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Friday, January 31, 2020

Bristol-Myers Squibb pulls European application for lung cancer combo

Bristol-Myers Squibb (NYSE:BMY) has withdrawn its marketing application in Europe seeking approval to use the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) (O+Y) to treat advanced non-small cell lung cancer in a first-line setting.
The company originally filed the application in 2018 based on the successful achievement of the co-primary endpoint of progression-free survival (PFS) in patients with mutational burdens of at least 10 mutations/megabase (CHECKMATE-227 study).
The application was later amended to include the successful achievement overall survival (OS), the other co-primary endpoint, in patients whose tumors expressed at least 1% PD-L1.  These participants received O+Y+chemo.
The European Medicines Agency determined that it could not conduct a full assessment of the filing due to the multiple protocol changes BMY made in response to rapidly evolving science and data.
It has no plans to refile the application.
Its submission in the U.S. is currently under FDA review.
https://seekingalpha.com/news/3537043-bristol-myers-squibb-withdraws-european-application-for-o-y-for-lung-cancer

Co-Diagnostics up 24% on advancement of coronavirus test

Nano cap Co-Diagnostics (CODX +23.5%) jumps on an 8x surge in volume on the heels of its announcement that it has completed the initial verification of a screening test for the coronavirus responsible for the current outbreak.
https://seekingalpha.com/news/3537005-co-diagnostics-up-24-on-advancement-of-coronavirus-test

NYC Officials Deny Report Of Coronavirus Amid Confusion

Topline: Despite a news report of a potential first case of coronavirus in New York City that temporarily sparked panic and confusion on social media Friday, city health officials vehemently denied the report, saying that there are still no confirmed or suspected cases of the virus in the city.
  • The Daily News first reported that eight NYPD precincts in Queens were warned early on Friday morning to be careful over “one confirmed case” of coronavirus at Elmhurst Hospital.
  • But the New York City Department of Health quickly denied the report, saying that there were no confirmed cases anywhere in the city’s five boroughs.
  • NYC Health Commissioner Oxiris Barbot tweeted in response, “THIS IS NOT ACCURATE. There are still ZERO confirmed cases of novel coronavirus in NYC.”
  • “There are no confirmed or suspected cases in NYC,” NYC Department of Health spokesman Michael Lanza told Forbes.
  • “As of now, there have been no suspected cases sent to CDC from NYC for further testing,” confirmed another NYC health department spokesman, Patrick Gallahue. “Thus, no confirmed cases either. Report was wrong,” he told Forbes.
  • “There is no coronavirus at Elmhurst Hospital,” added Christopher Miller, spokesman for NYC Health + Hospitals.
Crucial statistics: As of Friday, the deadly coronavirus has now infected nearly 10,000 people and killed at least 213, according to Chinese authorities. Originating in Wuhan, China, the fast-spreading illness has now reached more than 21 different countries. There are a total of five confirmed cases in the U.S., which issued its highest travel alert possible for China on Thursday night—advising Americans to avoid all “nonessential” travel to the country. Numerous airlines have suspended travel as well, and a host of countries, including the U.S., have also evacuated citizens from China and placed them under quarantine.
Big number: New York has the largest Chinese population of any city outside of Asia, The New York Times reports.
Key background: The World Health Organization (WHO) in a press conference on Thursday said that it is declaring coronavirus an international health emergency. “We don’t know what sort of damage coronavirus could do if it spreads to a country with a weaker health system,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. “We must act now.”
https://www.forbes.com/sites/sergeiklebnikov/2020/01/31/nyc-officials-deny-report-of-coronavirus-amid-confusion/#76bcefd2652c

