Australian officials agree that postponing the Tokyo Olympic and Paralympic Games until next year because of coronavirus is a positive move, saying it will come as a relief to athletes around the world.

Neither of the major football codes seem likely to emerge from the coronavirus outlook unscathed and nor do the free-to-air television networks that broadcast their matches.

Coronavirus has changed sport forever. But what will it look like when it comes back?

Jo Brigden-Jones was planning to retire after the Tokyo Games, but with her Olympic farewell delayed, she is back on the frontline as a paramedic with NSW Ambulance.

The IOC and Olympics organisers have reset the clock on the Tokyo games for a year-long delay from the intended opening — but they warn there is no blueprint for getting to the new start line.

The head of the Australian Olympic Committee says the Gold Coast has a key role to play in south-east Queensland's 2032 bid.

With the recent flurry of changes in Rugby Australia leadership, confusion increases for those involved with a game already in crisis as concerns continue that an expected loan won't be large enough to help.

AOC chief John Coates says history suggests the Tokyo Olympics could provide a special way for the world to emerge from the coronavirus pandemic.

Essentially, you surface your first-ever Facebook profile picture — and then nominate three friends to do the same.

Tekashi just streamed from in-home incarceration, setting an Instagram Live record with 2 million people tuning in. 6ix9ine trolled off the bat, bumping "Bad Boys" while toying with a pair of handcuffs. Tekashi got a lot off his plate ... admitting…

Rs.4,610 - Bengaluru to Kolkata 14 Nov on SpiceJet found 0 days ago

Rs.3,500 - New Delhi to Bengaluru 1 Jun on SpiceJet found 0 days ago

Our editor Laura Hughes highlights her five must-read articles for this week.

Our editor Laura Hughes highlights her five must-read articles for this week.

Our editor Laura Hughes highlights her five must-read articles for this week.

They don’t stand on one leg around just anybody but often prefer certain members of the flock.

-- Read more on ScientificAmerican.com

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the risks from using Picato are too high to end its suspension.

Investors in Regeneron could afford a rare smile in these difficult times, as the company’s first quarter…

Endoscopic Technologies Inc. (Estech), a medical device manufacturer, has agreed to pay the United States $1.4 million to resolve civil claims in connection with the alleged promotion of its surgical ablation devices. Surgical ablation devices use focused energy to create controlled lesions or scar tissue on a patient’s heart or other organs.

Kaiser Foundation Hospitals - Kaiser Sunnyside Medical Center, Kaiser Foundation Health Plan of the Northwest and Northwest Permanente P.C., Physicians & Surgeons (collectively, Kaiser NW) has agreed to pay the United States $1,830,322.41 to settle False Claims Act liability.

Keshawn Deron Wilson of Asbury Park, N.J., pleaded guilty today in Tampa, Fla., to federal charges of using a video camera to record then newly-released motion pictures in a New Jersey theater.

The Department of Justice today announced that it has entered into a settlement agreement with private plaintiffs and the Pickens County, Ala., Board of Education that requires the board to institute a series of educational reforms designed to eliminate the remaining vestiges of its formerly segregated school system.

The United States has intervened and filed a complaint in a whistleblower suit against AseraCare Hospice, the Justice Department announced today.

Odyssey HealthCare, a subsidiary of Gentiva, has agreed to pay $25 million to resolve civil liability under the federal False Claims Act arising from its billing of claims for certain hospice services, the Justice Department announced today. Odyssey Healthcare currently provides hospice services in approximately 27 states, including Wisconsin. Odyssey was purchased by Gentiva Healthcare in 2010.

Hospice Care of Kansas LLC and its parent company, Ft. Worth, Texas-based Voyager HospiceCare Inc., have agreed to pay $6.1 million to resolve allegations that they violated the False Claims Act by submitting claims to the Medicare program for ineligible hospice services, the Justice Department announced today. Hospice Care of Kansas currently provides hospice services throughout the state of Kansas. Hospice Care of Kansas, which is based in Wichita, Kan., was purchased by Voyager in 2004.

