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Thursday, April 30, 2020

3 of 4 largest U.S. airlines now require facial masks on flights

United Airlines (NASDAQ:UAL), Delta Air Lines (NYSE:DAL) and American Airlines (NASDAQ:AAL) announce they will require facial coverings on all U.S. flights to address the spread of the coronavirus and convince reluctant passengers to resume flying.
Delta and United’s new rules start May 4, while American’s requirements begin May 11.
Southwest Airlines (NYSE:LUV) is the only one of the four largest U.S. airlines that has not yet required facial coverings.
JetBlue started the “new flying etiquette” earlier this week, and the other domestic carriers are now following suit.
Airlines in the U.S. have suffered a 95% drop in passengers and are striving to reassure customers about the safety of air travel by instituting new cleaning and social distancing procedures.

Blood clotting a significant cause of death in patients with COVID-19

A study led by clinician scientists at RCSI University of Medicine and Health Sciences has found that Irish patients admitted to hospital with severe COVID-19 infection are experiencing abnormal blood clotting that contributes to death in some patients.
The study, carried out by the Irish Centre for Vascular Biology, RCSI and St James’s Hospital, Dublin, is published in current edition of the British Journal of Haematology. (DOI: 10.1111/bjh.16749)
The authors found that abnormal blood clotting occurs in Irish patients with severe COVID-19 infection, causing micro-clots within the lungs. They also found that Irish patients with higher levels of blood clotting activity had a significantly worse prognosis and were more likely to require ICU admission.
“Our novel findings demonstrate that COVID-19 is associated with a unique type of blood clotting disorder that is primarily focussed within the lungs and which undoubtedly contributes to the high levels of mortality being seen in patients with COVID-19,” said Professor James O’Donnell, Director of the Irish Centre for Vascular Biology, RCSI and Consultant Haematologist in the National Coagulation Centre in St James’s Hospital, Dublin.
“In addition to pneumonia affecting the small air sacs within the lungs, we are also finding hundreds of small blood clots throughout the lungs. This scenario is not seen with other types of lung infection, and explains why blood oxygen levels fall dramatically in severe COVID-19 infection.
“Understanding how these micro-clots are being formed within the lung is critical so that we can develop more effective treatments for our patients, particularly those in high risk groups.
“Further studies will be required to investigate whether different blood thinning treatments may have a role in selected high risk patients in order to reduce the risk of clot formation,” Professor O’Donnell said.
Emerging evidence also shows that the abnormal blood-clotting problem in COVID-19 results in a significantly increased risk of heart attacks and strokes.
Professor O’Donnell led the cross disciplinary study, with joint first authors Dr Helen Fogarty and Dr Liam Townsend, along with Consultants from multiple specialities within St James’s Hospital and researchers at RCSI University of Medicine and Health Sciences and Trinity College Dublin.
Further research on these findings will continue under Irish COVID-19 Vasculopathy Study (iCVS) which has been jointly funded by the Health Research Board and Irish Research Council as part of the Irish government’s COVID-19 Rapid Response Research Funding.

Nanodevices for the brain could thwart formation of Alzheimer’s plaques

Alzheimer’s disease is the sixth leading cause of death in the United States, affecting one in 10 people over the age of 65. Scientists are engineering nanodevices to disrupt processes in the brain that lead to the disease.
People who are affected by Alzheimer’s disease have a specific type of plaque, made of self-assembled molecules called β-amyloid (Aβ) peptides, that build up in the brain over time. This buildup is thought to contribute to loss of neural connectivity and cell death. Researchers are studying ways to prevent the peptides from forming these dangerous plaques in order to halt development of Alzheimer’s disease in the brain.
In a multidisciplinary study, scientists at the U.S. Department of Energy’s (DOE) Argonne National Laboratory, along with collaborators from the Korean Institute of Science and Technology (KIST) and the Korea Advanced Institute of Science and Technology (KAIST), have developed an approach to prevent plaque formation by engineering a nano-sized device that captures the dangerous peptides before they can self-assemble.
We’ve taken building blocks from nanotechnology and biology to engineer a high-capacity cage’ that traps the peptides and clears them from the brain.” — Elena Rozhkova, scientist, Center for Nanoscale Materials
The β-amyloid peptides arise from the breakdown of an amyloid precursor protein, a normal component of brain cells,” said Rosemarie Wilton, a molecular biologist in Argonne’s Biosciences division. In a healthy brain, these discarded peptides are eliminated.”
In brains prone to the development of Alzheimer’s, however, the brain does not eliminate the peptides, leaving them to conglomerate into the destructive plaques.
The idea is that, eventually, a slurry of our nanodevices could collect the peptides as they fall away from the cells — before they get a chance to aggregate,” added Elena Rozhkova, a scientist at Argonne’s Center for Nanoscale Materials (CNM), a DOE Office of Science User Facility.

Decorating the surface

The researchers covered the surface of the new nanodevice with fragments of an antibody — a type of protein — that recognizes and binds to the Aβ peptides. The surface of the nanodevice is spherical and porous, and its craters maximize the available surface area for the antibodies to cover. More surface area means more capacity for capturing the sticky peptides.
To find the optimal coating, the scientists first searched previous literature to identify antibodies that have high affinity to Aβ peptides. It was important to choose an antibody that attracts the peptides but doesn’t bind to other molecules in the brain. Then the team, led by Wilton, produced the antibodies in bacteria and tested their performance.
A full antibody molecule can be up to a few dozen nanometers long, which is big in the realm of nanotechnology. However, only a fraction of this antibody is involved in attracting the peptides. To maximize the effectiveness and capacity of the nanodevices, Wilton’s group produced tiny fragments of the antibodies to decorate the nanodevice’s surface.

