Contact tracing ‘no longer possible across US South due to rapid coronavirus surges’

Despite hopes for relief this summer, the US is battling the first wave of the Covid-19 pandemic — so much so that across the South and Southwest contact tracing is no longer possible, according to a health expert.

“The cases are rising so rapidly, that we cannot even do contact tracing anymore. I don’t see how it’s possible to even do that,” Dr. Peter Hotez, dean of tropical medicine at Baylor College of Medicine, said Monday.

His comment comes as the United States nears 3 million officially reported cases. The country averaged just under 50,000 new cases daily over the last week — the highest rate recorded, and twice as high as a month ago.

The rapid rise in cases is considered a surge, not a second wave, because the infection numbers never lowered to where officials hoped they would, director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci said in a Facebook and Twitter livestream Monday.

“We are still knee-deep in the first wave of this,” Fauci said.

More than 130,300 people in the US have died from coronavirus, according to data from Johns Hopkins University.

Though Florida set a record for most new cases in a single day over the weekend, Commissioner of the Florida Department of Education Richard Corcoran announced Monday in an emergency order that its schools will open their doors in August.

But the state is among at least 24 that are pausing or rolling back their reopening plans for the summer in light of surging cases.

At least 31 states have showed an upward trend in average new daily cases — an increase of at least 10% — over the last seven days, as of Tuesday morning, according to data from Johns Hopkins University.

Those states are: Alabama, Alaska, Arizona, California, Delaware, Florida, Georgia, Hawaii, Idaho, Indiana, Kansas, Louisiana, Michigan, Mississippi, Missouri, Montana, Nevada, New Mexico, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington state, West Virginia and Wisconsin.

Only four states have seen average daily cases decline more than 10% over those seven days: Maine, Massachusetts, New Hampshire and Rhode Island.

One of the main drivers of cases now could be “silent spreaders,” or people who are asymptomatic or presymptomatic, according to a new study.

The report, published in the Proceedings of the National Academy of Sciences, found that asymptomatic or presymptomatic hosts could be responsible for half of cases.

“We are in free fall,” said Dr. Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital. “You see the footage of what happened this past weekend. And people are either naive to the influence of their actions, or they’re simply resigned to ignore it.”

After weeks of health officials encouraging the public to wear face masks, at least 35 states along with Washington DC and Puerto Rico have implemented face covering requirements to help mitigate the virus’ spread.

Rising cases threaten hospital capacity

With increased spread comes concerns about exceeding hospitals’ capacity.

Along with 1,214 new cases, Dallas County, Texas, reported a 16% increase in new hospitalizations Monday.

Dallas County Judge Clay Jenkins released a letter urging the governor to implement more statewide restrictions as the state reached its highest number in both categories.

“Think of hospitalizations as the sickest of the sick, the part of the iceberg above the water. In order for the numbers to increase dramatically with hospitalizations, the amount of the iceberg underneath the water must grow exponentially,” Jenkins said.

In Florida, 43 hospitals across 21 counties — including Miami-Dade, Broward, Hillsborough and Orange Counties — have hit capacity and show zero ICU beds available, according to data released by the Agency for Health Care Administration (AHCA).

In response to President Donald Trump’s claim that 99% of coronavirus cases are “totally harmless,” Dr. Boris Lushniak told Wolf Blitzer Monday on the Situation Room that the hospitalizations tell a different story.

“Yes, some people asymptomatic. Yes, some people have mild cases of disease. But in essence, we also are having a lot of people who are being hospitalized,” said Lushniak, who is dean of the University of Maryland School of Public Health and a former deputy surgeon general.

“These are not harmless cases; this is not a harmless pandemic. And we need to be strong enough to begin correcting the president,” he said.

Contact tracing no longer possible across US South due to rapid coronavirus surges, health expert says

Texas county to arrest Covid-positives who don’t self-quarantine

Brooks County is adopting a tough posture in dealing with those who test positive for the virus, but refuse to self-quarantine. Brooks County attorney David Garcia said anyone found to be doing that could be arrested.

Garcia said the announcement comes after community members notified his office of seeing a few people who tested positive at grocery stores and businesses.

“If you’re going to go out and endanger other people, and we find out about it, we will prosecute you,” Garcia said. “People have not really embraced the dangers of COVID-19. It’s dangerous. It’s killing people, and it’s making people very sick. So either do it because you’re concerned about others or do it because you’re going to be punished if you don’t.”

