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Khirys NYFW SS22 Is Only The Beginning For Black Reclamation In Fashion And Culture – Forbes
Posted: September 17, 2021 at 9:13 pm
Jameel Mohammed, founder and creative director of KHIRY.
A Reminder, a film by the afro-futurist fashion brand Khiry, sets the record for body politics relating to the Black community and cultural diaspora. Visual queues of Civil Rights footage, familiar pop icons of today, and various images of Black people, famous or not, throughout history, are juxtaposed in a tension between the popular and the oppressed. A deep-rooted role in this film is in dispelling any doubts of fashion and its association to oppressive practices of policing and pillaging Black people, culture, and trends.
Model Veronika Collins in NYFW SS22 Khiry runway show.
Jameel Mohammed is the founder and creative director behind Khiry and is pushing forth a narrative of the afro-fashion diaspora. A leader in the movement to reclaim Black bodies in the public eye, especially in fashion, Mohammed put forth a New York Fashion Week Spring Summer 2022 show that reflected grace and enlightenment through Khirys third collection.
The collection entitled Fights, Flights, and Fantasies (go but so far), is an exploration of escapism, a liberation of Black people throughout popular culture as well as politics. The fight is something Mohammed deals with as a multidisciplinary artist, jewelry maker and a newly-minted fashion designer, with the debut of one-of-one garments and other fine wearable objects by Khiry.
Model in NYFW SS22 Khiry runway show.
Beyond the fine and demi-fine jewelry pieces weve seen from the Khiry brand, wearables fill in a void that Mohammed was in search of filling. Undertaking a year-long process in his escapist state birthed unique garments that spoke to the historical existence of the Black legacy. Mohammed adorned his models in garments like the Macrame Flogger top, Highflier dress, Highflier tank top, and America in Tatters skirt, all created in Khirys Brooklyn studio using techniques from Mohammeds jewelry craftsmanship.
Hand-sewn fringe, cannabis bags and tassels accentuated the models who would move gracefully - dancing - in sync on the runway dressing in fine jewelry pieces from Khiry placed on installations throughout. An installation titled Dont Mean It, Dont Cost was an inspired piece from old drawings that highlighted the tender moments of the connectedness of people and dealing with trauma. The Iklwa shaped top was also reflective of a jewelry piece inspired by the legend of Shaka Zulu, founder of the Zulu Empire in Southern Africa who defended against European colonialism.
Model in NYFW SS22 Khiry runway show.
The show entitled Point of Departure was not only a runway show, gallery, installation, celebration of Black joy and trauma, but it was also a concert performance which Jameel Mohammed would lead with the film A Reminder followed by a song. At the One Fulton Street location in New York City, Mohammed delivered a surprise performance with a song titled Goodbye, which was written and performed with the R&B and soul band, founded by Devin Hobdy and Corey Smith-West, called BatheBoys. "Goodbye" is a story of a protagonist escaping their mental state and reflecting on avoidance, emotional acknowledgment, and growth.
More meaning than one could decipher, Khirys sculptural fine jewelry and afro-futurist aesthetic reflect generational trauma. A trauma that brings strength, especially when pieces are worn by some of the most graceful and empowering women, like Michelle Obama, Megan Thee Stallion, and Amanda Gorman, to name a few. Illustrating a historical continuum of experienced trauma, Khiry delves into ideas of reclamation that allow for ownership and the liberation of Black people through the triumph over oppressive politics.
Jameel Mohammed at the 2021 MET Gala, wearing a Khiry top from the NYFW SS22 runway show.
Only three days after showing at NYFW, and two days after his debut attendance at the prestigious MET GALA, on September 15th, Jameel Mohammed would be announced as a nominee for the 2021 CFDA American Emerging Designer of The Year Award. The 26-year old is already a 2021 Finalist for the CFDA/Vogue Fashion Fund, solidifying his voice, mission, and Blackness, in the fashion industry and pop culture.
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Larry Elder Speaks to Newsweek on Why He Lost to Gavin Newsom and What He May Do Next – Newsweek
Posted: at 9:12 pm
It was a landslide victory for Governor Gavin Newsom on Tuesday when a large majority of Californians voted against his recall. Had that not been the case, conservative talk-show host Larry Elder would have been elected the first Black governor in the state's history, as he easily beat the more than three dozen others on the ballot seeking to replace Newsom.
In a 32-minute post-election interview, Newsweek got Elder's thoughts on what went wrong, what went right and what comes next, and the media-savvy former candidate didn't pull any punches.
Newsweek: Are you still a Libertarian or are you now a Republican?
Larry Elder: I was always both. I was always a small "L" libertarian and registered Republican, just like Milton Friedman.
Newsweek: Has the Republican party made you an offer to head the RNC in California or nationally?
Elder: Has anybody called me and said, 'Hey, do you want a job?' No. But have I gotten support from Republicans up and down the state and nationally? Yes. I haven't gotten an offer to head the RNC, nor would I expect one.
Newsweek: So you'll be getting your own TV show?