Engineering and testing the nanodevice

The scientists at CNM constructed the base of the porous, spherical nanodevices out of silica, a material that has long been used in biomedical applications due to its flexibility in synthesis and its nontoxicity in the body. Coated with the antibody fragments, the nanodevices capture and trap the Aβ peptides with high selectivity and strength.
Many attempts to prevent Alzheimer’s have focused on inhibiting enzymes from cutting β-amyloid peptides off of the cell’s surface,” said Rozhkova, who led the project at CNMOur elimination approach is more direct. We’ve taken building blocks from nanotechnology and biology to engineer a high-capacity cage’ that traps the peptides and clears them from the brain.”
At CNM, the scientists tested the effectiveness of the devices by comparing how the peptides behaved in the absence and presence of the nanodevices. Using in vitro transmission electron microscopy (TEM), they observed a notable decline in peptide aggregation in the presence of the nanodevices. They further analyzed the interactions using confocal laser scanning microscopy and microscale thermophoresis measurement, two additional techniques for characterizing interactions at the nanoscale.
The scientists also performed small-angle X-ray scattering to study the processes that make the nanodevices porous during synthesis. The researchers performed the X-ray characterization, led by Byeongdu Lee, a group leader in Argonne’s X-ray Science division, at beamline 12-ID-B of the lab’s Advanced Photon Source (APS), a DOE Office of Science User Facility.
These studies supported the case that the nanodevices sequester the peptides from the pathway to aggregation by more than 90 percent compared to the control silica particles without the antibody fragments. However, the devices still needed to demonstrate their effectiveness and safety within cells and brains.
Joonseok Lee — who originally proposed this experiment at Argonne as a Director’s Postdoctoral Appointee and pioneered the design for the nanodevice — continued the study of the therapeutic potential of this device at KIST and KAIST.
The Director’s Postdoctoral Position is a rare opportunity offered at Argonne that allows for unique research projects and cross-field collaborations that might not otherwise be possible,” said Rozhkova. We have incredible minds at the lab who want to explore topics that don’t fall under a predefined area of research, and this program encourages this creativity and innovation.”
The in vivo experiments — experiments that took place in living cells — performed by Lee and his collaborators showed that the nanodevices are nontoxic to cells. They also tested the effectiveness of the devices in the brains of mice with Alzheimer’s, demonstrating around 30 percent suppression of plaque formation in brains containing the nanodevices compared to control brains.  The research on mice was conducted at KIST and KAIST in South Korea with appropriate government approvals.
This study combined the strengths of antibody engineering and nanotechnology, the power of two DOE User Facilities at Argonne and innovative collaboration resulting from the laboratory’s postdoctoral program to explore a technological approach to preventing Alzheimer’s.
Using a similar approach, scientists may also be able to pair the silica nanoparticles with different antibodies that target molecules related to other neurodegenerative diseases, such as Huntington’s disease and Parkinson’s disease, which also involve abnormal protein aggregation. The porous nanoparticles may be further upgraded for use in imaging applications including fluorescent imaging and magnetic resonance imaging.
A paper on the research, titled Silica nanodepletors: Targeting and clearing Alzheimer’s β-amyloid plaques“, was published in the April issue of Advanced Functional Materials and was featured on its cover.
This research was supported by the Korea Institute of Science and Technology Institutional Program and the National Research Foundation via the Creative Research Initiative Center and Basic Science Research Program, Republic of Korea. The researchers also acknowledge the Director’s Postdoctoral Fellowship from Argonne National Laboratory.

Cytokine storms and T cell counts may offer clues on how to treat COVID-19

Cytokine storms may affect the severity of COVID-19 cases by lowering T cell counts, according to a new study published in Frontiers in Immunology. Researchers studying coronavirus cases in China found that sick patients had a significantly low number of T cells, a type of white blood cell that plays a crucial role in immune response, and that T cell counts were negatively correlated with case severity.
Interestingly, they also found a high concentration of cytokines, a protein that normally helps fight off infection. Too many cytokines can trigger an excessive inflammatory response known as a cytokine storm, which causes the proteins to attack healthy cells. The study suggests that coronavirus does not attack T cells directly, but rather triggers the cytokine release, which then drives the depletion and exhaustion of T cells.
The findings offer clues on how to target treatment for COVID-19, which has become a worldwide pandemic and a widespread threat to human health in the past few months. “We should pay more attention to T cell counts and their function, rather than respiratory function of patients,” says author Dr. Yongwen Chen of Third Military Medical University in China, adding that “more urgent, early intervention may be required in patients with low T lymphocyte counts.”
Chen says he and his co-authors became interested in examining T cells when they noticed that many of the patients they treated for COVID-19 had abnormally low numbers of lymphocytes, a type of white blood cell that includes T cells. “Considering T cells’ central role of response against viral infections, especially in the early stage when antibodies are not boosted yet, we took the T cells as our focal point,” says Chen.
Authors examined 522 patients with coronavirus along with 40 healthy controls. All patients studied were admitted to two hospitals in Wuhan, China between December 2019 and January 2020, and ages ranged between 5 days and 97 years old. Of the 499 patients who had their lymphocytes recorded, 76% had significantly low total T cell counts. ICU patients had significantly lower T cell counts compared with non-ICU cases, and patients over the age of 60 had the lowest number of T cells.
Importantly, the T cells that did survive were exhausted and could not function at full capacity. Not only does this have implications for COVID-19 patient outcomes, but T cell exhaustion leaves patients more vulnerable to secondary infection and calls for scrupulous care.
Chen says that future research should focus on finding finer subpopulations of T cells in order to discover their vulnerability and effect in disease, along with identifying drugs that recover T cell numbers and boost function.
Authors say that Tocilizumab is an existing drug that may be effective, but that it needs to be investigated in the context of coronavirus. Antiviral treatments, such as Remdesivir, may also prevent the progression of T cell exhaustion, but all future treatments will require further study.
In the meantime, this new research deepens our understanding of how the novel coronavirus affects the body and it indicates ways to lessen its impact.

