U.S. Food and Drug Administration assigned an action date of December 23, 2021
The sBLA is supported by the Phase 2 ABA2 Trial evaluating Orencia in adults and children to prevent aGvHD
If approved, Orencia would become the first therapy for the prevention of aGvHD
https://finance.yahoo.com/news/u-food-drug-administration-accepts-105900235.html
Axsome Therapeutics Inc said on Monday the U.S. Food and Drug Administration (FDA) was not able to complete its review of the company's drug to treat major depressive disorder by the target action date of Aug. 22.
The company said the FDA did not request additional information, adding that the review of the application was ongoing.
https://finance.yahoo.com/news/u-fda-unable-complete-review-101136441.html
VASCEPA found in prespecified and post hoc analyses to reduce first and total primary endpoints by 26% and 35%, respectively, in patients with prior Myocardial Infarction
Amarin Corporation plc (NASDAQ:AMRN) today announced that data adding to the growing body of knowledge on VASCEPA®/VAZKEPA (icosapent ethyl) in patients with prior heart attack, known as myocardial infarction (MI), at risk for major adverse cardiovascular events were delivered in a Late Breaking Science Presentation at ESC Congress 2021, organized by the European Society of Cardiology (ESC), taking place virtually from August 27 – August 30, 2021.
The presentation titled, “Reduction in Ischemic Events, Including Cardiovascular Mortality, with Icosapent Ethyl in Patients with Prior Myocardial Infarction: REDUCE-IT PRIOR MI,” was presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, Professor of Medicine at Harvard Medical School, and principal investigator of REDUCE-IT® and is available On-Demand beginning today at 3:00 am ET (9:00 am CEST) through the completion of the Congress.
The Late Breaking Science Presentation included both prespecified and post hoc analyses of patients who had prior MI from the REDUCE-IT study (prior to trial randomization) to determine if treatment with VASCEPA (icosapent ethyl) reduced further ischemic events in those subjects.
https://finance.yahoo.com/news/amarin-reports-data-reduce-showing-071500427.html
Early results from a new study led by researchers from the University of Toronto and Sinai Health reveals subtle differences between the immune responses of long-term care residents receiving the Pfizer-BioNTech and Moderna vaccines.
The research, which has not yet been peer-reviewed, suggests that long-term care residents in Ontario who received the Pfizer vaccine had lower antibody responses to Alpha, Beta and Gamma variants of COVID-19 than those vaccinated with the Moderna vaccine.
The researchers did not assess the Delta variant.
“Our study does raise concerns about the response to vaccination in some residents of long-term care homes in Ontario who overall responded more weakly to vaccination,” said Anne-Claude Gingras, a professor of molecular genetics in U of T’s Temerty Faculty of Medicine and a senior scientist at the Lunenfeld-Tanenbaum Research Institute (LTI), Sinai Health.
“In this population, the Moderna vaccine permitted more residents to generate an antibody response capable of neutralizing several SARS-CoV-2 variants,” added Gingras, who led study with LTRI Senior Scientist Allison McGeer, a professor in U of T’s department of laboratory medicine and pathobiology and at the Dalla Lana School of Public Health.
The study, funded by the Government of Canada through the COVID-19 Immunity Task Force, was posted last week on medRxiv, the pre-print server for health sciences. It examined the total and neutralizing antibodies produced before and after vaccination, comparing 198 long-term care residents to 78 caregivers and long-term care staff. All vaccines were given three to four weeks apart and samples were taken 14 to 28 days after the second dose of vaccine.
It showed that the differences between resident responses to the two vaccines were more common against variants of concern. Neutralizing antibodies against the Beta variant were undetectable in nearly 38 per cent of residents vaccinated with the Pfizer vaccine, compared to 11.5 per cent of residents vaccinated with the Moderna vaccine.
When it came to the Gamma variant, 29 per cent of those vaccinated with Pfizer did not neutralize the variant, whereas only five per cent of those vaccinated with Moderna were unable to neutralize Gamma.