Elder: I have no idea. I was not running to get a TV show. I've been on television many, many times. By the way, I started out in television, even though people call me a radio host. When offers come, I'll consider them. But right now, I'm just chilling, figuring out what to do with my new-found footprint that I didn't have before.
Newsweek: But you said you're not going back to your radio show.
Elder: I didn't say that.
Newsweek: At your election party you referred to yourself as a 'former radio host.'
Elder: That was tongue in cheek. My goodness. I wasn't hosting radio during my campaign, but I didn't mean I'd never go back to radio. Really, Paul, look into my baby brown libertarian eyeballs I honestly don't know what I'll do next.
Newsweek: Why did you lose to Gavin Newsom?
Elder: Because he outspent me five to one and we're outnumbered two-to-one Democrat compared to Republican. Even independents outnumber Republicans in California, and Newsom was successfully able to scare people into thinking I'd do everything but reenact slavery. The only actual issue he discussed was that I am anti-vax, which I'm not. I would have had a very different approach to coronavirus, and that's accurate. He never defended his record on crime, homelessness, how he shut down the economy or how he shut down schools while his kids were enjoying in-person private education and he was yucking it up at the French Laundry while incurring a $12,000 wine tab. I don't know what he was drinking, but it sure wasn't Mad Dog 2020. He didn't mention wildfires and how he mismanaged forests, or a water shortage, or rolling brownouts, or how people are leaving California for the first time. All he did was say "Republican takeover" over and over and show Larry Elder and Donald Trump side-by-side, and it worked, because 83 percent of Democrats believe Trump is a racist, and 61 percent believe all Republicans are racist slash sexist slash bigoted.
Newsweek: The ad with you and Trump was funded by Netflix founder Reed Hastings, and it claimed it was a matter of life and death that you be defeated. Did that surprise you?
Elder: Nothing surprised me. I've been critical of the media for a long time. When I decided to run, I knew that the wrath of God was going to come down on me. The flat-out lies didn't surprise me, like "Larry Elder is anti-vax." I'm vaccinated and I encourage people to get vaccinated, but I also encourage freedom.
Newsweek: I spoke to celebrities who supported you and they told me that the ad from Hastings sent a chill through conservative Hollywood, as if to say, 'if you want a relationship with Netflix, you'd better not support Elder.' Does that make sense to you?
Elder: Of course it does. Two high-profile Hollywood people who support me, Clint Eastwood and Jon Voight, said that I could say they support me but that they wouldn't put out a statement. Voight later allowed me to post a picture of me and him. And I'm not mad about them not giving a statement, I'm just telling you that this is how it rolls in this state and in this open-minded, tolerant industry.
Newsweek: So you're saying the media didn't cover you fairly?
Elder: I put a tweet out, Paul, saying that only in America could a Black man become president and be called the Black face of white supremacy. And not one reporter has said to me, 'well, Larry, you got smoked on the recall, but, my God, you smoked all these Republicans. You got 47 percent and the next Republican got nine or 10, and you were only campaigning for seven weeks!' Paul, it is stunning what I have done. I am actually stunned by the margin of my victory.
Newsweek: So then you have further political aspirations, perhaps nationally?
Elder: Stay tuned.
Newsweek: What's the biggest problem in California and how should Newsom solve it?
Elder: Crime, the fact that people are leaving because they can't afford a house, and homelessness. I have no idea what he'll do about those because if he did, he would have mentioned it in his commercials. He didn't. He's clueless. He lives in a $5 million house in a gated community. He got attacked during his campaign by a mentally ill homeless person and his security crew took care of it. The things that working-class people have to deal with don't affect him at all. I believe it will take California hitting rock bottom, like an alcoholic, before we turn this around, because all he had to say was 'Trump' and 'Republican takeover,' and people got scared and pulled the lever for him. They hate Republicans more than the rise in crime, rise in cost of living, rise of homelessness, rolling brownouts and wildfires. It's a remarkable achievement by the left and they did it with the complicity of the media.
Newsweek: Was it a fair election with no irregularities?
Elder: We know that a bunch of people in Republican districts tried to vote and were told they already voted. It was investigated, and they eventually were able to vote, but if that's not an irregularity, I don't know what is. When all is said and done, with the margin of victory, whatever shenanigans there may or may not have been won't matter, but we all should have an interest in making sure the election was handled with integrity. I'll tell you one thing more, Paul; I was asked repeatedly by reporters if I thought Joe Biden won the 2020 election fair and square. I told several reporters, and none of them did anything with it, that just once I'd like them to ask Newsom if Trump won the 2016 election fair and square, because for four years Hilary Clinton said the election was stolen from her and that Trump was illegitimate, and the result is that 66 percent of Democrats, according to a YouGov poll, believe that Russians changed vote tallies. Never mind a 1,000-page report that said the Russians did not change a single vote tally ... a greater percentage of Democrats believe the 2016 election was stolen than Republicans believe the 2020 election was stolen. Even if Newsom said he believed Trump won in 2016, the next question should be whether Hillary Clinton should have her social media platform shut down for pushing the big lie the way Trump has had his shut down. Nobody ever asked him. Nobody. One reporter said, 'well, that's what-aboutism.' I said, 'no, it's called consistency and being fair.'
