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Novartis rare disease drug sees approval chances rise after trial completes
Novartis’ PI3K-delta inhibitor CDZ173 (leniolisib) had its LoA increase by five points to 20% on the heels of its Phase II/III trial, which has completed. The trial is recruiting patients with PASLI disease (p110d-activating mutation causing senescent T cells, lymphadenopathy, and immunodeficiency), also known as activated phosphoinositide 3-kinase delta syndrome (APDS).To get more novartis updates, you can visit shine news official website.
The LoA appraisal occurred on 21 September, after the Phase II/III trial’s ClinicalTrials.gov listing was updated on 17 September to show its actual completion was on 16 August. The Phase II/III trial had two parts: the first is an open-label, within-patient up-titration study, and the second is a blinded, placebo-controlled fixed-dose study. Part I has coprimary endpoints collecting safety and pharmacokinetic data, while Part II had efficacy-relevant endpoints.
High expression of PI3K-delta in leukocytes, as well as its pivotal role in B and T cells, is assumed that PI3K-delta selective inhibition would be valuable in allergic and inflammatory disease. PASLI disease is recognised by recurrent sinopulmonary infections that can pave the way to airway damage.Kalyra Pharmaceuticals’ KP-1199 for chronic pain saw its PTSR nosedive 36 points to 31% after its Phase I trial was terminated. The PTSR change occurred on 21 September after ClinicalTrials.gov listed the trial as “terminated early by sponsor” on 9 September.
The San Diego, California-based Kalyra had planned to enroll 97 healthy subjects in a Phase I single and multiple ascending dose study. The trial was designed to enrol participants into three groups where they would receive KP-1199, placebo or the active comparator oxycodone. The study enrolled only 26 subjects before it was terminated. KP-1199 is a small molecule acetaminophen analog that can help alleviate chronic pain.
The trial termination also resulted in a four-point drop to the drug’s Likelihood of Approval (LoA), which fell to 3%.CCH Pharmaceuticals’ intranasal ketamine for acute cluster headaches saw its PTSR sink 30 points to 14% after its Phase I/II trial missed its primary efficacy endpoint. The PTSR change occurred on 17 September after the Phase I/II trial’s abstract was presented at this year’s International Headache Conference (9 September).
The proof-of-concept trial enrolled 23 patients, with a primary endpoint of 50% pain intensity reduction within 15 minutes of initiating treatment. While the study did not meet its primary endpoint, pain intensity was reduced by 59% from 7.25 to 2.94 along an 11-point rating scale at 30 minutes (p=0.0002). There were no serious adverse events reported.
Ketamine can reduce pain by targeting the N-methyl-D-aspartate (NMDA) receptor; it is known to hold abuse potential. Phase I/II results also lead to a nine-point drop to the drug’s Likelihood of Approval (LoA), which fell to 5%. CHH is based in Copenhagen, Denmark.
Will Beijing rescue China's Evergrande?
The plight of the heavily indebted Chinese property company Evergrande has sparked fears of contagion that could damage economic growth in China, the world's second-biggest economy, then spill over into the supply chain and wreak havoc on global growth.To get more China business news, you can visit shine news official website.
There is a general perception that the Chinese government will intervene in some way to rescue Evergrande, despite its debts of $300 billion (€256 billion) and that Evergrande, unlike Lehman Brothers in the global financial crisis in 2008, is too big to fail.
The main reason the ruling Communist Party will intervene to support Evergrande is to preserve the stability it needs to maintain its grip on power. If anyone is too big to fail, it's the Communist Party.
Evergrande's fall has always been a matter of when, not if. The firm's founder, the flamboyant ex-steelworker Xu Jiayian, is the latest Chinese tycoon to fall victim to the old saying "two tigers cannot share the same mountain."
President Xi Jinping's crackdown on business in recent months is sold as a crackdown on inequality and a common prosperity campaign.
But the crackdown goes deeper than that. It's a shift from centrally planned capitalism to a more doctrinaire Marxist approach to business and marks a fundamental shift in China's economic landscape. The chief goal appears to be to further entrench the power of the Communist Party.Recent months have seen a flurry of slogans and economic policies from the Communist Party aimed at reining in what the leadership sees as capitalism's more egregious impulses.
