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FDA Approves Self-Injectable Form of Xolair

The U.S. Food and Drug Administration approved a prefilled syringe for self-injection of the allergic diseases treatment Xolair developed by Novartis and Genentech, a Roche company.

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Genentech and Novartis Win FDA Approval for Self-Injectable Form of Xolair

Published: April 13, 2021

By Alex Keown

BioSpace

 

The U.S. Food and Drug Administration (FDA) approved a prefilled syringe for self-injection of an allergic diseases treatment developed by Novartis and Genentech, a Roche company.

On Monday, the FDA greenlit the supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection in appropriate patients across all approved U.S. indications. Xolair is the only biologic approved in the U.S. designed to target and block immunoglobulin E (IgE) for the treatment of people living with moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps.  

Levi Garraway, Roche’s chief medical officer and head of Global Product Development, said the new indication for Xolair reflects the commitment of both Genentech and Novartis to continue developing Xolair as a treatment for people who have allergic and inflammatory conditions.

“Appropriate patients will now have the flexibility to administer Xolair from home, which is particularly important for those who are considered high-risk during the COVID-19 pandemic,” Garraway said in a statement.

MediaNews Group/The Mercury News via Getty Images

The ongoing COVID-19 pandemic demonstrated a need for patients to be able to provide their own self-injection of Xolair, the companies said. 

Xolair, which was most recently approved in December for the treatment of nasal polyps, is an antibody that blocks IgE, which minimizes the release of mediators throughout the allergic inflammatory cascade. Other indications Xolair has been approved for in the U.S. include moderate to severe persistent asthma in people six years of age and older whose asthma symptoms are not well controlled with corticosteroids, and chronic idiopathic urticarial, chronic hives without a known cause, in patients 12 and older who have hives that are not controlled with H1 antihistamine treatments. 

Kenneth Mendez, president and chief executive officer of the Asthma and Allergy Foundation of America, said expanded treatment options for personalized care are always appreciated by the patient community.  

“The possibility of administering FDA-approved treatment outside of the healthcare provider’s office, but still guided by that healthcare provider, may reduce barriers to care for patients and their caregivers,” Mendez said in a statement. 

There are several safety precautions in place before a patient can begin self-treatment with a Xolair prefilled syringe. According to Genentech and Novartis, patients must not have a prior history of anaphylaxis. A healthcare provider must closely watch them for at least three injections to ensure there are no allergic reactions. 

Safety protocols also say that after therapy with the self-injecting mode has begun and is safely established in a healthcare setting, a healthcare provider may determine whether self-injection with a Xolair prefilled syringe by the patient or a caregiver is appropriate. Healthcare providers must train the patient or caregiver on the correct subcutaneous injection technique in recognizing the signs and symptoms of anaphylaxis and treat anaphylaxis appropriately before the first self-injection outside a healthcare setting.

 

BioSpace source:

https://www.biospace.com/article/genentech-and-novartis-win-fda-approval-for-self-injectable-form-of-xolair

 

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PR55α-controlled PP2A Inhibits p16 Expression and Blocks Cellular Senescence Induction

“Our results show that PR55α specifically reduces p16 expression […]” Credit: 2024 Palanivel et al. “Our results show that PR55α specifically…

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March 19, 2024

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“Our results show that PR55α specifically reduces p16 expression […]”

Credit: 2024 Palanivel et al.

“Our results show that PR55α specifically reduces p16 expression […]”

BUFFALO, NY- March 19, 2024 – A new research paper was published in Aging (listed by MEDLINE/PubMed as “Aging (Albany NY)” and “Aging-US” by Web of Science) Volume 16, Issue 5, entitled, “PR55α-controlled protein phosphatase 2A inhibits p16 expression and blocks cellular senescence induction by γ-irradiation.”

Cellular senescence is a permanent cell cycle arrest that can be triggered by both internal and external genotoxic stressors, such as telomere dysfunction and DNA damage. The execution of senescence is mainly by two pathways, p16/RB and p53/p21, which lead to CDK4/6 inhibition and RB activation to block cell cycle progression. While the regulation of p53/p21 signaling in response to DNA damage and other insults is well-defined, the regulation of the p16/RB pathway in response to various stressors remains poorly understood. 

