Monthly Archives: September 2021

28 September 2021

Canada's Bruce Power has received approval from the Canadian Nuclear Safety Commission for the commercial production of the medical radioisotope lutetium-177 (Lu-177) in its nuclear power plants. The project to produce the innovative therapeutic isotope, which is used in the treatment of prostate cancer and neuroendocrine tumours, is a partnership between Bruce Power, IsoGen, Saugeen Ojibway Nation (SON) and ITM.

IsoGen, a joint venture of Framatome and Kinectrics, designed and manufactured the Isotope Production System (IPS) that will be used to produce Lu-177 by irradiating ytterbium targets inside Candu reactors at Bruce. The IPS is being installed as part of the ongoing Life-Extension Program, which began in 2016 and aims to add about 30 to 35 years of operational life to each reactor at the Bruce site in Ontario.

As the commissioning process continues there will be additional regulatory hold points to allow CNSC staff to confirm operational readiness of the IPS prior to the start of Lu-177 production, Bruce Power said. The company will finalise documentation and CNSC staff will review commissioning test results to verify the IPS meets its design and safety analyses requirements.

Irradiated targets will then be processed by Germany-based ITM to produce pharmaceutical quality no-carrier-added Lu-177, which will be marketed under the name Endolucin Beta.

Bruce Power is one of the world's largest producers of cobalt-60 - used for the sterilisation of single-use medical equipment as well as in cancer treatments - through its partnership with Nordion. The company said the approved Lu-177 project will expand its established isotope production and "solidify" it as an integral producer of critical medical isotopes. Chief Development Officer James Scongack said the Lu-177 project is a "game-changer" for the supply of medical isotopes and the global medical community.

SON has been working with Bruce Power to create economic benefits within SON territory - which encompasses the Saugeen (Bruce) Peninsula - by establishing new isotope infrastructure connected with lutetium-177 production, and last year became the first indigenous community to join the Canadian Nuclear Isotopes Council.

Chief Lester Anoquot, Chippewas of Saugeen First Nation, said: "It's very exciting times for SON as we move forward to the next phase of the Isotope project with Bruce Power We are proud to play a leadership role in the global fight against cancer, while building economic opportunities in our community."

The partnership, which includes an equity stake and revenue-sharing model for SON, is named Gamzook'aamin aakoziwin, which means 'We are Teaming up on the Sickness' in the traditional Anishinaabe language.

Researched and written by World Nuclear News

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Regulatory approval for new isotope production at Bruce : Regulation & Safety - World Nuclear News

Effective altruism is a philosophy and social movement concerned with finding the most effective ways to make the world a better place, according to Graeme McDonough, a junior on the Effective Altruism clubs executive board.

At its core, effective altruism is really about philosophy and thinking about how we can analyze giving back to the world. But in practice, its really about thinking about giving back and also about in what ways you might go about doing that, McDonough said.

Rachel Weinberg and David Gantt, co-presidents of the Effective Altruism club on campus, are working closely with 15 other members to seek the clubs university recognition by the Tufts Community Union Judiciary in mid-October. The renewed push for TCU Judiciary recognition represents an effort to reinstate the club after Effective Altruism first arrived at Tufts through Dillon Bowen (A16) who learned about the movement during his year abroad at the University of Oxford.

One of the advantages of joining Effective Altruism is career exploration.

In terms of actionable items, especially if youre a student, [effective altruism involves] actually just taking the time to think about what careers might benefit the most people. Think about your skills and your interests and how you can best give back, McDonough said.

McDonough added that while effective altruism as a philosophy shares many common tenets with utilitarianism, the movement does not officially subscribe to any specific school of thought.