Newsweek: Do you regret your decision to run?
Elder: Not for one moment. Nor am I surprised about anything. I complained about being called 'the Black face of white supremacy and 'the Black David Duke,' but I certainly anticipated it, because I have zero respect for the media. They are the public relations bureau for the Democrats. They long stopped even trying to be objective. I just hope that now people are seeing what I've been seeing for decades. I know that even people at the L.A. Times were embarrassed about a columnist calling me 'the Black face of white supremacy,' because they told me they were. But not only was she not fired, she was on PBS, so our taxpayer dollars were hosting a woman who said that about me. Scottie, beam me the hell up.
Newsweek: So at your election night party, your handlers told you not to talk to me. Did you like having handlers?
Elder: Every candidate has handlers. It didn't bother me. But ultimately the candidate decides what to do. I got advice I didn't follow, and was happy I didn't. I also got advice I didn't follow and later regretted it. Most candidates have been at it for years and have relationships, but I had to do it on the fly with people I didn't know. I went through a few campaign managers before finding the right one.
Newsweek: What's an example of you not taking advice, or taking it and regretting you did?
Elder: I did an interview with the L.A. Times where I jumped all over them for calling me 'the Black face of white supremacy,' and my communications manager was not happy with how combative I was. But she soon learned that that's why people like me, because I'm authentic and I fight back, so she began to tailor her advice to my personality. Another time, the Today Show asked me if I'd appoint a Republican to replace Sen. Dianne Feinstein. I knew it was a question designed to upset Democrats, so I didn't answer it directly. Afterwards, one of my handlers told me I should have just said, 'yes,' and I should have. I regret fumbling around and not being myself.
Newsweek: You did sound a little more stifled on the campaign trail than on radio, no?
Elder: Oh come on. It's a different thing. On the radio I'm taking calls and giving my opinion on events of that day; on the campaign trail I was discussing issues.
Newsweek: At your party, there was a guy dancing around with a giant cutout of your head. Is that sort of adulation giving you a big head?
Elder: No, but there definitely was adulation. There's no question. I was treated like a rock star; like a Beatle. Experienced people told me they've never seen anything like it. I thought I'd have a connection, but, my goodness, middle-age men, forget about women, came up to me crying because they were thinking of leaving California until I entered the race. I did not expect that.
Newsweek: Well, you've painted a grim picture of California. Are people right to be moving out?
Elder: Do you think things are going to get better? I don't see any evidence of that. Just recently at a restaurant on Melrose that I've eaten at, people in masks held up diners at gunpoint and took their purses and watches, and Newsom has released 20,000 convicted felons early, even though studies say the majority of them are likely to re-offend. We have a law that allows people to steal up to $950, not just a day, but at multiple stores in a day, without any fear of going to prison because they're not a felon, and we have district attorneys who are soft on crime and support cashless bail, and there's no consequences if they simply don't show up to court. You tell me if people should leave. It's bleak in California. I wasn't kidding when I said it's got great resources where else can you go surfing in the ocean and skiing in the mountains in one day? but it's being ruined by horrible leadership.
Newsweek: The accusation I have heard that hurt you most were reports saying you wanted former slaveholders to get reparations. Is that the case?
Elder: Oh good grief. No one on the campaign trail ever asked me about that, just members of the media. I was being interviewed by Candace Owens, and I said that reparations is the extraction of money from people who were never slaveholders to people who were never slaves. If you really want to play this game, the Dred Scott decision called slaves property. It was vulgar, but that's what the Supreme Court said. But people always leave this part out; the slave trade could have never existed without African chieftains selling people to Arab and European slavers. Should we get reparations from them? It was a long conversation that was boiled down to, 'Elder believes white slave owners should get reparations.' It's totally unfair.
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Larry Elder Speaks to Newsweek on Why He Lost to Gavin Newsom and What He May Do Next - Newsweek
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Trio of election experts offers Arizona Senate another chance to check Cyber Ninjas audit work – The Arizona Republic
Posted: at 9:12 pm
Call them the anti-ninjas.
Since June,three men with years of election experience have tried to get the attention of the Arizona Senate bysaying they have a way to check the work done by the Cyber Ninjas, the contractor hired to lead the review of Maricopa County's 2020 election results.
But they can't do it without help from the Senate. They would need some of the detailed data produced by the Ninjas as part of the audit andso far, Republican leaders have rebuffed the group's overtures.
On Thursday, the trio, who call themselves "the Audit Guys," renewed their challenge.
Using a method they had developed by obtaining the county's "cast vote" record through a public records request, they released the number of ballots contained in each of 24 boxes of returns without touching a single ballot.
They matched it up against the tally of those 24 boxesdone by high-speed paper-counting machines the Senate had commissioned.Senate audit liaison Ken Bennett shared those results with them in July. It was almost a perfect match:99.9%.
Then, they posted the number of votes on the ballots in those boxes won by Libertarian presidential candidate Jo Jorgenson last fall, again using the records they had compiled from the cast-vote file. In a post on their website, real-audits.org, the trio challenged the Senate to provide the Ninjas' findingsto see how the counts compare.
