Health experts warn China travel ban will hinder coronavirus response

The Trump administration’s decision to ban most foreign nationals who had been to China in the last two weeks from traveling to the United States amid an accelerating outbreak of a novel coronavirus there was preceded by calls for similar policies from conservative lawmakers and far-right supporters of the president. Public health experts, however, warn that the move could do more harm than good.
The administration’s public health emergency declaration also requires U.S. citizens returning from China to undergo some level of quarantine, depending on where they had been in China.
Before the announcement Friday, Sen. Tom Cotton (R-Ark.) had called for a ban on all commercial flights from China, and Rep. Paul Gosar (R-Ariz.) said the government should consider “implementing a temporary travel ban on travelers from China until the threat is resolved.”

Beyond Capitol Hill, Mike Cernovich, a prominent conspiracy theorist and early Trump supporter, had agitated on Twitter for a Chinese travel ban, as has Michael Savage, another conspiracy theorist and a radio host with white nationalist beliefs. “QUARANTINE! STOP TRAVELERS FROM CHINA NOW!” he said on Twitter last week.
The ban comes on top of moves by major U.S. airlines halting flights to and from mainland China.
The outbreak has sickened nearly 10,000 people, mostly in China, and killed more than 200. A few countries have responded by imposing full or limited travel bans. The Philippines, for instance, has banned travel from the city of Wuhan, the epicenter of the outbreak. Countries including the Bahamas, Mongolia, and Singapore have banned all travel from China.
Public health experts have warned that travel bans are not effective at stemming the spread of a virus and can make responding to an outbreak more challenging.
“From a public health perspective, there is limited effectiveness. And then there are a host of other reasons why they can actually be counterproductive,” said Catherine Worsnop, who studies international cooperation during global health emergencies at the University of Maryland.
The World Health Organization, which declared the outbreak a global health emergency this week, has recommended against any travel or trade restrictions in response to the outbreak. Member countries, however, do not have to comply with that guidance.
“Although travel restrictions may intuitively seem like the right thing to do, this is not something that WHO usually recommends,” said Tarik Jašarević, a WHO spokesperson. “This is because of the social disruption they cause and the intensive use of resources required,” he added.
Experts said travel bans could lead to a slew of downstream effects and risk complicating the public health response.
“There’s not only the financial toll on a country that is dealing with this outbreak, but this can discourage transparency, both in this outbreak and in the future,” Worsnop said.
Travel and trade restrictions can lead to dire economic consequences for countries involved, creating a disincentive for them to quickly disclose potential outbreaks to the WHO or other nations. They can hinder the sharing of information, make it harder to track cases and their contacts, and disrupt the medical supply chain, potentially fueling shortages of drugs and medical supplies in the areas hit hardest by the outbreak. They also send a punitive message, which could contribute to discrimination and stigmatization against Chinese nationals, experts warned.
Any effort and money spent crafting and enforcing travel and trade restrictions also take away already-stretched resources from public health measures that have been proven to be far more effective, experts said. Those measures include providing assistance to countries with weaker health systems, accelerating the development of a vaccine or rapid diagnostic test, and clearly communicating with the public about when and how to seek care.

But for politicians, those responses might not feel as tangible an action as enacting a travel ban. During the 2013-2014 Ebola outbreak, there was a flurry of calls for a U.S. ban on travel from the affected countries, including from Donald Trump, then a private citizen.
“People want their government to do something when these outbreaks are happening, and adopting a border restriction is a visible policy that people think works,” Worsnop said.
Enacting such a ban would go directly against the recommendation of the WHO, which has said countries must inform the organization of any travel restrictions they put in place.
“Adopting these restrictions undermines the cooperative approach we need to respond to this kind of outbreak, specifically by undermining the authority of the WHO, which has recommended against these restrictions,” Worsnop said.
Worsnop said she is hopeful that the WHO will be able to hold countries accountable for disregarding its guidance, including pressing countries for scientific justification for their travel policies and calling out governments that have gone against its recommendations.
“Unfortunately, [governments] face domestic and international pressures, and have faced few costs in the past for not following WHO recommendations,” she said.

Health experts warn China travel ban will hinder coronavirus response

Gilead Offers Experimental Drug for Coronavirus Treatments, Testing

Gilead Sciences Inc. said on Friday that it had provided doses of an experimental antiviral drug to doctors for the emergency treatment of a small number of patients infected by the new coronavirus.
Gilead, based in Foster City, Calif., also said it has formalized an agreement with Chinese authorities to conduct a clinical trial of the drug remdesivir in patients infected with the coronavirus.
Health authorities have been searching for a treatment for China coronavirus infections, which lack an approved drug or vaccine. Several drugmakers have said they are trying to develop a vaccine, which could prevent but not treat infections.
Researchers had been hoping to study whether Gilead’s remdesivir and other antivirals could work as treatments.
Unlike some of the other antivirals being examined, Gilead’s drug isn’t approved for use in humans by regulators in the U.S. or internationally.
Separately, the drug was administered to an infected patient in Washington state, researchers reported in the New England Journal of Medicine on Friday. The man, 35 years old, had traveled to Wuhan, the Chinese city where the outbreak started, and after returning to the U.S. was the first person in the country to test positive for the China coronavirus.
The patient was given remdesivir on the seventh day of his hospitalization, Jan. 26, and the following day the patient’s clinical condition improved. As of Jan. 30, the patient remains hospitalized, but “all symptoms have resolved with the exception of his cough, which is decreasing in severity,” the researchers wrote.
On the day he was treated with the Gilead drug, the patient’s fever reached 39.4 degrees Celsius (102.9 degrees Fahrenheit). The following day it dropped to 37.3 degrees Celsius (99.1 degrees Fahrenheit) and declined into the normal range over subsequent days, the paper said.
“Before treatment he had high fevers and was getting sicker,” George Diaz, the patient’s attending physician at Providence Regional Medical Center Everett, said in an interview on Friday. “After treatment, he had reduced fevers and no longer required oxygen; his lungs cleared up, and he generally felt better.”
Dr. Diaz cautioned, however, that the drug has to be studied in large clinical trials to determine whether it is an effective treatment for the coronavirus.
A Gilead spokeswoman declined to say how many patients are receiving the drug or where they are based. In clinical trials of Ebola patients, the drug was less effective than rival treatments. In animal studies, the drug helped lessen lung disease in mice infected with Middle East respiratory syndrome, a coronavirus known as MERS.
https://www.marketscreener.com/GILEAD-SCIENCES-4876/news/Gilead-Sciences-Offers-Experimental-Drug-for-Coronavirus-Treatments-Testing-29923511/

U.S. Declares Public Health Emergency for Coronavirus

Citing the U.S. cases of novel coronavirus, including one case of human-to-human transmission and several unknown factors, the U.S. Department of Health and Human Services declared a public health emergency in the U.S. on Friday.
Beginning on February 2, 2020 at 5 p.m. Eastern time, the U.S. government will be enacting several temporary measures involving U.S. citizens returning from China back to this country, HHS Secretary Alex Azar announced at a press conference of President Trump’s Novel Coronavirus Task Force:

• U.S. citizens returning from Hubei province within 14 days, the epicenter of the outbreak in China, will be medically quarantined for up to 14 days
• All U.S. citizens returning from China within 14 days, once medically cleared in airport screening, will be asked undergo mandatory self-isolation for up to 14 days once medically cleared
• Foreign nationals considered to pose a risk of transmitting novel coronavirus will be denied entry to the country

These actions were described by officials as “prudent, targeted and temporary,” and mainly designed to reduce the burden of screening on public health officials screening for novel coronavirus.
Azar reiterated the government’s position that risks to the U.S. from the coronavirus remain low. “Our job is to keep it that way,” he added.
“Safety of the American people” was repeated over and over during the briefing, but Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, cited the “unknown aspects of this particular outbreak” as the chief reasons why this was necessary from a medical standpoint.
While the novel coronavirus has killed far fewer people than seasonal flu, the difference, Fauci said, was “unknown” versus “certainty.” Whereas with novel coronavirus, he cited asymptomatic transmission, and the inability to detect the illness when patients are asymptomatic, as a major factor.
“One of the problems is when a virus is transmitted in an asymptomatic way, it puts a terrible burden on the screening process,” Fauci said. “We still have a low risk to the American public, but we want to keep it at a low risk … because there are so many unknowns here.”

CDC Director Robert Redfield, MD, also emphasized the limitations of current novel coronavirus testing, adding that of the six cases we have seen in the U.S., a number were asymptomatic, but only one was picked up by airport screening, while the rest were “picked up by astute doctors.”
Fauci also cited the “unknown accuracy” of current diagnostic testing.
“If we absolutely had an accurate test that was very sensitive and very specific, we could test people and we’re good to go,” he said, adding “it’s not a test that’s absolute,” unlike, for example, an HIV test — which can determine with 100% accuracy if a person has HIV in their blood.
Fauci gave another example: “Ebola doesn’t get actively transmitted unless you’re very ill,” he said.
Redfield added that the self-isolation for U.S. citizens returning from China was the standard for the 2014 Ebola outbreak in West Africa, and “98% of the American public voluntarily accepted the importance of this.”

Officials stressed that this is not a “travel ban,” as all U.S. carriers to China have been taking down passenger flights, such that it has been a “market response by airlines and voluntary decisions taken by travelers.”
So far, there are 12 cases of human-to-human transmission outside China, and Redfield said they are most concerned with “expansion of sustained community human-to-human transmission,” such as the type occurring inside China.
“This is a precautionary message and action put out today,” he said, adding that it is “intended to keep this virus from causing significant consequences to the American public.”
A seventh U.S. case of novel coronavirus was confirmed by the CDC late Friday in Santa Clara County, California. This was a travel-associated case, with the man reporting travel history to Wuhan, according to NBC Bay Area. He is currently “self-isolated,” never having become sick enough to be hospitalized, the report said.
https://www.medpagetoday.com/infectiousdisease/publichealth/84662

FDA OKs Aimmune’s peanut allergy drug

Aimmune Therapeutics (NASDAQ:AIMT) +21.7% after-hours on news the Food and Drug Administration approved its Palforzia drug for patients with peanut allergies.

The oral medication is indicated for the mitigation of allergic reactions, including anaphylaxis, that occur with accidental exposure to peanuts, but it is not an emergency treatment of the reactions, the company says.

Aimmune says Palforzia is the first FDA-approved therapy for peanut allergy or for any food allergy.

Peanut allergies affect more than 1.6M children and teens in the U.S. alone.

https://seekingalpha.com/news/3537073-fda-oks-aimmunes-peanut-allergy-drug

Biogen gears up for Alzheimer’s drug launch

There are serious doubts about whether the FDA will approve Biogen’s Alzheimer’s candidate aducanumab – but is gearing up to file it with the regulator and is already looking ahead to a potential launch.
Chief executive officer Michel Vounatsos said that the company plan to file its dossier of clinical evidence for aducanumab with the FDA “as soon as possible” in a conference call with analysts as the troubled pharma announced its full year results.
The dry figures on display belie the drama that unfolded in 2019. In March, Biogen axed phase 3 development of aducanumab after deciding that it wasn’t working, only to stun markets in October by announcing plans for a filing after seeing what looks like a beneficial effect in certain patients at a high dose.
Earlier this week, the FDA even approved a re-dosing study for Alzheimer’s patients formerly enrolled on the abandoned trials, and could start receiving the drug again as early as March.
Meanwhile, Biogen is remaining coy about exactly when it plans to file its dossier with the FDA, although the company is already gearing up in case the regulator gives a positive decision.

Cited by Reuters, Vounatsos said: “We are actively preparing for the potential launch of aducanumab with an initial focus on the United States.”
Alfred Sandrock, executive vice president of research and development said the company has had a “high level of constructive engagement” with the FDA, adding that “it’s basically a matter of putting together documentation”.
The company is already factoring in launch costs in its guidance for 2020, saying it expects to spend up to 20.5% of total revenue as it ramps up its sales force to market the drug.
After a filing, the medical community and investors will get a strong indication about whether aducanumab is approvable if the FDA convenes a meeting of its expert advisors, which is highly likely in the case of a novel drug.
Any new drug for Alzheimer’s would be a major achievement as there has been nothing new to hit the market since 2003, and available treatments only help manage symptoms instead of slowing or halting progression.
If aducanumab is approved, it will be in the nick of time for Biogen, which could see its blockbuster multiple sclerosis pill Tecfidera face generic competition for the first time this year.
A key decision in a patent dispute is expected this week but in the meantime sales grew in Q4, and were up 5% to $1.2 billion.
Biogen has just launched a follow-up drug to Tecfidera called Vumerity, which is less likely to produce the gastrointestinal side-effects that cause some patients to quit.
After a launch in October it’s too early to say whether Vumerity has been a success with sales of just $5 million – but Vounatsos said it has had positive reception from health insurers.
Competition is tough though with Novartis’ Mayzent and Merck KGaA’s Mavenclad among recent MS launches.
Biogen said Q4 sales were up 4% compared with the same period last year, and total revenues grew 17% to $14.4 billion.

Biogen gears up for Alzheimer’s drug launch

University of Pennsylvania researchers nab grant for CAR-T prostate cancer test

The University of Pennsylvania, which has helped pioneer cell therapy approaches to blood cancers, has nabbed an ACGT grant to help battle solid tumors.
The research team has been handed a $500,000 grant from Alliance for Cancer Gene Therapy (ACGT), and follows on from the 2004 grant it gave Penn’s Carl June, M.D., one of the predominate scientists involved in CAR-T research.
His work helped pave the work for this type of cell therapy to halt a number of blood cancers, but the latest grant is geared toward its next-gen work: Solid tumors. This has proven a much harder nut to crack for CAR-T, but the Penn U. scientists are hoping this grant will help them on their way.

The ACGT grant was awarded to Joseph Fraietta, Ph. D, assistant professor of microbiology and a T-cell biologist with expertise in tumor immunology and translational medicine, and Naomi Haas, M.D., director of the Prostate and Kidney Cancer Program, associate professor of medicine.
“The goal of the ACGT-funded study is to overcome prostate cancer’s stubborn resistance to CAR T-cell therapy,” the University said in a statement.