Multi-site Adaptive Trials Using Pepcid, Hydroxycholoroquine for COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Brief Summary:
The overall objective of the study will be to evaluate the clinical efficacy of COVID-19 treatments consisting of standard of care (SOC) combined with pharmaceutical antiviral management using hydroxychloroquine, or SOC with hydroxychloroquine combined with high-dose intravenous famotidine, in hospitalized patients meeting nucleic acid diagnostic and radiologic criteria for COVID-19 disease. The trial will statistically compare the clinical benefit afforded by the two treatment strategies to internal historical “standard of care” data from Northwell patents treated without benefit of either hydroxychloroquine or high-dose famotidine. We will compare clinical outcomes associated with hydroxychloroquine and the addition of high-dose intravascular famotidine. The trial is designed to enroll at least 600 COVID-19 patients hospitalized with moderate to severe disease into each of the two active treatment arms, with a total enrollment target of at least 1200 patients. The proposed trial has been designed for rapid enrollment and completion and powered to support two interim analyses that will enable prompt assessment of benefits and risks of the two treatment groups while maintaining the rigorous gold standard of a randomized double blind clinical trial structure. Trial design has been guided by practical consideration of the current clinical context involving rapidly escalating demands on hospital staff and resources, and incorporates a minimalist approach employing existing laboratory information management systems and a clinically relevant binary primary outcome of 30-day endpoint of death or survival.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: HCQ + Intravenous FamotidineDrug: HCQ + Placebo Phase 3
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-Blind, Multi-Arm Historical Control, Comparative Trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-site, Randomized, Double-Blind, Multi-Arm Historical Control, Comparative Trial of the Safety and Efficacy of Hydroxychloroquine, and the Combination of HCQ and Famotidine for the Treatment of COVID-19
Actual Study Start Date : April 7, 2020
Estimated Primary Completion Date : September 7, 2020
Estimated Study Completion Date : April 7, 2021

Moderna, Lonza strike deal on potential COVID-19 vaccine

Moderna Inc and Swiss contract drugmaker Lonza Group said on Friday they would accelerate the manufacturing of the U.S. drug developer’s potential coronavirus vaccine.
The announcement comes at a time when drugmakers are pausing clinical trials for other disease areas as they focus on testing potential treatments for the coronavirus.
The experimental vaccine, mRNA-1273, is being tested in early-stage trial by the U.S. National Institutes of Health, with Moderna expecting to begin mid-stage trial in the second quarter.
Under the 10-year collaboration agreement, the companies aim to manufacture up to a billion doses per year as technology transfer is expected to begin in June, and the first batches of the vaccine are expected to be manufactured in Lonza U.S. in July.
“Over time, the parties intend to establish additional production suites across Lonza’s worldwide facilities, ultimately allowing for the manufacture of material equivalent to up to 1 billion doses of mRNA-1273 per year for use worldwide”, the statement added.
The disease, which infected more than 3.2 million people worldwide and killed around 232,000, set off a race among drugmakers to find an antidote.
Earlier this month, Moderna got a $483 million funding from a U.S. government agency to accelerate its COVID-19 vaccine development.
Separately, Basel-based Lonza’s pharmaceuticals, biotech and nutrition business has received more than 40 enquiries regarding projects relating to COVID-19, the company said earlier in April.

Nearly a dozen approved drugs could be effective against COVID-19

At least 10 different drug compounds ranging from cancer therapies to antipsychotics and antihistamines may be effective at preventing the new coronavirus from multiplying in the body, according to a multidisciplinary study conducted by a team of scientists in the United States and France.
The researchers mapped the human proteins the virus interacts with inside the body when it infects cells and makes copies of itself, then looked for compounds that could block the virus from using those proteins.
The result showed that 47 compounds in cell cultures had the desired effect, at least 10 of which are already in approved drugs or being studied for diverse conditions, but could be repurposed against COVID-19, the illness caused by the new coronavirus.
Researchers have been rushing to develop experimental therapies as well as to repurpose existing drugs to treat patients with COVID-19 and communities are pinning high hopes on Gilead Sciences Inc’s experimental antiviral drug, remdesivir.
In the new study, published in the journal Nature here on Thursday, candidates for repurposing included allergy medicine ingredients including clemastine, the antipsychotic haloperidol, and malaria drug hydroxychloroquine.
The study also revealed why hydroxychloroquine is often found to have toxic effects on the heart.
The malaria drug, which has been repeatedly touted by U.S. President Donald Trump, binds to a receptor on human cells, which the virus needs to infect the cell.
But hydroxychloroquine also hits a particular protein in the heart tissue, which could explain the drug’s effect on heart rhythms – a side effect recently flagged by U.S. and EU health regulators.
The team also found that an experimental chemical, PB28, was 20-times more potent than hydroxychloroquine in targeting the receptor, but had far less affinity for the heart protein.
The hormone progesterone was also found to act against the virus, which might shed some light on the reasons that men appear to be more susceptible to COVID-19 and more often suffer severe complications.
Another compound found to have antiviral activity was plitidepsin, used in Madrid-based PharmaMar’s experimental cancer therapy Aplidin that is currently being tested in COVID-19 trials in Spain.
“Some of our drugs and compounds are many times more potent than remdesivir, at least in a laboratory setting,” study author Nevan Krogan of the University of California San Francisco, said in a media briefing.

Gilead’s remdesivir could be the closest to regulatory approval after initial trial results on Wednesday found that the drug helped patients recover more quickly.
The team said it would continue testing the candidates they have identified and use the same methods to further study the biology of the disease for more insights.

