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Exclusive: FDA widens U.S. safety inquiry into AstraZeneca coronavirus vaccine – sources – Reuters

WASHINGTON (Reuters) – The U.S. Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca Plc’s COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters.

FILE PHOTO: A test tube labelled with the Vaccine is seen in front of AstraZeneca logo in this illustration taken, September 9, 2020. REUTERS/Dado Ruvic

AstraZeneca’s large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.

The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week, after which the FDA would need time to analyze it, two of the sources said.

Effective vaccines are seen as essential to help end a pandemic that has killed more than one million people worldwide.

The administration of President Donald Trump has pledged $1.2 billion to support development of the AstraZeneca vaccine and secure 300 million doses for the United States. Other leading companies in the U.S. vaccine race include Pfizer Inc, Moderna Inc and Johnson & Johnson.

Regulators in the UK, Brazil, India and South Africa have allowed AstraZeneca to resume its clinical trials there.

The FDA, however, wants to determine whether similar side effects emerged in trials of other vaccines designed by AstraZeneca’s coronavirus vaccine partner, researchers at Oxford University, the sources said. That does not mean the agency believes there were safety issues associated with any of these vaccines, they added.

“It just shows that the FDA is being thorough,” said one of the sources.

Further complicating the situation is that the data requested by FDA is in a different format than what the U.S. regulator requires, two of the sources said.

The FDA declined to comment on discussions involving an experimental product. Oxford did not respond to requests for comment. AstraZeneca, in a statement, said: “We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial.”

VIRAL VECTOR

All of the vaccines it wants to review use a modified adenovirus as vectors to safely deliver genetic material from the target illnesses – flu, Middle East Respiratory Syndrome, and other diseases – into the body to stimulate an immune system response to fight future infection.

While other vaccine developers have used human adenoviruses for such vaccines, the Oxford researchers chose an adenovirus found in chimpanzees. They felt this would reduce the likelihood that an individual’s immune system would attack the vector virus due to prior exposure rather than the intended target.

Reuters reviewed six research papers that detailed safety data of vaccines using the engineered chimpanzee adenovirus called ChAdOx1 for diseases including tuberculosis, prostate cancer and influenza.

In one of those trials, one serious adverse event cited by researchers was deemed unrelated to the vaccine.

The type of review being conducted by the FDA is generally intended to scrutinize raw data for other side effects, the sources said.

The U.S. government’s effort to speed development of a COVID-19 vaccine – and promises by Trump that one could be available prior to the Nov. 3 presidential election – has led to concerns of political interference in the regulatory process at the expense of safety. The FDA has denied this.

AstraZeneca’s vaccine development could also be slowed by a change to its clinical trial protocols to show that it has met pre-determined safety and efficacy standards.

Independent safety monitors will conduct their first review of the vaccine’s safety and effectiveness after 75 trial subjects become infected with COVID-19, up from the original initial review plan after about 40 infections, according to a Reuters review of protocol documents issued in July and amended in mid-September.

The safety monitors could decide to stop the trial if the vaccine proves either highly effective, and therefore should be considered for public use before the trial concludes, or if serious safety problems appear.

“Safety is likely to have been a major reason” for the change, said Thomas Lumley, chair of biostatistics at the University of Auckland who was not involved with the study.

AstraZeneca would not say why it had made the change to its protocol.

Reporting by Marisa Taylor in Washington and Dan Levine in San Francisco; Additional reporting by Nancy Lapid; Editing by Michele Gershberg and Bill Berkrot

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Exclusive: Nearly a fifth of enrollees in Pfizer, BioNTech COVID-19 vaccine study are Black or Latino – Reuters

(This August 21 story has been corrected to rectify percentages of people with fever in trial in the fourth from last paragraph)

FILE PHOTO: People gather in downtown amid the coronavirus disease (COVID-19) outbreak in Chelsea, Massachusetts, U.S., May 20, 2020. REUTERS/Brian Snyder

By Julie Steenhuysen and Michael Erman

CHICAGO/NEW YORK (Reuters) – Nearly a fifth of 11,000 people enrolled so far in a 30,000-volunteer U.S. trial testing a COVID-19 vaccine from Pfizer (PFE.N) and German partner BioNTech (22UAy.F) are Black or Latino, groups among the hardest hit by the coronavirus virus pandemic, a top Pfizer executive said.

