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Sunday, February 2, 2020

DoD chief OKs request for housing assistance to contain coronavirus

Secretary of Defense Mark T. Esper approved a request from the Department of Health and Human Services (HHS) Saturday to provide housing assistance for about 1,000 overseas travelers upon arrival from China that may have to be quarantined for exposure to the coronavirus.
The Department of Defense (DOD) will provide housing, while all other aspects of the quarantine like medical care, monitoring and transportation will be handled by HHS.
“Under the request, DOD will only provide housing support, while HHS will be responsible for all care, transportation, and security of the evacuees” a spokesperson for the DOD said in a statement obtained by The Hill via email.
In addition, the statement noted that personnel from the DOD will not interact directly with the evacuees from China, and those evacuated will not have access to other locations besides the ones that have been provided and assigned to them by the DOD.
The travelers from China will be monitored for 14 days, and further placement into a nearby hospital will be determined by HHS, should individuals’ medical condition worsen or require more immediate care.
The announcement comes as the U.S. has evacuated 195 Americans from China this week. Those evacuees are being held by The Centers for Disease Control and Prevention (CDC) at an airbase in California for a duration of 14 days as well.
On Friday, President Trump declared the coronavirus outbreak a public health emergency and restricted travel to and from China. Earlier this week, the World Health Organization called the outbreak a global health emergency.
As of Saturday, over 12,000 cases of the virus have been reported worldwide and over 250 people have died. In addition, on Saturday, a man in Massachusetts became the eighth case of the coronavirus found in the U.S.
https://thehill.com/policy/healthcare/481044-defense-secretary-approves-request-for-housing-assistance-to-contain

TSA tells airlines to ask passengers if they’ve been to China

The Transportation Security Administration (TSA) has told airlines to ask passengers on international flights if they’ve been to mainland China in the past two weeks.
The TSA issued the directive Saturday to go into effect Sunday at 5 p.m. ET in light of the new coronavirus spreading to 14,000 cases in more than 20 countries and territories, CNN reported.
U.S. citizens who have traveled to China in the past 14 days will be allowed to enter the country in one of seven airports: Honolulu, Los Angeles, San Francisco, Seattle-Tacoma, Chicago O’Hare, Atlanta and John F. Kennedy International airports, TSA administrator David Pekoske said in an email sent Saturday to employees.
But the Centers for Disease Control and Prevention is authorized to conduct medical screening with travelers from any airport with direct flights to the U.S., according to the email obtained by CNN.
U.S. citizens who have been to the Hubei province, the center of the epidemic, within the past 14 days will be subject to up to 14 days of mandatory quarantine. Other citizens who have been to mainland China in the past two weeks will experience a health screening and up to two weeks of monitored self-quarantine to limit public health risk
Airlines will deny travel to Chinese nationals coming from China to another foreign airport, with those with pre-clearance being exempted. Non-U.S. citizens who have been to China in the past two weeks also will not be allowed to fly to the U.S., according to the email.
All frontline employees will also be allowed to wear surgical masks.
The coronavirus has spread to at least 20 countries and territories, killing 304 people in China and one man in the Philippines.
There are eight confirmed cases in the U.S., but Heath and Human Services Secretary Alex Azar said, “I want to stress: the risk of infection for Americans remains low, and with these and our previous actions, we’re working to keep the risk low,” CNN reported.
https://thehill.com/policy/healthcare/public-global-health/481098-tsa-tells-airlines-to-ask-passengers-if-theyve-been-to

