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Category Archives: Life Extension
Cooperative Extension News – The Stokes News
Posted: May 20, 2021 at 4:43 am
DANBURY Summer Fun registration is now open; you can register in 4-H Online 2.0. If your child is not a 4-H member, please complete a profile, then you may register for Summer Fun Camps.
Join us for the 2021 Summer Fun day camp series where face-to-face opportunities for youth ages 5-18 are offered to actively create lasting summer memories through engaging activities. Become a Junior Master Gardener. Make tasty treats at Nutrition in the Kitchen. Become familiar with tree identification in Forestry for Beginners. Learn more about lambs and goats. There is something for everyone.
Junior Master Gardener Camp (June 8-10) For youth ages 5-18: Do you enjoy getting your hands dirty in the garden? Do you want to learn more about being a gardener? This program will introduce young gardeners to the art and science of gardening, while helping them develop life skills to become good citizens in their communities, schools and families. Join us from 9 a.m.-2 p.m. at the Stokes County Cooperative Extension office in Danbury. Bring your own lunch and something to drink.
Nutrition in the Kitchen Camp (June 14-16) For youth ages 5-18: Do you love being in the kitchen and cooking your favorite snacks or meals? Nutrition in the Kitchen will teach youth food and kitchen safety, and a number of recipes that they will be able to do on their own at home. Youth will gain cooking skills from their experience of being in the kitchen at this camp. Join us from 9 a.m.-2 p.m. at the Stokes County Cooperative Extension office. Bring your own lunch and something to drink.
Forestry for Beginners (June 29) For youth ages 5-18: There are trees all around us, but do you know what type of trees they are? The Stokes County Forest Service will teach us how to identify trees, identify the different parts of a tree and the function of each part. Join us on June 29 from 9 a.m. to 2 p.m. at the Stokes County Cooperative Extension office. Bring your own lunch and a drink.
Lamb and Goat Camp (June 30 & July 1) Youth ages 5-18: Learn all abaaaa-out taking care of sheep and goats. Well learn about being safe around animals, what sheep and goats eat, and even showmanship skills. We will end with a mock show for youth to showcase what theyve learned to their families. (Yes, youth will be working with live sheep and goats.) June 30 will be for youth ages 5-11 and July 1 will be for youth ages 12-18. Each day will be from 8 a.m. to noon for camp and 12:30-1 p.m. for the mock show, with a lunch break in between. (Please pay attention to which day youre signing up for so youre attending the correct age group.)
Cloverbud Camp (July 6-8) Youth ages 5-7: Calling all the Cloverbuds! If youre between the ages of 5-7 please join us! Youth will be learning all the basics to 4-H such as cooking, gardening and animal care, just to name a few. Each day we will focus on a different topic and youth will experience hands-on learning activities. Cloverbud Camp will be held from 9 a.m.-2 p.m. at the Cooperative Extension office. Bring your own lunch and something to drink.
Moooving Milk from the Farm to Table (July 15) Youth ages 8-12: How does milk end up on our tables? It doesnt just come from the grocery store. Come learn about the dairy industry and how milk moooves from the farm to the table. Were going to learn about the importance of nutrition for dairy cows, how to milk a cow, how cheese is made, and virtually tour a dairy farm. This camp will be held July 15 from 9 a.m.-2 p.m. and is geared towards youth ages 8-12 years old. Please bring your own lunch and a drink.
(Youth who are 5 years old must have completed Kindergarten or Pre-school.)
For more information visit: https://stokes.ces.ncsu.edu/stokes-county-4-h/2021-summer-fun/.
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Aluminum Foil Packaging Market 2021 Competitive Insights Amcor Limited, Zenith Alluminio Srl, Constantia Flexibles, Nicholl Food Packaging Ltd(Bawtry…
Posted: at 4:43 am
Aluminum Foil Packaging Market with COVID-19 Impact by Component, Application, Services, and Region- Forecast to 2026
The Global Aluminum Foil Packaging Market Research Report 2021-2026 is a significant source of keen information for business specialists. It furnishes the business outline with development investigation and historical and futuristic cost analysis, income, demand, and supply information (upcoming identifiers). The Aluminum Foil Packaging market research analysts give a detailed depiction of the Market worth chain and Aluminum Foil Packaging wholesaler examination. The Aluminum Foil Packaging Market study gives extensive information which upgrades the agreement, degree, and use of this report. This is a latest report, covering the COVID-19impact on the Aluminum Foil Packaging market.
The aluminum foil packaging market was valued at USD 17.9 billion in 2020 and is expected to reach USD 24.18 billion by 2026 and work at a CAGR of 3.27% over the forecast period (2021-2026).
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Top LeadingCompaniesof Emergency Location Transmitter Market areUbisense Group PLC, AeroScout, Inc., TeleTracking Technologies, Inc., Savi Technology, Zebra Technologies, CenTrak Healthcare company, Ekahau, Inc., Midmark Corporation, Identec Group AG, Sonoitor Technologies, Inc., Awarepoint Corporation (Centrak Inc.), Kontact.io, Alien Technology, Stanley Healthcare , Impinj and others.
Industry News And Updates-
April 2019 Tetrapack announced connected packing platform which will transform the milk packing and juice packing market into interactive information channels, full-scale carriers, and digital tools.
July 2018- Nicholl Food Packaging Ltd made a unique skin pack aluminum poultry tray and film combination, the first of its kind on the foil packaging market. The innovation is aimed at poultry processors. The product combines the convenience of a chicken-shaped aluminum foil tray and shelf-life extension to minimize the potential for food waste.
Key Market Trends-
The food, tobacco, and cosmetics industries are expected to be the major drivers for the growth of aluminum foil wraps over the forecast period.
The global cigarette market has shown a steady growth in the review period, and this growth is expected to continue over the forecast period as the next generation of tobacco and nicotine products, such as e-cigarettes, are increasingly being commercialized
Statistics released by the British American Tobacco estimated that around 5,600 billion cigarettes are consumed each year worldwide.
An aluminum foil wrap provides certain characteristics, such as dead fold and embosses ability, which cannot be obtained by other methods of packaging materials.