“Between Latinx and Black or African American populations, we’re running at about 19 percent or so,” Dr. Bill Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told Reuters in an interview.

“We’re trying to push even higher than that.”

Black and Latino Americans are infected with COVID-19 at more than twice the rate of white Americans, with Native Americans infected at even higher rates, research has shown. The groups are historically underrepresented in clinical trials.

The companies’ vaccine has quickly advanced into late-stage testing, with some participants already getting their second of two doses.

Physicians and scientists have been urging companies testing coronavirus vaccines to include Black, Latino and indigenous Americans in COVID-19 vaccine trials in hopes of building trust among at-risk populations.

“We have a lot of campaigns to reach out to those communities because they are overrepresented in terms of COVID-19 illness, so we are very keen to have those individuals as part of our trial,” Gruber said on Thursday. “They have higher attack rates and they are most likely to benefit.”

According to a Reuters/Ipsos poll in May, only half of Black Americans said they were somewhat or very interested in taking a COVID-19 vaccine.

Gruber did not disclose the number of Native Americans enrolled in the trial, but said Pfizer plans to draw on ties from its Prevnar 7 pneumococcal vaccine tests in the southwestern United States.

“I’m hopeful we’ll be able to make further inroads in that community as well,” he said.

Pfizer and BioNTech expect to have data sufficient for an emergency use authorization (EUA) or to start a full submission in October, according to Gruber.

The company does not need to finish recruiting the full 30,000 patients planned for the trial in order to have enough data to support an EUA, he said.

The U.S. Food and Drug Administration (FDA) has said COVID-19 vaccine trials need to have a safety database of at least 3,000 individuals for each of the younger and elderly populations in which it is tested.

Ultimately, the speed with which the vaccine can be approved depends on how quickly patients in the placebo arm become infected with the virus, starting about a week after the second dose is administered. That began this week.

“We won’t really know until we get a little farther,” Gruber said.

“We’re following the rules that assure rigor,” he added, saying the company was taking no short cuts.

“I can’t tell you what will happen politically,” Gruber said, when asked about concerns the Trump administration might pressure companies and regulators to announce progress before the November election.

Gruber said the companies were now in talks with the FDA about how to begin testing the vaccine in children, a group the regulatory agency itself is eager to gather data on.

Vaccines work differently in children and adults.

Gruber said vaccine tests often progress in stages, first in older adolescents, then younger adolescents, and finally in children. But younger adults have higher rates of reactions, such as fevers and sore arms, to Pfizer’s vaccine than older adults do, Gruber said.

Roughly 17% of adults between the ages of 18-55 in Pfizer’s most recent trial had fevers after being given the vaccine, most of them mild, compared with 8% among those aged 65-85.

There is a risk those reactions could be even more heightened in younger populations, he added.

“Younger children – maybe that’s not going to be tolerated. Maybe we’re going to have severe fevers,” he said. “That’s why we’re adopting a very thoughtful, graduated approach. Children are not just small adults.”

Gruber said the company is submitting safety data to the FDA and working out a testing plan for children, which he expects to start soon.

Reporting by Julie Steenhuysen in Chicago and Michael Erman in New York

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Coronavirus Exclusive

Exclusive: U.S. to make coronavirus strain for possible human challenge trials – Yahoo News

By Julie Steenhuysen

CHICAGO (Reuters) – U.S. government scientists have begun efforts to manufacture a strain of the novel coronavirus that could be used in human challenge trials of vaccines, a controversial type of study in which healthy volunteers would be vaccinated and then intentionally infected with the virus, Reuters has learned.

The work is preliminary and such trials would not replace large-scale, Phase 3 trials such as those now under way in the United States testing experimental COVID-19 vaccines from Moderna Inc and Pfizer Inc , according to a statement emailed to Reuters by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

U.S. officials organizing the fight against the pandemic have been under pressure from advocacy groups such as 1 Day Sooner and others that see challenge trials as a way to speed up tests of a COVID-19 vaccine. Most vaccine trials rely on inadvertent infection, which can take time to occur.

Some drugmakers, including AstraZeneca and Johnson & Johnson , have said they would consider human challenge trials to test COVID-19 vaccines if needed.