Documenting first case of coronavirus spread by a person showing no symptoms

People showing no symptoms appear to be able to spread the novel coronavirus that has caused an outbreak in China and led world health authorities to declare a global emergency, researchers reported Thursday in the New England Journal of Medicine. If confirmed, the finding will make it much harder to contain the virus.
The case described — from Germany — could help resolve one of the major unknowns about the virus, which as of Thursday night had infected nearly 9,700 people in China and killed 213. About 100 more infections have been reported in 18 other countries, but no deaths.
Some viruses, including SARS, which is another coronavirus, can only be passed when a person is showing symptoms. Others, like the flu, can be spread a day or two before the onset of symptoms. If people are contagious before they become sick, they can be unknowingly spreading the virus as they go shopping or to work or to the movies. Trying to snuff out the virus in that case is a much more difficult task.
What’s also concerning is that the spread from an asymptomatic person appeared to lead to two generations of cases, meaning the person who contracted the virus then passed it on to others.
The infection described in the new paper involved a woman from Shanghai who traveled to Germany for a business trip from Jan. 19 to Jan. 22 and displayed no signs of the disease, which include cough and fever. She only became sick on her flight back to China, and was confirmed on Jan. 26 to have the virus, known provisionally as 2019-nCoV.
On Jan. 24, however, a 33-year-old German businessman who had had meetings with the woman on Jan. 20 and 21, developed a sore throat, chills, and muscle soreness, with a fever and cough arriving the following day. He began to feel better and returned to work Jan. 27.
After the woman was found to have the virus back in China, disease detectives went to work, getting in touch with people who had been in touch with the woman — including the German businessman, who by then had recovered and appeared healthy during an examination in Munich. Tests, however, showed he had the virus.
On Jan. 28, three coworkers of the businessman tested positive for the virus. Only one of these patients had contact with the woman from Shanghai; the other two only had contact with the German man.
All four patients in Germany were isolated in hospitals and have not shown any signs of severe illness.
“The fact that asymptomatic persons are potential sources of 2019-nCoV infection may warrant a reassessment of transmission dynamics of the current outbreak,” the experts wrote.
Germany is one of four countries, along with Vietnam, Japan, and, as of Thursday, the United States, to report limited local transmission of the virus outside of China. The large majority of cases outside China were identified in people who had picked up the virus in China and then traveled to other countries.
The increasing risk the virus seems to be posing to countries outside of China led the World Health Organization on Thursday to declare a public health emergency of international concern, or PHEIC.
Until now, there was some debate whether asymptomatic transmission of the coronavirus was possible. Health officials in China said last weekend that they had seen evidence of such spread, but U.S. health officials and leaders at the World Health Organization had repeatedly said that was a question they were still trying to answer.
Even if asymptomatic people can spread the virus, they may be less likely to than people who are sneezing and coughing — routes for the virus to jump from one person to another.
Study documents first case of coronavirus spread by a person showing no symptoms

Biotech week ahead, Feb. 3

Biotech stocks see-sawed through the week ended Jan. 31 and ended the month lower overall. Big pharma earnings of the week were mostly disappointing.
Pfizer Inc. PFE 0.49% reported disappointing fourth-quarter earnings and Amgen, Inc. AMGN 4.47% guided 2020 below consensus, while Eli Lilly And Co LLY 2.11% managed to outperform expectations.
The week continued to see coronavirus-related spikes, with Cleveland BioLabs, Inc. CBLI 34.29%, NanoViricides, Inc. NNVC 40.15%, Vir Biotechnology, Inc. VIR 13.17% and Vaccinex, Inc. VCNX 8% among the stocks riding on the momentum.
Acceleron Pharma Inc XLRN 5.19% was one of the standout gainers of the week, thanks to a positive midstage clinical readout.
The much-anticipated FDA verdict on Aimmune Therapeutics Inc’s AIMT 2.91% peanut allergy drug Palforzia came through in the week, with the regulatory agency greenlighting the drug.

Turning ahead to the unfolding week, the following are key catalysts that could create a ripple in the biotech space.

Conferences

  • 2nd International Scientific & Clinical Congress on Spinal Muscular Atrophy: Feb. 5-7 in Paris, France
  • The European Association for Hemophilia and Allied Disorders, or EAHAD, 2020 Congress: Feb. 5-7 in Hague, Netherlands
  • ASCO-SITC Clinical Immuno-Oncology Symposium: Feb. 6-8 in Orlando, Florida
  • Angiogenesis, Exudation, and Degeneration 2020: Feb. 8 in Miami, Florida

Clinical Readouts

Forty Seven Inc FTSV 7.11% is due to present at the ASCO-SITC Symposium Phase 1b data for magrolimab + avelumab in ovarian cancer.
Jounce Therapeutics Inc JNCE 0.47% will present at the ASCO-SITC Symposium Phase 1/2 data for vopratelimab, codenamed JTX-2011, in solid tumors. (Feb. 6)
Catalyst Biosciences Inc CBIO 5.46% is scheduled to present at the EAHAD Congress Phase 2b data for dalcinonacog alfa in hemophilia B. (Feb. 7)
Kodiak Sciences Inc KOD 2.19% is due to present at the Angiogenesis, Exudation, and Degeneration 2020with Phase 1b data for KSI-301 in diabetic macular edema (Feb. 8)
Adverum Biotechnologies Inc ADVM 5% will present at the Angiogenesis, Exudation, and Degeneration 2020 with Phase 1 data for ADVM-022 in wet age-related macula degeneration. (Feb. 8)