The goal, said Larry Moore, one of the three Audit Guys, is to get the Senate to release the Ninjas' count of the votes for not just Jorgenson, but also Joe Biden and Donald Trump. Moore is betting the numbers won't be anywhere near close.
They can use that to test out their methodologies," Moore said of the data the three menposted on Jorgenson's votes (a total of 342 votes from the 24 boxes of ballots for which they had data). "Were withholding the Biden and Trump votes because we want them (the Ninjas)to show their totals first.
Hours after the Audit Guys issued their latest challenge, the Senate announced it will release the audit report Sept. 24. Moore said he is skeptical the report will have the detail he needs to check the Ninjas'work.
Instead, he said he and his colleagues are relying on a public-records request they filed last month to obtain that data. Those details include the numbers Maricopa County used to identify each of the 1,691 boxes of ballots that were handed over to the Ninjas under a court subpoena, as well as the totals of ballot counts and vote counts that were recorded for each box.
Moore is the retired founder of the Clear Ballot Group, which created a method to independently audit voting systems. Theother "audit guys" are Benny White, a Tucson Republican who has done elections and voter-registration analysis for the Republican Party and TimHalvorsen, Clear Ballot's retired chief technology officer.
Senate President Karen Fann, R-Prescott, said Thursday that the Senate has received various offers to check the ballot count, but wouldn't consider opening up any of the Ninja's data until their report is finished.
Reach the reporter atmaryjo.pitzl@arizonarepublic.comand follow her on Twitter@maryjpitzl.
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Trio of election experts offers Arizona Senate another chance to check Cyber Ninjas audit work - The Arizona Republic
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What Do Psoriasis, Eczema, and Erectile Dysfunction Have in Common? – Californianewstimes.com
Posted: at 9:06 pm
Have you ever thought these three health conditions can have something in common? It turns out that they do. Even more. Every health condition shares some similarities with a very different one for one apparent reason: they all come from within. Everything that one human can experience has to do with her psychological and physiological health simultaneously. As the body works as a synchronized mechanism, one issue can bring about different conditions.
Want to learn what these three share?
Well, you know the answer already.
The Driver Inside
These three conditions are all connected to the inner driver the blood. You may call it a transport or driver as blood delivers significant nutrients and oxygen and takes all the unnecessary elements and chemicals from all the cells. Your mind communicates with the body through sending hormones. If the brain is the sender, hormones are the package, and organs are the receiver, then blood is the courier. When something goes wrong with it, conditions ranging from skin issues to sexual disorders can arise.
Psoriasis: Attacking Yourself
Psoriasis is responsible for the uncontrolled growth of skin cells as the body itself attacks them. Blood is involved in this process through its cells called white blood cells (also known as T cells). A typical body would make its immune system produce such cells to attack hazardous elements and chemicals penetrating the body.
When a person has psoriasis, those white cells mistake skin cells for some threat. Subsequently, they attack those cells, and the skin has to replenish the attacked ones quickly. It starts producing new cells, which pile up as they appear on the skins surface. This becomes a vicious cycle, and doctors are still not sure about the exact causes of it. One thing is clear: blood is an accomplice here.
Eczema: Itchy and Dry
Broadly speaking, eczema or dermatitis is about skin inflammation. If a person has this condition, her skin starts itching and aching, becomes red and dry. Eczema can showcase itself starting from childhood, but adults are not free from it as well. Doctors are not sure about what causes eczema as well. However, blood has its say in the process too.
For example, there is an eczema type called stasis dermatitis, which usually attacks adults. It develops as a result of poor blood circulation and mainly affects the legs. Blood pressure increases, which makes water build up in the capillaries. This brings out the inflammation mentioned above.
If you think you might have such issues, calling for home blood draw services would help you get safely tested and timely prevent or learn about what goes on in your body.
Erectile Dysfunction: You Want, But You Cant
Erectile dysfunction (ED) also has to do with blood flow and circulation. As the name suggests, this condition affects mens ability to develop and maintain a firm erection. While an average man would experience this from time to time, a person with ED would often face this issue. As a result, his self-esteem and sexual performance would suffer.
One can develop ED when the penile muscles or the penis itself do not get enough blood, or the blood vessels are clogged. While getting erect, the penis needs blood support, which is directed by the brain to flow to this area. If there is a plaque on its way or any other issues hindering its circulation, the penis will not get the necessary foundation to develop an erection.
These three represent just a small number of conditions that you may stumble upon due to bloody issues. Blood is the natural transmitter, so regularly testing it would help you keep your health in check.
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What Do Psoriasis, Eczema, and Erectile Dysfunction Have in Common? - Californianewstimes.com
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New cell type in human skin discovered to contribute to inflammatory skin diseases like atopic dermatitis and psoriasis – EurekAlert
Posted: at 9:06 pm
image:Immunofluorescence labeling of healthy and psoriatic patient skin. Dotted line shows the dermalepidermal junction. HLA-DR: green, GLUT3 (SLC2A3): red, and DAPI: blue. Scale bar = 100 m (low magnification) and 10 m (high magnification). view more
Credit: Please credit image to A*STAR Singapore Immunology Network (SIgN) and Skin Research Institute of Singapore (SRIS).