Drs. Fraietta and Haas are exploring approaches for re-engineering T-cells to enable them to induce safe, long-term remission for advanced, metastatic prostate cancer patients.
“The grant from ACGT will help us advance our clinical work in a very novel way,” said Dr. Fraietta. “If we can unlock the epigenetic code that controls the fate and function of T-cells, it could be a game changer.”
Both Haas and Fraietta will explore the connection between nutrient availability and epigenetic programming, and how these factors influence the viability of T-cells and their anti-tumor functionality.
“For so many years, chemotherapy, radiation and surgery were the traditional treatments for cancer. For prostate cancer, there’s also hormone therapy,” said Honeycutt. “Unfortunately, as the cancer progresses, it often stops responding to these traditional treatments. New cell and gene therapy approaches like the ones Drs. Fraietta and Haas are employing offer new hope to all cancer patients. ACGT has been dedicated to funding innovative science that harnesses the power of cell and gene therapy and transforms how cancer is treated. The work of Drs. Fraietta and Haas is a great example of this promise.”
https://www.fiercebiotech.com/biotech/university-pennsylvania-researchers-nab-grant-for-car-t-prostate-cancer-test

No kickback: Novartis Kymriah travel assistance program gets nod from HHS

Normally, a pharma company paying a patient to take its drug looks suspicious—like a kickback—and it’s considered so under federal law. But HHS has just made a special ruling for a novel therapy.
The federal health agency now allows Novartis to pay for travel, lodging, meals and other out-of-pocket expenses for Medicare and Medicaid patients taking its CAR-T therapy Kymriah, the department’s Office of Inspector General said in an advisory opinion (PDF).
The so-called Kymriah Travel Assistance Program assists “eligible low-income patients” with expenses incurred during their travel to receive the drug—and the ensuing post-infusion monitoring phase—at one of some 100 designated treatment centers across the U.S. under an FDA-required safety program.

HHS issued the ruling at the special request of Novartis because otherwise the scheme could be punishable under anti-kickback statue of the Social Security Act. Generally, federal regulators view that these payments could unfairly steer patients to a particular drug and result in increased costs to the federal health system. But Novartis managed to persuade them.
In making the request, Novartis argued that rural patients living far from a treatment center could suffer from significant health risks or even death if they couldn’t afford travel. Because of its potentially dangerous side effects, such as cytokine release syndrome, patients who get Kymirah are monitored for at least a month.

“Due to the nature of the patient population and the serious safety risks associated with Kymriah therapy, financially needy patients may need enhanced support to access their prescribed treatment,” Novartis said in a statement shared with FiercePharma.
Several limitations have been put on the program. For example, patients must live more than two hours’ driving distance or 100 miles from the nearest available center. In addition, Novartis promises not to advertise the arrangement. Patients will not learn about it until they have been diagnosed with on-label indications and are prescribed Kymriah.
Still, while patients might not be tipped off beforehand, caregivers are aware of the existence of the program. Therefore, they may choose Kymriah over Gilead Sciences’ rival drug Yescarta for some patients.

Regulators made it clear that the ruling is meant only for this Kymriah program. Gilead didn’t immediately respond to a FiercePharma request about whether it’s seeking a similar opinion for Yescarta.
Currently, Kymriah is trailing behind Yescarta sales-wise, even though it was the first CAR-T therapy approved. In the third quarter, the Novartis drug sold $79 million, and that number went up in the fourth quarter to $96 million. In comparison, Yescarta generated $118 million in Q3.
It wasn’t so long ago when drugmakers paid up millions of dollars to settle federal allegations that they used donations to patient charities as kickbacks to cover copays for their medicines. These include Astellas coughing up $100 million, Amgen $24.75 million, Jazz Pharma $57 million, Lundbeck $52.6 million and Alexion $13 million, among others. Two charities—Good Days and Patient Access Network Foundation—also recently shelled out a combined $6 million to close U.S. Department of Justice claims.
https://www.fiercepharma.com/marketing/not-kickback-hhs-allows-novartis-kymriah-travel-assistance-program-for-public-patients

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 health treatment workforce, 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 disorders 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 substance use disorder treatment.”

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Medicaid expansion linked to gains in insurance coverage

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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

https://medicalxpress.com/news/2020-01-effect-medicaid-expansion-substance-disorder.html

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.

https://seekingalpha.com/news/3536949-boqi-medical-latest-to-capture-coronavirus-money-flow-up-44

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

France’s Pasteur Institute Foundation hoping to develop coronavirus vaccine

France’s Pasteur Institute Foundation is looking into developing a vaccine to treat the coronavirus, an official at the institute said on Friday.
Christophe D’Enfert also told reporters the vaccine could be made available in 20 months’ time.
https://www.reuters.com/article/us-china-health-france-vaccine/frances-pasteur-institute-foundation-hoping-to-develop-coronavirus-vaccine-idUSKBN1ZU1RJ

India bans export of protective masks, clothing amid coronavirus outbreak

India on Friday banned the export of personal protection equipment such as masks and clothing amid a global coronavirus outbreak.
It did not give a reason for the ban but it reported its first case of the new coronavirus on Thursday, a woman in the southern state of Kerala who was a student of Wuhan University in China.
The central Chinese city of Wuhan is the epicenter of the outbreak, and the virus has since spread to more than 9,800 people globally and killed 213 people in China.
Several Indian citizens living in Wuhan will arrive in India by plane on Saturday and be taken to a quarantine center on the outskirts of the capital New Delhi.
India, the world’s second most heavily populated country after China, has taken measures to ensure that all people arriving from China report to health authorities.
https://www.reuters.com/article/us-china-health-india/india-bans-export-of-protective-masks-clothing-amid-coronavirus-outbreak-idUSKBN1ZU20A

CMS cuts payments to 786 hospitals over high rates of infection, injury

CMS will trim 786 hospitals’ Medicare payments in fiscal year 2020 for having the highest rates of patient injuries and infections.
Five things to know:
1. Created under the ACA, the Hospital-Acquired Conditions Reduction Program aims to prevent harm to patients by providing a financial incentive for hospitals to prevent hospital-acquired conditions. Under the program, a hospital’s total score is based on performance on six quality measures. Each year, Medicare cuts payments by 1 percent for hospitals that fall in the worst-performing quartile.
2. On Jan. 29, CMS identified the 786 hospitals that will have their Medicare payments reduced for patients discharged between last October and this September, according to Kaiser Health News. The penalties will be applied as hospitals submit claims to Medicare for reimbursement.
3. According to KHN, Medicare is penalizing the following seven hospitals named to U.S. News‘ Best Hospitals Honor Roll:

• UPMC Shadyside (Pittsburgh)
• Ronald Reagan UCLA Medical Center (Los Angeles)
• Keck Hospital of USC (Los Angeles)
• Stanford (Calif.) Hospital
• UCSF Medical Center (San Francisco)
• NewYork-Presbyterian Hospital (New York City)
• Mayo Clinic (Phoenix)