Earnings

Monday
  • Catalent Inc CTLT 1.39% (before the market open)
  • Taro Pharmaceutical Industries Ltd. TARO 0.64% (after the close)
Tuesday
  • Zimmer Biomet Holdings Inc ZBH 2.19% (before the market open)
  • Haemonetics Corporation HAE 1.84% (before the market open)
  • BIO-TECHNE Corp TECH 1.42% (before the market open)
  • Neurocrine Biosciences, Inc. NBIX 1.41% (after the close)
  • Gilead Sciences, Inc. GILD 1.3% (after the close)
  • Qiagen NV QGEN 0.66% (after the close)
Wednesday
  • Merck & Co., Inc. MRK 1.21% (before the market open)
  • Boston Scientific Corporation BSX 3.59% (before the market open)
  • Arrowhead Pharmaceuticals Inc ARWR 0.94% (after the close)
  • Cardiovascular Systems Inc CSII 3.86% (after the close)
  • Misonix Inc MSON 5.06% (after the close)
  • SurModics, Inc. SRDX 1.3% (after the close)
Thursday
  • ABIOMED, Inc. ABMD 0.3% (before the market open)
  • Bristol-Myers Squibb Co BMY 1.35% (before the market open)
  • Alnylam Pharmaceuticals, Inc. ALNY 0.57% (before the market open)
  • Regeneron Pharmaceuticals Inc REGN 0.52% (before the market open)
  • Twist Bioscience Corp TWST 3.28% (after the close)
  • Anavex Life Sciences Corp AVXL 1.04% (after the close)
  • Pacific Biosciences of California PACB 0.43% (after the close)
  • Enanta Pharmaceuticals Inc ENTA 1.94% (after the close)
  • Myriad Genetics, Inc. MYGN 2.23% (after the close)
  • Seattle Genetics, Inc. SGEN 1.35% (after the close)
  • Natus Medical Inc NTUS 1.57% (after the close)
  • LeMaitre Vascular Inc LMAT 0.85% (after the close)
  • Ligand Pharmaceuticals Inc. LGND 2.23% (after the close)
Friday
  • AbbVie Inc (NYSE: ABBV (before the market open)
  • Meridian Bioscience, Inc. (NASDAQ: VIVO (before the market open)

IPOs

Beam Therapeutics plans to offer 6.25 million shares in an IPO, with the offering expected to be priced between $15 and $17. The company, which is engaged in developing therapies based on single-base gene editing, has applied for listing its shares on the Nasdaq under the ticker symbol “BEAM.”
Contract research organization PPD is planning a 60-million-share IPO to be priced in the range of $24-$27. The shares are to be listed on the Nasdaq under the ticker symbol “PPD.”
https://www.benzinga.com/general/biotech/20/02/15229115/the-week-ahead-in-biotech-merck-bristol-myers-earnings-conference-presentations-in-focus

Impacts of Apple’s China closure are negligible – Wedbush

How will Apple’s (NASDAQ:AAPL) decision to temporarily shutter its stores in China (through Feb. 9) affect the iPhone maker’s top line?
“We believe with the limited transportation in major cities throughout China and limited foot traffic in Shanghai, Beijing, and other cities that at most ~1M iPhones in the region could be at risk of shifting out of the March quarter into the June quarter if this continues into late February,” according to Wedbush analysts Daniel Ives and Strecker Backe.
That the sum represents less than 3% of annual Chinese iPhone sales and the impact will likely be negligible.
https://seekingalpha.com/news/3537092-impacts-of-apples-china-closure-are-negligible-wedbush