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The report contains detailed country-level analysis, market revenue, market value and forecast analysis of ingestion, revenue and Emergency Location Transmitter Market share,growth speed, historical and forecast (2016-2026) of these regions are covered:
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Boise will revive Spaulding Ranch as a city park – Post Register
Posted: at 4:43 am
BOISE Spaulding Ranch, a historical but long inactive farmstead in the middle of Boise, will rise again, this time as a monument to the regions rich agricultural history.
The city of Boise is creating a park at the property that is also a farm.
The project is being built on 20 acres at the site of the historical Spaulding Ranch, a farmstead with a grand barn that has been preserved but not used for agricultural purposes for a quarter century.
The property is surrounded by subdivisions and is located off of North Cole Road, a busy transportation corridor.
Though the Settlers Canal still runs through the property, its heyday as a farmstead is long over. The city of Boise, with assistance from University of Idaho Extension employees who understand farming, plans to revive Spaulding Ranch.
Ada County has the second most farms in Idaho, behind Canyon County, although most of those farms are much smaller than the states average-size farm of 468 acres.
But agricultures presence within Boise, Idahos largest city, is virtually non-existent.
We want to restore this site so urban agriculture can still happen in Boise, said Lisa Duplessie, the project manager for the Spaulding Ranch project for Boise.
The revived Spaulding Ranch will be a nod to the areas agricultural history and a reminder to Boise residents that agriculture is still a major player in the states economy and way of life.
Boise Parks and Recreation staff will oversee the project and staff from University of Idaho Extension, given their farming expertise, will manage the agricultural operations at Spaulding Ranch.
The University of Idaho is a perfect and logical fit for us, given all the agricultural research they do, Duplessie said.
The city acquired the historical farmstead in 2016 as part of a land swap and citizens helped formulate a master plan for the property.
The master plan calls for the possibility of several agricultural-related features, including a six-acre demonstration farm, an orchard that includes apple, peach and pear trees, a small animal farm, pollinator gardens, farm-themed play equipment and a meadow maze.
The project could also include meeting and event space in a rebuilt barn, a community kitchen and farmers market.
The property will also include historical and current information about Idahos agricultural industry, which is responsible for one in every eight jobs in the state and 13 percent of Idahos gross state product, according to a recent U of I study.
What it will ultimately look like is still up in the air because there are so many possibilities, said Ariel Agenbroad, a University of Idaho Extension educator in Ada County.
The park-farm has already started to take form with the planting of 100 fruit trees in March. The idea is to begin planting crops in 2023.
It was super exciting to finally see stuff starting to happen, Duplessie said. This is a one-of-a-kind project. Its honestly a dream project.
The city worked with the community over the past three years to come up with a master plan of what the property could become, said Sara Arkle, the open space superintendent for Boise Parks and Recreation.
What weve heard pretty loud and clear is that people want to see urban agriculture done on this site, she said. They want to see orchards, they want to see veggie plots, they want to see agricultural education.
Boise was once a major part of Idahos agricultural community but its now by far the states biggest population center and farming and ranching havent existed within the city in any significant way in a long time.
As we become more of an urban area, its so much more important that were teaching our children where our food comes from and how its grown, Arkle said.
Besides being used to teach people about farming, a myriad of research and demonstration projects could take place on the six-acre demonstration farm site, Agenbroad said.
We could have a lot of really neat things happen there, she said. It will be a combination of research plots and actually engaging the public in farm training programs.
The city also plans to partner with 4-H programs to provide students a hands-on learning experience.
I am very, very excited about this project and its something that will be valuable to all youth in Idaho, said Allen Taggert, a 4-H Extension educator in Ada County. A property like this could really afford hands-on learning opportunities where kids can get their hands dirty and really understand what is going on in the world of agriculture.
While Boise residents obviously will get to enjoy the park-farm, the revived Spaulding Ranch property will be a real destination site for every Idahoan, Duplessie said.
Theres nothing else like this in the state, she said. Its within the city of Boise and a city project but Its really for everyone in the state to come and enjoy.
There is also almost unlimited potential for the project to develop, Duplessie added.
While theres a master plan for the project, the skys the limit, she said.
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Boise will revive Spaulding Ranch as a city park - Post Register
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New FASENRA Data From the MELTEMI Extension Trial Confirm Long-Term Safety and Efficacy in Severe Eosinophilic Asthma for up to Five Years – Business…
Posted: at 4:43 am
WILMINGTON, Del.--(BUSINESS WIRE)--Results from a new integrated analysis including data from the MELTEMI Phase III open-label extension trial showed FASENRA (benralizumab) was well-tolerated for up to five years, with a long-term safety profile consistent with previous Phase III trials in adult patients with severe asthma.
Results were presented today at the American Thoracic Society (ATS) 2021 International Conference.
During the period of the BORA and MELTEMI extension trials, adverse events (AEs) and serious adverse events (SAEs) did not increase from rates comparable to placebo observed in the Phase III pivotal trials. Rates of serious infection, hypersensitivity, immunogenicity, and malignancy were low across all treatment groups, with no deaths during the on-treatment window. The most commonly reported AEs during the open-label period for patients receiving FASENRA every eight weeks were nasopharyngitis, asthma, headache, and bronchitis. These data confirm FASENRAs well-established safety profile.
In secondary endpoints, FASENRA sustained the reduction in asthma exacerbation rates observed during predecessor SIROCCO, CALIMA, ZONDA and BORA Phase III trials with annualized asthma exacerbation rates (AAER) remaining consistently low over the five-year treatment period.
In patients taking high-dosage inhaled corticosteroids (ICS) with blood eosinophil levels of greater than or equal to 300 cells per microliter who received FASENRA every eight weeks, AAER decreased from 3.1 exacerbation/year pre-treatment to 0.5 in the predecessor studies with a further reduction to 0.2 by year four of the open-label trial. In the same treatment group 59% of patients experienced zero exacerbations during the four years of the open-label period (BORA and MELTEMI) and at least 75% of patients each year experienced zero exacerbations. In the final year of the trial 87% of patients experienced zero exacerbations.