“Should there be a need for human challenge studies to fully assess candidate vaccines or therapeutics for SARS-CoV-2, NIAID has begun investigations of the technical and ethical considerations of conducting human challenge studies,” the agency statement said.

That includes efforts to manufacture a suitable SARS-CoV-2 strain, draft a clinical protocol and identify resources that would be required to conduct such studies.

Small challenge studies would be done in small isolation units to control the virus. Larger challenge studies involving 100 people or so would have to be done in multiple locations, adding months of preparations to coordinate the studies.

Such trials are typically done when a virus is not widely circulating, which is not the case with COVID-19. Many scientists consider human challenge trials of the novel coronavirus unethical because there are no “rescue therapies” for those who fall ill.

Earlier this week, Johan Van Hoof, global vaccines chief for J&J, said in an interview with Reuters that the preparations for such trials are under way across the world, and the company is following those preparations.

Van Hoof said such trials would offer a testing option in case the virus stops circulating widely, but the company would only move forward with such trials if the ethical issues are resolved and an effective treatment is available.

Dr. Anna Durbin, a vaccine researcher at the Johns Hopkins Bloomberg School of Public Health, who has run a dozen challenge studies, estimates it could take nine to 12 months to set up a human challenge trial, and another six months to coordinate testing across multiple testing sites.

NIAID said it is continuing to prioritize field trials to evaluate SARS-CoV-2 vaccine candidates, but it opened the possibility to challenge trials for future generations of vaccines or treatments.

Dr. Dan Barouch, a vaccine researcher at Harvard’s Beth Israel Deaconess Medical Center in Boston, who helped design and conduct animal studies on J&J’s COVID-19 vaccine, said he is not aware of any manufacturers planning human challenge studies.

“In the setting of a pandemic that is raging, you don’t need it. You just do a trial and get a real result,” he said.

Moreover, vaccine trials would have to be done in healthy young people, said University of Maryland School of Medicine’s Dr. Kathleen Neuzil, co-leader of the Coronavirus Vaccine Prevention Network, which was formed by NIAID and is testing COVID-19 vaccines.

“A 20-year-old in a challenge study isn’t really going to give us the answer of will this vaccine keep an older person, someone with chronic kidney disease, from ending up in the hospital,” she said.

(Reporting by Julie Steenhuysen; Additional reporting by Francesco Guarascio in Brussels; editing by Peter Henderson and Leslie Adler)

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Arizona Exclusive

Exclusive: Arizona leads multi-state probe into older iPhones slowing, shutting down – Reuters

FILE PHOTO: A man takes pictures of iPhones in the new Apple flagship store on its opening day following an outbreak of the coronavirus disease (COVID-19) in Sanlitun in Beijing, China, July 17, 2020. REUTERS/Thomas Peter/File Photo

SAN FRANCISCO (Reuters) – Arizona is leading a multi-U.S. state probe into whether Apple Inc’s deliberate slowing of older iPhones violated deceptive trade practice laws, documents reviewed by Reuters on Wednesday showed.

Last week, a separate document released by a tech watchdog group showed the Texas attorney general might sue Apple for such violations in connection with a multi-state probe, without specifying charges.

In the ongoing probe since at least October 2018, investigators have asked Apple for data about “unexpected shutdowns” of iPhones and the company’s throttling, or slowing down, of the devices through power management software, documents Reuters obtained through a public records request showed.

The attorneys general offices in Arizona and Texas declined to comment. Apple did not immediately respond to a request for comment.

Apple came under fire in 2017 when Primate Labs, the maker of software for measuring a phone’s processor speeds, revealed that some iPhones became slower as they aged.

Apple later acknowledged that it reduced power demands – which can slow the processor – when an aging phone’s battery struggles to supply the peak current the processor demands. Apple said without its adjustments, iPhones would have unexpectedly shut down from power spikes.

Outraged iPhone users said that appeared to confirm long-held suspicions that Apple slowed older devices to encourage users to buy new phones. Apple publicly apologized and slashed prices on battery replacements.

Earlier this year, Apple agreed to pay up to $500 million to settle a proposed class-action lawsuit related to the battery issues.