What changed about the coronavirus over the weekend

Chinese officials reported a surge in new coronavirus cases. The death toll in China rose to at least 304. More than 2,000 new cases were also recorded in China in the past 24 hours. (NY Times)
The PBOC said it will inject 1.2T yuan ($174B) into markets via reverse repo operations on Monday to ensure sufficient liquidity supply. This is the largest single-day reverse repo operation it has ever conducted.
The CSRC has issued a verbal directive to brokerages to bar clients from shorting stocks Feb. 3. CSRC is also considering launching hedging tools for the A-share market to help dampen market panic and will suspend evening sessions of futures trading starting Monday. (Reuters)
The coronavirus claimed its first fatality outside of China, a 44-year-old Chinese man in the Philippines. (WSJ)
Gilead (NASDAQ:GILD) says it has provided doses of its experimental antiviral drug remdesivir to doctors for emergency treatment of a small number of patients infected by coronavirus. It also formalized an agreement with Chinese authorities to conduct a trial of remdesivir in patients infected with the coronavirus.
https://seekingalpha.com/news/3537113-changed-coronavirus-over-weekend

Herbal remedies for the coronavirus spark debate in China

A claim by Chinese scientists that a liquid made with honeysuckle and flowering plants could help fight the deadly coronavirus has sparked frenzied buying of the traditional medicine, but doubts quickly emerged.
As the from the SARS-like pathogen sweeping the country continues to rise, shoppers have swamped pharmacies in search of “Shuanghuanglian”.
The rush came after influential state media outlet Xinhua reported Friday that the esteemed Chinese Academy of Sciences had found the concoction “can inhibit” the virus.
Videos shared online showed long lines of people in surgical masks lining up at night outside drug stores, purportedly in hope of snapping up the product, despite official advice that people avoid public gatherings to prevent infection.
It quickly sold out both online and at brick-and-mortar stores, but responses to the remedy’s supposed efficacy have ranged from enthusiasm to scepticism on Weibo, China’s Twitter-like social media platform.
And state media sounded a more cautionary note on Saturday, with broadcaster CCTV publishing an interview with Zhang Boli, one of the researchers leading outbreak containment efforts, who warned of potential side effects from the medicine.
The People’s Daily newspaper, a government mouthpiece, said experts advised against taking traditional remedies without professional guidance.
But the claim comes as Beijing looks to incorporate traditional Chinese medicine (TCM) into its nationwide fight against the virus, which has killed more than 300 people and infected over 14,000 in the country. On Sunday the Philippines reported the first death outside of China.
Researchers at the state-run academy, a top government think tank, are also studying the potential use of a plant commonly known as Japanese knotweed to alleviate symptoms.
The National Health Commission on Tuesday said TCM practitioners were among nearly 6,000 reinforcement medical personnel being sent to Wuhan in Hubei province, ground zero of the outbreak.
‘No difference’
The strategy has reignited fierce and long-running debate about the efficacy of TCM, which has a history going back 2,400 years and remains popular in modern-day China.
Marc Freard, a member of the Chinese Medicine Academic Council of France, told AFP he believed traditional formulations could be used to treat people with symptoms ranging from fever to thick phlegm.
But he warned that many remedies on the market were of questionable quality and admitted that TCM “lacks scientific standards of efficacy” because it relied on “individualised treatment”.
Traditional medicines were widely used in China in conjunction with Western methods during the 2003 epidemic of SARS, or Severe Acute Respiratory Syndrome, which killed 774 people worldwide.
But a 2012 study in the Cochrane Database of Systematic Reviews found combining Chinese and Western medicines “made no difference” in battling the disease.
Nationalism
The Chinese government has increasingly promoted traditional medicine abroad in recent years, often with nationalistic undertones.
Beijing issued its first white paper on TCM in 2016, laying out plans to build medicine centres and dispatch practitioners to developing countries in Africa and Southeast Asia.
President Xi Jinping has called TCM a “treasure of Chinese civilisation” and said at a meeting in October that it should be given as much weight as other treatments.
China is “working hard to spread the message internationally about its traditional culture”, and medicine is a part of this, Freard said.
In 2019 the World Health Organization (WHO) even added Chinese medicine to its “International Classification of Diseases”—a reference document for medical trends and global health statistics—after years of campaigning by Beijing.
But the move was slammed by members of the scientific community, with the European Academies’ Science Advisory Council calling the decision “a major problem” due to the lack of evidence-based practice.
The WHO did not immediately respond to AFP’s request for comment.
Fang Shimin, a prominent writer in China known for his campaigns against academic fraud, told AFP he believes the government’s promotion of traditional “panders to nationalism and has nothing to do with science”.
It is an enormous industry in China worth more than $130 billion in 2016—a third of the country’s entire medical industry—according to state news agency Xinhua.

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