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Saturday, July 25, 2020

Young, healthy adults with mild COVID-19 also take weeks to recover: CDC

Young, previously healthy adults can take weeks to fully recover from even a mild COVID-19 infection, with about a fifth of patients under 35 years reporting not returning to their usual state of health up to 21 days after testing positive, according to the Centers for Disease Control and Prevention (CDC).
A telephone survey across 13 states of symptomatic adults with mild COVID-19 found 35% had not returned to their usual state of health when interviewed two to three weeks after testing, the CDC reported in the Morbidity and Mortality Weekly Report on Friday.
Cough, fatigue and shortness of breath were among the symptoms reported while testing that persisted even weeks later, according to the report.
The findings indicate recovery can be prolonged even in young adults without chronic medical conditions, making a case for public health messaging to target populations that might not perceive COVID-19 as being a severe illness.
Between April 15 and June 25, telephone interviews were done with a random sample of people over 18 years of age who got themselves tested for COVID-19 at an outpatient visit, CDC said.
The interviews were done 14 to 21 days after the test date, and patients were asked about symptoms during testing, whether they had returned to their usual state of health, and if they suffer from a chronic medical condition.
Among 292 people interviewed, 274 reported experiencing one or more symptoms at the time of testing. Among symptomatic respondents who reported not having returned to their usual state of health, 26% were between 18 and 34 years of age, 32% were between 35 and 49 years, and 47% were over 50.
Researchers said social distancing, frequent handwashing, and the consistent and correct use of face coverings in public should be encouraged to slow the spread of COVID-19.

CASI Pharma +11.9% as CEO buys nearly $7.9M in shares

CASI Pharmaceuticals (NASDAQ:CASI) is up 11.9% after hours following news that its Chairman/CEO, Wei-Wu He, bought nearly $7.9M worth of the company’s stock.
He directly purchased 2,952,426 shares on Wednesday at an average price of $1.90, bringing direct beneficial ownership to 4,836,523 shares, according to an SEC filing. He also indirectly bought 1,200,000 shares at the same price via ETP Global Fund.
Also, President Larry Zhang bought 20,153 shares at an average price of $1.90 on Wednesday, making up his entire direct beneficial holding in the company.

Friday, July 24, 2020

Quarter of NYC coronavirus tests stuck in backlog that’s over a week long

July 24, 2020

A quarter of coronavirus tests in New York City are caught in a backlog that’s more than a week long, complicating efforts by Gotham’s top health officials to contain and track the spread of the fearsome disease as the economy partially reopens.
Last week, it took laboratories at least eight days to check and process 25 percent of the tests conducted across all five boroughs, according to figures provided by the city’s Department of Health and Mental Hygiene in response to questions from The Post.
It was at least the second week in a row when it took labs at least a week to work through a quarter of the tests, the data shows.
The delays throw another curveball at the city’s strategy to prevent future COVID-19 outbreaks through mass access to rapid testing to find new positive cases — and then quickly moving to isolate the newly infected and trace their recent contacts.
Officials attribute the delays that have left many New Yorkers frustrated to the massive COVID-19 outbreaks across the country — especially in states in the South and West — that have stretched and overwhelmed the private labs.
“We had a really bad stretch where the national crisis and the strain it put on testing was clearly affecting everyone, including New York City,” Mayor Bill de Blasio acknowledged Thursday, when asked about anecdotes of weeklong testing delays at private health clinics across the city. “We’ve pushed back on that with a variety of new plans with the labs and with expanding the work that Health + Hospitals is doing.”
Those improvements mean the overall average for processing tests taken in New York City is down from four days to just two. The city’s own public lab is getting results out in less than a day on average, according to Department of Health statistics.
The changes touted by City Hall on Thursday include running several swabs at once — “pooling” them — and grouping the results if they come back negative.
Hizzoner also rolled out a new deal with a private clinic provider that will expand Gotham’s testing capacity to 50,000 tests per day — and touted the city’s partial reopening while keeping the lethal coronavirus bug largely in check.
“I’m proud to say that today our rates of new cases of the coronavirus through all of those phases of reopening have not had an uptick whatsoever, they’ve been completely stable. That’s good news,” said Dr. Ted Long, the head of the city’s Test and Trace Corps, during Hizzoner’s daily press briefing.
More than 30,000 coronavirus tests are being conducted daily.

