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Wednesday, March 4, 2020

FDA adds boxed warning to Merck’s asthma med Singulair

Citing a need to strengthen the existing warning about the risk of neuropsychiatric events associated with the drug, the FDA is now requiring a boxed warning in the labeling of Merck’s (MRK +4.6%) asthma med Singulair (montelukast sodium) and generic versions of the leukotriene receptor antagonist.
The agency says the precise incidence of said events is unknown but there have been reports of serious cases. It is also requiring a new medication guide to be given to patients with each prescription.
https://seekingalpha.com/news/3548701-fda-adds-boxed-warning-to-mercks-asthma-med-singulair

OrthoPediatrics EPS misses by $0.03, misses on revenue

OrthoPediatrics (NASDAQ:KIDS): Q4 GAAP EPS of -$0.29 misses by $0.03.
Revenue of $18.95M (+30.1% Y/Y) misses by $0.05M.
https://seekingalpha.com/news/3548723-orthopediatrics-eps-misses-0_03-misses-on-revenue

Outlook brightens for availability of coronavirus tests in U.S.

A group of diagnostic companies met at the White House today to discuss their progress in developing tests for SARS-CoV-2, the coronavirus causing the current outbreak.
Representatives of Abbott (ABT +4.6%), Thermo Fisher Scientific (TMO +5.1%), LabCorp (LH +5.2%), Quest Diagnostics (DGX +5.8%)and the Mayo Clinic were there. LH CEO Adam Schechter said the industry is working together to increase the availability of the tests, adding that his company expects to launch one “soon.”
Vice President Mike Pence stated that the U.S. Department of Health and Human Services has included coronavirus testing as an essential health benefit for health plans, a move that should increase availability.
In an interview with Fox News, HHS Secretary Alex Azar said the CDC was shipping enough tests to assay 75,000 samples per week, adding that its private contractor was shipping “over a million testing capability to hospitals, labs and others who want that.”
Related tickers: QIAGEN (QGEN +0.1%), Luminex (LMNX +1.1%), Chembio Diagnostics (CEMI -6.7%), Co-Diagnostics (CODX -18.2%), Roche (OTCQX:RHHBY +4%), Becton, Dickinson (BDX +2.6%)
https://seekingalpha.com/news/3548695-outlook-brightens-for-availability-of-coronavirus-tests-in-u-s

Pet dog infected with COVID-19, Hong Kong authorities confirm

The pet dog of a coronavirus patient in Hong Kong was confirmed to be infected with the disease, in a likely case of human-to-animal transmission, authorities said on Wednesday.
The canine, which belongs to a 60-year-old woman patient, had repeatedly tested “weak positive” for the new coronavirus since Friday, when it was quarantined at an animal centre.
The city’s Agriculture, Fisheries and Conservation Department (AFCD) said repeated tests suggest the dog—a pomeranian—has “a low-level of infection”.
The AFCD said experts from universities and the World Organisation for Animal Health have unanimously agreed that “it is likely to be a case of human-to-animal transmission”.
The pomeranian has not shown any novel coronavirus symptoms the AFCD said.
Since last Friday, all pets of people in Hong Kong infected with the coronavirus are to be quarantined for 14 days. Two are already in isolation.
The other dog in quarantine belongs to a second coronavirus patient that tested negative for the virus once and will be tested again before its release.
Authorities said it will continue to closely monitor the pomeranian and return it to its owner when it tests negative for the disease.
The financial hub has confirmed 102 cases of the new coronavirus in humans, with two deaths earlier this month.
https://medicalxpress.com/news/2020-03-pet-dog-infected-covid-hong.html