Molina to buy Magellan Complete Care for $820M

Magellan Health (NASDAQ:MGLN) +15.2% after-hours on news that Molina Healthcare (NYSE:MOH) agrees to acquire the Magellan Complete Care line of business for $820M, net of certain tax benefits.
Magellan Complete Care served 155K members in six states, and amassed more than than $2.7B in revenues in 2019.
With the addition of MCC, Molina will serve more than 3.6M members in government-sponsored healthcare programs in 18 states and have 2020 pro-forma projected revenue of more than $20B.
The announcement was separate from Molina’s reported Q1 earnings, which edged analyst expectations.

The Elephant In The Room Keeping Businesses From Reopening

Yes, COVID-19 kills people. But so does a collapsed economy. Finally, states are beginning to let more businesses open. But there’s a problem. A big one, that could keep crucial businesses closed.
Georgia allowed some businesses to open on Friday. Several other states will do that on May 1.
But some businesses might not open even when they can. Why? Because an employee or customer might get COVID-19 and sue them.
As long as someone might get sick, businesses might get sued. As long they’re sued, they could lose. They could face and lose dozens or hundreds of law suits. They could lose tens of millions of dollars. That would put the small and medium-sized business under. Why risk it? Why not wait?

A Warning

Lawsuits have already been filed against businesses over COVID-19. Cruise lines were the first businesses to get hit with suits. They’ve already lost almost a billion dollars worth of business. They won’t be sailing for at least another three months. With all the suits they might lose a lot more. (Suits against them have been hard to win in the past, but who knows how the pandemic will change the courts?)
Other businesses look at them as a warning. Small businesses that can’t afford lawyers are going to be very worried.
Some industries require close human contact. They include hotels, hair salons, daycares, gyms and restaurants. How are they going to achieve social distancing? They can’t guarantee employees or customers will always be safe. A wrongful death lawsuit was filed against Walmart over the death of an employee.
Some of the businesses that were allowed to open in Georgia aren’t doing so. Others are opening with numerous restrictions.

Businesses Shouldn’t be Liable

What’s the answer, then?
Protect businesses from being sued. More people are proposing this. President Trump said on Tuesday that he wants to shield businesses from liability. For example, he is going to order meat processing facilities to stay open, and will sign an executive order shielding them from lawsuits.
The U.S. Chamber of Commerce and several business groups are asking Congress to set a federal standard that limits liability for employers who follow CDC guidelines. White House economic advisor Larry Kudlow says reopened businesses shouldn’t be liable for coronavirus infections. Lawsuits may put them out of business. A writer at National Review urges state legislatures and Congress to pass laws shielding them. Both see that America needs businesses opening as fast as they can.
Some states are already working on this. The House and Senate in Utah passed a bill last Thursday to protect businesses. It would make business owners “immune from civil liability for damages or an injury” when someone has been exposed to COVID-19 while on the premises doing something associated with the business.
A law enacted in March in New York protects health care facilities and volunteer organizations from both civil and criminal liability due to COVID-19. While it shields businesses from negligence, they will still be liable for willful misconduct, recklessly or intentionally inflicting harm.

Protecting Themselves

Businesses can already protect themselves in some ways. But they also remain vulnerable. Employees who contract COVID-19 at work can file a worker’s compensation claim, which removes their right to sue. And they will have to prove they contracted the illness at work, which will not be easy. However, a handful of states have shifted the burden to the employer when it comes to essential employees. The states’ laws presume that the employee caught COVID-19 at work. However, a judge in Illinois issued a temporary restraining order against the rule after business groups filed lawsuits opposing it.
Businesses can also protect themselves to some extent by following the CDC guidelines. Only healthcare facilities are required to follow the guidelines, but businesses would be wise to. A court will take that into consideration when deciding a lawsuit. That means using social distancing, providing hand sanitizer, separating sick employees and possibly providing face masks.
The U.S. Equal Employment Opportunity Commission (EEOC) is allowing employers — for the time being — to take the temperatures of on-site employees, even though this constitutes a medical exam. Businesses should also follow workplace guidelines from the Occupational Safety and Health Administration. One lawyer recommends that businesses have employees sign a waiver making them aware of potential COVID-19 exposure.
Of course, there is always a risk. Businesses with immunity might shirk their responsibility to take precautions against the virus. But so far it appears from media reports that the businesses reopening are taking great precautions. They should not be punished. The country needs them open. A sensible law should protect them.

ResMed stock rises as earnings beat on ventilator production

ResMed Inc. RMD, -0.63% shares rose in the extended session Thursday after the medical equipment maker topped Wall Street estimates as it ramped up its manufacturing of ventilators amid the COVID-19 pandemic. ResMed shares rose 6.2% after hours, following a 0.6% decline in the regular session to close at $155.32. The company reported fiscal third-quarter net income of $163.1 million, or $1.12 a share, compared with $105.4 million, or 73 cents a share, in the year-ago period. Adjusted earnings were $1.29 a share, compared with 89 cents a share in the year-ago period. Revenue rose to $769.5 million from $662.2 million in the year-ago quarter. Analysts surveyed by FactSet had forecast earnings of $1.03 a share on revenue of $724.1 million. “We have rapidly pivoted our business to respond by ramping up production of life support ventilators, non-invasive ventilators, and ventilation mask systems for the people who need them most, wherever they live,” said Mick Farrell, ResMed chief executive, in a statement.

Bristol, Acceleron Anemia Treatment Gets Nod From Euro Regulators

Bristol Myers Squibb Co. and Acceleron Pharma Inc. said Thursday that a European Medicines Agency’s committee has recommended the approval of its anemia treatment for adults.
The regulator’s Committee for Medicinal Products for Human Use issued a positive opinion of the advanced Phase 3 trial of Reblozyl.
Reblozyl treats adult patients with transfusion-dependent anemia due to either low to intermediate myelodysplastic syndrome, a group of bone marrow failure disorders, or beta thalassemia, a blood disorder that reduces hemoglobin production.
“If approved, Reblozyl would be the first erythroid maturation agent approved in the EU, representing a new class of therapy for eligible patients,” the companies said.