Garcia said if people continue to ignore the safety precautions, they could face legal action.

“There’s a number of statutes out there that can be used so once you test positive, stay home,” Garcia said.

While many residents support the idea of the announcement, some show concern. Roxie Fuller is a resident in Falfurrias. She hopes the announcement will have an impact on the community, but she fears it won’t be as effective as it seems.

“I don’t see how something like that can be enforced,” Fuller said. “I don’t know that they can.”

Garcia and Fuller both agreeing it’s up to everyone to follow the safety guidelines for the good of their neighbors.

“This is the only way we can prevent this disease is on an individual basis,” Garcia said. “We need to be responsible for our actions, and if we’re not going to be responsible for our actions because we’re trying to protect other people, well there’s a punishment for it, too.”

https://www.khou.com/article/news/health/coronavirus/brooks-county-to-begin-arresting-those-who-test-positive-for-the-coronavirus-and-dont-self-quarantine/503-24af1678-d601-43c4-bbf0-57ea5d4bffd5

Virus surge focuses business decisions for next 3-6 weeks: Atlanta Fed’s Bostic

The renewed surge in U.S. coronavirus cases is making businesses and consumers “nervous again,” Atlanta Fed President Raphael Bostic said in webcast remarks to the Tennessee Business Roundtable.

That’s caused him to focus on company decisions in the next three to six weeks and how they are “thinking about staffing decisions.”

“We are hearing it more and more as we get more data,” Bostic said. “People are getting nervous again… And there is a real sense that this might go on longer than we have planned for.”

https://seekingalpha.com/news/3589131-virus-surge-puts-spotlight-on-business-decisions-for-next-3minus-6-weeks-bostic

Turning Point Therapeutics inks deal with Zai Lab for lead drug

Turning Point Therapeutics (TPTX +0.6%) signs an agreement with Zai Lab (ZLAB +4.3%) for Turning Point’s lead drug candidate, repotrectinib for lung cancer.

Under the terms of the agreement, Zai Lab will obtain exclusive rights to develop and promote repotrectinib in Greater China.

Turning Point will receive $25M upfront, with potential milestone payments of up to $151M, and royalties

Zai Lab anticipates opening additional sites for the TRIDENT-1 Phase 2 registrational study of repotrectinib currently active in 11 countries and enrolling patients with ROS1-positive advanced non-small cell lung cancer and NTRK-positive solid tumors.

Repotrectinib, tyrosine kinase inhibitor (TKI) is designed to target ROS1 and TRK A/B/C with potential to treat TKI-naïve or -pretreated patients.

https://seekingalpha.com/news/3589168-turning-point-therapeutics-inks-deal-zai-lab-for-lead-drug

FDA OKs Philip Morris modified risk tobacco product IQOS

The FDA approves Philip Morris’ (PM -1.4%) IQOS Tobacco Heating System, the second set of modified risk tobacco products (MRTPs) to receive the agency nod.

IQOS tobacco products are the first to receive “exposure modification” orders, which permits the marketing of a product as containing a reduced level of or presenting a reduced exposure to a substance or as being free of a substance when the issuance of the order is expected to benefit the health of the population.

The orders cover noncombustible cigarette products, including Marlboro Heatsticks, Marlboro Fresh Menthol Heatsticks and Marlboro Smooth Menthol Heatsticks.

FDA approval requires PM to conduct postmarket surveillance and studies to determine whether MRTP orders continue to be appropriate, including assessing the potential for increased use among youth.

Related tickers: British American Tobacco (BTI -1.1%), Altria (MO -0.8%), Imperial Brands (OTCQX:IMBBY -2.0%)

https://seekingalpha.com/news/3589145-fda-oks-philip-morris-modified-risk-tobacco-product-iqos

Incensed Applied Therapeutics vows to end ‘criminal activity’ from short report

Short reports are nothing new, but the aggressive “I’m coming after you” PR from Applied Therapeutics certainly is.

A week ago, a short report attacking the New York biotech floated onto Twitter and through a blog from Biotech Research Partners. It wasn’t as well covered as some of these reports but apparently still did a number on Applied Therapeutics, which saw its shares drop around 6% in the buildup to the July Fourth weekend.

The report questions the biotech’s trial data and “integrity” issues from one of its latest studies, questioning whether it can really gain approval and alleging the company is cutting corners.

Applied has been working on a series of drugs that target aldose reductase, an enzyme that converts glucose into sorbitol, a sugar alcohol involved in multiple diseases including complications of diabetes.