"Common prosperity" aims to fix the country's massive wealth inequality. It involves greater taxation of high incomes and capital, and even includes a long-discussed nationwide property tax.
Meanwhile, "dual circulation" refers to a focus on the domestic market and external circulation, or interaction with the global economy.
Evergrande is China's second-biggest property developer by sales and its earlier success was built on China's astonishing urbanization project of the past 20 years — the biggest the world has ever seen.
Surging demand for housing meant real estate companies were effectively able to print money, backed by local governments, for whom leasing the land to the real estate developers was the main form of income.
The central government in Beijing actively encouraged this massive expansion because so much of China's economic growth story is built on real estate — it accounts for 29% of GDP.
Whenever things get too hot, to maintain stability, the Communist Party intervenes. Recent efforts to put the party at the center of the economy have seen even more measures to strengthen its control.
As a real estate empire built on rapid expansion and heavy borrowing, with what many see as a Ponzi-like cash flow model based on selling apartments that haven't been built to construct units it had already sold, Evergrande's fate hangs in the balance.
Ho-fung Hung, a professor of political economy at Johns Hopkins University, describes this tightening of control over the Chinese economy as "North Koreanization" and he believes it is going to have huge consequences.
"If the Communist Party doesn't save Evergrande, its free fall will create huge economic dislocation and plausible social unrest. If it saves it one way or other, there are many other big developers which are in equally dire shape or worse, and the government obviously cannot rescue everyone. Either way, the economy will take a big hit, and the old China growth model heavily reliant on debt-financed fixed asset investment can no longer continue," Hung told DW.
Big Sell-Off In Chinese Real Estate Stocks Caused Worldwide Market Dip
There was a major sell-off in markets around the world today. The Dow fell 614 points, or about 1.8%, its worst day in more than two months. It did recover some of those losses at the end of the trading day. The big dip was all sparked by a Chinese property company that many Americans have never heard of. NPR's David Gura joins us to explain.To get more International finance news china, you can visit shine news official website.
GURA: So this is the world in which we live. I mean, one company can affect markets worldwide. There was this big sell-off in Chinese real estate stocks and one company in particular. The Evergrande Group is a real estate developer. It's a massive conglomerate based in the city of Shenzhen. And it's one of the largest companies in the world, with a debt burden of $300 billion. That's how much it owes its creditors. Now, sales have been down, and Evergrande has been trying to cut costs and offload buildings. But none of that has worked, and the company has told investors it may not be able to pay its bills. So that's how the trading day started, and it led to losses in Europe and the United States.
A SHAPIRO: You say we live in this world now where one company's well-being can affect worldwide markets. Explain why investors in London or New York would care about this real estate company in China.
GURA: Yeah. Wall Street was already on edge, concerned about the spread of the delta variant and the effect that could have on the economic recovery. Markets have been lagging in September so far. But when a company of this size faces a credit crunch, investors around the world get nervous because companies anywhere can hold some of that debt. Now, Jill Carey Hall is a senior equity strategist at Bank of America, and she says this is something she is going to monitor.
JILL CAREY HALL: The good news for the S&P 500 is there's not as high of a proportion of direct exposure to the region as some other regions within the world.
GURA: But a couple of other things are at play here, Ari. One of them is how it affects sentiment. That was already very weak, again, because of COVID-19. It also makes them nervous when they see something like this happening - a company of this size in this condition, then this kind of sell-off. And No. 2 is this big unknown - what, if anything, the Chinese government is going to do about Evergrande. And will that affect China's financial system? Chinese government's been cracking down on real estate developers, and it's unclear if the government will step in to keep Evergrande from collapsing.
A SHAPIRO: There's another factor here in the U.S., which is the potential debt default. Tell us about the impact that could have.
GURA: Yes. There's one in the U.S. as well - a potential one in the U.S. as well. Wall Street is watching what's unfolding in Washington as the U.S. is once again up against what's called the debt limit or the debt ceiling. Congress puts a limit on how much the government has available to pay its existing debts.