In this new study, researchers Chitra Palanivel, Lepakshe S. V. Madduri, Ashley L. Hein, Christopher B. Jenkins, Brendan T. Graff, Alison L. Camero, Sumin Zhou, Charles A. Enke, Michel M. Ouellette, and Ying Yan from the University of Nebraska Medical Center report a novel function of PR55α, a regulatory subunit of PP2A Ser/Thr phosphatase, as a potent inhibitor of p16 expression and senescence induction by ionizing radiation (IR), such as γ-rays. 

“During natural aging, there is a gradual accumulation of p16-expressing senescent cells in tissues [76]. To investigate the significance of PR55α in this up-regulation of p16, we compared levels of the p16 and PR55α proteins in a panel of normal tissue specimens derived from young (≤43 y/o) and old (≥68 y/o) donors.”

The results show that ectopic PR55α expression in normal pancreatic cells inhibits p16 transcription, increases RB phosphorylation, and blocks IR-induced senescence. Conversely, PR55α-knockdown by shRNA in pancreatic cancer cells elevates p16 transcription, reduces RB phosphorylation, and triggers senescence induction after IR. Furthermore, this PR55α function in the regulation of p16 and senescence is p53-independent because it was unaffected by the mutational status of p53. Moreover, PR55α only affects p16 expression but not p14 (ARF) expression, which is also transcribed from the same CDKN2A locus but from an alternative promoter. In normal human tissues, levels of p16 and PR55α proteins were inversely correlated and mutually exclusive. 

“Collectively, these results describe a novel function of PR55α/PP2A in blocking p16/RB signaling and IR-induced cellular senescence.”
 

Read the full paper: DOI: https://doi.org/10.18632/aging.205619 

Corresponding Authors: Michel M. Ouellette, Ying Yan

Corresponding Emails: mouellet@unmc.edu, yyan@unmc.edu

Keywords: p16, p14, CDKN2A locus, p53, RB, PR55α, PP2A, γ-irradiation

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About Aging:

Aging publishes research papers in all fields of aging research including but not limited, aging from yeast to mammals, cellular senescence, age-related diseases such as cancer and Alzheimer’s diseases and their prevention and treatment, anti-aging strategies and drug development and especially the role of signal transduction pathways such as mTOR in aging and potential approaches to modulate these signaling pathways to extend lifespan. The journal aims to promote treatment of age-related diseases by slowing down aging, validation of anti-aging drugs by treating age-related diseases, prevention of cancer by inhibiting aging. Cancer and COVID-19 are age-related diseases.

Aging is indexed by PubMed/Medline (abbreviated as “Aging (Albany NY)”), PubMed Central, Web of Science: Science Citation Index Expanded (abbreviated as “Aging‐US” and listed in the Cell Biology and Geriatrics & Gerontology categories), Scopus (abbreviated as “Aging” and listed in the Cell Biology and Aging categories), Biological Abstracts, BIOSIS Previews, EMBASE, META (Chan Zuckerberg Initiative) (2018-2022), and Dimensions (Digital Science).

Please visit our website at www.Aging-US.com​​ and connect with us:

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For media inquiries, please contact media@impactjournals.com.

 

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Journal

Aging-US

DOI

10.18632/aging.205619

Method of Research

Experimental study

Subject of Research

Cells

Article Title

PR55α-controlled protein phosphatase 2A inhibits p16 expression and blocks cellular senescence induction by γ-irradiation

Article Publication Date

4-Mar-2024

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Government

Bolsonaro Indicted By Brazilian Police For Falsifying Covid-19 Vaccine Records

Bolsonaro Indicted By Brazilian Police For Falsifying Covid-19 Vaccine Records

Federal police in Brazil have indicted former President Jair…

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March 19, 2024

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Bolsonaro Indicted By Brazilian Police For Falsifying Covid-19 Vaccine Records

Federal police in Brazil have indicted former President Jair Bolsonaro for falsifying his Covid-19 vaccine card in order to travel to the United States and elsewhere during the pandemic.

Federal prosecutors will review the indictment and decide whether to pursue the case - which would be the first time the former president has faced criminal charges.

According to the indictment, Bolsonaro ordered a top deputy to obtain falsified Covid-19 vaccine records of himself and his 13-year-old daughter in late 2022, right before he flew to Florida for a three-month stay following his election loss.

Brazilian police are also waiting to hear back from the US DOJ on whether Bolsonaro used said cards to enter the United States, which would open him up to further criminal charges, the NY Times reports.