Connecticut to begin phased reopening of coronavirus lockdown May 20

Connecticut will begin slowly reopening from its coronavirus lockdown beginning May 20, Gov. Ned Lamont announced Thursday.
Lamont unveiled a four-phase approach that will take effect next month — as long as cases and hospitalizations continue to drop, among other contingencies.
“If you want to make sure that this pandemic stays under control, we want to do everything we can to make sure there are no flare-ups around the region,” Lamont said.
Come May 20, the state plans to allow the reopening of outdoor areas at restaurants and bars; outdoor museums and zoos; offices, retail outlets and boutique shops.
Companies will still be urged to keep their employees working from home if possible.
Lamont, who designed the plan with an advisory committee that includes business groups, was confident hair and nail salons will also be allowed to reopen “on a limited basis” if his advisors can develop safe social distancing regulations.

“It’s tougher to enforce social distancing in an environment like that,” he said of the hair-styling hubs. “But based upon what we see in Georgia and other places — people aren’t flooding in. People are doing it by appointment.”
Businesses and events where it’s more difficult to practice social distancing will take longer to open, Lamont said. The final phase bringing a near-normal level of business might not come for 10 months, the governor added.
Lamont said more guidance for restarting school and other large gatherings would come next week.
The plan will only continue if the state can also ensure it maintains adequate supplies of protective gear, tests and hospital capacity and enough resources to perform contact tracing of confirmed COVID-19 patients, Lamont said.
“We’re monitoring this carefully … expansion of the ability to provide those masks to more and more stores, more and more employees, more and more factories, is key to our reopening strategy,” he said.
Connecticut has so far confirmed at least 27,700 coronavirus cases and has suffered 2,257 related deaths.

Delta tells passengers to mask up

Delta Air Lines (NYSE:DAL) says passengers will be required to wear masks starting on May 4.
The new policy requires travelers to wear a mask or other face covering on planes except for meals, in check-in areas, premium lounges and boarding gate areas. The airline is also suggesting passengers wear them in security lines and in restrooms.

Los Angeles coronavirus testing website strains as free appointments fill up

Less than 24 hours after Los Angeles became the first major U.S. city to offer free coronavirus tests for all, a website used for sign-ups strained under the demand on Thursday as appointments were completely booked for anyone not showing symptoms.
Los Angeles Mayor Eric Garcetti announced the free testing on Wednesday, saying tests were now available to anyone in the county of roughly 10 million people, although priority would be given to healthcare workers and people showing symptoms of COVID-19, the respiratory illness caused by the coronavirus.
“If you think you have COVID-19, if want the reassurance that you do not, if you’ve been around people that you have seen with symptoms, get a test,” Garcetti said at his daily coronavirus briefing. “You can’t put a price on the piece of mind of knowing that you can’t infect somebody around you.”
The tests were funded in part by CORE, a nonprofit organization co-founded by actor Sean Penn, using a $375,000 grant from the Rockefeller Foundation.
Garcetti conceded that the number of test centers currently open may not initially be able to handle demand.
On Thursday the website used to schedule appointments showed there were none available for people not showing symptoms or for those who are not “front-line workers” who interact with the public.
Local media reported the website had crashed several times since its launch shortly after the mayor’s announcement.

As of Thursday afternoon Los Angeles County had recorded 1,057 deaths from COVID-19 and more than 22,500 positive cases.
The entire state of California remains under strict “stay-at-home” orders meant to slow the spread of coronavirus while some other states begin to reopen their economies.
Garcetti said on Wednesday that large-scale testing of Los Angeles County residents was an important step toward loosening those restrictions.

Amgen studying Otezla for coronavirus, first-quarter results beat Street estimates

Amgen Inc (AMGN.O) on Thursday reported better-than-expected first-quarter results and said it plans to study psoriasis drug Otezla as a potential treatment for COVID-19, the respiratory disease caused by the new coronavirus.
Otezla, which Amgen acquired last year from Celgene Corp as part of Celgene’s buyout by Bristol Myers Squibb Co (BMY.N), is a pill that helps reduce overactive inflammation. Other similar medicines are also being tested to see if they can help COVID-19 patients.
Amgen, which maintained its full-year earnings forecast, also said it is working with partner Adaptive Biotechnologies Corp (ADPT.O) to identify antibodies targeting the novel coronavirus that may be developed into a drug to potentially prevent or treat COVID-19.
Amgen shares were up 1.5% in extended trading after earlier climbing as much as 2.4%
Amgen said strong first-quarter sales of Otezla, along with higher volume sales of drugs like cholesterol treatment Repatha, contributed to an 11% increase in revenue for the period.
The company last year launched a lower-priced Repatha option aimed at reducing out-of-pocket costs for Medicare patients.
Several other newer medicines also had double-digit percentage sales increase in the period.
“As we expected, Amgen’s results were strong, but we did not get a guidance raise,” Credit Suisse analyst Evan Seigerman said in a research note.
“We are encouraged with the progress and minimal disruption from COVID-19 across the business,” he added.
The biotechnology company reported an adjusted profit of $4.17 per share, up 17% from a year earlier and well above analysts’ average expectations of $3.76, according to Refinitiv IBES.

Amgen said the results were driven by revenue of $6.16 billion and fewer shares outstanding. That topped Wall Street estimates for revenue of just under $6 billion.
Net profit fell 3% to $3.07 per share due to higher operating costs that were partially offset by the lower share count.
For 2020, the Thousand Oaks, California-based company said it still expects adjusted earnings of $14.85 to $15.60 per share on revenue of $25 billion to $25.6 billion.

AbbVie Q1 2020 Earnings Preview

AbbVie (NYSE:ABBV) is scheduled to announce Q1 earnings results on Friday, May 1st, before market open.
The consensus EPS Estimate is $2.25 (+5.1% Y/Y) and the consensus Revenue Estimate is $8.31B (+6.1% Y/Y).
Over the last 2 years, ABBV has beaten EPS estimates 88% of the time and has beaten revenue estimates 88% of the time.
Over the last 3 months, EPS estimates have seen 3 upward revisions and 3 downward. Revenue estimates have seen 3 upward revisions and 2 downward.

