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Wednesday, January 25, 2023

Intercept Pharmaceuticals Unit On Jan 24 Entered Into Settlement Agreement With Amneal

 

Granted Amneal Non-exclusive, Non-Sublicensable, Non-Transferable, Royalty-free License To Commercialize Generic Version

https://www.benzinga.com/general/biotech/23/01/30566234/intercept-pharmaceuticals-unit-on-jan-24-entered-into-settlement-agreement-with-amneal-eu-limited

FDA clears Wandercraft's exoskeleton for stroke patient rehab

 Stroke patients in the US could soon take advantage of cutting-edge robotics during the recovery process. The Food and Drug Administration has cleared Wandercraft's Atalante exoskeleton for use in stroke rehabilitation. The machine can help with intensive gait training, particularly for people with limited upper body mobility that might prevent using other methods.

The current-generation Atalante is a self-balancing, battery-powered device with an adjustable gait that can help with early steps through to more natural walking later in therapy. While the hardware still needs to be used in a clinical setting with help from a therapist, its hands-free use lets patients reestablish their gait whether or not they can use their arms.

Wandercraft plans to deliver its first exoskeletons to the US during the first quarter of the year, though it didn't name initial customers. It only recently launched its commercial business in the country, but financial backer Quadrant Management says Wandercraft could "significantly scale" its operations within the next one to two years.

FDA-cleared exoskeletons are still relatively rare, and are still limited to helping with specific conditions. Last June, Ekso Bionics received permission to market its EksoNR device for multiple sclerosis rehab. Wandercraft's approval makes the technology accessible for a wider range of patients, and may be especially helpful when strokes are a major cause of long-term disability in the US. Over 795,000 people have a stroke in the country each year — this could help some of them regain freedom of movement.

https://www.yahoo.com/lifestyle/wandercraft-atalante-exoskeleton-fda-clearance-stroke-rehab-054521933.html

North Korea locks down capital city over 'respiratory illness'

 Authorities in the North Korean capital Pyongyang have ordered a five-day lockdown due to rising cases of an unspecified respiratory illness, the Russian embassy and Seoul-based NK News reported on Wednesday, citing a government notice.

The notice, shared by the embassy on its Facebook page, said that a "a special anti-epidemic period has been established" and it called on foreign delegations to keep employees inside. The order also called for individuals to measure their temperatures four times a day and report the results to a hospital by phone.

The notice made no mention of COVID-19 though cited an "increase in winter cases of recurrent flu and other respiratory diseases".

The lockdowns were first reported by South Korea's NK News, which monitors secretive North Korea.

On Tuesday, the website reported that Pyongyang residents appeared to be stocking up on goods in anticipation of stricter measures. It was unclear if other areas of the country had imposed new lockdowns.

North Korea acknowledged its first COVID-19 outbreak last year, but by August had declared victory over the virus.

It never confirmed how many people caught COVID, apparently because it lacks the means to conduct widespread testing.

Instead, Pyongyang reported daily numbers of patients with fever, a tally that rose to some 4.77 million, out of a population of about 25 million. But it has not reported such cases since July 29.

State media have continued to report on anti-pandemic measures to battle respiratory diseases, including the flu, but have yet to report on the lockdown order.

On Tuesday, state news agency KCNA said the city of Kaesong, near the border with South Korea, had intensified public communication campaigns "so that all the working people observe anti-epidemic regulations voluntarily in their work and life".

https://news.yahoo.com/1-north-korea-locks-down-135712207.html

China says COVID deaths, severe cases have fallen over 70% since peak

 Critically ill COVID-19 cases in China are down 72% from a peak early this month while daily deaths among COVID-19 patients in hospitals have dropped 79% from their peak, the Center for Disease Control and Prevention said on Wednesday.

The figures, published on the centre's website, come after a prominent government scientist said over the weekend that 80% of China's 1.4 billion population had already been infected, making the possibility of a big COVID-19 rebound over the next two or three months remote.

China abruptly ended its strict zero-COVID policy in early December after three years and infections surged across the world's most populous country.

While officials have said infections have peaked, some global experts have warned about the possibility of a surge in cases in rural areas less equipped to deal with them as millions of Chinese travel home for family reunions during the ongoing Lunar New Year holiday.

The CDC said the number of critically ill patients in China peaked on Jan. 4 at 128,000 cases and fell to 36,000 cases by Jan. 23.

The number of deaths in hospitals, meanwhile, reached a daily peak of 4,273 on Jan. 4 and fell to 896 by Jan. 23. Visits to fever clinics fell 96.2%, from a peak of 2.867 million on Dec. 22 to 110,000 on Jan. 23.

The CDC added that on Dec. 22, 2022, the number of infected people and the number of fever outpatient consultations reached a peak, with the number of new infections "exceeding 7 million per day and the number of daily fever outpatient consultations peaking at 2.867 million".

The data follows comments from an official at the National Health Commission, who last week said that China had passed the peak of COVID patients in fever clinics, emergency rooms and in critical condition.

On Jan. 12, authorities announced that nearly 60,000 people with COVID had died in hospitals since China dismantled its strict zero-COVID policy.