Bolsonaro has repeatedly claimed not to have received the Covid-19 vaccine, but denies any involvement in a plan to falsify his vaccination records. A previous investigation by Brazil's comptroller general concluded that Bolsonaro's vaccination records were false.

The records show that Bolsonaro, a COVID-19 skeptic who publicly opposed the vaccine, received a dose of the immunizer in a public healthcare center in Sao Paulo in July 2021. [ZH: hilarious, Reuters calling the vaccine an 'immunizer.']

The investigation concluded, however, that the former president had left the city the previous day and didn't leave Brasilia until three days later, according to a statement.

The nurse listed in the records as having applied the vaccine on Bolsonaro denied doing so and was no longer working at the center. The listed vaccine lot was also not available on that date, the comptroller general's office said. -Reuters

"It's a selective investigation. I'm calm, I don't owe anything," Bolsonaro told Reuters. "The world knows that I didn't take the vaccine."

During the pandemic, Bolsonaro panned the vaccine - and instead insisted on alternative treatments such as Ivermectin, which has antiviral properties against Covid-19. For this, he was investigated by Brazil's congress, which recommended that the former president be charged with "crimes against humanity," among other things, for his actions during the pandemic.

In May, Brazilian police raided Bolsonaro's home, confiscating his cell phone and arresting one of his closest aides and two of his security cards in connection to the vaccine record investigation.

Brazil's electoral court ruled that Bolsonaro can't run for public office until 2030 after he suggested that the country's voting system was rigged. For that, he has to sit out the 2026 election.

Tyler Durden Tue, 03/19/2024 - 11:00

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Spread & Containment

TJ Maxx and Marshalls follow Costco and Target on upcoming closures

Many of these stores have information customers need to know.

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March 19, 2024

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U.S. consumers have come to increasingly rely on the near ubiquity of convenience stores and big-box retailers. 

Many of us depend on these stores being open practically all day, every day, even during some of the biggest holidays. After all, Black Friday beckons retail stores to open just hours after a Thanksgiving Day dinner in hopes of attracting huge crowds of shoppers in search of early holiday sales. 

Related: Walmart announces more store closures for 2024

And it's largely true that before the covid pandemic most of our favorite stores were open all the time. Practically nothing — from inclement weather to bad news to holidays — could shut down a major operation like Walmart  (WMT)  or Target  (TGT) . 

Then the pandemic hit, and it turned everything we thought we knew about retail operations upside down. 

Everything from grocery stores to shopping malls shut down in an effort to contain potential spread. And when they finally reopened to the public, different stores took different precautionary measures. Some monitored how many shoppers were inside at once, while others implemented foot-traffic rules dictating where one could enter and exit an aisle. And almost every one of them mandated wearing masks at one point or another. 

Though these safety measures seem like a distant memory, one relic from the early 2020s remains firmly a part of our new American retail life. 

A woman in a face mask shopping in the HomeGoods kitchen aisle.

Jeff Greenberg/Getty Images

Store closures announced for spring 2024

Many retailers have learned to adapt after a volatile start to this third decade, and in many ways this requires serving customers better and treating employees better to retain a workforce. 

In some cases, the changes also reflect a change in shopping behavior, as more customers order online and leave more breathing room for brick-and-mortar operations. This also means more time for employees. 

Thanks to this, big retailers have recently changed how they operate, especially during holiday hours, with Walmart recently saying it would close during Thanksgiving to give employees more time to spend with loved ones.

"I am delighted to share that once again, we'll be closing our doors for Thanksgiving this year," Walmart U.S. CEO John Furner told associates in a video posted to Twitter in November. "Thanksgiving is such a special day during a very busy season. We want you to spend that day at home with family and loved ones." 

Other retailers have now followed suit, with Costco  (COST) , Aldi, and Target all saying they would close their doors for 24 hours on Easter Sunday, March 31. 

Now, the stores that operate under TJX Cos.  (TJX)  will also shut down during the holiday, including HomeGoods, TJ Maxx and Marshalls. 

Though it closed on Thanksgiving, Walmart says it will remain open for shoppers on Easter. 

Here's a list of stores that are closing for Easter 2024: 

  • Target
  • Costco
  • Aldi
  • TJ Maxx
  • Marshalls
  • HomeGoods
  • Publix
  • Macy's
  • Best Buy
  • Apple
  • ACE Hardware

Others are expected to remain open, including:

  • Walmart
  • Ikea
  • Petco
  • Home Depot

Most of the stores closing on Sunday will reopen for regular business hours on Monday. 

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