Fenofibrate increases amount of sulfatide which may be beneficial against Covid-19

Abstract

Fenofibrate, which is a PPAR-alfpha agonist, increases the level of sulfatide. In this letter we hypothesize on the background of various findings that this is beneficial against COVID-19. Fenofibrate has been used for decades against hypercholesterolemia and has no serious side effects. Therefore, a trial giving fenofibrate to patients with corona virus infection is recommended.

German COVID-19 vaccine developer CureVac files for U.S. IPO

German biotech CureVac said on Friday it had filed for an initial public offering in the United States as it races to develop a vaccine for COVID-19.

The company, valued at around $1.6 billion and backed by Microsoft Corp co-founder Bill Gates whose foundation has been a shareholder and provided grants, started its clinical study in healthy volunteers in June.
Results of the safety-focused trial are expected in the fourth quarter of 2020, regulatory filings showed.
It previously had said approval was possible in the middle of next year, under favourable conditions.
CureVac’s filing, which confirms previous reports by Reuters of plans to launch an IPO, comes days after it raised 560 million euros ($652 million), giving the German government a 19% stake, the filing showed.
At the same time, British drugmaker GlaxoSmithKline Plc got a 9% stake in the company and Qatar Investment Authority (QIA) a 3.5% stake.
Earlier this year, German government officials, concerned over reports that the U.S. government was attempting to acquire CureVac or its assets, voiced support for keeping CureVac German.
The German government had disclosed plans in June to invest a stake to further aid the development of the company’s COVID-19 vaccine program.
Software firm SAP co-founder Dietmar Hopp, who once held more than an 80% stake in CureVac, has agreed to purchase shares worth 100 million euros ($116.37 million) at the IPO.
Tuebingen-based CureVac is a pioneer in the so-called messenger RNA approach for developing vaccines and monoclonal antibodies (mAbs) for infectious diseases.
The approach, also being deployed in experimental COVID-19 vaccines by BioNTech and partner Pfizer and Moderna, is yet to be approved in any therapy.
Founded in 2000, CureVac has more than 450 employees, 116 of whom have advanced scientific degrees, the company said.
The underwriters for the IPO are Bank of America, Credit Suisse, Jefferies and Kempen & Co.

Solid Biosciences Updates on IGNITE DMD Phase I/II Clinical Hold

Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, today announced that it received written communication from the U.S. Food and Drug Administration (FDA) that the Company’s IGNITE DMD Phase I/II clinical trial remains on clinical hold.
In November 2019, the FDA placed IGNITE DMD on clinical hold as the result of a serious adverse event (SAE) that occurred in the sixth patient dosed in the trial; as previously reported the SAE has fully resolved. In April 2020, Solid provided the FDA with information and measures intended to improve patient safety and in May 2020, Solid received written communication from the FDA that the trial remained on hold. In June 2020, the Company submitted a response to the FDA that provided data related to manufacturing process improvements. Today, the FDA responded by maintaining the clinical hold and requesting further manufacturing information, updated safety and efficacy data for all patients dosed, and providing direction on total viral load to be administered per patient. Solid is evaluating next steps and will provide an update as appropriate.
“Patient safety is our highest priority and we plan to continue our dialogue with the FDA to determine the appropriate path for SGT-001,” said Ilan Ganot, Co-Founder, President and Chief Executive Officer of Solid Biosciences. “We are disappointed with the outcome today, however, we will continue to work with the FDA as we believe the clinical development of SGT-001 could offer meaningful benefits to patients with this devastating disease.”

Moderna: Patent ruling not to affect COVID-19 vaccine development

Moderna Inc said on Friday its formula used in developing a COVID-19 vaccine was not covered under patents owned by Arbutus Biopharma.

An administrative court run by the U.S. Patent and Trademark Office on Thursday rejected Moderna’s arguments to invalidate a U.S. patent owned by Arbutus, sparking worries over its efforts to develop next-generation vaccines, including a coronavirus vaccine.
Moderna said the court’s ruling relates to actions it took in response to “longstanding aggressive posture” taken by Arbutus against developers of nucleic acid-based therapeutics and began well before the development of mRNA-1273, its COVID-19 vaccine candidate.
Moderna shares were up slightly in extended trading, while Arbutus shares closed down 20% on Friday.