[As I see it,] effective altruism is the idea that what is ethical, and by extension what is the right thing to do, generally improves the quality of life or improves the happiness of the most people and in the greatest quantity, McDonough said. Utilitarianism as a philosophy on its own has a lot of flaws It can easily slip into minority underrepresentation or marginalized communities underrepresentation. But certainly, with some tweaks, theres something called prioritarianism, which is where you prioritize underprivileged communities over others, even if it means a slightly smaller increase in happiness overall. So with some tweaks, Effective Altruism is really based on that.

In explaining effective altruism, Gantt introduced quality-adjusted life-year (QALY), a way to measure and quantify the effectiveness of doing good.

Gantt discussed how a charity could compare two disparate interventions: contributing to a cancer treatment or contributing to a deworming initiative in a low-income country. For a cancer treatment, it costs between $30,000 to $50,000 per year to extend one persons life by one year. Whereas with the latter option, you can do that for a matter of cents. If you take QALY as a metric, you can begin to compare one cause against another.

By quantifying a charitys effectiveness, some critics point out that the movement comes across as calculating and cold-blooded. Weinberg, however, explained the rationale behind Effective Altruisms approach.

If we want to support people equitably, we need to support causes unequally, because some causes help people more effectively than others, Weinberg said. We should be pouring our resources into causes which can help people the most per dollar and hour that we spend.

Weinberg added how Harrison Sweet, a first-year who joined the club, understands Effective Altruisms premise in the context of mindfulness.

[Sweet] said meditation is in part about increasing the distance between impulse and your action in an intentional way, Weinberg said. In Effective Altruism, we want a similar thing: everybody has all these natural impulses to help people, and thats good, but we want to intentionally consider how to best channel that into effective action, rather than acting on first impulse.

On top of that, it is important to note that Effective Altruism is not all about charity and there is no one right way to join and help the cause. McDonough explained the importance of prioritizing your skills when giving back.

Since Im studying chemical engineering, Im not going to swerve paths and start introducing climate change legislation. I dont have those skills [I could instead focus on] developing carbon capture systems for climate change action, McDonough said.

As the Effective Altruism club grows in size, Weinberg hopes that the club can foster an intellectual and mindful community where its members engage deeply with what it means to do good for the world.

We are trying to get students to think more deeply about a question, which is, how can you have the most impact possible, the most positive way possible? Weinberg said. Our mission is not to really answer this question our goal is to think really deeply about it together, consider it read all sorts of things that we can together and also get many different perspectives.

The Effective Altruism club also attempts to examine how people extend their moral circle beyond their immediate communities, Weinberg explained.

If you look at history a few 100 years ago, people didnt care about people who were outside of their country, outside of their race or outside of their religion, Weinberg said. We should look at ourselves critically and think, maybe we arent taking into account everybody that we ought to care about.

According to many effective altruists, including Weinberg and Gantt, peoples moral circles should encompass all sentient beings, including animals.

Seventy-two billion land animals are killed for food around the world every year, Weinberg said. Animals have the capacity to feel the same, or at least a significant fraction of joy and pain we do, and yet 97% of our philanthropic funding goes only towards humans We should expand our compassion to [animals] too.

Despite how demanding it may come across as a philosophy, Gantt added that effective altruism can imbue ones life with a profound sense of purpose and meaning in return.

Something that people can get out of effective altruism, I think, is a sense that your work, whatever it may be, can carry great meaning, Gantt said. To feel that you can have an immense impact by consistently giving a portion of your income to a charity or a cause is what effective altruism can offer.

Drawing from their experiences and involvement with the Effective Altruism community, Weinberg and Gantt organized a fall fellowship program that will run from Oct. 10 to Dec. 4 this semester.

Joining the fellowship program will be the best way to get involved with the club and participate in the cause, Weinberg said. It will also serve as an opportunity for participants to discuss and debate a wide range of pertinent ideas.

The fellowship is about an hour of reading and an hour of discussion per week, Weinberg said. Its super interdisciplinary. Anybody, regardless of their interests, can help us. We have a place for anybody who wants to have an impact.

Weinberg added that there will be more regular meetings and club events once the club is recognized by the TCU Judiciary this fall.

