89bio closes enrollment in study of lead drug in NASH

Citing challenges during COVID-19, 89bio (ETNB +0.2%) has closed enrollment in its Phase 1b/2a clinical trial evaluating lead candidate BIO89-100 in patients with nonalcoholic steatohepatitis (NASH) or nonalcoholic fatty liver disease (NAFLD) at high risk of NASH. The study was 98% enrolled so the effect should be minimal. Topline data should be available in H2. It plans to initiate the Phase 2b trial in H1 2021.

It has decided to delay the launch of a Phase 2 study of BIO89-100 in patients with severe hypertriglyceridemia due to the pandemic.

https://seekingalpha.com/news/3560168-89bio-closes-enrollment-in-study-of-lead-drug-in-nash

Chembio adds to COVID-19 test-stoked rally, up 19%

Chembio Diagnostics (CEMI +18.8%) continues its torrid pace on almost double normal volume. Shares have rallied four-fold since touching $2.25 on March 16.

Investors have clearly liked the steady stream of developments since March 16 when the FDA announced that it would allow the distribution of commercially developed COVID-19 tests prior to its OK for emergency use and the distribution of blood tests if they are properly validated.

On March 20, the company announced a $4M order from Brazil for its DPP COVID-19 IgM/IgG point-of-care blood test.

On April 1, it announced the U.S. launch of the 15-minute test.

On April 9, Stony Brook Medical chose the test for use in identifying people who have recovered from COVID-19 who could be donors for a study to assess the efficacy of convalescent plasma in hospitalized patients.

https://seekingalpha.com/news/3560187-chembio-adds-to-covidminus-19-test-stoked-rally-up-19

Slow Start for Rapid Coronavirus Tests Frustrates States

A rapid test for the new coronavirus that was touted by the White House as a game-changing development has proved vexing for state officials, who say the federal government has failed to provide enough necessary equipment.
“It’s incredibly frustrating,” said New Hampshire Gov. Chris Sununu, whose state got 15 of Abbott Laboratories’ testing machines for Covid-19, the illness caused by the new coronavirus — and cartridges to conduct only about 100 tests. Mr. Sununu, speaking at a news conference, said most of the machines would sit idle until he could figure out how to get more of the cartridges, one of which is needed to complete each test.
“There was a lot of hype on this nationally,” the Republican said. “To have 13 of these devices and no way to use them — I’m banging my head against the wall.”
After conducting a bulk purchase with Abbott, the federal government this month gave every state except Alaska 15 devices and 120 cartridges, regardless of its population or severity of its coronavirus outbreak.
In Illinois, where Abbott Laboratories is based, Gov. J.B. Pritzker said he spoke to the company more than a week ago and thought he had an agreement to conduct 88,000 tests a month, or about 3,000 tests a day. He subsequently learned that the federal government was taking over purchasing and distribution of the tests.
Instead, Illinois received 15 Abbott machines and 120 cartridges. “That’s eight tests per machine for all of Illinois,” Mr. Pritzker, a Democrat, said.
The frustration over how the Abbott tests are being doled out underscores the Trump administration’s ongoing struggle to respond to national testing shortages. While more coronavirus tests have been made available in recent weeks, via private laboratories that now have FDA approval, results can take days. High-volume tests have been hampered by inaccurate results, delays and technical problems.
During a press conference last week, President Trump touted the Abbott tests, which deliver results in under 15 minutes, as “a whole new ballgame” in the fight against the new coronavirus.
In a statement, U.S. Health and Human Services spokeswoman Mia Heck said the federal government had purchased limited quantities for state labs because it wanted to allow enough for hospitals to buy as well. Ms. Heck said that states could order more supplies through the Centers for Disease Control and Prevention. Ms. Heck didn’t respond to a question about why 49 states received a similar number of tests and machines, which process one test at a time.
Despite having the third-smallest population of any state, Alaska received 50 machines to ramp up testing in remote areas, she said.
HHS said it had also purchased 250 Abbott machines for the Indian Health Service, which provides health care for 2.6 million Native Americans. But Tori Kitcheyan, chairwoman of the National Indian Health Board, said the number of individual cartridges available for those machines wasn’t enough for tribal members living on remote reservations with limited access to any Covid-19 testing.
Abbott is currently manufacturing 50,000 cartridges daily and has vowed to continue increasing production. As of Friday, it had shipped nearly half a million cartridges to doctors’ offices, universities and laboratories that have placed their own orders, a spokeswoman said, in addition to those purchased by the federal government. The rapid test machines cost $4,500 per device, while each cartridge costs $40.
Detroit, was able to buy and deploy a large number of Abbott’s rapid tests shortly after the company got approval from the FDA on March 27. The quick results helped reshape the city’s response to the virus.
Since the start of the month, Detroit has administered more than 1,000 tests, initially focusing on first responders and bus drivers who had been in quarantine, said John Roach, a spokesman for the mayor. The city has already purchased 4,000 additional tests from Abbott and recently said that rapid tests would be used at nursing homes and homeless shelters.
But for states, their comparatively tiny number of Abbott tests cannot make that sort of impact.
Officials in New York, at the epicenter of the coronavirus outbreak, said that their Abbott devices wouldn’t be used until enough cartridges arrived to make them practical.
In Louisiana, another hot spot, Gov. John Bel Edwards said his administration had hoped to deploy the Abbott tests to help health-care workers statewide so they could stay on the job and preserve personal protective equipment.
“We have the machines, but not necessarily the cartridges to make a big difference,” Mr. Edwards said.
https://www.marketscreener.com/ABBOTT-LABORATORIES-11506/news/Abbott-Laboratories-Slow-Start-for-Rapid-Coronavirus-Tests-Frustrates-States-Update-30401735/