Now, lawmakers have raised the ceiling dozens and dozens of times, but there is not much more the treasury secretary can do if lawmakers don't raise it again. Janet Yellen has written to Congress. She's urged them to raise that limit. She has an op-ed in the Wall Street Journal describing what could happen if lawmakers do not act. And Yellen doesn't say the world is going to end, but she comes pretty close. She writes, (reading) it would likely precipitate a historic financial crisis and default that could trigger a spike in interest rates, a steep drop in stock prices and other financial turmoil.
reusable face mask that’s as effective as an N95
At the beginning of the Covid-19 pandemic, the shortage of N95 respirator masks presented a dire situation for the healthcare and frontline workers who needed them most. Essential workers who relied on N95 masks had no choice but to wear what were meant to be disposable N95 masks for weeks at a time. Some started disinfecting the masks to be redistributed and reused. To get more news about china type II mask factory outlet, you can visit tnkme.com official website.
Now, as Covid-19 infections surge and states such as Texas and Florida and hospitals and healthcare workers once again become overwhelmed with the volume of patients, N95 respirators still remain in short supply.
But engineers and researchers at MIT and Brigham and Women’s Hospital have a created a new type of face mask that could be a game-changer. In a laboratory setting, the prototype worked as well as a N95 respirator at filtering out virus-containing particles.The biggest innovation? While N95 masks are made entirely from a special material that filters out airborne droplets and fluids that could contain the Covid-19 virus, the new MIT mask is made from silicone, with slots for just two small, disposable disks of the N95 material (which serve as filters). That means the masks themselves can be quickly and easily sterilized and reused, and though the small filters must be thrown out, each mask requires much less N95 material.
Called the iMASC, which stands for Injection Molded Autoclavable, Scalable, Conformable, this design could help solve shortage issues. The new iMASC system can also be sterilized a few different ways without sacrificing its effectiveness, the researchers wrote in a paper published in the British Medical Journal Open. For example, researchers were able to use a steam sterilizer on the masks, put the masks in an oven, as well as soak them in both bleach and rubbing alcohol. (Treating used N95 masks with hydrogen peroxide disinfectants to neutralize any viruses requires special equipment and takes a few days. It also only allows the masks to be re-worn for one day at a time, up to 20 more times.)
The iMASC researchers “wanted to maximize the reusability of the system,” Giovanni Traverso, an MIT assistant professor of mechanical engineering and a gastroenterologist at Brigham and Women’s Hospital, said in a press release.
The new mask could also be more environmentally-friendly — it uses less disposable material, which produces much less waste than tossing a whole mask, Adam Wentworth, a research engineer at Brigham and Women’s Hospital and a research affiliate at the Koch Institute, said in a press release.A group of 24 healthcare workers (including nurses, physicians and technicians) wore the new masks and completed tests that involved breathing, talking, moving their head and body and making facial expressions. The participants said that the mask fit well and felt breathable. Most importantly, the mask successfully filtered out a sugar solution in the air that was used to mimic aerosolized respiratory droplets.
More tests need to be done, and the group is currently working on a second mask design.
The team plans to eventually have the rubber mask approved by the Food and Drug Administration and the National Institute for Occupational Safety and Health. Once complete, the masks could cost hospitals $15 each, Fast Company reported. (N95 masks can cost between $2.80 and $6.95 per unit, according to data compiled by nonprofit Project N95.)
How to shop for the best KN95 face masks
Americans are increasingly curious about KN95 face masks, with search trends and reader interest in the topic rising exponentially this summer — and it’s not the first spike in popularity for KN95 masks. First published in March while the country was facing an N95 mask shortage and KN95s provided a similar level of protection to the general public, our recommendations were based on expert guidance regarding features and properties, and the brand’s alignment with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).To get more news about famous KN95 mask wholesale, you can visit tnkme.com official website.
Our recommendations have remained largely the same, and some of the same issues we reported in March are creeping back, from supply shortages to the prevalence of counterfeits. Increasing concerns around coronavirus variants across the U.S. are right now elevated with Americans going back to schools and offices, too. As a result, KN95 masks are again in high demand and short supply — and they’re also growing increasingly difficult to buy online. Popular face mask brand VIDA, for example, has been replacing KN95 orders with M95 face masks, and has confirmed to us that they don’t contact customers about the switch since “the situation is extremely dynamic” — on product pages, VIDA tells customers they “may receive” the M95 replacement and attributes that potential to “global shortages.”