It is unknown how these laboratory assays compare to real-life protection from COVID-19.
The study also showed that caregivers and staff, with a median age of 47, produced more neutralizing antibodies compared to residents, whose median age was 89. This is consistent with what is known about immune responses and age.
The scientists note that they only looked at one facet of the immune response – the production of antibodies – adding residents who do not mount strong neutralizing antibody responses may still be protected by other facets of their immune system, such as their T cells.
The levels of antibody needed to protect against COVID-19 infection, severe disease or hospitalization are also unknown.
“The first two waves of the pandemic had a devastating impact on LTC home residents, staff and families,” said McGeer. “As we may face a fourth wave of the pandemic, we need to be sure that we are using all the tools we have to ensure that we protect residents and staff from further harm. This includes considering whether a third vaccine dose should be offered to residents.”
McGeer said this study is timely given recent reports of several COVID-19 outbreaks due to variants of concern in Ontario long-term care homes.
Catherine Hankins, a co-chair of the COVID-19 Immunity Task Force, said the findings were valuable.
“The question of booster strategies for vulnerable people who may not mount as strong an immune response and who have had a suboptimal reaction to two doses of mRNA vaccines is drawing lots of attention and debate,” said Hankins. “The effect of the higher antigen dose in Moderna is clearly part of the puzzle.”
Hankins added that the task force is organizing a meta-analysis of data from seven studies that they have supported in long-term care settings, and they expect to have additional insights in the near future.
https://www.utoronto.ca/news/moderna-gives-bigger-antibody-boost-pfizer-elderly-u-t-researchers
With the latest wave of return-to-office delays from Covid-19, some companies are considering a new possibility: Offices may be closed for nearly two years.
That is raising concerns among executives that the longer people stay at home, the harder or more disruptive it could be to eventually bring them back.
Many employees developed new routines during the pandemic, swapping commuting for exercise or blocking hours for uninterrupted work. Even staffers who once bristled at doing their jobs outside of an office have come to embrace the flexibility and productivity of at-home life over the past 18 months, many say. Surveys have shown that enthusiasm for remote work has only increased as the pandemic has stretched on.
"If you have a little blip, people go back to the old way. Well, this ain’t a blip," said Pat Gelsinger, chief executive officer of Intel Corp. , whose company has benefited from the work-from-home boom. He predicts hybrid and remote work will remain the norm for months and years to come. "There is no going back."
Return dates have been postponed repeatedly. On Thursday, Apple Inc. told corporate employees that its planned return to U.S. offices would be delayed until at least January. Companies such as Chevron Corp. and Wells Fargo & Co. have postponed September returns, while tech companies such as Amazon.com Inc. and Facebook Inc. have pushed them to early next year. Lyft Inc. said it would call employees back to its San Francisco headquarters in February, about 23 months after the ride-sharing company first closed its offices.
Prudential Financial Inc. delayed its office reopening from September to October at the earliest, though Rob Falzon, vice chair of the company, said that date could change, too, depending on health conditions.
Prudential plans to allow for a mix of in-person and remote work once U.S. offices reopen. But the longer people stay at home, the more Mr. Falzon worries about employees feeling disconnected. "My single greatest concern is around talent," he said. "As individuals disassociate themselves with their organizations from a cultural standpoint, it becomes increasingly easy for them to make decisions to leave and go elsewhere."
Already, many employees are "bombarded" with messages from recruiters and friends, attempting to lure them elsewhere, he said. "When they’re in the workplace, I think they have a broader sense of connection to the platform, to the culture of the organization—their fellow employees, their teams—that makes them less inclined to want to leave," Mr. Falzon said.
Even so, what many have concluded over time is that their companies can operate largely effectively while remote, executives and workers say. After months spent hunched over kitchen tables, some employees say they have settled into a more comfortable rhythm of remote work. Others have finally sprung for more ergonomic desks or chairs at home. As more time passes until offices reopen, it could become difficult to convince existing employees to willingly upend their new lives and return to pre-pandemic schedules in offices, executives say.