South Korea set to ship coronavirus testing kits to U.S.

South Korea plans to send kits designed to run up to 600,000 coronavirus tests to the United States on Tuesday after an appeal from U.S. President Donald Trump, a Seoul official said.

Trump made the request in a telephone call with President Moon Jae-in on March 25, as the United States was grappling with fast-growing outbreaks in many states.
South Korean companies have previously shipped test kits to U.S. cities including Los Angeles, but this would mark the first bulk order from the U.S. federal government.
A U.S. Federal Emergency Management Agency cargo plane carrying the equipment is scheduled to leave at 10:30 p.m. (1330 GMT) on Tuesday, the official said on Monday, speaking on condition of anonymity due to the sensitivity of the issue.
South Korea’s foreign minister Kang Kyung-wha confirmed the Reuters report in an interview on French news channel France 24, saying that contracts have been signed and the shipments will be “ready any time soon”.
The first shipments will be handed over to and paid for by the U.S. government, the official told Reuters.
An additional package of kits that can conduct as many as 150,000 tests will be exported in the near future and will be sold through an unspecified local retailer, the official said.
The polymerase chain reaction (PCR) kits will be sourced from three companies that secured preliminary approval late last month from the U.S. Food and Drug Administration (FDA) to export kits to the United States, the official said.
He declined to name the two companies that will provide the shipments on Tuesday.
However, a person with direct knowledge of the matter said, on condition of anonymity, that one of the two firms is Osang Healthcare and the company will provide kits for 300,000 tests.
Calls to Osang Healthcare for a comment were not answered.
Once struggling with the first large outbreak outside China, South Korea has largely managed to bring its coronavirus cases under control without major disruptions thanks to a massive testing campaign and intensive contact tracing.

South Korea credits part of its success to moves by government officials and private companies to develop and secure regulatory approval for tests, allowing the country to quickly test thousands of people.
The United States has recorded more fatalities from COVID-19, the respiratory disease caused by the coronavirus, than any other country, nearly 22,000 as of Sunday, with 42 states imposing strict stay-at-home orders.
“We’ve moved as quickly as possible to get necessary clearances given the urgency of the situation there,” the South Korean official said.
https://www.reuters.com/article/us-health-coronavirus-southkorea-usa-exc/exclusive-south-korea-set-to-ship-coronavirus-testing-kits-to-u-s-source-idUSKCN21V0F6

‘God is with us’: Many Pakistan Muslims flout coronavirus ban in mosques

Sabir Durrani says he offers prayers almost every day at a mosque in the central Pakistani city of Multan. He says that often a dozen or more men are in attendance – none of them wearing protective face masks.