We will have a few meetings [where] club members can give presentations on EA-related issues they care about, Weinberg said. We are definitely interested in running a follow-up, more in-depth fellowship program next semester as well.

Moving forward, the club hopes to encourage students to have conversations about pursuing careers that maximize social impact. They also plan on helping the Tufts community donate and contribute to organizations and causes that can best actualize their goals, Weinberg explained.

According to Weinberg, the club aims to discuss and address three main areas of interest: global health and poverty, animal welfare and protecting humanitys long term future.

[These] three areas are highly neglected and tractable to make a difference, Weinberg said. We need to preserve humanity so that future generations, who will be wiser than we are, can take humanity to its full potential.

Weinberg reflected on how joining Effective Altruism has changed her life.

I think a lot of college kids dont know what they want to do with their careers, Weinberg said. Overall, being involved with the EA community has given me a clearer sense of purpose and direction in life, which has made me much happier.

Link:

Effective Altruism club hopes to promote a deeper understanding of doing good on campus - Tufts Daily

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca will present data across its COVID-19 and respiratory syncytial virus (RSV) pipeline at the 10th Annual IDWeek Virtual Conference, September 29 to October 3, 2021, illustrating its commitment to advancing innovative science in infectious diseases.

Data featuring AstraZenecas investigational long-acting antibody (LAAB) programs AZD7442 for COVID-19 and nirsevimab for RSV as well as AZD1222, will be presented as three late-breaking oral presentations.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: The compelling data being presented at IDWeek reflect our scientific advances across infectious diseases in response to the COVID-19 pandemic and surges in respiratory syncytial virus cases. Our PROVENT Phase III data demonstrate AZD7442 may offer much-needed protection for vulnerable populations who may not mount an adequate immune response to COVID-19 vaccination.

Advancing COVID-19 prevention with cutting-edge science

High-level efficacy and safety data from the PROVENT Phase III trial investigating AZD7442 for prevention of COVID-19 will be presented for the first time following the initial announcement in August. The data showed that AZD7442 compared to placebo achieved a statistically significant reduction in the risk of developing symptomatic COVID-19 prior to virus exposure (pre-exposure prophylaxis).1 More than 75% of participants in the trial had co-morbidities, which includes those with a reduced immune response to vaccination.1 In PROVENT, the LAAB was well tolerated and preliminary analyses show adverse events were balanced between the placebo and AZD7442 groups.

A late-breaker oral presentation of Phase III results will show whether AZD1222 prevents asymptomatic cases of COVID-19, as well as its capability to shorten viral shedding in breakthrough infections. Understanding the duration of viral shedding may help the implementation of effective public health efforts to control the spread of the virus.2

Late breaking data on nirsevimab

The MELODY Phase III trial data for nirsevimab, an investigational long-acting antibody being developed by AstraZeneca and Sanofi, will demonstrate the potential of nirsevimab to help protect all infants entering their first RSV season with a single dose.

Key AstraZeneca presentations during IDWeek 2021

Lead author

Abstract title

Presentation details

COVID-19 (Long-acting antibody)

Levin, M

PROVENT: Phase 3 Study of Efficacy and Safety of AZD7442 (Tixagevimab/Cilgavimab) for Pre-exposure Prophylaxis of COVID-19 in Adults

Abstract #LB5

Session: Late Breaker Abstracts: COVID-19 Treatment & Prophylaxis

September 30, 2021

5:15 6:30pm EDT

Presentation time:

6:15 6:30pm EDT

COVID-19 (Vaccine)

Sobieszczyk, M

Asymptomatic Infection and Duration of Viral Shedding in Symptomatic Breakthrough Infections in a Phase 3 Study of AZD1222 (ChAdOx1 nCoV-19)

Abstract #LB6

Session: Late Breaker Abstracts: COVID-19 Vaccines, Epidemiology, and Clinical

October 1, 2021

10:00 11:15am EDT

Presentation time:

10:00 10:15am EDT

Respiratory Syncytial Virus (Long-acting antibody)

Hammitt, L

The Efficacy and Impact in Healthy Infants of Nirsevimab on Medically Attended RSV Lower Respiratory Tract Infection

Abstract #LB13

Session: Late Breaker Abstracts

October 2, 2021

1:15 3:00pm EDT

Presentation time: 1:45pm EDT

AZD7442

AZD7442 is a combination of two LAABs - tixagevimab (AZD8895) and cilgavimab (AZD1061) - derived from B-cells donated by convalescent patients after SARS-CoV-2 virus.3-4 Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein4-5 and were optimized by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. The half-life extension more than triples the durability of its action compared to conventional antibodies and could afford up to 12 months of protection from COVID-19 following a single administration.6-9 The reduced Fc receptor binding aims to minimize the risk of antibody-dependent enhancement of disease - a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.10

AZD7442 is being studied in a comprehensive clinical trial program for both prevention and treatment of COVID-19. In August 2021, AstraZeneca announced positive high-level results from the PROVENT Phase III pre-exposure prophylaxis trial. Other ongoing trials include TACKLE COVID-1911, a Phase III mild-to-moderate COVID-19 outpatient treatment trial, and collaborator treatment trials in outpatient and hospitalized settings.

Preliminary in vitro findings demonstrate that AZD7442 neutralizes recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.12,13

AstraZeneca is preparing regulatory submission of the prophylaxis data to health authorities for potential emergency use authorization or conditional approval of AZD7442.

AZD1222

AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

AZD1222 has been granted a conditional marketing authorization or emergency use in more than 80 countries across six continents. More than 1.1 billion doses of AZD1222 have been supplied to more than 170 countries worldwide, including more than 100 countries through the COVAX Facility.

Nirsevimab

Nirsevimab is an investigational long-acting antibody, being developed by AstraZeneca and Sanofi using AstraZenecas proprietary YTE technology, designed to protect all infants for the RSV season. Due to its extended half-life technology, nirsevimab is being developed as a single dose for all infants experiencing their first RSV season and infants with congenital heart disease or chronic lung disease entering their first and second RSV season.14 The current anti-RSV antibody, AstraZenecas Synagis, is limited to high-risk infants and provides one-month protection, requiring five injections to cover an RSV season.15

Nirsevimab is designed to provide RSV protection to all infants via an antibody given directly to an infant to help prevent LRTI caused by RSV. Unlike an active immunization, monoclonal antibodies do not require the activation of the immune system to help offer rapid and direct protection against disease.16 There has been a recent resurgence of RSV during the easing of COVID-19 public health measures.17

Nirsevimab has been granted regulatory designations to facilitate expedited development by three major regulatory agencies around the world. These include Breakthrough Therapy Designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the US Food and Drug Administration; and access granted to the European Medicines Agency PRIority MEdicines (PRIME) scheme. Nirsevimab is currently under clinical investigation and has not been approved by any regulatory authority.

In March 2017, AstraZeneca and Sanofi announced an agreement to develop and commercialize nirsevimab. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities and Sanofi will lead commercialization activities and record revenues. Under the terms of the global agreement, Sanofi made an upfront payment of 120m, has paid a development milestone of 30m and will pay up to a further 465m upon achievement of certain development and sales-related milestones. The two companies share all costs and profits. Revenue from the agreement is reported as Collaboration Revenue in the Companys financial statements.