To help guide anyone wondering where to find KN95 face masks — or even hoping to understand what they are — we consulted medical experts about who should use KN95 masks and when and how to responsibly source and shop for them.
Highly rated KN95 face masks
To recommend KN95 masks, we independently confirmed expert-guided qualifications with the brands listed below, asking each to prove their masks’ efficacy with relevant lab tests and documentation, as well as proof of registration with the FDA or formerly getting listed in the FDA’s Emergency Use Authorization (EUA).
1. Powecom KN95 masks
5-layer mask | filters 95 percent (or more) of particulate | includes earloops | formerly EUA-authorized
Powecom’s KN95 masks are available in Black and White, and come in a pack of 10. They feature an adjustable nose piece and their earloops are latex-free.
2. WWDOLL KN95 Face Masks
5-layer mask | filters 95 percent (or more) of particulate | includes earloops | FDA-registered | formerly EUA-authorized
WWDOLL’s KN95 masks come in a pack of 25 and can be purchased in Black or White, or a 50-piece multi-color pack. Masks also feature an adjustable nose bridge.
3. Hotodeal KN95 Mask
5-layer mask | filters 95 percent (or more) of particulate | includes earloops | FDA-registered | formerly EUA-authorized
These White KN95 masks come in a pack of 40. They’re built with an adjustable nose clip and you can also purchase them in Black (in stock soon
4. WellBefore KN95 Masks
5-layer mask | filters 95 percent (or more) of particulate | includes earloops | FDA-registered
WellBefore, a company that sells PPE, offers its KN95 masks in White and Black, and you can choose between standard ear loops, adjustable earloops and adjustable head straps. The masks have an adjustable nose bridge, and you can purchase a minimum of 10 masks, which come individually wrapped.
Best face masks of 2021: Doctors share their favorite masks
Face masks have become the new normal in America and while vaccination rates have increased, the nation has experienced a recent surge of Covid cases given the delta variant. Most recently, Arkansas and Florida have been in the spotlight as coronavirus epicenters. And as students prepare for in-person lessons in the fall and remote workers begin their soft return to offices over the next few months, you’re probably concerned with staying safe indoors. Notably, the Centers for Disease Control (CDC) recently advised the more than 165 million fully vaccinated Americans to wear face masks indoors because of breakthrough infections.To get more news about quality type II mask factory, you can visit tnkme.com official website.
Medical professionals in high-risk environments regularly wear N95 masks while at work, according to the CDC. Although those types of masks are available to shop online, the CDC and doctors also argue these high-grade masks are unnecessary if you’re not in a high-risk environment. In fact, when the medical experts we consulted aren’t at their respective practices, they like to sport non-medical face masks, including reusable and disposable models. Opting for non-medical face masks also allows you to double mask — the government health agency does not recommend double masking with a KN95 mask.
To find out which face masks doctors prefer, we consulted seven medical experts about their favorite masks, which range from high fashion silk masks to antimicrobial and antibacterial ones.
Sumayah Jamal, MD, PhD, looks for face masks with "ample breathing room” like the moisture-wicking Fydelity mask. The board-certified dermatologist at Schweiger Dermatology Group said this two-ply mask offers a "very good fit that won't keep slipping down or up." It also sports an adjustable nose bridge and earloops, plus a chin cup, preventing your mask from riding up.
Konstantin Vasyukevich, MD, prefers wearing these "stylish, comfortable and durable" face masks from medical scrubs maker Jaanuu, which he noted is a "well-respected brand within the medical community." For Konstantin, a double-board certified facial plastic surgeon in New York City, breathability is critical and he told us the face mask’s moisture-wicking fabric is “perfect” — especially during long days of surgery. He added that the mask’s set of antimicrobial properties is a “game changer.” You can get the masks in packs ranging from five a piece to 5,000.
Caroline Robinson, MD, a board-certified dermatologist, "loves" to wear Evolvetogether face masks when she's at the office for administrative work and opts for medical-grade surgical masks or N95s when seeing patients. She's a fan of the three-ply masks because they equip a water-resistant outer layer, a meltblown center and a water-absorbing inner layer, which is "great for both the office and when I'm running around for errands." Shopping readers have also shown a keen interest in Evolvetogether's disposable face masks in both adult and kid’s sizes.