The government has intervened in a whistleblower lawsuit against Hospice of the Comforter Inc. (HOTCI) alleging false Medicare billings, the Justice Department announced today. HOTCI provides hospice services to patients residing in the vicinity of Orlando, Fla.

Harmony Care Hospice Inc. (Harmony) and Harmony owner and chief executive officer Daniel J. Burton have agreed to pay the United States $1,286,999.32 to settle allegations that the South Carolina-based company submitted false claims to Medicare for patients under care at its hospice facilities, the Justice Department announced today.

Hospice of Arizona L.C., along with a related entity, American Hospice Management LLC, and their parent corporation, American Hospice Management Holdings LLC, have agreed to pay $12 million to resolve allegations that they violated the False Claims Act by submitting or causing the submission of false claims to the Medicare program for ineligible hospice services.

A jury convicted Stephen M. Kerr and Michael Quiel yesterday on federal tax charges stemming from their failure to disclose secret offshore bank accounts in Switzerland.

The United States has filed suit against Chemed Corporation and various wholly owned hospice subsidiaries, including Vitas Hospice Services LLC and Vitas Healthcare Corporation, alleging false Medicare billings for hospice services.

A federal jury sitting in the Eastern District of Pennsylvania convicted Eugene Goldman, M.D., 55, of Philadelphia, of one count of conspiring to violate the anti-kickback statute and four counts of violating the anti-kickback statute in relation to his role in a kickback scheme arising from his employment as the Medical Director at Home Care Hospice Inc. (HCH).

The Department of Justice today restrained the 1909 Pablo Picasso painting “Compotier et tasse” – estimated to be worth $11.5 million – on behalf of the Italian government.

Hospice of the Comforter Inc. (HOTCI) has agreed to pay $3 million to resolve allegations that it violated the False Claims Act by submitting false claims to the Medicare program for hospice services provided to patients who were not eligible for the Medicare hospice benefit.

Joel Rakower, along with his solely-owned corporation, Transship Discounts Ltd., pleaded guilty today in federal court in Brooklyn, N.Y., to violating the Lacey Act by mislabeling imported piranhas.

At the Department of Justice, we are devoting significant resources and energy to fighting computer hacking and other types of cybercrime. The recent revelations about the massive thefts of financial information from large retail stores have served as a stark reminder to all of us about how vulnerable we are to cyber criminals who are determined to steal our personal information. The Justice Department is more committed than ever to ensuring that the full range of government enforcement tools is brought to bear in the fight against cybercrime.

California attorney Christopher M. Rusch was sentenced to serve 10 months in prison for helping his clients Stephen M. Kerr and Michael Quiel, both businessmen from Phoenix, hide millions of dollars in secret offshore bank accounts at UBS AG and Pictet & Cie in Switzerland, the Justice Department and the Internal Revenue Service announced today.

The United States has partially intervened against defendants in two whistleblower lawsuits in the Federal District Court for the District of Colorado alleging Evercare Hospice and Palliative Care submitted false claims for the Medicare hospice benefit.

From : Communities>>Regulatory Open Forum
Dear Roy, You do not mention any important functions of the syringe/applicator, other than the Primary Packaging function for which you have identified testing to assess impact. The determination of these functions (e.g. deliverable dose or dose accuracy) could provide important testing to verify that no impact on performance. Also, an assessment on the impact of the change on the usability could be required (particularly if the ergonomics/forces change) or patient risk would be prudent, which [More]

From : Communities>>Regulatory Open Forum
Dear Lee & Spyros, Many thanks for your invaluable advice - really appreciate your time in considering and providing deep insight. Kind regards, Roy Jamieson (BPharm Hons) Regulatory CMC Consultant

