US FDA authorizes emergency use of Gilead’s COVID-19 drug remdesivir

US President Donald Trump (L) is joined by (2nd L-R) Food and Drug Administration head Stephen Hahn, White House coronavirus task force coordinator Dr. Deborah Birx and Health and Human Services Secretary Alex Azar to announce that the Food and Drug Administration issued an emergency approval for the antiviral drug remdesivir. (Erin Schaff-Pool/Getty Images/AFP)
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Updated 02 May 2020
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US FDA authorizes emergency use of Gilead’s COVID-19 drug remdesivir

  • During a meeting in the Oval Office of the White House with President Donald Trump, Gilead Chief Executive Daniel O’Day called the move an important first step
  • The FDA authorization applies to patients hospitalized with severe COVID-19 who require oxygen supplementation

WASHINGTON: Gilead Science Inc’s antiviral drug remdesivir was granted emergency use authorization by the US Food and Drug Administration for COVID-19 on Friday, clearing the way for broader use of the drug in more hospitals around the United States.
During a meeting in the Oval Office of the White House with President Donald Trump, Gilead Chief Executive Daniel O’Day called the move an important first step and said the company was donating 1.5 million vials of the drug to help patients.
“We’re humbled by this being an important first step for ... hospitalized patients. We want to make sure nothing gets in the way of these patients getting the medicine, so we made a decision to donate about 1.5 million vials,” he said.
Gilead did not immediately respond to a request for the price it plans to charge for the drug after those donations are used up.
The FDA authorization applies to patients hospitalized with severe COVID-19 who require oxygen supplementation.
Gilead said the federal government will coordinate the donation and distribution of remdesivir to hospitals in cities hardest hit by COVID-19. Citing the drug’s limited supply, the company said hospitals with intensive care units and other hospitals that the government deems most in need will receive priority.
Countries around the world are reeling from the novel coronavirus. There are more than 1 million cases and over 63,000 people have died in the United States, where much of the country is on lockdown to contain the spread of the virus.
Gilead said on Wednesday the drug, which is given by intravenous infusion, had helped improve outcomes for patients with COVID-19, the respiratory disease caused by the novel coronavirus, and provided data suggesting it worked better when given earlier in the course of infection.
Data released this week from a National Institutes of Health trial showed that remdesivir reduced hospitalization stays by 31% compared to a placebo treatment.
Interest in Gilead’s drug has been high as there are currently no approved treatments or preventive vaccines for COVID-19, and doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in extremely severe cases.
The recent clinical data has raised hopes remdesivir might be an effective treatment for the novel coronavirus that has infected more than 3 million people and killed over 225,000 worldwide.
A draft study abstract released inadvertently by the World Health Organization (WHO) last week said remdesivir failed to improve patients’ condition or reduce the pathogen’s presence in the bloodstream. The drugmaker said the findings were inconclusive because the study was terminated early.
Remdesivir, which previously failed as a treatment for Ebola, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses, including the new coronavirus, make copies of themselves and potentially overwhelm their host’s immune system.
Vice President Mike Pence said the 1.5 million vials would start being distributed to hospitals on Monday.


UK military personnel’s data accessed in hack, BBC reports

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UK military personnel’s data accessed in hack, BBC reports

  • MPs could be informed about the development in the Commons on Tuesday

Some personal information in a payroll system used by Britain’s defense department has been accessed in a data breach, the BBC reported on Monday.
The system was managed by an external contractor and no operational Ministry of Defense data was obtained, the broadcaster said, adding that the department took the system off-line immediately.
Information like names and bank details of current and some former members of the Royal Navy, Army and Air Force was compromised, according to the report.
The Ministry of Defense did not immediately respond to a Reuters’ request for comment outside working hours.
MPs could be informed about the development in the Commons on Tuesday, the report added.