A team of international scientists and clinical experts have unravelled a new cell type in human skin that contributes to inflammatory skin diseases such as atopic dermatitis (AD) and psoriasis (PSO). Their study findings were published in the Journal of Experimental Medicine in September 2021. The team hails from A*STARs Singapore Immunology Network (SIgN), in collaboration with the Skin Research Institute of Singapore (SRIS), Singapores National Skin Centre, Department of Dermatology, Kyoto University Graduate School of Medicine, Japan, and industry partner Galderma.
Chronic inflammatory skin diseases such as AD and PSO are characterised by the presence of an activated T cell subtypes secreting pro-inflammatory cytokines in the skin. This T cellmediated immune dysregulation is central to the pathogenesis of a wide range of inflammatory skin diseases. Thus, understanding the factors modulating T cell priming and activation in healthy and diseased skin is key to developing effective treatments for these diseases.
Recently, single-cell RNA sequencing (RNA-seq) approach has been used to analyse immune cells in human skin including dendritic cells (DCs) and macrophages, which are cell populations controlling T cell activation. To address the role of DCs and macrophages in chronic inflammatory skin diseases, the team used a combination of complex approaches (single-cell flow cytometry and RNA-seq of index-sorted cells from healthy and diseased human skin) to generate an unbiased profile/ landscape of DCs and macrophages, and to describe their distinct molecular signatures and proportions in skin lesions of AD and PSO patients.
This uncovered a significant enrichment in the proportion of CD14+ DC3s in PSO lesional skin, where they were one of the major cell types co-expressing IL1B and IL23A, two cytokines essential for PSO pathogenesis. This finding suggests that targeting CD14+ DC3 might represent a novel therapeutic option in the treatment of PSO, and demonstrates the potential for the single-cell myeloid cell landscape database to provide important insights into skin biology in health and disease.
Dr Florent Ginhoux, Senior Principal Investigator, SIgN and last author of the study said, The findings from this study are significant as it will allow the design of new strategies to target or modulate myeloid cell populations for better health outcomes for patients of atopic dermatitis and psoriasis.
The roles of antigen-presenting cells in the development of inflammatory skin diseases remain unclear. This study clearly revealed the functions of each antigen-presenting cell subset, which is very informative and valuable to understand the pathogenesis of atopic dermatitis and psoriasis. We expect that this study will lead to the design of new treatment for refractory inflammatory skin diseases. said Prof Kenji Kabashima, Adjunct Principal Investigator from SIgN and SRIS.
More information on the study, Single-cell analysis of human skin identifies CD14+ type 3 dendritic cells co-producing IL1B and IL23A in psoriasis can be found from the teams published paper in the Journal of Experimental Medicine: https://pubmed.ncbi.nlm.nih.gov/34279540/
About the Agency for Science, Technology and Research (A*STAR)
The Agency for Science, Technology and Research (A*STAR) is Singapore's lead public sector R&D agency. Through open innovation, we collaborate with our partners in both the public and private sectors to benefit the economy and society. As a Science and Technology Organisation, A*STAR bridges the gap between academia and industry. Our research creates economic growth and jobs for Singapore, and enhances lives by improving societal outcomes in healthcare, urban living, and sustainability. A*STAR plays a key role in nurturing scientific talent and leaders for the wider research community and industry. A*STARs R&D activities span biomedical sciences to physical sciences and engineering, with research entities primarily located in Biopolis and Fusionopolis. For ongoing news, visit http://www.a-star.edu.sg.
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Single-cell analysis of human skin identifies CD14+ type 3 dendritic cells co-producing IL1B and IL23A in psoriasis
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Roundup: Adalimumab Biosimilar Advancements and a Biosimilar Pill – The Center for Biosimilars
Posted: at 9:06 pm
Alvotech of Reykjavik said it has received a recommendation for approval of its adalimumab biosimilar (AVT02) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
The approval concerns a high-concentration, citrate-free 100-mg/mL formulation of adalimumab, referencing Humira. The positive opinion from the CHMP will go to the European Commission, which is the authority that has the power to authorize marketing of the drug in the European Union and EU member states (Iceland, Liechtenstein, and Norway).
Adalimumab inhibits the activity of tumor necrosis factor, a protein in the body that causes inflammation. The drug is used in the treatment of multiple conditions, including Crohn disease, rheumatoid arthritis, and psoriatic arthritis.
Alvotech noted that Humira has annual sales of about $20 billion. AbbVie, the owner of the Humira franchise, has captured significant market share with its own high-concentration, citrate-free formulation, and Alvotechs product has the potential to take a portion of that business away from the drug company giant.
However, Alvotech would not be the first company to bring a high-concentration biosimilar of adalimumab to market in the European Union. Celltrion Healthcare achieved that milestone in February 2021 when it received European Commission approval to market Yuflyma, a 100-mg formulation.
Both Celltrion and Alvotech hope to gain FDA approval to market their high-concentration adalimumab biosimilars in the United States.