Related, in November 2018, AstraZeneca divested US commercial rights for Synagis to Swedish Orphan Biovitrum AB (publ) (Sobi) in addition to the right to participate in payments that may be received by AstraZeneca from the US profits or losses for nirsevimab. Under the agreement, AstraZeneca received upfront consideration of $1.5bn, consisting of $1.0bn in cash and $500m in ordinary shares of Sobi upon completion, and will have received a total of $60m in non-contingent payments for nirsevimab during 2019-2021. AstraZeneca will also receive up to $470m in sales-related payments for Synagis, a $175m milestone following the submission of the Biologics License Application (BLA) for nirsevimab and potential net payments of approximately $110m on achievement of other nirsevimab profit and development-related milestones. Upon payment of the $175m milestone on BLA submission, Sobis ongoing participation will amount to AstraZenecas full share of profits or losses under the agreement with Sanofi for nirsevimab in the US. AstraZeneca will continue to manufacture and supply nirsevimab globally and is entitled to an additional royalty from Sobi if profits from nirsevimab in the US exceed a pre-specified level.

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, 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.

References

Read more here:

AstraZeneca COVID-19 and RSV presentations at IDWeek 2021 will showcase scientific progress in infectious diseases - Business Wire

ADG20 Continues to be Well Tolerated in Healthy Volunteers with Prolonged Half-Life and Serum Virus Neutralization Activity Observed out to Six Months in Ongoing Phase 1 Study

Data from Quantitative Systems Pharmacology/Whole-Body Physiologically Based Pharmacokinetic Modeling Support Evaluation of 300 mg Intramuscular Dose of ADG20 Given as a Single Intramuscular Injection in Ongoing Phase 2/3 Studies

Data to be Presented During IDWeek 2021 and 19th Annual Discovery on Target Conference

WALTHAM, Mass., Sept. 29, 2021 (GLOBE NEWSWIRE) -- Adagio Therapeutics, Inc., ( ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today announced new data from the companys COVID-19 antibody program. Updated, six-month data from its ongoing Phase 1 study of ADG20 in healthy participants and data validating the selection of the 300 mg intramuscular (IM) dose given as a single injection that is being evaluated in the companys ongoing global Phase 2/3 treatment (STAMP) and prevention (EVADE) clinical trials will be presented during four poster sessions at the Infectious Disease Society of Americas IDWeek 2021, being held from Sept. 29 Oct. 3, 2021. In addition, Adagios chief scientific officer, Laura Walker, Ph.D., will present a subset of the ADG20 Phase 1 data as well as background on the identification and optimization of this differentiated antibody clinical candidate in an oral presentation at the 19th Annual Discovery on Target Conference on Sept. 30, 2021.

The continued strength of the safety and pharmacokinetic data from our Phase 1 study is encouraging and further underscores the potential impact an antibody like ADG20 which was designed to be potent, broadly neutralizing and delivered as a single IM injection could have on people with or at risk of COVID-19, said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. These Phase 1 data combined with our dose selection strategy, which relied on our innovative modeling approach, have allowed us to initiate and advance our pivotal trials of ADG20 in the treatment and prevention of COVID-19. We anticipate these data will support an Emergency Use Authorization (EUA) application in the first quarter of 2022, which could enable us to bring an important treatment option to patients.

Phase 1 Trial UpdateAdagio is evaluating ADG20 in a Phase 1 randomized, double-blind, placebo-controlled single ascending-dose study to assess safety and tolerability, pharmacokinetics (PK), immunogenicity, and serum virus neutralizing activity of ADG20 ex vivo against SARS-CoV-2. Data from a six-month evaluation timepoint confirmed the extended half-life of ADG20, which approached 100 days based on data from the 300 mg IM dose that was given as a single injection. In addition, 50% serum virus neutralization titers at six months after a 300 mg IM dose of ADG20 were similar to observed peak titers with the mRNA-1273 vaccine and exceeded those achieved with the AZD1222 vaccine series. Importantly, ADG20 was well tolerated with no study drug-related adverse events (AEs), serious AEs, or injection-site or hypersensitivity reactions reported through a minimum of three months follow-up across all cohorts. Participants will continue to be followed through 12 months to assess safety and tolerability, PK, immunogenicity and serum virus neutralizing activity.