Reporting by Paresh Dave and Stephen Nellis in San Francisco; Editing by Greg Mitchell and Richard Chang

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COVID Exclusive

Exclusive: EU eyes COVID-19 vaccines at less than $40, shuns WHO-led alliance – sources – Reuters

BRUSSELS (Reuters) – The European Union is not interested in buying potential COVID-19 vaccines through an initiative co-led by the World Health Organisation as it deems it slow and high-cost, two EU sources told Reuters, noting the bloc was in talks with drugmakers for shots cheaper than $40.

FILE PHOTO: A woman holds a small bottle labeled with a “Vaccine COVID-19” sticker and a medical syringe in this illustration taken April 10, 2020. REUTERS/Dado Ruvic/Illustration/File Photo

The position shows the EU has only partly embraced a global approach in the race for COVID-19 vaccines as, while it is a top supporter of initiatives for worldwide equitable access, it prefers prioritising supplies for the EU population.

It could also deal a blow to the WHO-led COVAX initiative to secure vaccines for all.

“Using COVAX would lead to higher prices and later supplies,” one of the two officials said.

The COVAX mechanism meant to buy vaccines in advance is targeting a $40 price for COVID vaccines for wealthy countries, the official said, adding the EU could buy at cheaper prices with its own scheme for upfront purchases.

A spokeswoman for GAVI, a public-private vaccine alliance which also co-leads the COVAX initiative, declined to comment on the $40 target, saying it was impossible at this stage to predict the exact price of future doses.

“Any pricing structure will need to reflect (the) at-risk investments in R&D and manufacturing necessary, as well as meet expectations that eventual vaccines are made available during the acute phase of the pandemic as a global good,” she said.

The WHO had no immediate comment.

On Wednesday, Pfizer (PFE.N) and BioNtech (22UAy.F) said the U.S. government had agreed to pay nearly $2 billion to secure their potential COVID-19 shot which, if successful, would be used to vaccinate 50 million people at a price of about $40 dollar per person.

The EU is currently in talks with several drugmakers to secure in advance their potential vaccines against the coronavirus, officials told Reuters last week.

These possible deals would be financed with about 2 billion euros ($2.3 billion) from an EU rainy-day fund known as Emergency Support Instrument (ESI), officials said.

The EU also wants to secure vaccines by the end of the year, should they be available. This timetable “is not feasible” for COVAX, one official said.

PARALLEL TRACKS

The European Commission, which is the bloc’s executive arm and leads EU talks with drugmakers, has advised EU states to join COVAX if they wish, but not for buying vaccines, the official said. A Commission spokesman declined to comment.

An official said joining the two initiatives may not be legally feasible, as EU states have accepted an exclusivity clause when they backed the EU advance purchase scheme.

Some EU states have expressed interest in joining COVAX but have not yet signed up.

The EU has been a keen supporter of global initiatives to secure vaccines for all. It has promoted two global fund-raising campaigns that have so far raised nearly $19 billion, of which three quarters came from EU states and institutions, to help develop COVID-19 vaccines and ensure equitable access.

However, taken aback by U.S. moves to secure potential vaccines and drugs, the EU has recently taken a more assertive role in the global race.

If COVID-19 vaccines prove effective in trials they are unlikely to be immediately available in large amounts. Buying them for the EU population could thus temporarily deprive poorer countries of doses.

The official said however that the two tracks to buy vaccines remained complementary, but added, “budgets are limited”.

Reporting by Francesco Guarascio @fraguarascio; Additional reporting by Kate Kelland in London; Editing by Frances Kerry and Hugh Lawson

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audio Exclusive

Exclusive Audio: Three Original Kanye West (Presidential Campaign) Freestyles – Forbes

On Tuesday, Kanye West spent four rambling hours with Forbes clarifying where he stands on various issues related to what he’s been teasing as a 2020 presidential run, from management style (Wakanda in Black Panther) to public health (promoting the lie that viruses are a way to implant chips in people) to his decision to stop supporting Donald Trump (“I’m taking the red hat off”). He also occasionally broke out into verse, reeling off spontaneous raps based on the topics we were discussing. “If I catch a vibe, I’m gonna catch that vibe,” West said.

And so he did. Below, three Kanye West freestyles:

This Is What The Covid’s Made


With a special shout-out line for Donald Trump: “How about we stop hiding in the bunkers and be a real man?”

Thou Shalt Not Kill


West’s reflections on the death penalty, in verse, inspired in part on how his family experienced the O.J. Simpson case.