Arnaud Bourdin, Head of Pulmonology, Professor of Respiratory Medicine at Arnaud de Villeneuve Hospital, Montpellier, France and primary investigator for MELTEMI, said: Clinicians treating severe eosinophilic asthma want to ensure the therapy they prescribe will continue to help patients control their illness in the long term, with a consistent safety profile. Based on the new MELTEMI data, physicians and their patients should feel confident that FASENRA provides a treatment option that can do exactly that reduce exacerbations, with a known safety profile.
Mark White, Global Franchise Head, FASENRA, said: The new data from MELTEMI are exciting as they confirm FASENRAs efficacy and safety profile seen in previously reported Phase III trials. These results should offer further confidence to physicians and patients that the positive outcomes theyre experiencing whilst using FASENRA can be maintained for the longer-term.
FASENRA is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries and is approved for self-administration in the US and EU. The Food and Drug Administration (FDA) granted Orphan Drug Designation for FASENRA for eosinophilic granulomatosis with polyangiitis (EGPA) (November 2018), hypereosinophilic syndrome (HES) (February 2019) and eosinophilic oesophagitis (EoE) (August 2019).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSKnown hypersensitivity to benralizumab or excipients.
WARNINGS AND PRECAUTIONSHypersensitivity ReactionsHypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.
Acute Asthma Symptoms or Deteriorating DiseaseFASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.
Reduction of Corticosteroid DosageDo not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Parasitic (Helminth) InfectionIt is unknown if FASENRA will influence a patients response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves.
INDICATIONFASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
ADVERSE REACTIONSThe most common adverse reactions (incidence 5%) include headache and pharyngitis. Injection site reactions (eg, pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo.
USE IN SPECIFIC POPULATIONSA pregnancy exposure registry monitors pregnancy outcome in women exposed to FASENRA during pregnancy. To enroll call 1-877-311-8972 or visit http://www.mothertobaby.org/fasenra.
The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.
Please read full Prescribing Information, including Patient Information.
You may report side effects related to AstraZeneca products by clicking here.
Severe asthmaAsthma is a heterogeneous disease affecting an estimated 339 million people worldwide. Approximately 10% of asthma patients have severe asthma. Despite the use of inhaled asthma controller medicine, currently available biologic therapies and oral corticosteroids (OCS), many severe asthma patients remain uncontrolled. Due to the complexity of severe asthma, many patients have unclear or multiple drivers of inflammation and may not qualify for or respond well to a current biologic medicine.
Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced health-related quality of life. Patients with severe asthma are at an increased risk of mortality and have twice the risk asthma-related hospitalizations. There is also a significant socio-economic burden, with these patients accounting for over 50% of asthma-related costs.
MELTEMIMELTEMI is a multicenter, open-label safety extension, Phase III trial to assess the safety and tolerability of FASENRA administered subcutaneously in severe, uncontrolled asthma patients on ICS and long-acting beta2-agonists therapy with or without chronic OCS and/or other asthma controllers. Participants had completed one of three Phase III placebo-controlled predecessor trials (SIROCCO, CALIMA, ZONDA), then enrolled in the double-blind BORA safety extension trial, further transitioning into the MELTEMI open-label extension trial.
The integrated analysis results include patients who had received FASENRA for up to five years from the beginning of the treatment period in the predecessor studies. A total of 446 patients were included in the analysis. Of these, 384 (86.1%) completed the on treatment period and 16% were on treatment for greater than or equal to five years. Mean on treatment duration was equal to or greater than three years in each group. As typically observed in longer-term trials, due to the duration of time participants were followed, fewer patients continued through to the later stages of the study than completed the predecessor trials.
The primary endpoint in MELTEMI was FASENRA safety and tolerability, which was measured by rates of AEs and SAEs during the on-treatment period. The secondary endpoints included a subset of primary and secondary endpoints from the Phase III predecessor studies: annual asthma exacerbations, in-patient hospitalization, and/or an emergency department visit, absolute blood eosinophil counts over the course of the on-treatment period; and immunogenicity.
FASENRAFASENRA (benralizumab) is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis (programmed cell death).
FASENRA is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries, and is approved for self-administration in the US, EU and other countries.
FASENRA is in development for other eosinophilic diseases and chronic obstructive pulmonary disease. The US Food and Drug Administration granted Orphan Drug Designation for FASENRA for EGPA (November 2018), HES (February 2019) and EoE (August 2019).
FASENRA was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd., Japan.
AstraZeneca in Respiratory & ImmunologyRespiratory & Immunology, part of BioPharmaceuticals, is one of AstraZenecas three therapy areas and is a key growth driver for the Company.
AstraZeneca is an established leader in respiratory care, and its inhaled and biologic medicines reached more than 53 million patients in 2019. Building on a 50-year heritage, the Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. The Companys early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.
With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Companys growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including Systemic Lupus Erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZenecas ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.
About AstraZenecaAstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory & Immunology. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit http://www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.
US-53643 Last Updated 5/2021
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Defence spending and ADF readiness need to match the risk of conflict | The Strategist – The Strategist
Posted: at 4:43 am
In last weeks expansionary budget, one area that felt a bit underdone was defence. Here, the government delivered what it promised 12 months ago: $44.6 billion, an increase over last years budget of 4.1% in real terms.
At any time in the last 25 years a defence budget growing at that level would have been welcome. But now Australia and the wider region faces the direst strategic outlook since perhaps the end of World War II.
Its clear that Scott Morison and his ministers understand that the region is facing a crisis brought on by an increasingly bellicose Chinese Communist Party. Taiwan is the immediate flashpoint and the level of risk will peak in perhaps four to five years time. In that period, according to the United States Defense Department, the Peoples Liberation Army will gain a strong military edge over the Taiwan Strait in air power, missiles and ships.
Would Xi Jinping risk his own future, as well as that of the CCP, to stage an attack on Taiwan? Xi has learned to turn risky situations to his advantage. In the illegal annexation of the South China Sea, in cyber spying and intellectual property theft, the imposition of communist authority in Hong Kong, and in the economic coercion of Australia, Xi took significant risks to strengthen his rule and largely got away with them.