Trump outlines initiatives to protect nursing homes

President Trump on Thursday outlined a handful of new initiatives intended to aid and protect nursing homes as the coronavirus pandemic takes a heavy toll on older Americans.
Trump announced the creation of a commission focused on safety in nursing homes composed of industry experts, patient advocates and state and local officials. The group will meet in May and issue recommendations for steps to protect seniors.
The administration will allocate $81 million in congressional funding toward increased inspections of nursing homes to ensure they are complying with infectious disease protocols, the president said.
The federal government will also require nursing homes to report information about coronavirus cases to the Centers for Disease Control and Prevention.
“My administration will never waver in its relentless commitment to America’s seniors,” Trump said. “We owe them a sacred and unbreakable obligation, and we will fulfill that obligation with every resource and power that we have.”
The coronavirus has ravaged nursing homes and elder care facilities, where many residents have weakened immune systems and are already susceptible to the disease. Nursing homes have been closed to visitors to slow the spread of the virus, and federal guidelines call for visits to remain prohibited until states have seen the number of cases decline for several weeks.
Trump’s outreach to seniors also comes as polls in the last week have shown him trailing presumptive Democratic nominee Joe Biden with voters 65 and older.
Trump spoke from the East Room of the White House, where he was joined by several administration officials, Tennessee Gov. Bill Lee (R) and leaders from the long-term care industry.
“The tragic reality is the coronavirus seemed almost tailor made to put major pressure on nursing homes,” said Seema Verma, administrator of the Centers for Medicare and Medicaid Services.
The New York Department of Health has reported there were 3,688 coronavirus deaths in nursing homes or adult care facilities as of Wednesday.
California officials have reported that 40 percent of the state’s coronavirus-related deaths are linked to nursing homes, though they have yet to release detailed numbers, according to local reports.
The South Carolina Department of Health released data this week that showed there have been 44 deaths at long-term care facilities in the state, accounting for roughly 23 percent of the state’s total coronavirus deaths.

Wall St. caps best month in decades with broad sell-off

U.S. stocks lost ground on Thursday as grim economic data and mixed earnings prompted investors to take profits at the close of the S&P 500’s best month in 33 years, a remarkable run driven by expectations the economy will soon start recovering from crushing restrictions enacted to curb the coronavirus pandemic.
While risk-off selling pulled all three major U.S. stock averages into the red, the S&P 500 and the Dow posted their largest monthly percentage gains since January 1987, with the Nasdaq having its best month since June 2000.
The three indexes remain well within 20% of record highs reached in February, having quickly rebounded since shutdown efforts to curb the spread of the coronavirus pandemic brought the economy to a grinding halt.
The five-week tally of unemployment claims topped 30 million and consumer spending has plummeted, according to the latest round of dismal indicators providing another snapshot of the crushing economic effects of the widespread shutdown.
“We’ve had a tremendous run but we’ve had the worst economic data since the Great Depression,” said Paul Nolte, portfolio manager at Kingsview Asset Management in Chicago. “Business and earnings might not be snapping back as quickly as the v-shaped recovery on Wall Street would imply.”
The Federal Reserved announced that it would broaden its “Main Street Lending Program” by lowering the minimum loan size and expanding eligibility.
“Wall Street is liking all the programs that the government and the Fed are putting together,” Nolte added. “So Wall Street is doing fine but Main Street is going to be a longer process.”
The Dow Jones Industrial Average .DJI fell 288.14 points, or 1.17%, to 24,345.72, the S&P 500 .SPX lost 27.08 points, or 0.92%, to 2,912.43 and the Nasdaq Composite .IXIC dropped 25.16 points, or 0.28%, to 8,889.55.
Of the 11 major sectors in the S&P 500, all but consumer discretionary .SPLRCD and communications services .SPLRCL closed in negative territory, with materials .SPLRCM and financials .SPSY suffering the largest percentage losses.
Earnings season continues apace, with 236 of the companies in the S&P 500 having reported quarterly results. Of those, two-thirds have surprised consensus estimates to the upside, according to Refinitiv data.
But there have been 90 negative pre-announcements in the first quarter, compared with 40 positive, and analysts see aggregate S&P 500 earnings dropping by a year-on-year rate of 14.4% in the first three months of 2020, per Refinitiv.
Market leaders Apple Inc (AAPL.O) and (AMZN.O) reported results after the closing bell. In post-market trading, Apple shares gained more than 2% while was down over 5%.
Facebook Inc (FB.O) climbed 5.2% after the social media company reported better-than-expected quarterly revenue.
American Airlines (AAL.O) posted its first quarterly loss since emerging from bankruptcy in 2013, sending its shares down 4.9%.

Declining issues outnumbered advancing ones on the NYSE by a 2.58-to-1 ratio; on Nasdaq, a 2.81-to-1 ratio favored decliners.
The S&P 500 posted three new 52-week highs and one new low; the Nasdaq Composite recorded 25 new highs and four new lows.
Volume on U.S. exchanges was 12.80 billion shares, compared with the 12.3 billion average over the last 20 trading days.