Columbia University cancels main commencement after weeks of pro-Palestinian protests

Updated 18 min 27 sec ago
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Columbia University cancels main commencement after weeks of pro-Palestinian protests

  • Israel has killed more than 34,600 Palestinians, about two-thirds of them women and children, according to the Health Ministry in the Hamas-ruled territory
  • Similar encampments sprouted up elsewhere as universities struggled with where to draw the line between allowing free expression while maintaining safe and inclusive campuses

NEW YORK: Columbia University canceled its large university-wide commencement ceremony Monday following weeks of pro-Palestinian protests that have roiled its campus and others across the US, but said students will still be able to celebrate at a series of smaller, school-based ceremonies this week and next.
The decision comes as universities around the country wrangle with how to handle commencements for students whose high school graduations were derailed by COVID-19 in 2020. Another campus shaken by protests, Emory University, announced Monday that it would move its commencement from its Atlanta campus to a suburban arena. Others, including the University of Michigan, Indiana University and Northeastern, have pulled off ceremonies with few disruptions.
Columbia’s decision to cancel its main ceremonies scheduled for May 15 saves its president, Minouche Shafik, from having to deliver a commencement address in the same part of campus where police dismantled a protest encampment last week. The Ivy League school in upper Manhattan said it made the decision after discussions with students.
“Our students emphasized that these smaller-scale, school-based celebrations are most meaningful to them and their families,” officials said.
Most of the ceremonies that had been scheduled for the south lawn of the main campus, where encampments were taken down last week, will take place about 5 miles (8 kilometers) north at Columbia’s sports complex, officials said.
Speakers at some of Columbia’s still-scheduled graduation ceremonies include Pulitzer Prize-winning playwright James Ijames and Dr. Monica Bertagnolli, director of the National Institutes of Health.
Columbia had already canceled in-person classes. More than 200 pro-Palestinian demonstrators who had camped out on Columbia’s green or occupied an academic building were arrested in recent weeks.
Similar encampments sprouted up elsewhere as universities struggled with where to draw the line between allowing free expression while maintaining safe and inclusive campuses.
The University of Southern California earlier canceled its main graduation ceremony. Students abandoned their camp at USC on Sunday after being surrounded by police and threatened with arrest.
Other universities have held graduation ceremonies with beefed-up security. The University of Michigan’s ceremony was interrupted by chanting a few times Saturday. In Boston on Sunday, some students waved small Palestinian or Israeli flags at Northeastern University’s commencement in Fenway Park.
Emory’s ceremonies scheduled for May 13 will be held at the GasSouth Arena and Convocation Center in Duluth, almost 20 miles (30 kilometers) northeast of the university’s Atlanta campus, President Gregory Fenves said in an open letter.
“Please know that this decision was not taken lightly,” Fenves wrote. “It was made in close consultation with the Emory Police Department, security advisers and other agencies — each of which advised against holding commencement events on our campuses.”
The 16,000-student university is one of many that has seen repeated protests stemming from the conflict that started Oct. 7 when Hamas militants attacked southern Israel, killing about 1,200 people, mostly civilians, and taking roughly 250 hostages. Student protesters are calling on their schools to divest from companies that do business with Israel or otherwise contribute to the war effort.
Vowing to destroy Hamas, Israel launched an offensive in Gaza that has killed more than 34,500 Palestinians, about two-thirds of them women and children, according to the Health Ministry in the Hamas-ruled territory. Israeli strikes have devastated the enclave and displaced most of its inhabitants.
Hamas on Monday announced its acceptance of an Egyptian-Qatari ceasefire proposal, but Israel said the deal did not meet its “core demands” and that it was pushing ahead with an assault on the southern Gaza town of Rafah.
“Ceasefires are temporary,” said Selina Al-Shihabi, a Georgetown University sophomore who was taking part in a protest at George Washington. “There can be a ceasefire, but the US government will continue to arm the Israeli military. We plan to be here until the university divests or until they drag us out of here.”
Also Monday, the University of California, Los Angeles, alerted students that all classes were moving online due to ongoing disruptions following the dismantling of a pro-Palestinian encampment last week. The university police force reported 44 arrests but there were no specific details, UCLA spokesperson Eddie North-Hager said in an email to The Associated Press.
At the University of California, San Diego, police cleared a pro-Palestinian encampment and arrested more than 64 people, The San Diego Union-Tribune reported.
Schools are trying various tactics from appeasement to threats of disciplinary action to get protesters to take down encampments or move to campus areas where demonstrations would be less intrusive.
The School of the Art Institute of Chicago said in a Facebook post Sunday that it offered protesters “amnesty from academic sanction and trespassing charges” if they moved.
“Many protesters left the premises of their own accord after being notified by the police that they were trespassing and subject to arrest,” the school said. “Those that remained were arrested after multiple warnings to leave, including some of whom we recognized as SAIC students.”
A group of faculty and staff members at University of North Carolina at Chapel Hill asked the administration for amnesty for any students who were arrested and suspended during recent protests. UNC Faculty and Staff for Justice in Palestine said in a media advisory that it would deliver a letter on behalf of more than 500 faculty who support the student activists.
Other universities took a different approach.
Harvard University’s interim president, Alan Garber, warned student’s that those participating in a pro-Palestinian encampment in Harvard Yard could face “involuntary leave.” That means they may would not be allowed on campus, could lose their student housing and may not be able to take exams, Garber said.
At the Massachusetts Institute of Technology, police restricted access to an encampment after a school deadline for them to leave had passed. About 200 protesters gathered outside the camp, chanting, “MIT can’t you see? Palestine will be free” and other slogans.
 