He will apply the same strategy to Taiwan, using all means short of war and indeed some measures that cross that offensive line right up to the limits of US tolerance.
Ill come to what this might mean for Australia and for the defence budget soon, but first consider a remarkable phenomenon, which is the ability of so many in Australia to deny what is obvious about Beijings intentions.
Writing in the Australian Financial Review, former foreign minister Gareth Evans judged that no Chinese political or military preparations suggest an invasion is remotely imminent. That is an astonishing misjudgement.
On 24 April Xi presided over a ceremony commissioning three major warships for Chinas southern fleet. Communist party newspaper the Global Times declared: These vessels will play important roles in solving questions in places like the island of Taiwan and the South China Sea.
Hardly a day goes by without PLA aircraft, often in large numbers, encroaching Taiwanese airspace. CCP rhetoric about taking Taiwan by force if necessary is increasingly being used in speeches and editorials.
Xi will hope this show of strength will deter the US and the allies from stepping in and that his aims can be realised short of war, but we all need to understand that the risk of conflict is sharply growing.
In Washington last Thursday, US Secretary of State Antony Blinken and Foreign Minister Marise Payne held talks and gave a press conference, underlining the closeness of the alliance relationship.
The secretary of state stressed the Biden administrations interest in reaffirming and revitalizing Americas alliances and partnerships and, in the 70th year of the ANZUS Treaty, finding ways for the alliance to evolve to meet the challenges we face.
Blinken said the US will not leave Australia alone on the field, or maybe I should say alone on the pitch, in the face of economic coercion by China. Thats what allies do. We have each others backs.
Understand that the US has every expectation that the requirement for support runs in both directions. Washington wants Australia to do more, is telling us that the alliance needs to be revitalised and that challenges will be faced together.
This will include working out how to jointly respond to CCP belligerence over Taiwan, which wasnt mentioned once in the BlinkenPayne press conference. Sometimes you can judge the significance of an issue by the way it isnt mentioned publicly.
Back to the defence budget. The Morrison government has delivered everything that it has promised to do in the 2016 defence white paper and more, including two additional P-8 Poseidon maritime surveillance and anti-submarine warfare aircraft and four extra CH-47 Chinook heavy lift helicopters. There is also an accelerated plan to establish a missile manufacturing capability in Australia.
While these are positive steps, the uncomfortable truth is that the bulk of the $270 billion allocated over the coming decade to build ships, submarines and other military equipment will only come into service well after the riskiest period for Taiwan.
Defence Minister Peter Duttons most pressing challenge is to strengthen the Australian Defence Force in the shortest time frame possible. An immediate candidate will be to move quickly on the life extension and upgrade program for the Collins submarines. The government should also explore options to add yet more P-8s to the current 14 airframes but there are limits to what can be done quickly.
A faster way to strengthen deterrence would be to re-open a discussion with the US about increasing the US Marine Corps presence in northern Australia and getting some US Navy ships operating out of our west coast base, HMAS Stirling.
When the US marine presence was being negotiated a decade ago, the initial American offer was to deploy a 7,500-strong Marine AirGround Task Force. The Australian government of the day baulked, and instead we had a decade-long slow growth to the current annual contingent of 2,500.
A larger marine presence ultimately hinges on access to a port facility. Consider the thought that if Beijing wanted to slow down the growth of AustraliaUS defence cooperation in the Top End a clever way to do it would be to take control of the areas most viable port, which is exactly what happened in 2015 when Darwin Port was leased to a Chinese company for 99 years.
The world has fundamentally changed since then. Now, the opportunity to strengthen a shared US and Australian deterrent posture in the Indo-Pacific needs to be urgently reconsidered.
A conflict over Taiwan would be a disaster for all concerned, but disastrous conflicts happen all the time. At this point the best hope to keep the peace is to change Xis calculation about the level of risk China would face if it initiated such a crisis.
The only short-term way to strengthening deterrence is by lifting the defence readiness of democracies. If US President Joe Biden does visit Australia for the ANZUS anniversary, you can be assured this will be the number one item on his agenda.
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Navigo Proteins and MDimune Enter into a Research Collaboration on Affilin-Mediated Targeting of Extracellular Vesicles – BioSpace
Posted: May 11, 2021 at 10:59 pm
Solid tumor-specific scaffold protein ligands from Navigo combined with MDimunes BioDrone technology to create novel targeted extracellular vesicle-based therapeutics
Halle/Saale, Germany and Seoul, Korea, May 11th, 2021. Navigo Proteins, a protein engineering biotech company generating scaffold protein-based affinity ligands, and MDimune, a biotech company developing an innovative drug delivery platform based on exosome-like, nanosized cell-derived vesicles (CDVs), today announced a technology collaboration to achieve tissue-targeting of extracellular vesicles (EVs). The ongoing research combines Navigos target-binding Affilin molecules with MDimunes CDV technology, to enable Affilin-mediated delivery of CDVs specifically to solid tumor targets.
For the current collaboration, Navigo Proteins will contribute its existing solid tumor-specific Affilin molecules to decorate the surface of the exosome-like CDVs from MDimunes BioDrone technology, thereby pioneering next-generation, targeted extracellular vesicle-based therapeutics (See Figure 1).
Figure 1: Affilin-mediated tumor targeting of CDVs
Dr. Ulrich Haupts, Chief Scientific Officer of Navigo Proteins commented: We are looking forward to combining our selectivity-conferring Affilin molecules with MDimunes extracellular vesicles manufacturing platform, since this opens up an exciting new application for our scaffold protein-based Affilin molecules in the upcoming field of exosome-based therapeutics. The modular and highly engineerable Affilin technology can be a very attractive solution for the precise, targeted delivery of exosome-like vesicles, carrying different payloads to different target tissues.
Recently, we have invested significant efforts and resources to expedite effective steering of our vesicles, CDVs, to tumors or other resistant tissues. The current collaboration with Navigo Proteins is one of them highlighting our recent focus. Navigo Proteins demonstrated expertise in generating highly tissue-specific ligands will be key to enable this goal and ultimately build a foundation for our BioDrone platform technology, said Dr. Seung Wook Oh, Chief Scientific Officer of MDimune.