Phase 1 Poster Information: (633) Preliminary Results from a Phase 1 Single Ascending-Dose Study Assessing Safety, Serum Viral Neutralizing Antibody Titers (sVNA), and Pharmacokinetic (PK) Profile of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment and Prevention of Coronavirus Disease (COVID-19)

Dose Selection StrategyTo support dose selection for Adagios global Phase 2/3 STAMP and EVADE clinical trials, the company modified an existing quantitative systems pharmacology whole-body physiologically-based pharmacokinetic (QSP/PBPK) model to better characterize the PK of extended half-life monoclonal antibodies in serum and key sites of viral replication in the respiratory tract. Adagios model adequately a priori predicted the observed ADG20 serum PK in non-human primates (NHPs) and humans. The model was further optimized based on data from Adagios Phase 1 clinical trial and then applied for dose selection for STAMP and EVADE.

For the STAMP treatment trial, data compiled to date suggest that the 300 mg IM regimen has a projected ability to rapidly achieve and maintain target concentrations at key tissue sites of viral replication, including the ability to attain near complete (> 90%) and durable (> 28-day) SARS-CoV-2 receptor occupancy across a range of baseline viral loads. Further, for the EVADE prevention trial, data compiled to date suggest the 300 mg IM regimen has a projected ability to rapidly exceed target serum concentrations in the majority of simulated patients and to maintain potentially effective concentrations for up to 12 months.

Dose Selection Poster Information

The STAMP and EVADE clinical trials are currently ongoing and enrolling patients globally. For more information, please visit clincialtrials.gov.

About ADG20ADG20, a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is being developed for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2. ADG20 was designed and engineered to possess high potency and broad neutralization against SARS-CoV-2 and additional clade 1 sarbecoviruses, by targeting a highly conserved epitope in the receptor binding domain. ADG20 displays potent neutralizing activity against the original SARS-CoV-2 strain as well as all known variants of concern. ADG20 has the potential to impact viral replication and subsequent disease through multiple mechanisms of action, including direct blocking of viral entry into the host cell (neutralization) and elimination of infected host cells through Fc-mediated innate immune effector activity. ADG20 is administered by a single intramuscular injection, and was engineered to have a long half-life, with a goal of providing both rapid and durable protection. Adagio is advancing ADG20 through multiple clinical trials on a global basis.

About Adagio TherapeuticsAdagio ( ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. The companys portfolio of antibodies has been optimized using Adimabs industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagios portfolio of SARS-CoV-2 antibodies includes multiple, non-competing broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers to support the completion of clinical trials and initial commercial launch. For more information, please visit http://www.adagiotx.com.

Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as anticipates, believes, expects, intends, projects, and future or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the timing, progress and results of our preclinical studies and clinical trials of ADG20, including the timing of our planned EUA application, initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; our ability to obtain and maintain regulatory approvals for, our product candidates; our ability to identify patients with the diseases treated by our product candidates and to enroll these patients in our clinical trials; our manufacturing capabilities and strategy; and our ability to successfully commercialize our product candidates. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, those risks described under the heading Risk Factors in Adagios prospectus filed with the Securities and Exchange Commission (SEC) on August 6, 2021 and in Adagios future reports to be filed with the SEC, including Adagios Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. Such risks may be amplified by the impacts of the COVID-19 pandemic. Forward-looking statements contained in this press release are made as of this date, and Adagio undertakes no duty to update such information except as required under applicable law.

Contacts:Media Contact:Dan Budwick, 1AB[emailprotected]

Investor Contact:Monique Allaire, THRUST Strategic Communications[emailprotected]

Original post:

Adagio Therapeutics Announces - GuruFocus.com

Congress is considering implementing measures that would make it more difficult for the U.S. Navy to retire many of its aging surface ships.