Biosimilar Adalimumab in New Zealand
New Zealands Pharmaceutical Management Agency (Pharmac), the government entity that decides which medicines are subsidized for use in hospitals and community settings, said it is contemplating making the adalimumab biosimilar Amgevita the principal adalimumab product in that country, displacing Humira, in February 2022.
Pharmac said the proposed change would save money. The list price of Amgevita would be lower than the current adalimumab list price, Pharmac said.
Amgevita is available in citrate-free formulation, which reduces pain on injection, and is dispensed in prefilled pens and syringes in doses of 20 mg/0.4 mL and 40 mg/0.8 mL; however, Pharmac said dosing restrictions would be removed for patients using Amgevita.
Higher concentration Humira is available, also in citrate-free formulations, and it was not explained whether the removal of dosing restrictions on Amgevita is intended to compensate for that. A public comment period on the proposal closes on September 22, 2021.
Patients who start on adalimumab treatment would automatically receive Amgevita, and those who are currently treated with Humira would have to switch to Amgevita by September 1, 2022. The Amgevita preference would continue at least through June 2026.
This proposal results from a competitive process for the principal supply of funded adalimumab. It would release significant funds for Pharmac to invest in other medicines for the benefit of New Zealanders, the government organization said.
Theres a (Biosimilar) Pill for That
BioFactura, a Maryland-based biopharmaceutical company, said it will partner with Rani Therapeutics to package its proposed ustekinumab biosimilar (BFI-751) in the form of a robotic pill that is ingested and delivers a drug payload into the small intestine via injection.
The ustekinumab biosimilar candidate would reference Stelara and be used in the treatment of Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. Ustekinumab reduces inflammation that causes these conditions.
The robotic pill concept, if successful, would substitute for subcutaneous or intravenous administration, BioFactura said. The RaniPill capsule is designed to be a pain-free alternative for delivering large molecule chronic disease treatments that are typically administered via injection, the company said.
Rani Therapeutics will conduct preclinical studies to determine whether pill administration is suitable for ustekinumab administration.
BioFactura Australia, the BioFactura subsidiary charged with development of BFI-751, initiated a phase 1 double-blind trial in April 2021 to compare pharmacokinetics, safety, and tolerability between the originator and biosimilar candidate agents.
Rani Therapeutics created a simulation video that demonstrates how the robotic pill would travel through the body to deliver a drug agent.
For Related Reading:
The Center for Biosimilars recently interviewed Anil Okay, chief commercial officer for Alvotech, about the company's biosimilar development and marketing plans. Okay explained why the company believes the high concentration formulation, AVT02, will have a marketing advantage.
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Roundup: Adalimumab Biosimilar Advancements and a Biosimilar Pill - The Center for Biosimilars
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Abingworth, Gimv and Pfizer back stealthy Swiss startup’s $61M round to crack gene therapy delivery – FierceBiotech
Posted: at 8:53 pm
In 2017, Jol de Beer dropped out of his Ph.D. program and began trying to build a leading genetic medicines company from a site the size of a parking space. After working quietly for several years to realize the vision, de Beers Anjarium Biosciences has now broken cover with 55.5 million Swiss francs ($61 million) from top-tier investors including Abingworth, Gimv and Pfizer Ventures.
Anjarium secured the series A funding by persuading investors it could be the company that cracks the challenge of delivering nucleic acid payloads. Viral vectors have enabled early successes in the gene therapy space, but their immunogenicity, limited payload capacity and complex manufacturing are headwinds for the field. Anjarium is squarely focused on those challenges.
We wanted to set up this one-stop-shop for non-viral gene therapy with three aspirations: using the most potent cargo, safely delivering enough of it into the right tissue with every application and, very importantly, being able to manufacture at scale in order to not leave anybody behind, de Beer, founder and chief scientific officer of Anjarium, said.
Anjarium is aiming to address those shortcomings with a non-viral gene therapy delivery vehicle. A few companies are already active in the space, such as Fierce 15 winner Carmine Therapeutics, but Anjarium has put its own spin on the idea of getting nucleic acids into human cells without using viruses.
RELATED: Hopkins team invents non-viral system for getting gene therapy into cells
We do this by combining this new DNA vector, which allows for bespoke expression of the genes in the right tissue, with a very deep expertise around synthetic and natural delivery systems in order to get it to the right tissue. We're really at the interface of genetic medicine, synthetic biology and nanoparticle engineering, de Beer said.
De Beer cites lipid nanoparticles and exosomes as technologies that have influenced Anjarium. The biotech also looked to viruses for inspiration. Mimicking viruses, which have evolved to get nucleic acids into human cells, using synthetic materials may lower immunogenicity and allow repeat dosing, thereby addressing two of the main limitations of current delivery methods. Anjarium is aiming to overcome those limitations while also enabling the delivery of larger payloads.
You can start to address indications that are beyond the reach of what is possible today with many of the viral approaches. And then if you can really have individualized dosing and multiple dosing, I think it's a paradigm shift in how we view gene therapy in general, de Beer said.