From : Communities>>Regulatory Open Forum
Hello,  I can see many unapproved combinations of Minoxidil as topical solution like minoxidil+ Azelaic Acid; Minoxidil + Finasteride; Minoxdil+ niacin+retinol+caffeine that are available online for sale in US but these drug products are not approved by FDA as visble from USFDA website.  Can anyone explain that is there any mechanism or guideline to allows to sell such unapproved drug products online in US and also in EU? Or is this totally illegal practice?  Thanks Ankur RAC

From : Communities>>Regulatory Open Forum
Hi, Ankur - Some may be "legal," others not. It's a big industry, and it is fair to be cynical. Combination products for sale that have not been approved-as the combination-by FDA are just that, unapproved drugs. I assume you checked for the approval status in FDA's "Orange Book" (https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm). Even if both active pharmaceutical ingredients in a 2-drug mixture were approved separately on their own, it does not mean the combined product is approved for [More]

From : Communities>>Regulatory Open Forum
These are all unapproved new drugs. Many people who have very limited knowledge of our OTC drug system, assume that if it is sold OTC, it is a monographed drug and they can change the formulation. They do not know that there are two types of OTC drugs allowed-compliance with a monograph or NDA. Minoxidil is one and chlorhexidine antiseptic wash is another. ------------------------------ David Steinberg,FRAPS President Steinberg & Associates, Inc. Pompton Plains NJ USA 609-902-8860 -------------- [More]

From : Communities>>Regulatory Open Forum
The only  possible way I can see any of these products being legally marketed in the US without going the OTC NDA route would be if the ingredients  other than Minoxidil are considered "inactive" and have some purpose (other than their active ingredient purposes) in the formulation.  That said, this might work for the last combination in your listing because all of these can and are often used in OTC products as inactive ingredients with understood and current reasons for existing in a formulation [More]

From : Communities>>Regulatory Open Forum
These types of products and combinations you mention are all unapproved drugs and unapproved combinations.  Unless the specific combination is approved or listed in an OTC monograph, it is a new drug and requires a NDA to market it.  Minoxidil is a Rx to OTC switch product so it requires a NDA or ANDA to market this drug in the US, even as a OTC drug.  Thus any combination with minoxidil is a new drug. In the past the FDA has also specifically stated that combining different types of products (drug [More]

by Adriana Gallardo, ProPublica, and Ariel Goodman for ProPublica

They’ve gotten to know New York City in a way many have not, through the low-wage work of cleaning its skyscrapers, serving its restaurants and crisscrossing its streets on bicycles, through long subway rides very early in the morning and very late at night. The saying goes: You’re not a true New Yorker unless you’ve lived here for a decade. They’ve done their time and felt a deep sense of belonging in this city of immigrants.

But, in the epicenter of a pandemic, the undocumented have never felt more alone.

They are losing loved ones but do not qualify for city funding to help bury them. They are getting sick but hesitating to get tested or go to the hospital, balancing their fear of the virus with their fear of exposure to immigration authorities. They are worried about supporting their families abroad as well as those who live with them, weighing whether to keep working perilous jobs or to stay home and somehow keep food on the table.

They’ve experienced separation, but not like this — out in the world, in a skeleton crew, wearing a mask to deliver food to closed doors; in cramped apartments, sectioned off, in an attempt to quarantine. They are divided across national borders as family members die, praying novenas on Google Hangouts. Their bodies cannot be buried, intact, where they were born; they move from hospital bed, to refrigerated truck, to incinerator.

ProPublica interviewed two dozen undocumented Latino immigrants and their families about their experiences with death, illness and survival. Some spoke on the condition of anonymity, afraid of being targeted. Others allowed us to use their first names or the full names of their family members who died.

One kitchen worker from the Bronx worked in the World Trade Center two decades ago. “We used to fill the back elevators of those towers,” he said. He lost friends on Sept. 11, 2001, who were not identified or acknowledged among the dead because their names did not match those on record or their families were unable to claim the bodies.

He and others spoke to ProPublica because this time they wanted their experiences to be counted as part of the story of their city, overtaken by a virus.