Affilin Affinity Ligands
Navigos Affilin molecules are target-specific, small, stable, highly engineerable, single-chain affinity ligands and are based on human Ubiquitin as a protein scaffold. Since Ubiquitin is an evolutionarily conserved natural human protein, also present in plasma, Affilin molecules have low immunogenic potential in humans and can also be directly used in various pre-clinical animal models.
Affilin molecules are currently being developed as antibody-alternatives in protein-drug conjugates, radio conjugates, CAR-T cell therapy, and as bi/multi-specific molecules by combining them with antibodies. With this collaboration, Navigo aims to extend the applicability of Affilin molecules to direct exosomes and extracellular vesicles to the target tissues of interest.
BioDrone Platform Technology
MDimunes BioDrone platform facilitates the production of CDVs, exosome-like, nanosized vesicles, in large quantities from various cell types by a proprietary extrusion method. CDVs are similar to exosomes in size, properties, and functions, but exhibit substantial advantages in yield that is more suitable for large-scale production and versatility to allow highly sophisticated engineering, starting from virtually any cell type. BioDrone technology is emerging as a highly versatile and scalable delivery system to address many human diseases, including cancer, neurodegeneration, and more.
While the current project is aimed at Affilin-CDV-mediated payload delivery to solid tumors, this technological advance will not only be limited to cancer but could be expanded to other tissues and diseases.
About Navigo Proteins GmbH
Navigo Proteins is a premier protein engineering company developing affinity ligands, based on its proprietary platform of selected, small, and stable, yet highly engineerable scaffold proteins. These ligands serve as target-binding proteins in biotherapeutic molecules (PRECISION TARGETING) or for commercial custom affinity purification of biologics (PRECISION CAPTURING).
Navigos PRECISION TARGETING unit creates proprietary Affilin molecules based on the human Ubiquitin scaffold a highly conserved, small (8.5kDa) and stable natural human protein. A major strength of the Precision Targeting toolbox is its modular engineerability. The target-specific Affilin molecules can be combined with a variety of carrier units for site-specific payload coupling as well as half-life extension moieties and function-conferring effector modules to convert them into different biopharmaceutical modalities. Navigos ligands are currently being developed as Affilin-drug conjugates, Affilin-radio conjugates, Affilin CAR-T cell therapy and can also be fused to antibodies to create robustly-to-produce bi-/multi-specific molecules (MabfilinTM/FabfilinTM).
For more information visit https://www.navigo-proteins.com/ and follow Navigo Proteins on LinkedIn.
About MDimune Inc.
MDimune, a South Korean biotech founded in 2015, has been committed to the development and implementation of state-of-the-art BioDrone platform technology. BioDrone is an innovative technology that relies on human-sourced CDVs, nanosized vesicles obtained from various cells by using a proprietary extrusion method to achieve target-specific drug delivery. With superior productivity compared to exosomes, BioDrone is emerging as a highly versatile and scalable delivery system to combat diverse debilitating human diseases, including cancer, neurodegeneration, and rare diseases.
MDimune is expanding its global network to harness effective tissue targeting strategies to achieve highly tissue-specific delivery of various cargos such as miRNA, siRNA, mRNA, and proteins. The company envisions applying this novel BioDrone platform to address various needs of pharmaceutical clients who are looking for effective drug carriers.
For more information visit http://www.mdimune.com/en/.
Navigo Proteins Contact
Dr. Oliver Schub
Director Business Development
oliver.schub@navigo-proteins.com
Tel.: +49 (0)345 27996330
MDimune Contact
Brin Choi
Manager, Business Development
Tel.: +82 (0)70+7826
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US Nuclear Weapons Systems Facing Risk with Replacements – The Cipher Brief
Posted: at 10:59 pm
Walter Pincusis a contributing senior national security columnist for The Cipher Brief. He spent forty years at The Washington Post, writing on topics from nuclear weapons to politics.
OPINION Last Wednesday, the Government Accountability Office released a declassified version of a once-secret June 2020 report titled: Nuclear Triad: DOD and DOE Face Challenges Mitigating Risks to US Deterrence Efforts.
Conducted under the Trump administration, the report raised questions about whether the Defense Departments (DOD) replacement programs for todays strategic nuclear weapon delivery systems [submarines, bombers, ICBMs] face schedule risks that could exacerbate challenges with existing triad systems.
In addition, the nearly year-old report questioned whether the Department of Energys (DOE) nuclear warhead life extension programs, which depend on manufacturing and assembly facilities that are outdated or obsolete, also face schedule risks.
As a result, the GAO said, DOD and DOE have limited ability to mitigate risks to the efficacy of the nuclear deterrent with their current strategy and are beginning to consider alternatives.
The GAO said it did the 2020 study because DOD has reported that due to prior delays and challenges with aging nuclear Triad systems, there is little to no margin for delaying replacement systems without incurring risk to the nuclear deterrent. Similarly, DOE faces a demanding schedule for infrastructure projects and programs for the life extension and production of warheads and bombs.
The report went on, We found that every nuclear Triad replacement programincluding the B-21 [new strategic bomber], LRSO [new long-range, stand-off, air-launched, nuclear cruise missile], GBSD [new Ground Based Strategic Deterrent Intercontinental Missile], and Columbia class submarine, and every ongoing bomb and warhead modernization programfaces the prospect of delays due to program-specific and DOD-and DOE-wide risk factors. These risk factors include an insufficient DOD nuclear certification workforce, limited DOE infrastructure capacity, and supply-chain risks. If realized, these delays would prolong DODs operation of existing Triad systems.
Two points about this report make it interesting.
It was based on requirements set by the 2018 Trump Nuclear Posture Review, and as the GAO pointed out in the declassified version released last week the report does not reflect the effects of these COVID-19 measures on program schedules or progress.
In short, the report showed the Trump administration was pushing ahead with programs to replace its three major strategic nuclear delivery systems, at costs in the hundreds-of-billions of dollars, in the face of what the GAO said were risk factors that include concurrency between phases of acquisition programs from development through production, immature technologies, and limited schedule margins.