 


Russia says it takes control of two more settlements in eastern Ukraine

Updated 07 May 2024
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Russia says it takes control of two more settlements in eastern Ukraine

  • Russia has made slow but steady advances since taking Avdiivka in February, with a string of villages in the area falling to Moscow’s forces

MOSCOW: Russian forces have taken control of the settlements of Soloviove in Ukraine’s eastern Donetsk region and Kotliarivka further north in the Kharkiv region, the defense ministry said on Monday.
Ukraine’s military made no mention of either locality in its evening General Staff report. Kharkiv Regional Governor Oleh Syniehubov said on Monday that Kotliarivka, located near the town of Kupiansk, was one of several locations to come under Russian shelling.
But Ukrainian bloggers appeared to acknowledge that both villages were in Russian hands.
DeepState, a popular forum on the war, noted on Saturday that Kotliarivka had been captured by Russian forces and on Sunday said the neighboring village of Kyslivka was also in Russian hands.
DeepState reported that Soloviove, northwest of the Russian-held town of Avdiivka, had been taken by Russian forces last week.
Russia has made slow but steady advances since taking Avdiivka in February, with a string of villages in the area falling to Moscow’s forces.


UNICEF warns 600,000 children face ‘catastrophe’ in Rafah

Updated 06 May 2024
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UNICEF warns 600,000 children face ‘catastrophe’ in Rafah

  • Calling again for a ceasefire and safe access for humanitarian organizations, the agency highlighted there are some 78,000 infants under age two sheltering in the city, along with 175,000 children under five who are affected by infectious disease
  • Israel has killed more than 34,000 Palestinians in Gaza, mostly women and children, according to the health ministry in the Hamas-run territory

NEW YORK: Some 600,000 children packed into Gaza’s Rafah city face “further catastrophe,” UNICEF warned on Monday, urging against their forced relocation after Israel ordered an evacuation ahead of its long-threatened ground invasion.
“Given the high concentration of children in Rafah ... UNICEF is warning of a further catastrophe for children, with military operations resulting in very high civilian casualties and the few remaining basic services and infrastructure they need to survive being totally destroyed,” the UN children’s agency said in a statement.
It said Gaza’s youth were already “on the edge of survival,” with many in Rafah — where the agency said the population has soared to 1.2 million people, half of them children — already displaced multiple times and with nowhere else to go.
“More than 200 days of war have taken an unimaginable toll on the lives of children,” said UNICEF Executive Director Catherine Russell.
“Rafah is now a city of children, who have nowhere safe to go in Gaza,” she said, warning that a large-scale military operation by Israel would bring “chaos and panic, and at a time where (children’s) physical and mental states are already weakened.”
UNICEF estimates that Rafah’s population has swelled to nearly five times its normal figure of 250,000 residents.
Calling again for a ceasefire and safe access for humanitarian organizations, the agency highlighted there are some 78,000 infants under age two sheltering in the city, along with 175,000 children under five who are affected by infectious disease.
Gaza’s bloodiest-ever war began following Hamas’s unprecedented Oct. 7 attack on Israel.
Israel has conducted a retaliatory offensive that has killed at least 34,735 people in Gaza, according to the Hamas-run
territory’s Health Ministry.
Of that toll, more than 14,000 are children, the ministry has said.
Israeli Prime Minister Benjamin Netanyahu has vowed to send ground troops into Rafah regardless of any truce, despite concerns from the US, other countries, and aid groups.
Hamas official Izzat Al-Rashiq said in a statement that any Israeli operation in Rafah would put the truce talks in jeopardy.
Senior Hamas official Sami Abu Zuhri said the evacuation order was a “dangerous escalation” that would have consequences.
“The US administration, alongside the occupation, bears responsibility for this terrorism,” the official said.
Hamas said later in a statement that any offensive in Rafah would not be a “picnic” for Israeli forces and said it was fully prepared to defend Palestinians there.
Aid agencies have warned that the evacuation order will lead to an even worse humanitarian disaster in the crowded coastal enclave of 2.3 million people reeling from seven months of war.
“Forcing 1 million displaced Palestinians from Rafah to evacuate without a safe destination is not only unlawful but would lead to catastrophic consequences,” British charity ActionAid said.
Nick Maynard, a British surgeon trying to leave Gaza on Monday, said in a voice message from the Gaza side of the Rafah crossing into Egypt: “Two huge bombs have just gone off immediately outside the crossing. There’s a lot of gunfire as well about 100 meters from us. We are very unclear whether we will get out.”
“Driving through Rafah, the tension was palpable with people evacuating as rapidly as they could.”
Witnesses said the areas in and around Rafah where Israel wants to move people are already crowded with little room for more tents.
“The biggest genocide, the biggest catastrophe, will take place in Rafah. I call on the whole Arab world to interfere for a ceasefire — let them interfere and save us from what we are in,” said Aminah Adwan, a displaced Palestinian.
Israel has been threatening to launch incursions in Rafah, which it says harbors thousands of Hamas fighters and potentially dozens of hostages.
Victory is impossible without taking Rafah, it says.