Barriers to a Proper Burial

Adrian Hernandez Lopez, 38, never planned to stay in New York City. His 15 year stint here was dotted with visits to his family in Mexico, for the baptism of his son, who is now almost a teen, and to check on the house he had been sending his paychecks to build.

He and brother worked at an Italian restaurant in Times Square. “We were always together,” his brother said. They crossed the border together and, years later, commuted together from Queens to midtown Manhattan.

The last time they spoke by phone, Lopez waited in agony in a hard chair at Elmhurst Hospital, breathing in oxygen from a machine. He was transferred to Woodhull Hospital in Brooklyn. One day later, the father of two wound up in a vegetative state.

He died on April 2. His mother, who lives in Allende, a small village in the state of Puebla, wants him buried there, alongside two babies she lost just after birth.

He can’t be traditionally buried, despite the strong Mexican custom. More than 400 Mexican migrants are known to have died of COVID-19 in the New York area, but for health reasons, Mexico will only accept their bodies if they are cremated.

In place of seeing the body one last time, Lopez’s brother was sent photos by the funeral home, which will hold the cremains while the family figures out how to get them to Mexico.

The Mexican Consulate pledged financial aid to the families of nationals who died of COVID-19 complications, but it has been slow to materialize. According to Lopez’s brother, they’ve been asked to follow guidelines to receive a reimbursement. The Consulate General’s office in New York said it was not authorized by the Mexican government to give interviews at the time of our request for comment.

The city of New York provides burial assistance, but it requires a Social Security number for both the deceased and the person requesting funds. City officials say they are limited by federal and state law in the help they can offer. “We are exploring every possible option to ensure that all New Yorkers, regardless of immigration status, are able to bury their loved ones in the way they feel is most fitting,” city spokesperson Avery Cohen said.

Two members of the City Council have called for an emergency fund to provide assistance to all low-income families, including the undocumented.

“One of the most devastating calls I’m regularly getting is from people who can’t afford to bury their loved ones and aren’t eligible for any assistance,” Council Member Francisco Moya said in a release. “That’s simply not acceptable.”

Lopez’s family is one of several raising money for the transport and burial of their loved one who died in the United States.

As he tries to figure out how to send Lopez home, his brother sits in the small apartment they shared in Queens, with his wife and 6-year-old daughter, listening to the sirens that have become a constant reminder of their loss. He and his wife have been out of work for a month. They don’t know how they will pay the rent.

Deterred From Seeking Care

More than a dozen undocumented people told ProPublica that when they got sick, they stayed home, deterred from seeking care by the worry that they would not get it if they tried. They faced the same obstacles as everyone else in New York, where hospitals were crowded and unsafe, and feared additional ones involving their immigration status.

Fani lives in East Harlem. Over the last 18 years, she’s worked at a laundromat and a factory, a restaurant and as a babysitter. When she and her husband got sick they called 311. She said the voice on the other end confirmed their COVID-19 symptoms and told them to stay home unless they couldn’t breathe.

“They said there were no beds, no respirators. We healed each other as best we could with soups, teas and Tylenol,” she said.

Sonia, who became ill with COVID-19 symptoms almost three weeks ago, was afraid to go to the hospital. “I knew several people who went into the hospital with symptoms and they never came back,” she said. “That was my fear and why I decided to not go in. I preferred to isolate myself at home, with a lot of home remedies and hot teas.”

Multiple people said they knew hospitals had limited resources and worried they would be placed last in line for care because they were undocumented. “They’re going to let us die,” one man told his brother. A woman named Yogi in the Bronx said, “It might not be that they don’t want to treat us, maybe there weren’t enough supplies.”

Stories rippled through the Latino community about those who had difficulty getting care and those who could not be saved. According to a recent poll of voters in New York City, more than half of Latinos there said they know someone who died, the highest percentage of any group asked.

They hear stories about people like Juan Leonardo Torres, a 65-year-old retired doorman who knew someone on every corner of Corona, Queens. Unlike the others, Torres, from the Dominican Republic, was a citizen. Even so, he grew discouraged when he tried to get care.