Medicaid expansion hardly affects substance use treatment workforce

Lawmakers have focused a great deal of attention on alleviating the opioid public health crisis, while at the same time addressing across-the-board concerns regarding affordability of healthcare. State level Medicaid expansion through the Affordable Care Act is one of those efforts, which targets low-income non-elderly adult populations, who tend to be more at risk of substance use disorders.
While Medicaid expansion has led to substantial increases in Medicaid reimbursement for substance use treatment, it has not specifically led to a detectable increase in hiring attempts to increase the substance use disorder and behavioral treatment , according to a study by Indiana University researchers.
“Effective treatment strategies exist and continue to improve for substance use disorder, but there are still severe hurdles in ensuring an adequate workforce in substance use disorder treatment,” said Olga Scrivner, co-author of the study and research scientist at the Luddy School of Informatics, Computing and Engineering. “While policies such as Medicaid expansion have increased access to treatment, it is still unclear whether such actions are large enough to expand the workforce in a robust way.”
“A lack of an increased workforce means people in need of substance use disorder treatment are not receiving it,” said Thuy Nguyen, another author of the study and post-doctoral researcher at the O’Neill School of Public and Environmental Affairs.
The study, published today in Plos One and part of IU’s Responding to the Addiction Crisis Grand Challenge, examined hiring attempts in the substance use disorder and behavioral health treatment sector from 2010-2018. Using a novel database, Burning Glass Technologies, covering 174 million job ads—virtually all U.S. online job postings by employers—researchers compared U.S. job postings in this sector in Medicaid expansion and non-expansion states, testing for changes after expansion.
Nationally, researchers found little growth in job postings in the field—which for this study included outpatient, residential and hospital inpatient services in the substance use disorder and behavioral health treatment sector.
However, they detected some changes in the hiring landscape over the study period: a shift from registered nurses, psychiatric aides and surgeons to mental health counselors and assistants in outpatient and residential facilities, and from nursing assistants and human resources assistants to psychiatrics, sales managers and pharmacy technicians.
Overall, the five most frequent occupations that organizations attempted hiring in this sector were mental health counselors, registered nurses, medical and health service managers, psychiatric technicians, and clinical, counseling, and school psychologists. The highest spike in workforce needs was detected for mental health counselors during the years of 2016-2018.
“The health care workforce has been growing tremendously in the recent decades,” said co-author Kosali Simon, the Herman B Wells Endowed Professor at the O’Neill School of Public and Environmental Affairs. “Health care is now the nation’s largest employer, surpassing retail and manufacturing. But there are still important deficits in the workforce, especially in behavioral health areas.”
The team’s next steps are to continue to look into the effect of policies, such as insurance reimbursement and scope of practice prescription laws, on the substance use disorder treatment workforce to better understand how policies affect workforce demand and contribute to creating a workforce that can meet the needs of people with substance use disorder.
“Understanding, managing and reducing substance use requires expertise from different areas of research,” said co-author Katy Börner, the Victor H. Yngve Distinguished Professor of Information Science at the Luddy School of Informatics, Computing and Engineering. “This project brings together students, faculty and industry experts who analyzed and visualized large-scale datasets to increase our understanding of the impact of policy changes on hiring practices related to treatment.”

Explore further
Medicaid expansion linked to gains in insurance coverage

More information: Olga Scrivner et al, Job postings in the substance use disorder treatment related sector during the first five years of Medicaid expansion, PLOS ONE (2020). DOI: 10.1371/journal.pone.0228394

BOQI Medical latest to capture coronavirus money flow

Chinese pharmacy operator and drug distributor BOQI International Medical (BIMI +43.9%) is, yet another, tiny outfit aiming to capture some of the tsunami of money flowing into any company even mentioning activity related to coronavirus.
In this case, the company announced that it has a “sufficient” inventory of drugs (including antivirals) and supplies (e.g., N95 masks, surgical masks, rubbing alcohol) to help meet demand during the outbreak.
BIMI, founded in 2006, was formerly known as NF Energy Saving Corp.

Travelers breach China virus lockdown by taking bridge over Yangtze

People are leaving and entering China’s Hubei province by foot over a bridge spanning the Yangtze river despite a virtual lockdown on vehicle traffic due to a coronavirus epidemic that has killed about 200 people.
The Yangtze marks the dividing line between Jiujiang in Jiangxi province and Huanggang in neighboring Hubei, one of the cities hit hardest by the coronavirus outbreak and now sealed off from the rest of China to try to contain the pathogen.
But the foot traffic over the Yangtze shows the lockdown is permeable, raising doubts over its effectiveness and providing a glimpse at life inside the epicenter of what the World Health Organization (WHO) has called a global emergency.
Wu Minzhou, a 40-year-old business owner who was fishing near the bridge on the Jiangxi side, said he was worried about the exceptions being made for people leaving Hubei.
“Because there’s an … incubation period at play here, if they head out, for example, to cities in the north of China then it’s highly possible they will infect those areas too,” he said.

While vehicles are not allowed over the bridge, it is still open to pedestrians. Police explained that people were still entering Hubei and they could still get out, but only in “special circumstances”.
Those include people who were in Hubei but booked train tickets to leave from Jiujiang before the Lunar New Year.
“Everyone’s panicking right now but I think things are not that bad,” migrant worker Guan, 45, told Reuters after crossing from Hubei.
Another man told Reuters that he had driven to the bridge from Jiujiang with his friend, who was returning home to Hubei, a province of about 60 million people.
“But once you get back you cannot come out again,” said the man, who gave his surname as Tian. “You have to stay there, stay at home. You can’t come out.”

