dosed across international sites. These studies will assess Lambda’s ability to reduce COVID-19 replication and limit virus transmission.
https://www.biospace.com/article/releases/eiger-biopharmaceuticals-announces-first-covid-19-patients-dosed-with-peginterferon-lambda/

Karyopharm teams up with CRO in study of selinexor in COVID-19

Karyopharm Therapeutics (KPTI -5.3%) is collaborating with contract research organization (CRO) PROMETRIKA on an international, randomized, 230-subject study evaluating low-dose Xpovio (selinexor) in severely ill hospitalized COVID-19 patients.

PROMETRIKA will be responsible for managing U.S. clinical trial sites, including on-site monitoring and ensuring accurate data collection.

Financial terms are not disclosed.

Selinexor is a nuclear export inhibitor that was approved in the U.S. in July 2019 for treatment-resistant multiple myeloma. It works by interfering with the action of a protein called XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus which amplifies tumor suppression.

https://seekingalpha.com/news/3567092-karyopharm-teams-up-cro-in-study-of-selinexor-in-covidminus-19

How much HCA, UHS and CHS took in CARES Act cash

Three publicly-traded health systems—among some of the largest systems in the U.S.—collectively took home more than $1.1 billion in federal stimulus funds for woes caused by the COVID-19 pandemic.
During earnings calls over the last week, executives from HCA Healthcare, Universal Healthcare Services and Community Health Systems each told analysts how much in bailouts they took home from the feds.
They also said they received more than $5.5 billion in accelerated Medicare payments.

The CARES Act, passed last month, allocated $100 billion to cover related expenses for meeting COVID-19 outbreak and for recouping lost revenue. The Centers for Medicare and Medicaid Services also announced healthcare providers and suppliers could receive accelerated and advance payments from the Medicare program to offer emergency funding and address cash flow issues caused by COVID-19 disruptions.
CMS has since said it was suspending advance payments to providers and is reevaluating accelerated payments for hospitals after doling out about $100 billion.
HCA Healthcare Chief Financial Officer Bill Rutherford said the economic assistance that made a major difference in stabilizing the health system included about $700 million in funds from the stimulus package.
The company also benefited from about $4 billion in accelerated Medicare payments. That money will be repaid over an eight-month period beginning in August, he said.
The company has also benefited from the deferral of the employer portion of payroll taxes, which the company estimates at $75 million a month. Those deferrals will have to be paid in 2021 and 2022, he said.

Meanwhile, UHS officials said this week while releasing earnings that they received $195 million in grants from the $100 billion allocated for hospitals under the CARES Act. The health system also received $375 million in accelerated Medicare payments.
Community Health Systems received about $245 million in grants under the CARES Act, as well as $1.2 billion in accelerated Medicare payments as part of federal relief that had been made to hospitals.

Tenet Healthcare releases its first-quarter earnings early next week.
https://www.fiercehealthcare.com/hospitals-health-systems/here-s-a-look-at-just-how-much-hca-uhs-and-chs-took-cares-act-cash

Glaxo fields worries on fast-growing Shingrix as virus hits routine doc visits

With supply constraints loosening late last year, GlaxoSmithKline’s shingles vaccine Shingrix was finally ready to jet ahead. Then COVID-19 happened, sparking a new concern about the high-flying product: Doctors aren’t eager right now to protect patients from a disease they might never get.
There’s little doubt Shingrix’s fast rise will once again be interrupted, this time by ebbing demand, GSK executives acknowledged during the company’s first-quarter earnings call. Wellness visits are down by more than 66%, said Luke Miels, president of global pharmaceuticals for GSK. That’s a decline that could affect some of the company’s other vaccines, too, including its hepatitis and meningitis shots.
Still, Miels and his colleagues played down COVID-19 impact: It doesn’t affect GSK’s overall expectations for the product, they said. “We’re really pleased with the progress we’re making on the supply,” said CEO Emma Walmsley during the call, adding that “the overall demand is very strong.”

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Perhaps, but investors have good reason to be nervous. Shingrix sales soared 81% year-over-year to £647 million during the first quarter, beating the consensus estimate of £526 million—but physicians and pharmacies continue to hold off on routine services such as vaccinations. Total Shingrix prescriptions fell 84% since February, according to a Bernstein report citing IQVIA data.

Assuming routine doctor visits start back up in the latter half of the year, GSK has a plan in place to restart demand for Shingrix, Miels said. Part of the company’s marketing effort will focus on encouraging physicians to “link” Shingrix shots with the upcoming flu vaccination season, he said.
“Once [quarantine] restrictions are lifted, the physicians are going to seek to recover these patients. They’ve got practices to run,” Miels said during the call. “I think the key thing here is we haven’t seen a reduction in people wanting to get a Shingrix shot. What we’ve seen is a reduction of people who don’t want to get COVID and have been told to stay at home.”

Vaccine worries overshadowed what was otherwise a strong quarter for GSK. The company reported that its first-quarter sales rose 19% year over year to £9.1 billion ($11.3 billion), beating the consensus estimate of £8.8 billion. Earnings per share of 37.7p beat estimates by 20%.
Much of the growth, ironically enough, may be attributable to COVID-19. Like several of its Big Pharma peers, GSK reported that sales growth was driven by “stock building for many products.” Jefferies analysts said in a note to investors that although the degree of COVID-19’s impact on stocking couldn’t be quantified, it’s likely the virus has increased demand for some of GSK’s prescription and over-the-counter products.
COVID-19 stocking likely benefitted GSK’s HIV portfolio, including the newly launched Dovato, Jefferies said. Sales of the product, which has been heavily advertised, came in at £66 million for the quarter—far surpassing the £45 million analysts were expecting.

And the pandemic could also benefit GSK’s ongoing efforts to build up its pipeline—a cornerstone of the company’s newly launched restructuring. GSK has embarked on a plan to split into two companies, one of which will encompass its consumer health joint venture with Pfizer and the other focused on developing biopharma products.
Vaccine development is one of GSK’s priorities as it beefs up its biopharma product line, and Walmsley hopes a COVID-19 vaccine will be one of the successes to emerge from the pipeline. Earlier this month, GSK teamed up with Sanofi to work on a vaccine, in the hopes of launching a clinical trial in the second half of this year. That would put the vaccine on track for an FDA filing in 2021.
That’s one reason Jefferies analysts are urging investors to ignore the short-term impact of COVID-19 and focus on the long-term potential of GSK’s R&D strategy. They predict earnings momentum will pick up after 2021, saying in their report that “we see clinical news kick-starting belief in the steadily reinvigorated pipeline.”
https://www.fiercepharma.com/pharma/glaxosmithkline-fields-worries-about-shingrix-demand-as-covid-19-halts-routine-doc-visits