I write about the GAO report today because the Biden administration has its own Nuclear Posture Review underway, which will allow reassessment of Trumps nuclear programs, and possibly offer the prospect of slowing down the new Columbia submarine, GBSD ICBM, and B-21 systems to reduce some risks pointed out by the GAO.
Will that harm todays deterrence effect?
The GAO report notes that much of the concern raised by Trump Pentagon personnel rested on the ability to generate additional numbers of strategic nuclear systems called force generation based on U.S. Strategic Command (STRATCOM) operational requirements in some future crisis. Those requirements could very well change under the Biden administration given President Bidens intention to try to reduce the role of nuclear weapons in national security. Meanwhile, as the GAO report points out, the Navy already apparently has not met STRATCOMs current force generation requirements having operational and available 10 SSBNs [strategic ballistic missile submarines] because the current Ohio SSBNs have faced months of unplanned delays in extended mid-life maintenance, refueling overhauls and refit periods.
However, no one has claimed the U.S. deterrent is currently ineffective.
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Meanwhile, President Biden has agreed with Russian President Vladimir Putin to extend the New START (Strategic Arms Treaty) for five years. That extension keeps in place inspection and verification rules and, as Secretary of State Antony Blinken has said, Provides us with greater insight into Russias nuclear posture, including through data exchanges and onsite inspections that allow U.S. inspectors to have eyes on Russian nuclear forces and facilities.
Just what are the risks that the GAO said relate to replacement of the new delivery systems?
The first, new Columbia-class strategic submarine went into production in October 2020, despite the finding that additional development and testing are required to demonstrate the maturity of several technologies critical to performance, according to the GAO report. In addition, the GAO described as aggressive the Navys Columbia production plan noting it plans to build the lead submarine over 7 yearsor 84 monthsThis duration is shorter than what the Navy achieved on any recent lead submarine construction effortincluding during high levels of Cold War submarine production. The average construction time for the first of class submarine for the last four classes has been approximately 91 months.
A February 2021 Congressional Research Service report also raised risks to the Columbia program, citing the COVID-19 pandemic, technical challenges, and/or funding-related issuesof a delay in designing and building the lead Columbia-class boat, which could put at risk. the Navys ability to have the boat ready for its first scheduled deterrent patrol in 2031, when it is scheduled to deploy in the place of the first retiring Ohio-class SSBN.
The GAO report also claims that Pentagon officials called the current schedule for the GBSD aggressive and compressed compared to prior ICBM programs. Designed to replace the currently deployed 400 Minuteman IIIs beginning in 2029, The Air Force plans to deliver the first production unit of the GBSD missile at the earliest feasible date and reach initial operational capability in fiscal year 2029.
GAO said the missiles program schedule delays are likely because of several risks starting with the use of immature technology. To meet the planned first delivery, the Air Force developed an acquisition approach that calls for the use of mature technologies, but GBSD program officials acknowledge in the programs acquisition strategy that there is a risk that the program could be delayed if it does not demonstrate a mature design based on mature technologies, according to the GAO.
Another risk is the GBSD programs draft developmental testing schedule only includes two months to address deficiencies found in flight testing before the next test is expected to begin, including any resulting design changes. The GAO said, Our work on other acquisition programs shows that testing is a process of discovery and that programs need time to incorporate necessary changes and retest.
Another risk factor is the time it would take to convert Minuteman III launch facilities into the configuration needed for the GBSD. Current plans call for averaging 50 conversions per year with slightly more than that number going through the process before the first new ICBM is turned over to the Air Force. Under current deployments, there are 50 former Minuteman III launch facilities without missiles, a reduction undertaken under the New START treaty. The current estimate is that it could take up to six months to restore and convert a launch facility to handle a GBSD missile.
The Air Force has yet to evaluate all of the launch facilities and, accordingly, the full scope of work necessary to prepare the facilities for use by the GBSD program has yet to be determined. If the Air Force does not resolve the issues with the launch facilities in advance of the transition to GBSD, additional time could be needed for construction, which could result in delays to GBSD fielding, according to the GAO report.
As for programs to upgrade aging U.S. nuclear warheads, the GAO had previously, in 2019, found that the next decade is particularly challenging for DOEs nuclear modernization efforts because the agency needs to ensure sufficient production capacity to execute LEPs [Life Extension Programs] and modernization programs while conducting major construction projects and programs to modernize its uranium and plutonium capabilities. The GAO report goes over problems related to not only producing plutonium pits, the triggering devices for thermonuclear weapons, but also the availability of weapons-grade uranium, tritium, lithium, as well as specialized explosive materials that meet the exacting standards required for use in nuclear weapons.
What is clear from analysis of last weeks GAO report is that the long-planned, costly replacement of strategic nuclear delivery systems was already running behind meeting the Trump administrations schedule before the Biden presidency began. Nonetheless, Americas nuclear deterrent, in the form of todays deployed triad of submarines, ICBMs and bombers, remains unchallenged.
It follows, therefore, that there is some timing flexibility for the Biden administrations national security team to put together its own nuclear weapons policy, relate it to arms control approaches, and continue the Triad delivery systems replacement programs, although probably at a more responsible pace and perhaps calling for lesser numbers.
Read more expert-driven national security opinions, insights and analysis in The Cipher Brief
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Chris Berman signs multiyear extension with ESPN – ESPN
Posted: at 10:59 pm
Chris Berman will continue to host NFL PrimeTime after agreeing to a new contract with ESPN.
The multiyear agreement was announced on Berman's 66th birthday Monday.
"We've been working on it for a while, and this was the perfect time to do it," Berman said during a telephone interview. "ESPN has been almost two-thirds of my life. I'm honored that what I do still works."
Berman has been an integral part of ESPN throughout its history after joining the network a month after its launch in September 1979. Besides being one of the original SportsCenter anchors, he also has been a key part of the network's NFL and baseball coverage.