But some experts said that figure probably vastly undercounts the full impact, as it excludes those who die at home and because many doctors have said they are discouraged from citing COVID as a cause of death.

https://www.yahoo.com/entertainment/china-says-peak-covid-infections-122204905.html

U.N. aid chief asks Taliban authorities for more exemptions to female NGO worker ban

 The U.N. aid chief said on Wednesday the humanitarian community was speaking with Taliban officials to try and gain further exemptions and written guidelines to allow some female aid workers to operate despite a ban on women NGO staff.

U.N. Under Secretary-General for Humanitarian Affairs Martin Griffiths told Reuters that during discussions with authorities in Kabul over the last few days, his message had been: "If you can't help us rescind the ban, give us the exemptions to allow women to operate."

Taliban authorities ordered NGOs, many of whom carry out operations for the United Nations, to stop most female staff working last month.

Griffiths said some exemptions to the ban had been granted in health and education and they were hearing signs of a possible exemption in agriculture. But he said much more was needed, with nutrition and water and sanitation services a priority to prevent severe illnesses and malnutrition during Afghanistan's severe humanitarian crisis.

A spokesperson for the Taliban administration did not immediately respond to a request for comment on its plans over guidelines.

Griffiths said that based on discussions with authorities in recent days U.N. and humanitarian agencies were hopeful they would create a set of written guidelines to allow NGOs to operate with female staff in more areas with certainty in coming weeks.

"The next few weeks are absolutely crucial to see if the humanitarian community ... can stay and deliver," he said.

UNCERTAIN OUTCOME

However, Griffiths cautioned that the final outcome was still not certain.

"Let's see, I don't want to speculate as to whether we're going to come out of this in the right place," he said.

He also pointed out that as well as authorities in Kabul, provincial governors and leaders in the southern city of Kandahar - home of the Taliban's supreme spiritual leader who has the final say on major decisions - would be key.

Torn U.S. dollars get new life in Zimbabwe

 A dab of glue and this ten-dollar note is "as good as new".

So says black market trader Cuthbert Gudza as he sits patching up currency in Zimbabwe's capital Harare.

“I am a potato seller but I saw buying torn US dollar notes as another business opportunity."

Zimbabwe is a dual currency economy following the collapse of the Zimbabwean dollar in 2009.

Zimdollars were reintroduced in 2019, but locals generally rely on the greenback for daily transactions.

However, with U.S. currency in short supply, grimy old notes are making a comeback

Gudza buys well-worn cash, that he says would be rejected at supermarkets, at a discount.

He then fixes it up and sells for a profit on the black market.

“When a person brings their torn dollars, I pay $600 Zimdollars for every $1. I will then sell it and get $800 Zimdollars. There are others who do not want money, we give them what we sell, bananas, oranges, apples or potatoes. I gain at least $0.20 or $0.30 per every dollar."

Zimbabwean banks are mandated to accept soiled money in exchange for crisp notes.

The central bank has asked citizens make that exchange using official channels.

But, having lost their savings to hyperinflation, many mistrust the financial system and prefer black market traders.

Whilst not as severe as the crisis under former President Robert Mugabe, Zimbabwe's economy is again struggling.

Inflation is in the triple digits, unemployment is high and the local currency has been sliding.

For those like Gudza, breathing new life into old dollars is just one way to survive amid the financial onslaught.

https://sports.yahoo.com/torn-u-dollars-life-zimbabwe-154204641.html

SEC unveils trader conflicts rule, a decade after first try

 Wall Street's top regulator on Wednesday unanimously voted to propose a rule barring traders in asset-backed securities from betting against the very assets they sell to investors, behavior that became infamous in the wake of the 2008 global financial crisis.

The rule is among the last to be adopted under the landmark Dodd Frank Wall Street reform legislation of 2010, according to SEC officials. The 2010 legislation sought to address the root causes of the mortgage crisis. An earlier version of the conflicts rule first proposed in 2011 was never finalized.

The sweeping 2010 reforms, named for their sponsors - Senator Chris Dodd of Connecticut and Representative Barney Frank of Massachusetts - aimed to protect investors and taxpayers by preventing the buildup of risk and liability in the financial system.

Among other things, the legislation contained financial stability measures governing banks deemed "too big to fail" and created the Consumer Financial Protection Bureau.

The rule re-proposed on Wednesday is now subject to a public comment period during which industry criticisms of certain aspects of the proposal are likely to arise.

In the years after Dodd-Frank's enactment, Democratic lawmakers complained that the SEC had failed to meet a 270-day deadline to issue a rule implementing Dodd Frank's Section 621. When made effective with an SEC rule, the section would prohibit traders from betting against asset-backed securities they sold to investors.

According to SEC officials, the rule would ban such actions for up to a year following sale of the securities.

In remarks released ahead of the vote, SEC Chairman Gary Gensler said the rule would provide exceptions for legitimate activities, such as hedging to mitigate risk, market-making and liquidity commitments.

"Through these congressionally mandated exceptions, the rule would allow these market activities while targeting the conflicts that Congress identified," Gensler said, adding that the latest version of the rule had been refined in light of feedback from the public.