4. The Hospital-Acquired Conditions Reduction Program is in its sixth year. Sixteen hospitals across the U.S. have been penalized all six years, according to KHN.
5. The hospital industry has argued the program’s design causes hospitals that do the best job of testing for infections to appear among the worst based on statistics, while those with less thorough testing might appear better than they should.
Access the full Kaiser Health News article here.
https://www.beckershospitalreview.com/finance/cms-cuts-payments-to-786-hospitals-over-high-rates-of-infection-injury.html

EssilorLuxottica Takeover of Grandvision Faces Full EU Probe

Optical company EssilorLuxottica SA’s 7.2 billion-euro ($7.94 billion) bid for peer Grandvision NV faces full-scale EU antitrust scrutiny after it declined to offer concessions to address the European Commission’s concerns, Reuters reports, citing unnamed sources.
–Retailers and rival lens makers had expressed concerns about the merger to the EU’s antitrust authority, Reuters reports.
–EssilorLuxottica gave up the chance to offer concessions on Thursday, according to information on the website of the commission. The commission is set to conclude its preliminary review on the merger on Feb. 6, Reuters reports. Both the commission and EssilorLuxottica declined to comment when contacted by Reuters.
https://www.marketscreener.com/ESSILORLUXOTTICA-4641/news/EssilorLuxottica-Takeover-of-Grandvision-Faces-Full-EU-Probe-Reuters-29921403/

Bayer considers new tactic in Roundup settlement talks

As Bayer AG tries to settle U.S. lawsuits claiming that its weedkiller Roundup causes cancer, the company is considering a proposal that would bar plaintiffs’ lawyers involved in the litigation from advertising for new clients, according to a person familiar with the matter.

Bayer has said it is engaged in mediation to resolve the litigation, which has hit its share price since it acquired Roundup as part of its $63 billion takeover of Monsanto in 2018.
The company has denied claims that Roundup or its active ingredient glyphosate causes cancer, saying decades of independent studies have shown the product is safe for human use.
The person said that Bayer believes an agreement with plaintiffs’ attorneys to ban advertising would limit the company’s future legal exposure since the “vast majority” of U.S. law firms that would bring such claims would be bound by the agreement.
Bayer declined to comment.
German newspaper Handelsblatt reported on Thursday that Bayer was considering stopping retail sales of glyphosate while continuing to serve farmers, because the bulk of plaintiffs are private users. Bayer did not comment to Reuters on this report.
The company has ruled out putting a cancer warning on the weedkiller because market regulators such as the U.S. Environmental Protection Agency have deemed it save to use, but that means lawsuits could keeping piling in.
In October, Bayer largely blamed law firms’ TV ad campaigns for the more than doubling of U.S. plaintiffs seeking damages to 42,700 within just three months.
A provision such as the one the company is considering could result in “dramatically fewer claims” so that the litigation is no longer a “big drag on Bayer’s balance sheet,” said David Noll, a professor at Rutgers Law School and expert in mass torts, who is not involved in the litigation.
In January, court-appointed mediator Ken Feinberg put the number of Roundup cancer claimants at more than 75,000, which includes those that have not been filed. Bayer said the claims it has been served with in court were below 50,000.
While such a provision is unusual, there is precedent.
As part of a 2013 settlement between Merck & Co and plaintiffs claiming the company’s Fosamax osteoporosis drug caused jaw injury, lawyers pledged that they did not intend to “solicit claims” that arose after the settlement.
Perry Weitz of Weitz & Luxenberg, one of the leading plaintiffs’ firms involved in the Roundup litigation, criticized an idea to bar firms from advertising for future clients.
“A company cannot ask a lawyer to enter an agreement to restrict his practice in the future,” he said.
He said there had not been “serious discussions about future cases,” but declined to elaborate.
Michael Miller of The Miller Firm, another major party in the talks, said that “it is possible, if done correctly, to manage the exposure to future claims.” He declined to elaborate. Three other plaintiffs firms who have brought the bulk of the claims – Baum Hedlund Aristei & Goldman; Andrus Wagstaff PC; Holland Law Firm – declined to comment. Moore Law Group PLLC did not respond to requests for comment.
Bayer’s shares have lost about 20% of their value since August 2018 when a California jury in the first lawsuit over Roundup found Monsanto should have warned of the alleged cancer risks. Bayer has lost two more jury verdicts and is appealing all three rulings.

https://www.marketscreener.com/BAYER-AG-436063/news/Bayer-considers-new-tactic-in-Roundup-settlement-talks-29921616/?countview=0

Pilots, flight attendants demand flights to China stop as global virus fear mounts

Pilots and flight attendants are demanding airlines stop flights to China as health officials declare a global emergency over the rapidly spreading coronavirus, with American Airlines’ pilots filing a lawsuit seeking an immediate halt.

China has reported nearly 10,000 cases and 213 deaths, but the virus has spread to 18 countries, mostly, presumably, by airline passengers.
The United States has advised its citizens not to travel to China, raising its warning to the same level as those for Iraq and Afghanistan.
U.S. airlines, which have been reducing flights to China this week, were reassessing flying plans as a result, according to people familiar with the matter.
It is possible the White House could opt to take further action to bar flights to China in coming days, but officials stressed that no decision has been made.
The Allied Pilots Association (APA), which represents American Airlines pilots, cited “serious, and in many ways still unknown, health threats posed by the coronavirus” in a lawsuit filed in Texas, where the airline is based.
American said it was taking precautions against the virus but had no immediate comment on the lawsuit. On Wednesday, it announced flight cancellations from Los Angeles to Beijing and Shanghai, but is continuing flights from Dallas.
APA President Eric Ferguson urged pilots assigned to U.S.-China flights to decline the assignment. In a statement, the American Airlines’ flight attendants union said they supported the pilots’ lawsuit and called on the company and the U.S. government to “err on the side of caution and halt all flights to and from China.”
Pilots at United Airlines, the largest U.S. airline to China, concerned for their safety will be allowed to drop their trip without pay, according to a Wednesday memo from their union to members.
United announced on Thursday another 332 U.S.-China flight cancellations between February and March 28, though it will continue operating round trip flights from San Francisco to Beijing, Shanghai and Hong Kong.
The American Airlines pilot lawsuit came as an increasing number of airlines stopped their flights to mainland China, including Air France KLM SA, British Airways, Germany’s Lufthansa and Virgin Atlantic.
Other major carriers have kept flying to China, but protective masks and shorter layovers designed to reduce exposure have done little to reassure crews.
‘COUNTDOWN’
A U.S. flight attendant who recently landed from one major Chinese city said a big concern is catching the virus and spreading it to families, or getting quarantined while on a layover.”I didn’t understand the gravity of the situation until I went there,” she said on condition of anonymity, describing general paranoia on the return flight, with every passenger wearing a mask.
“Now I feel like I’m on a 14-day countdown.”
Thai Airways is hosing its cabins with disinfectant spray between China flights and allowing crew to wear masks and gloves.
Delta Air Lines is operating fewer flights and offering food deliveries so crew can stay in their hotels. The carrier is also allowing pilots to drop China trips without pay, a memo from its union to members said.
Korean Air Lines Co Ltd and Singapore Airlines are sending additional crew to fly each plane straight back, avoiding overnight stays.
The South Korean carrier also said it was loading protective suits for flight attendants who might need to take care of suspected coronavirus cases in the air.
Airlines in Asia are seeing a big drop in bookings along with forced cancellations because of the coronavirus outbreak, the head of aircraft lessor Avolon Holdings Ltd said, adding the impact could last for some months.
The outbreak poses the biggest epidemic threat to the airline industry since the 2003 SARS crisis, which led to a 45% plunge in passenger demand in Asia at its peak in April of that year, analysts said.
Fitch Ratings said airlines with more moderate exposure to China and the Asia-Pacific region were likely to be able to re-deploy capacity to alternative routes to mitigate the effect on traffic, but that could increase competition on those routes and reduce airfares.
Air France, which maintained China flights throughout the SARS epidemic, suspended its Beijing and Shanghai flights on Thursday after cabin crews demanded an immediate halt.
“When the staff see that other airlines have stopped flying there, their reaction is ‘Why are we still going?’,” said Flore Arrighi, president of UNAC, one of the airline’s four main flight attendants’ unions.