Perceptions of remote work have shifted as the pandemic has gone on. When professional-services giant PricewaterhouseCoopers LLP surveyed employers across the U.S. in June 2020, 73% of respondents said they deemed remote work successful. By January 2021, when PwC released updated data, that figure rose to 83%. Now, more workers also say they want to stay at home full time. In new data released by PwC on Thursday, 41% of workers said they wished to remain fully remote, up from 29% in the January survey.
Some employers, including Gusto, a payroll, benefits and human-resources technology company, say they have reduced any anxiety about office reopenings by providing assurances that employees will be able to largely select how they work—and change their minds over time.
The company earlier this year allowed most employees to select what it calls a work "persona." Those who want flexibility could commit to using an office two to three days a week, with the freedom to work from home the rest of the time. Others could ask to stay fully remote. Roughly 64% of the company’s more than 1,400 employees chose flexible schedules, while 35% decided to go remote. A small number of employees, such as those who work in facilities or security, will need to be in offices full time.
Danielle Brown, the company’s chief people officer, said employees will be able to change their work style, and she foresees a process similar to that used during annual enrollment, when employees decide on benefits for the coming year.
Because it was made clear that employees weren’t locked into a choice, many felt a sense of relief and empowerment, Ms. Brown said.
The prospect of two years out of the office still concerns many employers, though, if only because it is harder to get a sense for how employees are feeling now. Conning, a Hartford, Conn.-based institutional asset-management firm, recently told U.S. employees that they won’t be required back in offices, even on a hybrid schedule, until January at the earliest.
Chief Executive Woody Bradford said the company will be increasing training for managers over the coming months and encouraging them to communicate more with employees, setting up informal outdoor lunches and dinners, when possible, to help create a sense of connection.
"I think that’s going to be really important so people don’t feel like they’re just locked in their basements," Mr. Bradford said.
Mr. Bradford said he has heard from some employees that they are happy with their new routines and reluctant to give them up, even a few days a week.
"There are people who have been working from home for, like all of us, a long time, and say that because it’s habitual, we’re used to it, and change is difficult," Mr. Bradford said.
He is sympathetic to those arguments, but also tells employees that they must think of the organization as a whole. "An individual may be very productive at home, but the new employee who is trying to learn the culture and trying to develop through apprenticeship may really suffer too much," he said.
Employers have tried a variety of tactics to ease the transition back into offices. Some, like law firm Schwabe, Williamson & Wyatt PC, based in Portland, Ore., have held soft reopenings, giving workers a chance to get accustomed to commuting, wearing dress clothes and interacting with colleagues in person again. "It takes a lot longer" to prepare for work than many may remember, said Graciela Gomez Cowger, the firm’s CEO. "You’re out of practice. Just putting on a good shirt and getting dressed is a thing."
Others have provided detailed descriptions of the new office environment and protocols to try to ease concerns. State-owned Abu Dhabi National Oil Co. began bringing employees back into its offices in the United Arab Emirates last summer. The company found that many employees initially were uncertain and anxious about what awaited them in offices, said Coni Judge, a senior adviser for culture and employee engagement.
Company leaders attempted to demystify the corporate environment through messages, graphics and animations explaining new safety protocols. The company held town hall sessions before and after return dates to hear concerns and to answer questions. It focused on both the length and color of messages sent to employees. "People are in different psychological and physical states, and it’s important to recognize that," Dr. Judge said.
Many workers are still eager to see offices repopulated, said Ms. Cowger, the CEO of the law firm Schwabe, which employs about 400 people across the Pacific Northwest. Her firm delayed its mandatory office return until at least November, though Ms. Cowger said she eventually wants employees back in offices, some of the time, to help local cities recover economically and to ensure colleagues learn from each other.
"We can’t keep our office closed indefinitely," she said. "We just can’t."
https://www.foxbusiness.com/economy/remote-work-may-now-last-for-two-years-worrying-some-bosses