“This Is Earth”


His new campaign song? “We got more than that. Way more.”

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Exclusive Vindman

Exclusive: Vindman to retire from military. His lawyer blames White House ‘campaign of bullying, intimidation and retaliation’ – CNN

(CNN)Lt. Col. Alexander Vindman, a key witness in President Donald Trump’s impeachment inquiry, is retiring from the US Army after more than 21 years of military service because he determined that his future in the armed forces “will forever be limited” due to political retaliation by the President and his allies, his lawyer told CNN Wednesday.

Vindman has endured a “campaign of bullying, intimidation, and retaliation” spearheaded by the President following his testimony in the impeachment inquiry last year, according to his attorney, Amb. David Pressman who is a partner at Jenner & Block.
News of Vindman’s retirement marks the culmination of a months-long saga dating back to his public testimony in November.
Trump fired Vindman as the top Ukraine expert on the National Security Council in February and also ousted his twin brother who also played a key role in impeachment proceedings while serving at the White House as an NSC lawyer.
In recent weeks, the controversy has centered around allegations that the White House was attempting to block Vindman’s upcoming military promotion to the rank of colonel.
“The President of the United States attempted to force LTC Vindman to choose: Between adhering to the law or pleasing a President. Between honoring his oath or protecting his career. Between protecting his promotion or the promotion of his fellow soldiers,” Pressman said in a statement to CNN.
“These are choices that no one in the United States should confront, especially one who has dedicated his life to serving it,” he added, noting that Vindman “did what the law compelled him to do; and for that he was bullied by the President and his proxies.”
Top Pentagon leaders, including Secretary of Defense Mark Esper, have insisted that Vindman is not being targeted for political reasons, but a source familiar with his decision said military officials have communicated to Vindman that the White House has sought to become involved in the promotion process.
In response, Vindman was told that that there have been discussions within the Department of Defense about sending his name forward on a “list of one” or holding his name back until after the election to avoid impacting the promotions of other service members, the source said.
It is “absurd and frightening” for the White House to be involved in promotions at this level, the source added.
Ultimately, Vindman decided to retire from the military rather than attending the National War College, which was his next planned assignment, after speaking with senior Army officials who made clear that there were forces working against his advancement within the military.
Specifically, Vindman was told by senior Army officials that he would no longer be deployable in his area of expertise, which includes Ukraine, the source familiar with the situation told CNN.
He was also told by senior officers he would need a “rehabilitative assignment” even if he had opted to attend the National War College, an option he had been considering before Wednesday’s announcement, the source added.
In one case, a senior officer quipped about sending him to “man a radar station in Alaska,” the source said.
The White House and Pentagon did not immediately respond to CNN’s request for comment.

Impeachment retaliation

Vindman delivered explosive testimony during public impeachment hearings that Trump’s push for Ukraine to investigate former Vice President Joe Biden was “inappropriate” and that he knew “without hesitation” that he had to report it.
Vindman said that he reported his concerns out of a “sense of duty,” and he defended his fellow witnesses from what he described as “reprehensible” attacks.
Testifying in his Army uniform as an active-duty soldier, Vindman invoked his father’s decision to leave the Soviet Union and come to the US, noting that the testimony he was giving would likely get him killed in Russia. “Do not worry, I will be fine for telling the truth,” Vindman said in a now well-known line.
But Vindman remained a focal point of Trump’s ire as impeachment proceedings moved to the Senate, facing a wave of unfounded attacks from the President and his allies during the trial portion.
During oral arguments in the Senate trial in late January, Sen. Marsha Blackburn, a Tennessee Republican, attacked Vindman in multiple tweets over several hours, going so far as to question the Purple Heart recipient’s patriotism.
She also repeated the unfounded claim that Vindman had leaked knowledge of Trump’s July 25 phone call with Ukrainian President Volodymyr Zelensky to the whistleblower whose complaint initially prompted the investigation into the President’s conduct in Ukraine.
After he was fired from the NSC in February, an Army spokesperson told CNN that Vindman had been reassigned to the Department of the Army.
The President later defended Vindman’s firing from the National Security Council. Trump complained about news coverage of the firing in a tweet, saying reporting was done “as though I should think only how wonderful he was. Actually, I don’t know him, never spoke to him, or met him (I don’t believe!).”