He hosted NFL PrimeTime with Tom Jackson from 1987 to 2005 on ESPN and then starting again in 2019 when it returned on the ESPN+ streaming service. Berman -- who also hosted NFL Countdown from 1985 to 2016 -- teamed up with Booger McFarland for PrimeTime last year when Jackson could not travel due to the coronavirus pandemic.
Berman approached ESPN President Jimmy Pitaro when ESPN+ started about the possibility of reviving PrimeTime. Berman said seeing the success of PrimeTime on the streaming service has mirrored watching the growth of ESPN.
"The fact that I will get to do it again this season is something I have enjoyed the most," he said. "I love being able to help build another entity with it this time being in the streaming world."
Berman said it remains to be determined who will join him on PrimeTime during the coming season.
Berman was the 2010 recipient of the Pro Football Hall of Fame's Pete Rozelle Radio-Television Award and has been the master of ceremonies for the Hall's induction ceremony since 1999.
"Quite simply, Chris Berman has personified ESPN's success for more than four decades," Norby Williamson, ESPN's executive vice president and executive editor, said in a statement. "Fans respond to his authentic love of sports, his ability to savor and capture the big moments, and his on-air style that reminds us how live games can truly be equal parts essential and fun. We are delighted Boomer's magical ride at ESPN will continue for years to come."
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Global Nuclear Plant Life Extension Market Insights 2021 Industry Overview, Competitive Players & Forecast 2027| Areva,CNNC,Rosatom,Westinghouse…
Posted: at 10:59 pm
May 9, 2021 (Reports and Markets) Nuclear Plant Life Extension Market
Reports And Markets recently added a research report on the Nuclear Plant Life Extension Market, which represents a study for the period from 2021 to 2027. The research study provides a near look at the market scenario and dynamics impacting its growth. This report highlights the crucial developments along with other events happening in the market which are marking the growth and opening doors for future growth in the coming years. Additionally, the report is built on the basis of the macro- and micro-economic factors and historical data that can influence the growth.
The report offers valuable insight into the Nuclear Plant Life Extension Market progress and approaches related to the Nuclear Plant Life Extension market with an analysis of each region. The report goes on to talk about the dominant aspects of the market and examine each segment.
Key Players: Areva,CNNC,Rosatom,Westinghouse Electric Company,CGN,Hitachi GE Nuclear Energy,Mitsubishi Heavy Industries,KHNP,Kansai Electric Power,Japan Atomic Power,Alstom,Hitachi
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The global Nuclear Plant Life Extension Market segmented by company, region (country), by Type, and by Application. Players, stakeholders, and other participants in the global Nuclear Plant Life Extension market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by region (country), by Type, and by Application for the period 2021-2027.
Market Segment by Regions, regional analysis covers
North America (United States, Canada and Mexico)
Europe (Germany, France, UK, Russia and Italy)
Asia-Pacific (China, Japan, Korea, India and Southeast Asia)
South America (Brazil, Argentina, Colombia etc.)
Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)
Key Points of the Geographical Analysis:
Data and information related to the consumption rate in each region
The estimated increase in the consumption rate
The expected growth rate of the regional markets
Proposed growth of the market share of each region
Geographical contribution to market revenue
Research objectives:
To study and analyze the global Nuclear Plant Life Extension Market size by key regions/countries, product type and application, history data from 2013 to 2017, and forecast to 2027.
To understand the structure of the Nuclear Plant Life Extension Market by identifying its various sub segments.
Focuses on the key global Nuclear Plant Life Extension players, to define, describe and analyze the value, market share, market competition landscape, SWOT analysis and development plans in next few years.
To analyze the Nuclear Plant Life Extension with respect to individual growth trends, future prospects, and their contribution to the total market.
To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).
To project the size of Nuclear Plant Life Extension sub markets, with respect to key regions (along with their respective key countries).
To analyze competitive developments such as expansions, agreements, new product launches and acquisitions in the market.
To strategically profile the key players and comprehensively analyze their growth strategies.
The report lists the major players in the regions and their respective market share on the basis of global revenue. It also explains their strategic moves in the past few years, investments in product innovation, and changes in leadership to stay ahead in the competition. This will give the reader an edge over others as a well-informed decision can be made looking at the holistic picture of the market.
Table of Contents: Nuclear Plant Life Extension Market
Chapter 1: Overview of Nuclear Plant Life Extension Market
Chapter 2: Global Market Status and Forecast by Regions
Chapter 3: Global Market Status and Forecast by Types
Chapter 4: Global Market Status and Forecast by Downstream Industry
Chapter 5: Market Driving Factor Analysis
Chapter 6: Market Competition Status by Major Manufacturers
Chapter 7: Major Manufacturers Introduction and Market Data
Chapter 8: Upstream and Downstream Market Analysis
Chapter 9: Cost and Gross Margin Analysis
Chapter 10: Marketing Status Analysis
Chapter 11: Market Report Conclusion
Chapter 12: Research Methodology and Reference
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Key questions answered in this report
What will the market size be in 2027 and what will the growth rate be?
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What are the challenges to market growth?
Who are the key vendors in this market space?
What are the market opportunities and threats faced by the key vendors?
What are the strengths and weaknesses of the key vendors?
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Ascendis Pharma A/S Announces Preliminary 58-Week Results from Open-Label Extension of Phase 2 PaTH Forward Trial of TransCon PTH in Adult…
Posted: at 10:59 pm
COPENHAGEN, Denmark, May 10, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma, Inc.(Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, today announced preliminary 58-week results from the continuing open-label extension (OLE) portion of the PaTH Forward Trial, a global phase 2 trial evaluating the safety, tolerability, and efficacy of its investigational product candidate TransCon PTH in adult subjects with hypoparathyroidism (HP).
Today we announced results which demonstrated, after one year of treatment, that TransCon PTH was well-tolerated at all doses and provided durable benefit in adults with HP. Data from these subjects provided evidence suggesting they are establishing physiologic calcium metabolism based upon normalization of 24-hour urine calcium excretion and a downward trend toward mid-normal levels in bone markers without the use of therapeutic calcium and vitamin D supplementation. In addition, patient data also showed continued normalized quality of life as measured by the SF-36 questionnaire. Taken together, we believe these results further support the use of TransCon PTH as a potential new treatment paradigm for adults living with HP, said Jan Mikkelsen, President and CEO of Ascendis Pharma.