https://www.marketscreener.com/news/Pilots-flight-attendants-demand-flights-to-China-stop-as-virus-fear-mounts-worldwide–29916989/?countview=0

Aduro adds to rally as bargain hunters move in

Micro cap Aduro BioTech (ADRO +18.1%) is up on almost double normal volume. Shares have rallied 60% since touching $0.99 on December 23, 2019.

Shares were in a long-term downtrend before the recent rally, pressured by Novartis’ exit from STING pathway activator ADU-S100 and a recent downsizing that cut 59% of its workforce.

Despite the bad news, SVB Leerink’s Daina Graybosch raised her fair value target to $7 (335% upside) from $3 citing the company’s modest valuation considering the upside if either of two gene therapy programs are successful and/or one of its Big Biopharma collaborations bear fruit.

https://seekingalpha.com/news/3536944-aduro-adds-to-rally-bargain-hunters-move-in-shares-up-18

ResMed buys CPAP resupply software developer

ResMed (RMD -3.1%) subsidiary Brightree has agreed to acquire privately held SnapWorx, LLC, for an undisclosed sum.

The Brentwood, TN-based SaaS provider is focused on the continuous positive airway pressure (CPAP) resupply market.

https://seekingalpha.com/news/3536954-resmed-buys-cpap-resupply-software-developer

Profound Medical gets 2020 “Best Pick” honors from Raymond James

Profound Medical Corp (Profound Medical Corp Stock Quote, Chart, News TSX:PRN) takes top honors from Raymond James analyst Rahul Sarugaser who in a Monday update to clients upped his rating from “Outperform 2” to “Strong Buy” while raising his price target from $35.00 to $45.00 for PRN.
Toronto-based Profound Medical’s TULSA-PRO technology, which is designed for the ablation of prostate tissue, combines real-time MRI with transurethral robotically-driven therapeutic ultrasound and closed-loop thermal feedback control. Last fall, the TULSA-PRO was given 510(k) marketing authorization in the US and Profound has started its marketing of the product.
On Monday, Profound announced the closing of its previously-announced equity offering of 3.4 million shares at $15.14 per share for net proceeds of C48.3 million. The injection puts PRN’s cash position at roughly $71.6 million, says Sarugaser, enough to call it the company’s last equity raise needed to fully commercialize the TULSA-PRO.
Sarugaser likes Profound’s move from a capital equipment sales model to a pure-play recurring revenue model, where the company will charge a pay-per-use fee with no installation costs. The analyst figures the model will reach a steady state COGS margin of 30 per cent by 2023, with Sarugaser projecting installations of ten, 22 and 38 units in years 2020, 2021 and 2022, respectively.
“These units, we estimate, will have average utilization rates increasing from 74, to 90, to 106 annual patients per device during those same years, driving revenues of $11.1 million, $27.2 million, and $63.4 million, respectively. Given that we anticipate PRN generating $5.4 million in 2019FY, we recognize that $11.1 million in 2020 appears relatively modest. These light 2020 revenues we see as a function of PRN substituting short-term capital equipment revenue with massive, long-term recurring revenue. We view this as a deft strategy enacted by PRN’s veteran management,” Sarugaser wrote.
The analyst warns that while PRN’s share price could have less upside over the shorter term, for investors looking at the long-term Profound “represents an extremely attractive investment proposition” and thus gets Sarugaser’s “2020 Best Pick” status.
In particular, Saruagser has high praise for Profound’s management, saying
“We remind you that PRN’s CEO, Dr. Arun Menawat, and CFO, Mr. Aaron Davidson, previously worked together at Novadaq technologies, growing the company from a small, Toronto-based start-up to a billion dollar Nasdaq-listed company, which was eventually sold to Stryker for 20x sales (US $700 million). This seasoned management team, indeed, has been there, done that. We have deep confidence in management’s capacity to execute the deft plan they have set out for PRN. For all these reasons, we have selected PRN as our 2020 Best Pick,” Sarugaser says.
The analyst sees PRN registering $11 million in revenue in fiscal 2020 and an EBITDA loss of $23 million. At the time of publication, his new $45.00 target represented a projected 12-month return of 182 per cent. PRN finished 2019 up 168 per cent for the year.

Profound Medical gets 2020 “Best Pick” honours from Raymond James

Lilly launches migraine med Reyvow

Eli Lilly (LLY -1.7%) announces that Reyvow (lasmiditan) C-V 50 mg and 100 mg tablets, indicated for the acute treatment of migraine with or without aura, is now available for prescription and will be available in U.S. pharmacies in the next several days.

Lasmiditan is an orally available 5-HT1F receptor agonist that blocks pain transmission without the side effects of the class of migraine therapies called triptans. The 5-HT1F receptor is a serotonin subtype that lacks the vasoconstrictive properties of other serotonin receptors which can cause adverse cardiac events in patients with cardiovascular or cerebrovascular disease.

The FDA approved the medicine in October 2019. The time lag before launch was due to a DEA review of the drug’s classification.

https://seekingalpha.com/news/3536929-lilly-launches-migraine-med-reyvow

Analyst action, Jan. 31

AdaptHealth (NASDAQ:AHCO) initiated with Buy rating and $17 (31% upside) price target at Stifel.

DURECT (NASDAQ:DRRX) initiated with Buy rating and $5 (158% upside) price target at B. Riley FBR. Shares up 6% premarket.

InMed Pharmaceuticals (IN CN) initiated with Buy rating and C$1.50 (341% upside) price target at Maxim Group (OTCQX:IMLFF).

Neptune Wellness Solutions (NEPT CN) initiated with Market Perform rating and C$3.75 (14% upside) (NASDAQ:NEPT).

Phreesia (NYSE:PHR) initiated with Overweight rating and $36 (15% upside) price target at KeyBanc.

Arena Pharmaceuticals (NASDAQ:ARNA) upgraded to Overweight with a $58 (32% upside) price target at JPMorgan. Shares up 2% premarket.

United Therapeutics (NASDAQ:UTHR) upgraded to Overweight with a $120 (25% upside) price target at JPMorgan.

Amgen (NASDAQ:AMGN) downgraded to Underperform with a $185 (18% downside risk) price target at Baird on soft 2020 guidance. Shares down 3% premarket.