Democrats called on Esper to protect Vindman

Top military leaders, including Esper, have insisted that Vindman would be protected from retaliation of any kind after he transitioned back to the Pentagon, but some Democratic lawmakers have made it clear they believe that he is still being targeted by the White House.
Democratic Sen. Tammy Duckworth of Illinois announced last week that she is blocking Senate confirmation of 1,123 senior US Armed Forces promotions until she receives assurances that Vindman’s promotion wouldn’t be blocked.
The initial list of promotions Duckworth is holding up does not include Vindman’s name, as he is included in a later batch.
Duckworth’s power play, which her office described as “unprecedented in modern history,” takes advantage of unanimous consent procedures in the Senate that are used to efficiently conduct Senate business. Typically, a large batch of non-controversial military promotions, like the ones Duckworth is holding up, would be passed all at once with just a few words exchanged on the floor between Majority Leader Mitch McConnell and whoever is the presiding officer.
But instead of granting consent to pass the promotions, Duckworth objected, meaning McConnell would have to go through the time-consuming process of filing motions to overcome what amounts to her filibuster.
Duckworth said in a statement Wednesday that Vindman’s decision to retire “puts the spotlight on Secretary of Defense Mark Esper’s failure to protect a decorated combat Veteran against a vindictive Commander in Chief” and that her partial hold on military promotions will remain in place until he “provides a transparent accounting of this disgraceful situation.”
“Secretary Esper’s failure to protect his troops sets a new, dark precedent that any Commander in Chief can interfere with routine merit-based military promotions to carry out personal vendettas and retaliation against military officers who follow duly-authorized subpoenas while upholding their oath of office and core principles of service,” Duckworth wrote.
In an interview with CNN last week, Trump’s former national security adviser John Bolton said he believed Vindman, who worked under him at the NSC, deserved to be promoted based on what he observed during his time in the administration.
“Based on not just his service, but his twin brother’s service at the NSC, both of whom were pushed out of their assignments early, I think they certainly deserve promotion based on what I saw,” Bolton said to CNN’s Jake Tapper while promoting his new book “In the Room Where it Happened.”
“They shouldn’t be discriminated against. I hope there’s nobody in the White House who’s holding this up or putting bureaucratic obstacles in the way,” he added. “I think this is something, this kind of corruption of this promotion process, unfortunately, typical of a number of things that have happened in the administration, I think it’s a bad signal to all of our military.”

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Exclusive Jordan

EXCLUSIVE: Jordan Henderson on captaining the Premier League champions – Liverpool FC














Liverpool FC




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Published on 25 Jun 2020

Watch as the skipper speaks immediately after the Reds secured the Premier League title, about how they team watched the game and enjoyed the moment together.

Enjoy more content and get exclusive perks in our Liverpool FC Members Area, click here to find out more: https://www.youtube.com/LiverpoolFC/join

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Buyout Exclusive

Exclusive: Buyout firm Sycamore Partners in talks to buy J.C. Penney – sources – Yahoo Finance

FILE PHOTO: An empty shopping cart sits in front of the J.C. Penney department store in North Riverside

By Mike Spector and Jessica DiNapoli

J.C. Penney, which employs roughly 85,000 people, filed for bankruptcy protection in May after the coronavirus pandemic forced it to temporarily close its more than 800 stores across the United States, compounding financial woes that stemmed from years of dwindling sales.

Sycamore is weighing acquiring J.C. Penney outright or making an investment in the troubled retailer, the sources said.

There is no certainty that the talks between Sycamore and J.C. Penney will result in a deal, which would require a bankruptcy judge’s approval, the sources said.

J.C. Penney shares surged 47% after Reuters reported on the talks, ending the day up 55% to close at 32 cents.

The sources requested anonymity because the discussions are confidential. Sycamore and J.C. Penney declined to comment. Brookfield had no immediate comment while Simon and Wells Fargo did not immediately respond to requests for comment.

J.C. Penney is in discussions about handing over control to its lenders in exchange for reducing its nearly $5 billion of debt. This hinges on a slew of investment firms that hold the company’s senior debt and have provided the company’s bankruptcy financing agreeing to J.C. Penney’s business plan by July 14.