Within one week at the end of March, Torres had gone from feeling slightly ill to experiencing difficulty breathing and fevers that his wife Mindy tried to manage using herbs and other “remedios caseros,” or home remedies. She and her five sons who lived with them finally persuaded him to go to Long Island Jewish Medical Center Forest Hills, just a five-minute drive from the house.

When Torres arrived, he told his family there were not enough seats in the crowded emergency room. He gave his chair up to an older woman and stood for hours as staff connected and disconnected him to an oxygen tank.

Fifteen hours later, on a drizzly night, Torres appeared at the door of the family home. It was 2:30 a.m. He had made the walk alone and declared in Spanish, “For no reason do I want to go to the hospital to die like a dog.”

He spent the next three days quarantined in his son’s room, where he died.

As the family waited six hours for his body to be retrieved, his wife sat in the living room “like a statue.”

Calculating Survival

Unable to qualify for relief programs like unemployment and stimulus cash, undocumented people are faced with the difficult choice of working dangerous jobs or running out of the money they need for essentials like food and housing.

“The little we have goes to food,” said Berenice, who suffers from kidney problems and whose son struggles with asthma. She’s been home for weeks along with her husband Luis, who before the pandemic worked at a cab company.

“Yes, we need money, but there is also our health,” Berenice said. “We have family who are sick and friends who died. We are trying to survive.”

Luis has lived in New York for 18 years, working his way up from delivering pizza on a bicycle to owning a cab. He worries about exposing his wife and son. “I just want this to pass and we’ll see about starting over again,” he said.

Adan lives in the Bronx with his two teenage sons, who were born in New York City, and his wife. She cleaned homes. He worked in a restaurant in East Harlem. Neither are working and both overcame COVID-19. “The little money we had went to pay last month’s rent,” he said. “I don’t know what to do, we just want to work.”

He said his landlord always comes looking for the rent in person. He told “el señor” that he’s spending all his money on food. The man gave him flyers about unemployment, but Adan knows he won’t qualify. “Me las voy a ver duras,” he said. He’s going to see hard times. He said he has lived in the same building for 11 years and has never missed a payment. Even though he can’t be evicted now, he said, “the debt will be there.”

Adding to the pressure, for some, is that they also work to support family members in their home countries, who count on the money they send.

One delivery worker in Queens sends $400 to Mexico every two weeks to help his son, who studies biomedicine at a university in Puebla; that helps him cover what he needs for school, including rent and transportation. He sends another $300 each month to his elderly mother.

He said he remains one of only a few bicycle delivery workers at his diner who are still on the job, and he is seeing more orders than usual. He’s always worked six days a week, but this past month was so busy, he couldn’t stop to eat lunch or take breaks.

He would much rather be outside than at home, but the streets feel tense. “I feel strange not seeing anyone or saying hi anymore, but I think it’s much better this way,” he said. “I understand why people are afraid.”

Even though he doesn’t see them in the buildings he visits, customers have been conscious about leaving tips in envelopes. He feels grateful as he passes the long lines in Queens of those waiting for free food. It makes him sad to know how many need it now.

He rents a room in an apartment he shares with three other men who have all lost their jobs. One was in construction, the other two in restaurants. He takes precautions to keep them safe when he comes home, including changing his clothes before coming in. “It would be irresponsible not to,” he said.

He hopes the rules of social distancing, and his mask and gloves, will protect him. “I’m not scared,” he said. “If you are afraid all the time, you will get sick faster.”

---

California reopening: Traffic volume is steadily creeping up, and travel times are getting longer.

Check the most important topics of Economics for the preparation of UPSC (IAS) Prelims Exam 2020. All the important topics have been added after a detailed analysis of the latest UPSC Prelims 2020 Syllabus.

The startup sources generic drugs directly from the manufacturer and sells it to retail pharmacies.

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