The epidemic, believed to have originated in a seafood market in the Hubei provincial capital of Wuhan, prompted the WHO to declare a global emergency on Thursday, only the sixth time it has done so.
Trains and other public transportation have been suspended, roads have been sealed off and checkpoints established at tollgates around Wuhan, and the special measures have been extended to other cities in Hubei province.
Though Jiujiang itself has not officially been locked down, its streets were mostly deserted and its tourist sites closed on what was officially the last day of China’s Lunar New Year celebrations on Thursday.
“You know before during this (holiday) time a taxi driver’s business would definitely be good because during Spring Festival lots of people come home to be with their families,” said local taxi driver Guo Dongbo, 59.
“But this year, because there is this epidemic, we are all just following what the government has asked us to do. That is, we’re at home almost all the time. We don’t go out and nobody else is out on the streets either.”
In one of the residential areas of Jiujiang, a city of nearly five million people, a man carried a loudspeaker playing a recorded message ordering anyone who has been to Hubei recently to go and register with the local residents committee.
By Friday, the city had 42 confirmed cases of infection.
Elsewhere, shops were mostly shuttered, and the few restaurants that remained open were mostly empty.
“Normally at this time of year a lot of people come here. Now there’s nobody,” said one vegetarian restaurant owner near the Donglin Buddhist temple in Jiujiang.
https://www.reuters.com/article/us-china-health-jiujiang/travelers-breach-china-virus-lockdown-by-taking-bridge-over-yangtze-idUSKBN1ZU0LB

Hong Kong leader rejects calls to close border despite virus fears

Hong Kong leader Carrie Lam rejected calls from a medical union on Friday to close the border with mainland China to contain the spread of the new coronavirus, and urged health staff not to go through with a threatened strike.
The recently formed Hospital Authority Employees Alliance said earlier on Friday 6,500 of its members would go on strike if the frontier stayed open, a day after the World Health Organization (WHO) declared the virus a global emergency.
The WHO recommended all countries try to prevent or reduce cross-border spread of disease, which originated in the central Chinese city of Wuhan. But it said measures should avoid unnecessary interference with trade or travel.
“I am afraid (closing the border) contradicts the WHO suggestion … which asks governments not to take any measures that may fuel discrimination,” Lam told a news conference.
She announced a raft of new measures against the disease and said any industrial action by medical staff would only make the situation worse.
“At the end of the day those who will suffer will be our Hong Kong citizens and the public health system,” she said.
Authorities have announced 12 confirmed infections in Hong Kong but no deaths. The number of confirmed cases in China has risen beyond 9,800, Beijing’s envoy to the United Nations in Vienna said, and 213 people have died, all in China.
Lam said that on Jan. 30, only 9.7% of arrivals into Hong Kong, excluding those at the airport, were from mainland China, and most of the rest were returning Hong Kong citizens. She said she expected the flow to shrink as many mainland cities were under lockdown.
About 37,000 Hong Kongers crossed the mainland border the other way into China that day, she said.

NEW MEASURES

The health scare comes after months of often violent anti-government protests in Hong Kong triggered by fears its high degree of autonomy, guaranteed under a “one country, two systems” formula, is being eroded by Beijing. The central government denies meddling.
Protesters frustrated by the government’s refusal to make concessions on demands for full democracy have in recent months formed about 40 unions to keep up the pressure on the authorities.
In a news conference earlier on Friday, Winnie Yu, the chairwoman of the Hospital Authority Employees Alliance, said its members may go a strike next week unless the border was closed. Other new unions have pledged support.
Lam had previously ordered the suspension of the high-speed rail service between the city and mainland China and all cross-border ferry services, but the unions said it was not enough.
The new measures announced on Friday included checks on people’s temperatures as they left Hong Kong.
Lam extended school holidays until at least March 2 and said civil servants not providing urgent or essential services would work from home next week in an arrangement which will be reviewed weekly.
She urged private sector employers to do the same.
Immigration officials have identified 48 visitors from China’s Hubei province, whose capital is Wuhan, and said they will either leave the city or be quarantined.
https://www.reuters.com/article/us-china-health-hongkong/hong-kong-leader-rejects-calls-to-close-border-despite-virus-fears-idUSKBN1ZU1K6