Investors share de Beers optimism about the impact of the technology. Abingworth and Gimv co-led the series A round with the support of Omega Funds, Pfizer Ventures and Surveyor Capital. Anjarium will use the money to move its early discovery pipeline toward the clinic while working to unlock further aspects of its technology and strengthen its manufacturing, which has been supported to date by a grant from the Swiss government.
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Albert Einstein College of Medicine awarded $5 million for research on intellectual and developmental disabilities – EurekAlert
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image:Steven Walkley, D.V.M, Ph.D. view more
Credit: Albert Einstein College of Medicine
September 15, 2021 (BRONX, NY) Albert Einstein College of Medicine has received a five-year, $5 million grant from the National Institutes of Health (NIH) to support the Rose F. Kennedy Intellectual and Developmental Disabilities Research Center (RFK IDDRC), which has been at the forefront of research on normal and abnormal brain development for more than 50 years. The funding will sustain and deepen collaborations between Einstein scientists and clinicians at Montefiore Health System aimed at improving the care and treatment of children with intellectual and developmental disabilities (IDD), including those stemming from rare diseases.
Our center is home to dozens of basic science and translational researchers who investigate the biological pathways and neurological mechanisms that underlie a range of intellectual and developmental disabilities, said Sophie Molholm, Ph.D., co-primary investigator on the grant and co-director of the RFK IDDRC. But ultimately, our sights are set on helping the children with IDDs in the Bronx and empowering their families and caregivers, a goal this new grant will help us achieve, added Dr. Molholm, who is professor of pediatrics, in the Dominick P. Purpura Department of Neuroscience, and of psychiatry and behavioral sciences at Einstein.
Investigating Gene Mutations
Previous NIH support helped establish a research program on 22q11.2 Deletion Syndrome (22q11.2DS), an incurable genetic disorder associated with delayed intellectual development and psychiatric conditions. Thisnew grants research focus involves the X chromosome'sKDM5Cgene, which plays a central role in brain development and behavior. Mutationsin theKDM5Cgene lead to intellectual disabilities and other conditions, particularly in males although females can also be affected.
In 2020, the IDDRCs annual Rare Disease Day event featured a special program in which 12 families with children who have a KDM5C variant came together from around the country and from England to meet for the first time. They learned about recent findings and the RFK IDDRC partnerships at Montefiore and Einstein that are addressing research and care. Hayden Hatch, an M.D./Ph.D. student at Einstein, spearheaded the effort.
Julie Secombe, Ph.D., professor of genetics and in the Dominick P. Purpura Department of Neuroscience, will lead basic science studies on KDM5C, along with Bryen Jordan, Ph.D., associate professor in the Dominick P. Purpura Department of Neuroscience and associate professor of psychiatry and behavioral sciences. The translational and clinical aspects of the work will be led by Dr. Molholm and Lisa Shulman, M.D., professor of pediatrics at Einstein, interim director of the Rose F. Kennedy Childrens Evaluation and Rehabilitation Center (CERC) at the Childrens Hospital at Montefiore, and a developmental pediatrician at Montefiore.
Advancing IDD Research and Collaboration
Einstein is one of 15 IDDRCs funded by the NIH and was among the first such centers established in the 1960s. More than 100 researchers study neurodevelopmental conditions including autism spectrum disorders, attention-deficit hyperactivity disorder, Rett and Williams syndromes, Niemann-Pick and other lysosomal storage diseases, neurocutaneous disorders, and infantile and childhood seizures. The RFK IDDRC also has more than 20 clinical partners in neurology and pediatrics.
Were in the unique position of having many different IDD-focused programs under one roof, said Steven Walkley, D.V.M, Ph.D., co-director of the IDDRC, co-primary investigator on the grant, professor in the Dominick P. Purpura Department of Neuroscience, of pathology, and in theSaul R. Korey Department of Neurology.In addition to the IDDRC, the Rose F. Kennedy Center includes CERC, which is part of our University Center for Excellence in Developmental Disabilities; the NIH-funded healthcare professional training program known as LEND (Leadership Education in Neurodevelopmental and Related Disabilities); and a postdoctoral fellowship training program. Were truly at the forefront of patient-oriented science both for the Bronx community and beyond.
The new grant also funds the centers four interdisciplinary scientific cores, which support biomedical, clinical, and translational research on IDDs. The cores include resources for clinical phenotyping, epigenetic and genomic analyses, and neural cell engineering and imaging.
The grant, titled Support for the Rose F. Kennedy IDDRC P50, is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of the National Institutes of Health (1 P50 HD105352-01).
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About Albert Einstein College of Medicine
Albert Einstein College of Medicineis one of the nations premier centers for research, medical education and clinical investigation. During the 2020-21 academic year, Einstein is home to 721M.D.students, 178Ph.D.students, 109 students in thecombined M.D./Ph.D. program, and 265postdoctoral research fellows. The College of Medicine has more than 1,900 full-time faculty members located on the main campus and at itsclinical affiliates. In 2020, Einstein received more than $197 million in awards from the National Institutes of Health (NIH). This includes the funding of majorresearch centersat Einstein in aging, intellectual development disorders, diabetes, cancer, clinical and translational research, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership withMontefiore, the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Einstein runs one of the largest residency and fellowship training programs in the medical and dental professions in the United States through Montefiore and an affiliation network involving hospitals and medical centers in the Bronx, Brooklyn and on Long Island. For more information, please visiteinsteinmed.org, read ourblog, followus onTwitter, like us onFacebook,and view us onYouTube.