Dendy Engelman, MD, gravitates toward BaubleBar and Love Shack Fancy face masks since "they're much prettier than the N95s I wear for work." Engelman, a celebrity dermatologist and Mohs surgeon at the Shafer Clinic Fifth Avenue, only employs reusable face masks that are two layers. BaubleBar cotton masks sport adjustable sliders on the ear loops for added comfort and come in trendy prints and colorways, like the Sequin and Mini Floral set and Black Floral and Pink set. They also make kid's face masks and face mask chains that you can buy premade or DIY.
Robinson likewise "loves" wearing Second Wind face masks because they are "functional and fit closely to the face and nose without compromising on style." The brand makes 100-percent silk and linen face masks featuring 100-percent organic cotton lining. You can pop in an activated carbon face mask filter into the interior pocket for an extra barrier of protection. These chic face masks flaunt adjustable ear straps for security and are available in three sizes: small, medium and large.
These "soft," satin-lined face masks came recommended by Robinson, who also favors masks made of cotton and satin. Because satin is a smooth material, it is less likely to cause any friction and irritation for those with sensitive skin. "It is so important to find a mask that you feel comfortable in because once the mask is on you should avoid touching it and adjusting it," explained Robinson, who will adjust the ear loops for the best fit.
Dentist Joseph Field, DDS, is such a “big fan” of these “very comfortable” and breathable face masks that he also ordered packs for his kids. These 32 Degrees face masks are treated with UPF50+, which provides an additional layer of sun protection. The athletic apparel brand also claims its face masks utilize yarn containing silver ions to help prevent odors.
KUWD 75% Shading Net, Rectangular Shade Cloth Net
The mesh sunscreen is made of high-density polyethylene, which has key anti-aging and weather resistance, allowing you to use it for a long time under various severe weather conditions.To get more news about Greenhouse Garden Shading Net Acting, you can visit dtwiremesh.com official website.
The mesh structure of the sunshade net is breathable, will not affect the photosynthesis of plants, can protect plants from direct sunlight, and allow water and air to pass through, providing a good growth environment for plants
Commodity name: White shade net
Material: Polyethylene
Product size: customized according to customer needs
Shading rate: about 75%
Product shape: rectangular
Product features: shading, sun protection, cooling
note:
1. The product is manually measured, which will cause slight dimensional errors.
2. Due to the influence of the shooting light, there will be slight chromatic aberration, please understand.
3. If you have any questions, please feel free to contact us, we will provide you with the best service.
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WELD MESH PANELS
Protective Wire Mesh Industries have significant capabilities in the production of welded wire mesh (also known as weldmesh, welded mesh, steelmesh and Mesh Plus). Three state of the art IDEAL mesh welding machines at our Somersby facility give Protective the ability to manufacture a wide range of sheet sizes and apertures in different wire diameters and finishes.To get more news about Metal Wire Mesh Panels Acting, you can visit dtwiremesh.com official website.
These meshes can be further enhanced by out in house trimming, folding and powder coating facilities.
Standard Sheet sizes available from 25mm x 25mm to 100mm x 100mm
Custom sheet sizes and mesh sizes available by quotation
Custom mesh available from 50mm long wire apertures and 12mm cross wire apertures
Common wire diameters – 3.15mm to 10mm
Wire types – standard or heavily galvanised, Zalcote, hard drawn low carbon, stainless steel
Standard sheet sizes up to 2.4M wide and 6M long (3m wide for apertures 100mm and over)
Computer-controlled variable apertures
Mesh Fabrication service including bending, crimping, folding and cutting
Protective Fencing supplies and manufactures a large range of general purpose welded wire mesh sheets. Custom sheets and aperture sizes are available subject to quantity and specification.
Protective Fencing manufactures a large range of rural mesh fencing products including sheep yard mesh, cattle yard mesh, farm gate mesh, tree guard mesh, intensive livestock floor mesh, gabion mesh and dog run mesh. Contact Protective with your requirements.
Protective Fencing manufactures a large range of safety mesh products including the AUSMESH roof safety mesh which can be supplied to the industries such as mining and safety in made to order rolls to provide fast efficient fixing and eliminate waste.
Protective Wire Mesh Industries have significant capabilities in the production of welded wire mesh (also known as weldmesh, welded mesh, steelmesh and Mesh Plus).