If the Plano, Texas-based company does not persuade enough lenders to approve its plan by the following day, July 15, the terms of its bankruptcy loan require J.C. Penney to abandon its reorganization efforts and pursue a sale.

It is unclear how much Sycamore is willing to pay for J.C. Penney, which is in the process of permanently closing stores and cutting jobs.

Sycamore, a New York private equity firm that specializes in retail and consumer investments, has in the past taken control of high-profile businesses such as office supplies chain Staples, women’s clothing retailer Talbots and department-store operator Belk.

Brookfield and Simon operate malls across the United States. Brookfield in May said it would devote $5 billion to non-controlling investments designed to revitalize retailers struggling in the wake of the coronavirus outbreak.

During a court hearing on Thursday, U.S. Bankruptcy Judge David Jones approved fresh financing from senior lenders to aid J.C. Penney’s operations while it navigates Chapter 11 protection, and expressed concern the 118-year old chain needed to restructure quickly to survive.

In July, the lenders will “decide whether the dream lives or the dream dies,” said Cathy Hershcopf, a creditors’ lawyer, during the hearing.

Sycamore, Brookfield, Simon and Wells Fargo are the four unnamed parties, one of the sources said.

Under a plan being discussed with its creditors, J.C. Penney would be split into two companies. One would be a real estate investment trust that would hold some of the company’s property and lease it back to J.C. Penney. The other would operate J.C. Penney’s retail business.

Joshua Sussberg, a Kirkland & Ellis LLP lawyer representing J.C. Penney, said during Thursday’s court hearing that the company needed to persuade lenders negotiating to take control of the restructured business to keep it alive and that he planned to hold them accountable for how the case ended.

Even in less-fraught times, many retailers, including Barneys New York Inc and Toys ‘R’ Us, have failed to reorganize under bankruptcy protection and gone out of business for good.

J.C. Penney on Thursday said it plans to permanently close 154 stores, and may shut more. It has so far reopened nearly 500 stores that were closed due to the pandemic, and plans to bring additional locations online in coming weeks. Still, concerns remain that customers might be slow to return amid health concerns and job losses not seen since the Great Depression.

J.C. Penney is also seeking permission from landlords to skip rent payments for June, July and August, Sussberg said last week.

(Reporting by Mike Spector and Jessica DiNapoli in New York; Editing by Daniel Wallis)

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AirPods Exclusive

Exclusive: AirPods Studio to feature head and neck detection, custom equalizer settings, more – 9to5Mac

We’ve been hearing about Apple’s upcoming over-ear headphones for some time, with evidence from multiple sources pointing to the official launch later this year. And now 9to5Mac has learned more exclusive details about the “AirPods Studio”, including specifications and settings, according to people familiar with the matter.

One of the key features of regular AirPods is ear detection, which automatically pauses the song when you take the earphones off. We’ve learned that AirPods Studio will have a similar feature, but it will work in a different way. Instead of ear detection, Apple is working to include sensors that can detect whether the headphones are on your head or neck.

Based on this, we assume that AirPods Studio will play or pause content when they detect being placed on your head. Neck detection can be used to keep the headset turned on while the music is paused, just like when you take just one of the AirPods out of the ear.

Another new sensor will be able to detect left and right ears to automatically route the audio channels. That means there’s likely no right or wrong side to use AirPods Studio, whereas current headphones have fixed left and right channels.

Just like the AirPods Pro, Apple’s new headphones will have Active Noise Cancellation and Transparency Mode. Users will be able to easily switch between the two modes to reduce external noise or to hear the ambient sound.

As AirPods Studio are expected to be mainly focused on professional users, pairing the earphones with a Mac or iOS device will unlock custom equalizer settings, with low, medium, and high frequency adjustments available, sources told us.

According to a Bloomberg recent report, Apple’s own-brand over-ear headphones will be available in at least two variations of the headphones — one using leather fabrics and another with lighter materials to fitness use cases. Bloomberg also said Apple is testing a new modular design with exchangeable magnetic ear pads.

9to5Mac has also found evidence of so-called AirPods Studio in the leaked iOS 14 beta code, including assets showing at least two color options for the new accessory. As for the price, rumors suggest that it will cost $349.

Are you considering buying the AirPods Studio? What features do you expect from Apple’s new headphones? Let us know in the comments section below.

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