Gilead Q1 earnings call: COVID-19 headwinds modest to date

Highlights from today’s Q1 earnings call at Gilead Sciences (NASDAQ:GILD):
Content of call adjusted to allow more Q&A related to remdesivir.
CEO O’Day:
Very confident with HIV position (~61% share in U.S.).
Forty Seven acquisition example of its business development strategy.
Reviewed results from the two recent remdesivir studies. Plan to have 1.5M doses by the end of May. Entire existing supply will be donated for patients in need. Five-day regimen will increase availability.
CFO Dickinson:
$120M in expenses to be recorded this year related to Forty Seven deal.
$500M in debt repaid.
Cash flow should be strong.
COVID-19 disruptions: some effect seen late qtr. To date, though, the overall impact has been modest. Q2 revenues may be impacted. HIV switching may slow.
Enrollment in most clinical trials suspended.
Post-donation economic model for remdesivir unclear at present.
Jefferies’ Michael Yee: remdesivir revenue expectations? O’Day: premature to say. Production expenses could be allocated to COGS and/or R&D.
JPMorgan: oral/inhaled version of remdesivir? O’Day: focus on current formulation. Not appropriate for oral use. Subcutaneous or inhaled approaches being investigated.
RBC: any more data from NIAID study? allocation of remdesivir? CMO Parsey: have not seen any more data than already released. Primary patient population: severely ill patients on or candidates for ventilation therapy.
BofA: access model? Parsey: believes remdesivir has the best potency for COVID-19. Dickinson: in discussions with other companies to explore alternative supply chains, too early to comment further.
SVB Leerink: how will ROI in COVID compare to HIV and hepatitis? O’Day: uncertain, but pricing to be sensitive to patient needs.

Select Medical EPS beats by $0.05, beats on revenue

Select Medical (NYSE:SEM): Q1 Non-GAAP EPS of $0.37 beats by $0.05; GAAP EPS of $0.40 beats by $0.08.
Revenue of $1.41B (+6.8% Y/Y) beats by $50M.

Stryker EPS beats by $0.10, beats on revenue

Stryker (NYSE:SYK): Q1 Non-GAAP EPS of $1.84 beats by $0.10; GAAP EPS of $1.30 misses by $0.26.
Revenue of $3.59B (+2.0% Y/Y) beats by $140M.

Molina Healthcare EPS beats by $0.02, beats on revenue

Molina Healthcare (NYSE:MOH): Q1 Non-GAAP EPS of $3.02 beats by $0.02; GAAP EPS of $2.92 misses by $0.05.
Revenue of $4.55B (+10.4% Y/Y) beats by $60M.

CareDx EPS misses by $0.03, beats on revenue April 30, 2020

CareDx (NASDAQ:CDNA): Q1 Non-GAAP EPS of $0.00 misses by $0.03; GAAP EPS of -$0.14 misses by $0.01.
Revenue of $38.38M (+47.7% Y/Y) beats by $0.11M.

Amgen Q1 product sales up 11.5%; adjusted earnings up 11%

Amgen (NASDAQ:AMGN) Q1 results:
Revenues: $6,161M (+10.9%); product sales:$5,894M (+11.5%).
Top sellers: Enbrel: $1,153M (+0.2%); Neulasta: $609M (-40.4%); Prolia: $654M (+10.5%); Xgeva: $481M (+2.1%); Repatha: $229M (+62.4%); Aimovig: $71M (+20.3%); Evenity: $100M (+488.2%).
Net income: $1,825M (-8.6%); non-GAAP net income: $2,476M (+11.0%); EPS:; non-GAAP EPS: $4.17 (+17.1%).
Cash flow ops: $2.1B (+16.7%).
2020 guidance: Revenues: $25.0B – 25.6B (unch); EPS: $10.65 – 11.45 from $10.85 – 11.65; non-GAAP EPS: $14.85 – 15.60 (unch).

ResMed EPS beats by $0.21, beats on revenue

ResMed (NYSE:RMD): Q3 Non-GAAP EPS of $1.29 beats by $0.21; GAAP EPS of $1.12 beats by $0.14.
Revenue of $769.46M (+16.2% Y/Y) beats by $48.04M.
Shares +1.08%.

Viking Therapeutics EPS misses by $0.01

Viking Therapeutics (NASDAQ:VKTX): Q1 GAAP EPS of -$0.13 misses by $0.01.
Cash, cash equivalents and short-term investments of $269.2M.
Shares -1.04%.

Emergent Biosolutions EPS beats by $0.10, misses on revenue

Emergent Biosolutions (NYSE:EBS): Q1 Non-GAAP EPS of $0.01; GAAP EPS of -$0.24 beats by $0.10.
Revenue of $192.5M (+1.0% Y/Y) misses by $5.71M.

Gilead Sciences EPS beats by $0.12, beats on revenue

Gilead Sciences (NASDAQ:GILD): Q1 Non-GAAP EPS of $1.68 beats by $0.12; GAAP EPS of $1.22 misses by $0.03.
Revenue of $5.55B (+5.1% Y/Y) beats by $110M.
Shares -0.7%.

‘Dead’ coronavirus particles may cause recovered patients to test positive

South Korean health officials said recovered coronavirus patients who later tested positive again only did so because “dead” virus particles remained in their bodies — not because they became reinfected.
A total of 292 people in the country who were cleared of the deadly bug later tested positive for COVID-19 again — a phenomenon that initially puzzled officials, the Korea Centers for Disease Control and Prevention said, according to a report in Newsweek.
But they’ve now determined that residual fragments of the virus are likely responsible.
“RNA fragments still can exist in a cell even if the virus is inactivated,” said Oh Myoung-don, who heads the KCDC’s clinical committee for emerging disease control, Newsweek said.
“It is more likely that those who tested positive again picked up virus RNA that has already been inactivated.”
Still, there are some concerns about South Korea’s positive retests as the number of second-time diagnoses has steadily risen. Two weeks ago, repeat diagnoses accounted for about 2 percent of the country’s recovered patients. By Wednesday, the number had risen to 2.7 percent, and 3.4 percent among children.
Preliminary tests released by the KCDC on April 17 determined that those patients re-tested positive an average of 13.5 days after being cleared and discharged from isolation — although the time spanned as long as 35 days, the report said.