What is particularly rewarding to me is that all 58 patients continue to participate in the open label extension. I believe this is a reflection of the positive impact TransCon PTH is having on these individuals lives, continued Mr. Mikkelsen.
Key Findings of the Preliminary OLE Results of PaTH Forward Trial at 58 weeks
A slide presentation with these data is available at the Investors & News section of the companys website here:https://investors.ascendispharma.com/
TransCon PTH Program Update
In addition to PaTH Forward, Ascendis Pharma is conducting the PaTHway Trial, a North American and European phase 3 clinical study evaluating the safety, tolerability and efficacy of TransCon PTH in adults with HP. Topline results are expected from PaTHway in the fourth quarter of 2021.
Ascendis plans to submit a Clinical Trial Notification to the Pharmaceuticals and Medical Devices Agency in Japan during the second quarter of 2021 to initiate a phase 3 trial of TransCon PTH in adults with hypoparathyroidism.
About the PaTH Forward Trial
PaTH Forward is a global, phase 2, randomized, double-blind, placebo-controlled group trial evaluating the safety and efficacy of three fixed doses of TransCon PTH (15, 18 or 21 g/day or placebo). The trial enrolled 59 adult subjects with chronic HP who received standard of care or were previously treated with PTH therapies. The goal of PaTH Forward is to evaluate TransCon PTH control of serum and urinary calcium and identify a titration regimen for complete withdrawal of standard of care (i.e., active vitamin D and calcium supplements). PaTH Forward has introduced a ready-to-use pre-filled pen injector and assesses disease-specific patient-reported outcomes. After four weeks of fixed dosing, all subjects were eligible to enter an open-label extension period with the opportunity to receive a customized maintenance dose of TransCon PTH to evaluate long-term safety and efficacy.
About TransCon PTH1
TransCon PTH is an investigational once-daily long-acting prodrug of parathyroid hormone (PTH[1-34]) in development as a treatment for adult hypoparathyroidism (HP) designed to restore PTH at physiologic levels for 24 hours each day to address both the short-term symptoms and long-term complications of the disease. TransCon PTH was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) in June 2018, and in October 2020 was granted Orphan Designation by the European Commission for the treatment of hypoparathyroidism.
About Hypoparathyroidism (HP)2,3,4,5,6,7
Hypoparathyroidism (HP) is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone (PTH), resulting in low calcium and elevated phosphate levels in the blood. HP affects approximately 200,000 patients in the United States, Europe, Japan and South Korea, the majority of whom develop the condition following damage or accidental removal of the parathyroid glands during thyroid surgery. Patients often experience decreased quality of life. In the short term, symptoms include weakness, severe muscle cramps (tetany), abnormal sensations such as tingling, burning and numbness (paresthesia), memory loss, impaired judgment and headache. Over the long term, this complex disorder can increase risk of major complications, such as extraskeletal calcium depositions occurring within the brain, lens of the eye, and kidneys, which can lead to impaired renal function.
HP remains among the few hormonal insufficiency states without a replacement therapy that restores the missing hormone at physiologic levels. Standard of care with active vitamin D analogs and calcium supplementation do not fully control the disease and may contribute to risk of renal disease. As a result, patients with HP have an estimated 4-fold to 8-fold greater risk of renal disease compared to healthy controls.
About TransCon Technology
TransCon refers to transient conjugation. The proprietary TransCon platform is an innovative technology to create new therapies that are designed to potentially optimize therapeutic effect, including efficacy, safety and dosing frequency. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic conditions (e.g., pH and temperature) initiate the release of the active, unmodified parent drug in a predictable manner. Because the parent drug is unmodified, its original mode of action is expected to be maintained. TransCon technology can be applied broadly to a protein, peptide or small molecule in multiple therapeutic areas, and can be used systemically or locally.
AboutAscendis Pharma A/S
Ascendis Pharmais applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon technologies to create new and potentially best-in-class therapies.
Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates and one oncology product candidate in clinical development. The company continues to expand into additional therapeutic areas to address unmet patient needs.
Ascendis is headquartered inCopenhagen, Denmark, with additional offices in Heidelberg andBerlin, Germany, inPalo AltoandRedwood City, California, and in Princeton, New Jersey.
Please visit http://www.ascendispharma.com (for global information) or http://www.ascendispharma.us (for U.S. information).
Forward-Looking StatementsThis press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis expectations regarding the timing of topline results from PaTHway, (ii) Ascendis plans to submit a Clinical Trial Notification to the Pharmaceuticals and Medical Devices Agency in Japan to initiate a phase 3 trial of TransCon PTH in adults with hypoparathyroidism, (iii) Ascendis ability to apply its platform technology to build a leading, fully integrated biopharmaceutical company, (iv) Ascendis product pipeline and expansion into additional therapeutic areas and (v) Ascendis expectations regarding its ability to utilize its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: unforeseen safety or efficacy results in its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs, selling, general and administrative expenses, other research and development expenses and Ascendis business generally; delays in the development of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; Ascendis ability to obtain additional funding, if needed, to support its business activities and the effects on its business from the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis business in general, see Ascendis Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on March 10, 2021 and Ascendis other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.
Ascendis,Ascendis Pharma, theAscendis Pharmalogo, the company logo and TransCon are trademarks owned by theAscendis Pharma Group. May 2021Ascendis Pharma A/S.
1 Karpf DB, et al. J Bone Miner Res. 2020; x:1-11.2 Mannstadt M, et al. Nature Reviews2017, 3: 170553 Ascendis Pharma HP Patient Experience Research.4 Hadker N, et al. Endo Pract. 2014, 20(7);671-679.5 Powers J, et al. J Bone Miner Res 2013, 28: 2570-2576.6 Mitchell DM, et al. J Clin Endocrinol Metab 2012, 97(12): 4507-45147 Underbjerg L, et al. J Bone Miner Res 2013, 28: 2277-2285
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