Global Blood Therapeutics (NASDAQ:GBT) downgraded to Hold with a $75 (10% upside) price target at SunTrust Robinson Humphrey.

Intra-Cellular Therapies (NASDAQ:ITCI) downgraded to Neutral with a $26 (13% upside) price target at JPMorgan. Shares down 9% premarket.

ResMed (NYSE:RMD) downgraded to Neutral at UBS after FQ2 results.

Rubius Therapeutics (NASDAQ:RUBY) downgraded to Neutral with a $9 (17% upside) price target at JPMorgan. Shares down 5% premarket.

https://seekingalpha.com/news/3536846-baird-downgrades-amgen-on-soft-guidance-in-premarket-analyst-action

Merck withdraws Keytruda application in Europe for esophageal cancer

Merck (NYSE:MRK) has withdrawn its marketing application in Europe seeking approval to use Keytruda (pembrolizumab) to treat cancer of the esophagus. The EMA determined that the data supporting the application were not sufficient to prove that treatment prolonged survival.
https://seekingalpha.com/news/3536882-merck-withdraws-keytruda-application-in-europe-for-esophageal-cancer

EMA accepts Seattle Genetics’ tucatinib application for HER2+ breast cancer

The European Medicines Agency (EMA) has accepted for review Seattle Genetics’ (SGEN +0.4%) marketing application seeking approval for tyrosine kinase inhibitor tucatinib, combined with HER2/neu receptor antagonist trastuzumab and chemo agent capecitabine, for adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, who have received at least two prior lines of anti-HER2 therapy.

The company filed its application in the U.S. a month ago under the FDA’s Real-Time Oncology Review Pilot Program.

https://seekingalpha.com/news/3536908-ema-accepts-seattle-genetics-tucatinib-application-for-her2-breast-cancer

Reata Pharma up 11% on potential acquisition interest

Reata Pharmaceuticals (RETA +10.9%) is up out the gate on reports that Amgen (AMGN -3.9%) is mulling acquiring assets in the space.

Reata’s lead candidate is bardoxolone methyl, in late-stage development for a kidney disorder called Alport syndrome, connective tissue disease-pulmonary arterial hypertension and focal segmental glomerulosclerosis.

Another late-stage candidate is omaveloxolone for a degenerative neuromuscular disorder called Friedreich’s ataxia.

https://seekingalpha.com/news/3536894-reata-pharma-up-11-on-potential-acquisition-interest

Celgene withdraws enasidenib application in Europe

Bristol-Myers Squibb (NYSE:BMY) unit Celgene (NASDAQ:CELG) has withdrawn its marketing application in Europe for Idhifa (enasidenib) for the treatment of adults with acute myeloid leukemia (AML).

The company took action after determining that it could not fully address EMA objections. Specifically, the agency concluded that the data supporting the application were insufficient to prove efficacy.

https://seekingalpha.com/news/3536875-celgene-withdraws-enasidenib-application-in-europe

European advisory group backs expanded use of J&J’s Rezolsta

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending an expanded label for Johnson & Johnson (NYSE:JNJ) unit Janssen-Cilag International NV’s HIV med Rezolsta (darunavir/cobicistat) to now include adolescents as young as 12 years old (previously 18 years old) weighing at least 40 kg.

A final decision from the European Commission usually takes ~60 days.

https://seekingalpha.com/news/3536851-european-advisory-group-backs-expanded-use-of-j-and-js-rezolsta

European advisory group backs Pfizer’s crisaborole for atopic dermatitis

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of Pfizer’s (NYSE:PFE) Staquis (crisaborole) for the treatment of adults and pediatric patients at least two years old with mild or moderate atopic dermatitis with no more than 40% of body surface area affected.

A final decision from the European Commission usually takes ~60 days.

https://seekingalpha.com/news/3536796-european-advisory-group-backs-pfizers-crisaborole-for-atopic-dermatitis

Bayer Gets EU Panel Recommendation for Prostate Cancer Treatment

Bayer AG said Friday that the European Union’s Committee for Medicinal Products for Human Use has given a positive opinion on its darolutamide medicine as a new treatment for men with a particular type of prostate cancer.
The compound–jointly developed with ORION Corp. (271560.SE)–is recommended for men with non-metastatic castration-resistant prostate cancer who have a high risk of developing metastatic disease, the pharmaceutical firm said.
In most cases a recommendation leads to marketing approval. Bayer said that it expects a decision to be made in the coming months.

https://www.marketscreener.com/BAYER-AG-436063/news/Bayer-Gets-EU-Medicines-Agency-Recommendation-for-Prostate-Cancer-Treatment-29920247/

EMA Recommends Novo Nordisk Diabetes Drug for Marketing Approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use said Friday that it is recommending Rybelus, a drug developed by Novo Nordisk A/S (NOVO-B.KO), as a treatment for type 2 diabetes.
The committee said this was the first oral glucagon-like peptide, or GLP-1, treatment to be recommended for this indication. This recently-developed class of drugs is a non-insulin medicine for type 2 diabetes which helps regulate insulin levels and has been shown to help achieve weight loss.
“We believe [Rybelus] has the potential to set a new standard for the treatment of type 2 diabetes in the EU,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk.
In most cases a recommendation by the CHMP leads to European marketing approval. Novo Nordisk said it expects to receive marketing authorization in the second quarter. The drug is already approved in the U.S.

https://www.marketscreener.com/NOVO-NORDISK-AS-1412980/news/Novo-Nordisk-EMA-Recommends-Novo-Nordisk-Diabetes-Drug-for-Marketing-Approval-29920377/

Astellas Pharma keeps profit forecast as prostate cancer drug sales rise

Japan’s Astellas Pharma Inc reiterated its full-year operating profit forecast on Friday, as a jump in sales of its prostate cancer drug Xtandi countered overseas acquisition costs.

The company said it expects an operating profit of 263 billion yen ($2.4 billion) for the year ending March 31, higher than analysts’ average expectation of 256 billion yen, according to IBES data from Refinitiv. Astellas reported an annual operating profit of 244 billion yen last year.
Shares in the company closed 2.4% higher in Tokyo compared with a 1% rise in the broader market.
Sales of Xtandi rose 18% to 298 billion yen in the third quarter ended Dec. 31.
However, core operating profit for the quarter was 3.3% lower, hurt partly by a 2.5% drop in revenue from Prograf, used to prevent rejection of organ transplants.
The company also said it will book a one-off charge of about $100 million in the fourth quarter related to its purchase of U.S.-based biotech Audentes Therapeutics Inc.
Astellas, the country’s second-biggest drugmaker by sales, has ramped up overseas acquisitions to broaden its drug pipeline.
The company said in December it would pay up to $665 billion for Xyphos Biosciences Inc to expand its immuno-oncology business. Earlier that month, Astellas said it would purchase Audentes in a deal worth $2.65 billion to expand into genetic medicines.
Both Xyphos and Audentes are based in San Francisco, a hub for biotech companies that are fetching huge premiums for global pharma firms eager to bolster their drug pipelines.
Among other major Japanese pharma companies reporting earnings, Daiichi Sankyo Co, Japan’s fourth-largest drug company by sales, raised its full-year operating profit forecast, citing lower taxes. It expects to earn 135 billion yen in the year ending March 31 versus 125 billion predicted in October.
Eisai Co, the partner of Biogen Inc on Alzheimer’s disease drug candidate aducanumab, maintained its full-year operating profit forecast at 110 billion yen, a 16% increase from last year, driven by sales of its cancer drug Lenvima.
Daiichi Sankyo shares rose 1.6% while Eisai gained 2.2%.