Scientists studied 137 of the initial cases and reported that 61 of the patients showed mild symptoms, 72 were asymptomatic and four others were still being studied.
However, health officials said there was no indication yet that those patients had spread the virus to others.
“Contact tracing on these re-positive cases is also underway to identify the possibility of secondary infection,” the center said in an April 26 report. “No new case has yet been confirmed that resulted from exposure to the re-positive cases. The contracts are still under monitoring.”
As of Thursday morning, South Korea had 10,765 reported cases of COVID-19, with 247 deaths, according to Johns Hopkins University, which is tracking the global pandemic.

How to control an influenza outbreak without a specific vaccine

A group of pandemic modeling experts from the University of Sydney’s Faculty of Engineering have published new research that simulated viral influenza outbreaks to examine the efficacy of pandemic interventions in the absence of a tailored vaccine.
The general use of low-efficacy vaccines, coupled with a targeted application of antiviral medications, may be effective at countering the spread of influenza pandemics, new research from the University of Sydney has found.
Published by the Journal of The Royal Society Interface, the modeling sought to examine the effectiveness of pandemic interventions in the absence of a strain-specific .
“Pandemics typically occur with the emergence of new viral strains for which no tailored vaccine exists,” said Dr. Cameron Zachreson from the University’s Centre for Complex Systems, who in 2018 published research that found urbanization and air travel were leading to a growing risk of pandemic in Australian cities.
“Without a readily available vaccine, governments must mitigate outbreaks in other ways, making do with mechanisms at hand, such as antiviral medications, social distancing and low-efficacy vaccines developed for different viral strains. These are known as pre-pandemic vaccines.”
Dr. Zachreson’s team found pre-pandemic vaccines are most effective at containing a pandemic when combined with fast, contact-targeted, antiviral medication, which helps reduce transmission.
“These targeted interventions need to be implemented quickly compared to the transmission rate of the disease,” said Dr. Zachreson.
“The more effective a targeted strategy is at mitigating the epidemic, the longer it will have to be in place,” he added. “Mitigation will slow down disease spread but is unlikely to eradicate the pathogen completely.”
Even if a pre-pandemic vaccine is unable to bring about herd immunity, it can slow the spread of the virus and open a longer time window in which other measures can be effectively implemented, the researchers found.
Lessons for the COVID-19 pandemic
“Our study focuses on , for which many vaccines have previously been developed. There are no coronavirus vaccines available so pre-pandemic vaccination is not currently possible for COVID-19,” said Dr. Zachreson.
“If, hypothetically, a low-efficacy coronavirus vaccine was developed, our study would support its distribution in combination with other measures, as this would likely make them more effective.
“Another takeaway is that timing is everything in preventing a with targeted interventions. Cases must be identified, contacts traced, and measures implemented before the disease has time to spread within the community.”
Targeting neighborhoods less effective than contact targeting
The study showed that giving antiviral medication to people living in the same neighborhoods as index cases (the first documented patients within a population) was inefficient and did not significantly impact the disease’s rate of spread.
“On the other hand, giving antiviral medication to the social contacts of index cases did slow down disease spread if the response was fast compared to disease transmission speed,” Dr. Zachreson said.
“While there are no known antivirals that are effective for COVID-19, our study does reinforce the importance of contact tracing for the targeting of mitigation measures, as opposed to targeting by residential location.”
How the modeling worked
The AceMod simulator, a peer-reviewed method created by the Centre for Complex Systems, comprises over twenty-four million software agents, each with attributes of an anonymous individual, such as age, occupation, susceptibility and immunity to diseases. Contact rates within different social contexts, such as households, household clusters, local neighborhoods, schools, classrooms and workplaces are also built into the program.
The set of generated agents captures average characteristics of the real population and is calibrated to 2016 Australian Census data with respect to key demographic statistics.

Explore further
Greater social distancing could curb COVID-19 in 13 weeks: study

More information: Cameron Zachreson et al. Interfering with influenza: nonlinear coupling of reactive and static mitigation strategies, Journal of The Royal Society Interface (2020). DOI: 10.1098/rsif.2019.0728

Thermogenesis rockets 74% on performance of COVID-19 blood test

Nano cap ThermoGenesis (THMO +73.6%) jumps more than a 13x surge in volume in apparent response to performance characteristics of its SARS-CoV-2 IgM/IgG Antibody Fast Detection Kit that it published on its website.
Although the sample sizes were modest, the data showed 100% sensitivity (n=10) and 95.8% [should be 96% (n=48/50)] specificity.
The latter is the most important characteristic for epidemiologists since too many false positive results will compromise their efforts in contact tracing and research into the spread and persistence of the pandemic.

Roth Downgrades Inovio On Valuation Despite Positive MERS Vaccine Data

Although Inovio Pharmaceuticals Inc INO 10.04% reported positive interim results from Phase 1 and 2a of its MERS vaccine, the valuation of the stock already reflects this, especially given the increase in share count since the end of 2019, according to Roth Capital Partners.

The Inovio Analyst

Jonathan Aschoff downgraded Inovio stock from Buy to Neutral and maintained a $13 price target.

The Inovio Thesis

Inovio Pharmaceuticals’ share count will rise by over 10 million shares with its at-the-market capital offering of $150 million, Aschoff said in the Thursday downgrade note. (See his track record here.)
The company has announced solid interim results for its MERS vaccine INO-4700 and is scheduled to present details at the ASGCT conference in mid-May, the analyst said. Yet there are several drug makers, many of which are much larger than Inovio and have global commercial operations, that are working aggressively on COVID-19 therapies, he said.
It may take more than just positive clinical data to “come out among the group that materially benefits from treating the world against this virus,” Aschoff said.

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,”

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.

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.


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.”

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.

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.

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.

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.”
A well-developed crystallization process can produce suitable particles that can facilitate consistent filtration, drying and formulation of the API and allow confident and reliable manufacturing of the final drug product, while avoiding unnecessary cost, risk and development delays.
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.”