Three state of the art IDEAL mesh welding machines at our Somersby facility give Protective the ability to manufacture a wide range of sheet sizes and apertures in different wire diameters and finishes.
All machines are capable of welding bright, standard galvanised, heavily galvanised, Galfan, Zalcote, Bezinal and stainless steel wire and are designed for quick change over allowing for greater flexibility in producing custom sizes.
All mesh is manufactured from pre cut and straightened wire which ensures a higher degree of sheet accuracy in squareness, size tolerance and flatness.
Mitef Anti-aging Orchard Anti-hail Netting Vegetable Garden Hail
This hail-resistant mesh made of anti-aging, UV and other chemical additives HDPE as the main Raw materials,by the drawing of knotted net-like fabric, with tensile strength, heat resistance, water resistance, corrosion resistance, resistance Aging, non-toxic and tasteless, waste treatment, etc. To get more news about Hail netting for gardens Acting, you can visit dtwiremesh.com official website.
Hail Mesh Cultivation is a practical and environmentally friendly agricultural new technology, the hail effectively control various types of hail, frost, rain and snow weather , prevent harm created due to bad weather, creating favorable conditions for crop growth
Also widely used to protect vegetables,flowers,rapeseed and other seed from pollen incoming when making isolation
Use it as garden netting, bird netting, pond netting depend on your need
Bird Netting is used to block birds from unwanted areas such as gardens, eaves, canopies, and more. The netting acts as a physical barrier to humanely prevent birds from reaching the desired location.
Bird Netting is also the most effective way to prevent birds from nesting. Nesting birds can be quite territorial and are known to relentlessly protect and return to an established nesting site. Bird Netting simply eliminates the area.
Bird Netting can be installed temporarily for seasonal problems or permanently for year round protection. If you need help with bird net installation, call Absolute Bird Control at 1-877-820-8205 for information or an authorized installer in your area.
CAD DECLINES AHEAD OF THE CANADIAN FEDERAL ELECTION
On Monday, September 20, 2021, the Canadian Federal election will take place, to elect members of the House of Commons to the 44th Canadian Parliament. Governor-General, Mary May Simon, issued the writs of the election on August 15, 2021, when the incumbent Prime Minister, Justin Trudeau, requested the dissolution of Parliament for a snap election.To get more news about fxtm, you can visit wikifx.com official website.
Justin Trudeau, who is a member of the Liberal Party remained in office as a minority government after his party lost both their parliamentary majority and the popular vote but still won the most seats.
The Canadian dollar declined ahead of the federal election as the market opens for the week. After suffering a huge crash last week, the Canadian dollar declined further, approaching its lowest price in August. The US market is yet to open but the market has already priced in. Volatility will increase as the US market opens, and CAD might make a new low as voting commences. Federal elections have a high impact on the financial market and this won't be any different.
The Canadian Dollar started falling against other currencies as the market opened for the week, Price declined further as the London session opened and this might continue as voting commences in Canada.
Brent Crude Oil also crashed as the market opened for the week. The Canadian Dollar has a huge effect on the price of Brent Oil because Canada is the major supplier of oil to the US and one of the largest producers of crude oil in the world. The price of Brent Crude Oil correlates positively with the Canadian Dollar. As the price of crude oil increases, CAD also gains strength against other currencies. Brent Crude Oil has dropped from $75 per barrel to $73.60 as of the publishing time. It's looking to decline further as the US market opens.
USDCAD, which is commonly known as Loonie in the forex market, continues to rally as the market opened for the week. Loonie has been rallying since last week as the Feds look to tapper with the rate amid the US inflation crisis. A decline in the price of the Canadian dollar is also good news for the Loonie as the price will continue to rally. Loonie will likely rally to 1.30000 this week as the price is currently trading near the 1.29000 psychological level.
CADJPY crashed from 86.218 to 85.100 in less than 12 hours after the market opening, approaching its lowest price in August. The further decline will see the price of CADJPY breach below this support zone.
Other currencies are gaining strength against the Canadian Dollar as trading commences for the week.
As the market priced in ahead of the election, a sudden change in direction is not likely to occur as the market already made the move before the election. The Canadian dollar might continue to fall or go into a range from this point.