 


New York’s Columbia University cancels graduation ceremony as students remain defiant

Updated 06 May 2024
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New York’s Columbia University cancels graduation ceremony as students remain defiant

  • Pro-Palestinian protests put paid to event planned for May 15

NEW YORK: New York’s prestigious Columbia University has announced that it is canceling its main graduation ceremony, scheduled for next week, because of ongoing pro-Palestinian protests.

The announcement on Monday is the latest development in a movement that began nearly three weeks ago at Columbia and has swept college campuses nationwide.

The graduation ceremony had been scheduled for May 15 on the south lawn of the Manhattan campus, where protest encampments had been based before authorities dismantled them last week.

The Ivy League institution said it would “forego the university-wide ceremony” and hold a series of smaller events instead.

“We are determined to give our students the celebration they deserve, and that they want,” Columbia announced, saying “smaller-scale, school-based celebrations are most meaningful to them and their families.”

The university added: “We will focus our resources on those school ceremonies and on keeping them safe, respectful, and running smoothly. A great deal of effort is already underway to reach that goal.”

Students across the US have protested and set up tents at dozens of universities to register their opposition to the war in Gaza, while calling on President Joe Biden to do more to stop the bloodshed.

They have also demanded their institutions cease supporting companies that support Israel’s government.

Maya James, a psychology student at Columbia, told Arab News: “Seeing the university’s really insane response to student protests has brought so many people together, because I feel like most people on this campus can agree, including faculty, that students should not be penalized for expressing their First Amendment rights to protest, to petition, to do all of these things we’ve been encouraged to do for so long.”

She called on the university to give amnesty to students who had been suspended for expressing their First Amendment rights, which protect freedom of speech, the press, assembly, and the right to petition.

James also called on the university to disclose its investments because as “of right now there’s no visibility for us students to be able to know what the university is expected to do.”

She described the “vibes” at the protest sites as “absolutely remarkable,” with cultural and educational programs being offered and all kinds of activities being held.

She said the demonstrations were a continuation of Columbia’s long tradition of protest which began in the 1960s with its opposition to the involvement of the US in the Vietnam War.

James said it was “incredible” to see the solidarity for the Palestinian cause spread in campuses across the US, and people pushing to ensure “that we do indeed see a free Palestine within our lifetime and that our universities are no longer complicit in the genocide.”

Demonstrators have gathered on at least 40 US university campuses since April 17, often erecting tent camps to protest against the soaring death toll in the Gaza Strip. Nearly 2,000 people have been detained, according to the US media.

Police officers have forcibly ended several student sit-ins in recent days, including one at New York University at the request of its administrators.

Demonstrators had barricaded themselves inside Columbia, the epicenter of student protests in New York, and some complained about police brutality when officers cleared the faculty.

(With Agencies)