New coronavirus cases in LA, New York as US lawmakers reach funding deal

The United States’ two biggest cities reported 10 more coronavirus cases Wednesday, as lawmakers in Congress reached a deal to provide more than $8 billion to fight the outbreak.
Los Angeles County officials declared an emergency as six new cases were reported in the West Coast metropolis, while New York reported four more patients—all close contacts of a man who tested positive.
Nine people have died of the COVID-19 illness in the US and more than 130 have so far been infected, with the detected in more than a dozen states.
A congressional aide told AFP that Republicans and Democrats had reached a deal to fund the response to the tune of $8.3 billion—with the House expected to vote today and the Senate tomorrow.
President Donald Trump had initially sought a much lower amount of $2.5 billion but later said he was happy to accept more money.
All of the newly infected individuals in LA were exposed to COVID-19 through close contact, said.
Dr Barbara Ferrer, director of the Los Angeles County Department of Public Health, said three of the cases concerned travelers who had gone together to northern Italy—a virus hotspot with more than 100 deaths.
Two other cases involved individuals who had come in contact with a family member who had the virus and the last concerned someone whose job exposed them to travelers.
“There’s one person that is hospitalized, and all of our other five new cases are being isolated at home and closely monitored by the public health department,” Ferrer said.
Officials said the emergency declaration was not aimed at spreading panic but rather at ensuring the county was well-prepared to prevent the spread of the virus.
“The step we’re taking today is about preparation, not panic,” said Mayor Eric Garcetti.
Officials said they expected the number of infections to rise in coming days and urged families to brace for possible school closures and the cancellation of public events.
There have now been seven people infected in LA County. Statewide, about 50 people are known to be infected, the most of any state.
All nine US deaths have been reported in the state of Washington so far, the majority of them involving residents of a nursing home.
In New York, reported on Wednesday that the and neighbor of a man who had the virus had also tested positive.
Governor Andrew Cuomo said the wife and two children of the man were now infected, as is a neighbor who had driven the man to hospital, taking the number of cases in the state to six.
https://medicalxpress.com/news/2020-03-coronavirus-cases-la-york-lawmakers.html

SEC adds ‘conditional’ disclosure delay relief for firms hit by coronavirus

The U.S. Securities and Exchange Commission (SEC) said on Wednesday that it would give companies affected by coronavirus more time to file certain disclosures.
The watchdog said companies affected by the outbreak of the flu-like respiratory disease now have an additional 45 days to file certain disclosures, including quarterly reports.
U.S.-listed companies seeking such a delay must explain why the relief is needed, the agency said. It would also consider providing additional extensions for any legally required disclosures normally due between March 1 and April 30.
SEC Chairman Jay Clayton urged all U.S.-listed companies to disclose risks stemming from coronavirus under regular filing conditions if material to investors, even if the companies plan to take advantage of disclosure extensions.

And while companies may have more time to make disclosures, directors and officers should refrain from buying and selling stock until investors have been appropriately informed about any relevant risk, the agency added.
“I urge companies to work with their audit committees and auditors to ensure that their financial reporting, auditing and review processes are as robust as practicable in light of the circumstances in meeting the applicable requirements,” Clayton added.
Wednesday’s order cane as staff of other U.S. financial regulators discuss global risks stemming from fears that the coronavirus has driven market turmoil not seen since the 2007-2009 financial crisis.
https://www.reuters.com/article/us-health-coronavirus-sec/u-s-sec-provides-conditional-disclosure-relief-for-firms-hit-by-coronavirus-idUSKBN20R2XK

JPMorgan to test emergency coronavirus plans with some working from home

JPMorgan Chase & Co is asking thousands of U.S. employees to spend a day working from home in the coming weeks to test its contingency plans should the coronavirus spread, sources familiar with the plan told Reuters.

This week the bank may also begin sending teams of traders to work from secondary office locations in Brooklyn, New York, and nearby in New Jersey, to test its systems and ensure that any kinks are worked out should the bank need to roll out emergency plans more broadly, one of the sources said.
The largest U.S. bank by assets is testing these contingency plans now because, if the coronavirus spreads further in the United States, it would need to separate employees of the bank’s many business lines to ensure that most business could continue as usual, one source said.
The bank began asking managers of each of its four main businesses to select employees and ask them to work from home starting last week.
Managers in the consumer & community banking division, which includes Chase bank and employs more than 120,000 people, have asked around 10% of employees to work from home a day this week. The corporate and investment bank employees were asked last week.
The project was code-named “Project Kennedy”, Bloomberg first reported on Tuesday.
Big U.S. banks have been rolling out contingency plans to respond to the global virus outbreak ? requiring some staff to work from home, implementing travel restrictions and talking to regulators about potential stresses. European banks are doing the same and also splitting shifts and isolating some teams.
Last week on Thursday, JPMorgan told employees it was restricting all but essential international work travel due to the continued spread of the virus.

https://www.marketscreener.com/JPMORGAN-CHASE-CO-37468997/news/JPMorgan-to-test-emergency-coronavirus-plans-with-some-employees-working-from-home-sources-30103194/