https://www.marketscreener.com/ASTELLAS-PHARMA-INC-6491262/news/Astellas-Pharma-keeps-profit-forecast-as-prostate-cancer-drug-sales-rise-29918320/

AbbVie Venclyxto Gets Positive Opinion from Euro panel

AbbVie said Friday the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for Venclyxto venetoclax in combination with obinutuzumab for the treatment of patients with chronic lymphocytic leukemia who were previously untreated.
The company said the European Commission is expected to deliver its final decision in the first half of 2020.
AbbVie said if Venclyxto is approved by the EC, the venetoclax and obinutuzumab combination would be the first chemotherapy-free option for treatment-naive patients with chronic lymphocytic leukemia where dosing can be completed in one year.
The CHMP positive opinion is based on results from the Phase 3 CLL14 clinical trial, which evaluated the efficacy and safety of Venclyxto in combination with obinutuzumab compared with chlorambucil in combination with obinutuzumab. The primary endpoint was progression-free survival as assessed by an investigator.
Venclyxto is being developed by AbbVie and Roche (RHHBY). It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

https://www.marketscreener.com/ABBVIE-INC-12136589/news/AbbVie-Venclyxto-Gets-CHMP-Positive-Opinion-29920345/

European advisory group backs Esperion’s bempedoic acid

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion backing approval of Esperion Therapeutics’ (NASDAQ:ESPR) bempedoic acid, branded as Nilembo, for  the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidemia. The applicant is FGK Representative Service GmbH (manages the regulatory filing process for companies without subsidiaries within the EU and Switzerland).

A final decision from the European Commission usually takes ~60 days.

https://seekingalpha.com/news/3536771-european-advisory-group-back-esperions-bempedoic-acid

NanoViricides up 38% after confirming work on coronavirus treatment

NanoViricides (NYSEMKT:NNVC) is, again, leading coronavirus outbreak-related tickers premarket. Shares are up 38% on average volume after it confirmed that it is working on a treatment for 2019-nCoV, also known as the Wuhan coronavirus.

President & Executive Chairman Anil Diwan, Ph.D. stated that the company has initiated a program but it will need support from governmental and international agencies such as the US CDC, WHO, and Chinese CDC but has not been contacted as yet.

2019-nCov is closely related to SARS-CoV which caused the outbreak in 2002-2003, with the same cell surface receptor, ACE2. According to Dr. Diwan, they have already identified some candidate ligands in their chemical library that can bind to the SARS-CoV spike protein in the same way as ACE2.

Related tickers and premarket movement: Allied Healthcare Products (NASDAQ:AHPI) (+7%), Novavax (NASDAQ:NVAX) (+2%), Alpha Pro Tech (NYSEMKT:APT) (+6%), Co-Diagnostics (NASDAQ:CODX) (+11%), Cleveland BioLabs (NASDAQ:CBLI) (+10%), Inovio Pharmaceuticals (NASDAQ:INO) (+1%)

https://seekingalpha.com/news/3536746-nanoviricides-up-38-after-confirming-work-on-coronavirus-treatment

Worst Month Since August in Sight Amid Virus Outbreak: EM Review

Emerging-market stocks and currencies are heading for their worst month since August amid concerns about the impact of the coronavirus on global growth. The following is a roundup of news and highlights in developing economies for the week ending Jan. 31.

Highlights:

• The World Health Organization called the outbreak of coronavirus in China a global health emergency, citing the risk that the sometimes-deadly virus could expand to other countries beyond the smattering of cases outside China so far
  • The U.S. and Japanese governments advised their citizens to avoid travel to China
  • The offshore yuan weakened past 7 per dollar for the first time this year on Thursday
  • Read: China’s Financial Markets Will Reopen to a Barrage of Selling
  • The death toll in China from the virus rose to 213 and confirmed cases in the Asian nation jumped to 9,692, the National Health Commission reported Friday, up from about 7,700 a day earlier. In the U.S., health officials reported the first case of human-to-human transmission of the virus
  • READ: Tourism Businesses Worldwide Brace for a Hit Worse Than SARS
• The first official indicator of the Chinese economy in 2020 signaled the nation’s factories were struggling even before the country shut down for the Lunar New Year holidays and the coronavirus outbreak worsened
  • Direct impact of the coronavirus outbreak is mostly on demand as people stay home, while on supply side there have been transport stoppages and workers idled, International Monetary Fund spokesman Gerry Rice said
• Federal Reserve Chairman Jerome Powell signaled the central bank would pull out all the stops to combat a global disinflationary downdraft, foreshadowing a potential shift toward an easier monetary policy
• Republican Senator Lamar Alexander said he will vote against calling witnesses in President Donald Trump’s impeachment trial, all but closing off chances that Democrats can secure new evidence and making it increasingly likely the trial will wrap up as soon as Friday
• Hungary left its monetary policy unchanged as central bankers looked past the weakest forint on record in anticipation that surging inflation will slow
• The U.S. and Kenya are expected to announce negotiations on a free-trade agreement, America’s first such deal with a sub-Saharan country, a person familiar with the plans said
• Kenya’s central bank joined its South African counterpart by unexpectedly cutting interest rates, citing well-anchored inflation expectations and an economy that’s operating below its potential. The monetary policy committee reduced its key rate to 8.25% from 8.5%
• Inflows to exchange-traded funds focused on emerging markets slumped to the lowest in seven weeks as a deadly virus from China spread throughout the world

Asset Moves as of 3:31 p.m. in Singapore on Friday:	Weekly	January
MSCI EM stocks index	-4.4%	-4.0%
MSCI EM FX index	-0.7%	-0.9%
Bloomberg Barclays Global EM Local Currency bond index (up to Thursday)	-0.3%	+0.2%

Asia:

• China’s onshore markets were shut for the extended Lunar New Year holidays
• The spread of the novel coronavirus may negatively affect South Korea’s economy, and sufficient and swift budget support is needed to prevent that, Finance Minister Hong Nam-ki said
  • South Korea will take steps to stabilize markets in case the fear of the coronavirus expands, Vice Finance Minister Kim Yong-beom said
  • Confidence among consumers jumped to the highest level since June 2018 in January
  • The nation’s industrial output rose in December the most in three years and semiconductor stockpiles dropped
  • The U.S. military has begun issuing furlough warnings to almost 9,000 civilian South Korean employees, as Washington and Seoul remain at loggerheads over President Trump’s demand its ally pay more money for its hosting of American troops
• U.S. Trade Representative Robert Lighthizer will be in India in the second week of February to finalize a trade deal ahead of Trump’s expected visit, according to people with knowledge of the matter
  • India has set up coronavirus screening across 21 airports and in border states
  • The Reserve Bank of India nominates Janak Raj as monetary policy panel member
  • India’s Finance Ministry officials recommended the government cut some subsidies and reallocate spending to sectors where it can help spur demand in the economy, according to people familiar with the matter
• Foreign direct investment into Indonesia rose 7.7% to 423.1 trillion rupiah ($31 billion) last year from 392.7 trillion rupiah a year earlier
  • Bank Indonesia projects economic growth of 5.5%-6.1% in 2024
  • Central banks cannot be the only game in town amid unprecedented uncertainty and global slowdown, according to Bank Indonesia Governor Perry Warjiyo
  • The central bank continued to intervene in the markets to stabilize rupiah
• Thailand’s government said it will consider new steps to support the economy, which is on course for disappointing performance because of the coronavirus outbreak, a stalled budget and a sapping drought
  • The Tourism Authority of Thailand expects the number of Chinese visitors to fall by “at least 2 million” amid the outbreak of virus, TAT Governor Yuthasak Supasorn said
  • Thailand “can 100% control” the spread of the novel coronavirus that originated in China, but won’t be complacent, Prime Minister Prayuth Chan-Ocha said
  • The Finance Ministry cut its 2020 economic growth forecast to 2.8% from its October projection of 3.3% and sees the baht averaging 30.50 per dollar this year
  • The Bank of Thailand cut the auction size for some bills and bonds. The maximum issue size per auction for three- and six-month bills and two-year bonds is reduced, the central bank said
  • The nation’s court accepted case seeking ruling on budget vote’s validity
• The Philippine central bank will go slow on monetary easing this year on signs that economic growth will stay robust and inflation will remain stable, Governor Benjamin Diokno said
• The virus outbreak could hurt Malaysia’s economy and the nation will monitor food trade movement to safeguard the safety of Malaysians, Economic Affairs Minister Azmin Ali said
• The outbreak of the coronavirus is unlikely to affect Taiwan’s investments or exports as Taiwanese companies with operations in China may accelerate repatriation of investments back to Taiwan, National Development Council Deputy Minister Cheng Cheng-mount said
  • President Tsai Ing-wen said she has instructed her administration to prepare measures to stabilize equity and foreign-exchange markets to weather the impact of the coronavirus on the economy
  • Economic growth outlook and repatriation of funds by Taiwanese companies indicate ample momentum, Taiwan’s Minister of Finance Su Jain-rong said
  • At least 5 board members of Taiwan’s central bank said they see no need to cut rates, according to the minutes of the Dec. 19 meeting released Thursday

EMEA:

• Polish economic growth slowed to its worst in three years in 2019, a result that suggests the expansion decelerated to below 3% on an annual basis in the last quarter
  • The European Union’s top official for judicial affairs pressed Poland to help find a solution to their clash over the rule of law, which legal experts warn can isolate the ex-communist country from the rest of the bloc
• Turkey’s central bank made no changes to its inflation outlook for the end of this year and next, reinforcing a message of confidence that it’s keeping a lid on prices despite a pickup in cost pressures and rapid-fire cuts to interest rates under the new governor
  • President Recep Tayyip Erdogan voiced rare recent criticism of Russia for its conduct in Syria, saying his “patience is running out” over the ongoing bombing of opposition Islamist forces in Idlib province
  • Turkey will take additional measures against “terror attacks” on civilians and its troops in Syria, especially in Idlib, despite agreements with “active nations,” according to National Security Council meeting declaration released late Thursday
• Moody’s Investors Service said it is looking for signs of a credible medium-term vision for South Africa and said it’s “a bit early” to judge the government’s policy and structural reforms after changing its outlook on the country’s credit ratings to negative almost three months ago
  • South Africa has no fiscal space left and must implement strong budget consolidation and state-owned company reforms to ensure its debt sustainability, the IMF said
• Saudi Arabia is “closely monitoring” the effect of the Chinese coronavirus outbreak on the oil market, but so far believes the crisis will have a “very limited impact” on global demand
• Russia plans to help Lebanon cope with its financial crisis and is considering a $1 billion deposit with its central bank, Beirut-based Al-Akhbar newspaper reports, citing information it obtained
• The United Arab Emirates reported the first cases of the novel coronavirus in the Middle East on Wednesday
• The Bank of Angola left its key rate unchanged at 15.5%
• Economic growth in Rwanda could accelerate to more than 10% this year if construction of a planned $1.3 billion airport starts, according to the World Bank, which increased its estimate for 2019 expansion for a second time
• Zimbabwe’s government has approached the U.A.E. in hopes of selling a stake in its national oil company, according to three company and government officials familiar with the plan. It also wants companies in the U.A.E. to buy more of its gold, they said

Latin America:

• Argentina’s government has laid out a timeline for its debt negotiations with private creditors, but analysts are skeptical about its ability to meet the March 31 deadline to wrap up talks with bondholders
  • The IMF expects to send staff to Buenos Aires in February for a technical mission as Argentina’s record $56 billion credit line remains on hold
  • The Province of Buenos Aires improved the terms it’s offering bondholders if they agree to accept delayed payments
  • Central bank lowered the floor of its benchmark interest rate for the fifth time under President Alberto Fernandez in an effort to stimulate growth and make credit more accessible.
  • Central bank is forecasting a “significant” slowdown in inflation after consumer prices rose 54% last year
• Brazil’s Lower House speaker Rodrigo Maia said the tax reform bill is expected to be voted on in April
  • Rapporteur of tax reform in the Lower House said Congress aims to pass the bill in both the House and the Senate in the first half of the year
  • Economy minister Paulo Guedes said the government will send a public sector reform proposal to Congress and will do everything to get the tax reform approved this year
  • Brazil economists lowered their forecasts for both the key rate and inflation this year after activity data disappointed
  • Country received $3.7 billion in foreign direct investment Jan. 1-23, the central bank’s statistics department head said
• Chile kept its benchmark rate unchanged as the worst social unrest in decades clouds the outlook for economic growth and saps demand for the peso
  • Congress approved a tax bill presented by the administration of President Sebastian Pinera to fund its social agenda and ease months of social unrest
• Mexico’s economy was flat in the fourth quarter as industrial output shrank, capping an economic contraction in 2019, the first year of President Andres Manuel Lopez Obrador’s term
  • Trump signed into law a new trade pact with Canada and Mexico on Wednesday, sealing a political victory that will help neutralize Democratic attacks on his economic record
  • Retail sales rose 2.1% in November from a year ago, exceeding a 0.4% forecast
• Peru’s “disappointing” 2019 economic growth figure didn’t accurately reflect strong numbers posted in several key areas, central bank President Julio Velarde said
  • A split new Congress in Peru and a dramatic collapse in support for the opposition Fujimori family may smooth the path of President Martin Vizcarra as he tries to pass economic and judicial reforms in his final 18 months in power
• Bolivia has depleted its “war chest” of international reserves to the point that it no longer has enough dollars to defend the nation’s fixed exchange rate, according to Fitch Ratings

https://www.bloomberg.com//news/articles/2020-01-31/worst-month-since-august-in-sight-amid-virus-outbreak-em-review