Durrani, 52, is among thousands of devout Muslims flouting Pakistan government orders issued late last month banning religious congregations of five or more people to stem the spread of the coronavirus. The disease has so far infected more than 5,300 people and killed 93 in the world’s second-most populous Muslim country.
“Our prayer leader told us that the virus can’t infect us the way it does Western people,” Durrani told Reuters. “He said we wash our hands and we wash our face five times a day before we say our prayers, and the infidels don’t, so we need not worry. God is with us.”
The Islamic lobby holds immense clout in Pakistan, a country of over 200 million people. Religious parties have not been successful in electoral politics but they are able to whip up large, often violent, crowds on matters pertaining to religion, such as in support of the country’s harsh blasphemy law.
“Religion and prayers are an emotional issue for many people in Pakistan, and the government has to be sensitive to that,” Mirza Shahzad Akbar, a special assistant to Prime Minister Imran Khan, told Reuters.
More than 60% of the coronavirus cases in Pakistan have so far been linked to Muslims returning from pilgrimages in the Middle East and followers of the Tablighi Jamaat, an orthodox proselytizing group.
But the worry is of a big spike coming from the congregational prayers held in mosques, especially on Fridays, the Islamic sabbath. The numbers in attendance at prayers are likely to increase with the onset of the holy month of Ramadan within two weeks, and authorities are struggling to cope.
While the Council of Islamic Ideology, a body that advises the government on religious issues, has called on clerics and the public to cooperate with government measures, several priests and local leaders have opposed the ban.
A prominent leader of a religious party told a crowd of hundreds of people gathered for a funeral last week that government orders to limit congregations were unacceptable.
“If you do this, we will be forced to think that mosques are being deserted on America’s instructions,” Mufti Kafayatullah told the crowd. “We’re ready to give our lives, but not ready to desert our mosques.”

BLIND EYE

In Karachi, Pakistan’s largest city, police were attacked for a second straight week as they attempted to halt prayers at a mosque last Friday. A policewoman was injured in the clashes, and in the previous week, police fired shots in the air to quell an angry mob.
In other cities, police seem to be turning a blind eye to some mosque gatherings.
Last Friday, one of the top Twitter trends in Pakistan was “Muslims, the mosque is calling you”.
In the capital, Islamabad, hundreds gathered on Friday without any hindrance at one of the city’s largest mosques, located just two miles (three km) from the seat of Pakistan’s government, including parliament and the prime minister’s secretariat.
On March 27, authorities filed 88 cases against mosque administrations in Karachi and arrested 38 people for defying restrictions on Friday congregations, but charges were dropped a day later, and the people were released.

“I think it’s partly appeasement and partly the fact that Pakistan’s governments and politics are locked permanently in an electoral framework in which they don’t want to lose support of the religious elite and religious proletariat,” Pakistani author and defence analyst Ayesha Siddiqa told Reuters.
Akbar, the special assistant to the prime minister, said most mosques were cooperating with the government.
He added however: “This is a sensitive matter, we don’t want to impose it using a stick. And even if we wanted to, there aren’t enough sticks to implement it across Pakistan.”
https://www.reuters.com/article/us-health-coronavirus-pakistan-congregat/god-is-with-us-many-muslims-in-pakistan-flout-the-coronavirus-ban-in-mosques-idUSKCN21V0T4

Space cadet: A Chinese father innovates to ward off coronavirus

As the spread of coronavirus eases in China, Cao Junjie and his family are making the most of the sunny days at a Shanghai amusement park – with one important twist.
Cao’s son is wearing an inflatable suit to protect him from the highly contagious virus, looking more like a miniature astronaut than a two-year old child.
The father created the suit himself, complete with an air purification system, a device to monitor air quality and an electric fan to keep it cool.
The innovative suit is not a first for Cao, though. Last month, the father of two designed a “baby safety pod” for his two-month-old.
For his older child, Cao found an “inflatable space suit” for children online for 2,000 yuan ($284) and set about modifying it.
After a week, his two-year old boy was ready to boldly go out with the suit on, first to the supermarket and then beyond.
Cao says the suit is ideal for toddlers because masks don’t stop them touching their faces, which doctors say is one of the main causes of infection.
“I designed this protection suit to replace masks because masks could make him uncomfortable,” Cao told Reuters.
China reported 108 new cases of the coronavirus on Sunday, the highest in nearly six weeks, bringing its total number of cases to 82,160. The death toll rose by two to 3,341.
The virus emerged in the Chinese city of Wuhan late last year and has spread around the world, infecting more than 1.8 million people and killing more than 113,500 of them.
The child can do most things in the inflatable suit except blow bubbles.

Passersby are suitably impressed.
“I think it’s great. He looks like a cartoon character,” said Wu Fengying, 53.
https://www.reuters.com/article/us-health-coronavirus-china-protection-s/space-cadet-a-chinese-father-innovates-to-ward-off-coronavirus-idUSKCN21V0MV

Aytu Bio launches Regoxidine in U.S.

Aytu BioScience (AYTU -5.2%) announces the launch of Regoxidine, an over-the-counter foam formulation of minoxidil available for use by both men and women.

Regoxidine is indicated for hair treatment and regrowth and is available through AYTU’s wholly-owned subsidiary, Innovus Pharmaceuticals.

Regoxidine is a branded alternative to JNJ’s hair regrowth treatment Rogaine.

https://seekingalpha.com/news/3560134-aytu-bio-launches-regoxidine-in-u-s