About Montefiore Health System
Montefiore Health System is one of New Yorks premier academic health systems and is a recognized leader in providing exceptional quality and personalized, accountable care to approximately three million people in communities across the Bronx, Westchester and the Hudson Valley. It is comprised of 11 hospitals, including the Childrens Hospital at Montefiore, Burke Rehabilitation Hospital and more than 200 outpatient ambulatory care sites. The advanced clinical and translational research at its medical school, Albert Einstein College of Medicine, directly informs patient care and improves outcomes. From the Montefiore-Einstein Centers of Excellence in cancer, cardiology and vascular care, pediatrics, and transplantation, to its preeminent school-based health program, Montefiore is a fully integrated healthcare delivery system providing coordinated, comprehensive care to patients and their families. For more information please visitwww.montefiore.org. Followus onTwitterand view us onFacebookandYouTube.
About RFK IDDRC
The Rose F. Kennedy Center at Einstein and Montefiore includes the RFK UCEDD and CERC. Annually, CERC serves about 5,000 patients with IDD and provides medical, psychiatric, and dental services, along with social services and speech language, occupational, and physical therapies. Most of its patients are children, but the center also serves people older than age 18 with IDD who have transitioned from pediatric care. They receive services in its Harold Diner Special Needs Dentistry program, Adult Literacy program, and a new primary care program.
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ONLINE: When Gene Therapy Meets Reality – Isthmus
Posted: at 8:53 pm
press release: Virtual Saving Sight Session: When Gene Therapy Meets Reality
Thursday, September 30, 6pm
Hosted by Melanie Schmitt, MD, assistant professor // pediatric ophthalmology and adult strabismus
Saving Sight Sessions are community events featuring leading research from the Department of Ophthalmology and Visual Sciences. Please join us online for this exciting discussion.
The event is free but registration is required.
Melanie Schmitt, MD
John W. and Helen Doolittle Professor, pediatric ophthalmology and adult strabismus specialist, director of the pediatric inherited retinal degeneration clinic, co-director of the ocular genetics program
Dr. Melanie Schmitt is a respected pediatric ophthalmologist and adult strabismus specialist. Her research focuses on inherited retinal degenerations. In this engaging session, Dr. Schmitt will present on gene therapy that is available for a rare genetic eye disorder, Leber congenital amaurosis.
Dr. Schmitt earned her medical degree at the University of Wisconsin School of Medicine and Public Health. She completed her internship year and ophthalmology residency at Beaumont Hospital in Royal Oak, Michigan, followed by a pediatric ophthalmology and adult strabismus fellowship at Cole Eye Institute in Cleveland, Ohio. She joined the DOVS faculty in 2014.
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ONLINE: When Gene Therapy Meets Reality - Isthmus
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AGC boost pDNA and mRNA capacity with expansion – BioProcess Insider – BioProcess Insider
Posted: at 8:53 pm
CDMO AGC Bio will expand its Heidelberg, Germany facility to increase its manufacturing capacities for customer pDNA and mRNA projects.
The expansion, of which financial details have not been disclosed, sees contract development manufacturing organization (CDMO) AGC Biologics boost its current production capacity for plasmid-DNA (pDNA) and messenger RNA (mRNA) by adding an additional manufacturing line.
The Heidelberg expansion will also include additional warehouse capacity, a cleanroom for mRNA development and production, and a process development lab for microbial protein and cell and gene therapy projects.
Image: Stock Photo Secrets
Cell and gene therapy products have brought new promising treatments in multiple areas of high unmet medical needs. However, a record-breaking cell and gene therapy pipeline is creating vast market opportunities yet causing a manufacturing capacity shortage, a spokesperson for AGC told BioProcess Insider.
Creating new manufacturing capacity requires investments, lead time, and technical expertise. [The expansion] puts AGC Biologics in a unique position as one of the few CDMOs in the world that can provide end-to-end services for the development and manufacturing of cell and gene therapies.
The Alliance for Regenerative Medicine reported that this year there are currently 1,320 industry-sponsored regenerative medicines and advanced therapies trials ongoing globally.
According to AGC Bio, the expansion also builds on the firms decision to buy a 622,000 square-foot cell and gene therapy facility in Longmont north of Denver, Colorado from Novartis in July.
A year prior to this, AGC Bio acquired a cell and gene therapy site in Milan, Italy, added through the 240 million ($284 million) acquisition of Molecular Medicine (Molmed).
The facilitys added capabilities are expected to be fully operational in 2023 and the CDMO said it will continue to invest in our Heidelberg facility and new jobs will be created as a result of this latest expansion.
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AGC boost pDNA and mRNA capacity with expansion - BioProcess Insider - BioProcess Insider
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