Previous efforts to block aldose reductase have had limited success as they have not been selective or specific enough, but in its SEC-1 filing for its IPO last year, the company said it designed its drugs to overcome these challenges.

Its lead program, AT-001, in diabetic cardiomyopathy has been in a mid- to late-stage study (and is also now being used in critical COVID-19 patients), with its second drug, AT-007, in galactosemia—a rare genetic disorder that affects how the body processes galactose, a simple sugar—in phase 1.

Galactose is produced in the body at low levels and, along with glucose, makes up lactose, found in milk and dairy products. There are a few types of galactosemia, which differ in severity and symptoms. But Type 1, the most severe kind, can be fatal if not caught early in life.

It is also working on a phase 1 study testing AT-003 in patients with diabetic retinopathy.

In addition to its aldose reductase programs, Applied Therapeutics is also working on a PI3K (phosphatidylinositol 3-kinase) inhibitor for blood cancers. It is developing the drug, AT-104, for peripheral T-cell lymphoma, cutaneous T-cell lymphoma and T-cell acute lymphoblastic leukemia.

The short attack, pulling no punches, says: “We believe that Applied Therapeutics’ stock is wildly overvalued and that its prospects for commercial success of any kind are dim.” It takes specific aim at its AT-007 data for galactosemia.

“In our opinion, the company is doing more than just leveraging a permissive FDA—we think they are cutting corners.” It says one of its main concerns is that the current trial size is “substantially smaller than originally planned” and that a patient was enrolled twice in the same trial.

Seeing the report, and the fallout for its shares, Applied hit back, saying it had “uncovered fraudulent attempts to manipulate the Applied Therapeutics stock.”

It went on: “On July 1, 2020, a fraudulent ‘short report,’ was posted on an online platform from an untraceable and anonymous source. Immediately following, individuals believed to have taken short positions in Applied Therapeutics’ stock shared the report on social media. The report includes fabricated graphs and fraudulent data which it falsely attributes to Applied Therapeutics for the apparent purpose of manipulating the company’s stock price.

“Applied Therapeutics will work with law enforcement and regulators to ensure that this criminal activity is prosecuted. The company has hired Reed Brodsky of Gibson, Dunn & Crutcher, a former federal prosecutor at the United States Attorney’s Office for the Southern District of New York, to assist in this matter.”

https://www.fiercebiotech.com/biotech/incensed-applied-therapeutics-vows-to-end-criminal-activity-from-short-report

To prep for flu season, FDA greenlights CDC’s combined influenza, COVID-19 test

The FDA issued a new emergency authorization to the Centers for Disease Control and Prevention for a combination influenza and COVID-19 diagnostic test—as the U.S. prepares to enter its annual flu season later this year in the midst of a global pandemic.

The test is designed to help tell the difference between patients with one of the two diseases, who may present with similar respiratory symptoms. It’s the third diagnostic authorized by the FDA for this purpose, following panels from Qiagen and BioFire Diagnostics, which also cover additional viruses.

“With just one swab or sample, combination tests can be used to get answers to Americans faster,” FDA Commissioner Stephen Hahn said in an agency statement. “This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”

Additionally, testing for multiple diseases using a single swab can help reduce the demand for testing supplies, and reduce the risk of exposure to healthcare workers gathering the sample.

The CDC’s multiplexed assay is designed to spot only the genetic material of the novel coronavirus as well as the influenza A and B viruses, using both swabs and sputum samples. However, negative results should not be used as the sole basis of ruling out an infection, according to the agency (PDF).

The test is designed to run on Thermo Fisher’s Applied Biosystems 7500 sequencing hardware. The CDC said the kits will be shipped to public health laboratories when production and quality control have been completed.

In the earliest weeks of the coronavirus’ spread through the U.S.—which currently counts nearly 2.9 million cases and 130,000 deaths—the CDC’s first coronavirus diagnostic failed to produce the correct result when one of its three reagents was tested against a certain control. That reagent was later eliminated from the test’s procedure, and the CDC says the kits are still in use. The newer test includes one primer mix and one probe mix.

The FDA said it is encouraging developers to pursue more combination tests before the flu season begins in earnest this fall and winter, and has updated its submission templates for molecular diagnostic Emergency Use Authorizations.

https://www.fiercebiotech.com/medtech/to-prep-for-complicated-flu-season-fda-greenlights-cdc-s-combined-influenza-covid-19-test