The Fiscal Year 2022 National Defense Authorization Act, published earlier this week, contains sweeping language that would require the service to seek a waiver from the secretary of the Navy in order to retire its ships early. The waiver must certify that: (A) maintaining the battle force ship in a reduced operating status is not feasible; (B) maintaining the ship with reduced capability is not feasible; (C) maintaining the ship as a Navy Reserve unit is not feasible; (D) transferring the ship to the Coast Guard is not feasible; (E) maintaining the ship is not required to support the most recent national defense strategy required by section 113(g) of this title; and (F) maintaining the ship is not required to support operational plans of any combatant commander.

The provision, first reported by Defense News, puts the onus on the secretary to explicitly consider every possible option short of retirement and to assert that the proposed retirement will in no way affect the overall defense strategy or the obligations of individual commanders.

The Navy seeks to retire seven Ticonderoga-class of guided-missile cruisers and four littoral combat ships (LCS) in the fiscal year 2022. The former includes Anzio, Port Royal, Hu City, San Jacinto, Vella Gulf,Lake Champlain, and Monterey; the latter, Freedom, Detroit, Little Rock, and Fort Worth. The Navy has expressed concerns that the aging Ticonderoga-class cruisers are becoming increasingly more difficult to repair, maintain, and refit. The service is engaged in a wide-ranging life extension program for its 22-strong Ticonderoga fleet, but those efforts are being stymied by rampant cost overruns and work availability delays. The cruisers right now in the modernization are running 175 percent to 200 percent estimated cost, hundreds of days delayed, Chief of Naval Operations Adm. Mike Gilday told lawmakers at an earlier hearing. The Ticonderoga class will eventually be replaced by the next-generation Large Surface Combatant DDG(X) destroyer, but that program is not expected to enter into an active acquisition stage until at least 2028.

The Navy has been pushing for months to decommission the first batch of LCS vessels, which it described as test ships. That characterization has been disputed by key lawmakers on the House Armed Services Committee (HASC). Im not buying it because we need to look at whats Battle Force 2025, we need to look at what we have today and how we can use it and how we can use it most efficiently, said HASC vice-chair Elaine Luria (D-Va). The idea of divesting of current platforms that still have a usable service life in order to invest in something that we might develop the technology for in the futurepaired with our poor track record on [developing new] platformsjust makes absolutely no sense to me. The lead Freedom-class ship, USS Freedom, is slated to be decommissioned later this month.

Facing tight budgets and other structural spending constraints, the Navy has sought to retire swathes of its aging inventory to free up resources for modern projects, including hypersonic strike weapons and the DDG(X) program. The services divest to invest '' growth strategy has been met with stiff resistance by some lawmakers, who have argued that the Navys downsizing efforts would deal a significant short-term blow to U.S. Navy capabilities at a time of growing Chinese military assertiveness in the Pacific.

Mark Episkopos is a national security reporter for the National Interest.

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Congress to Navy: You Can't Retire Those Ships Just Yet - The National Interest

If the application by Energiekontor to the councils Planning and Building Standards Committee on Monday is successful the Pines Burn Windfarm, south west of Lurgiescleuch, near Hawick, would extend its operational life from 25 to 30 years.

The original windfarm application failed to win over Borders councillors and they rejected the scheme in November 2017, saying it would have an adverse impact on the landscape and nearby historical sites.

But reporter Malcolm Mahony overturned the locally-elected members decision, stating that the projects benefits outweighed any impacts on landscape or tourism.

When members meet next week they will be recommended to agree the new application.

A report to the committee states: There is a valid consent for the development of a wind farm at Pines Burn that can lawfully operate for a period of 25 years.

"Extending the operational period of the wind farm for a further five years would allow for a 30-year operation period in total.

"This is commensurate with the duration of consent for other existing wind farms within the Scottish Borders.

"Since consent was originally granted for the development of Pines Burn wind farm, there has been no significant shift in policy or other material changes that would require that the original appeal decision to be re-examined.

"The extension of the operational life of Pines Burn wind farm by five years would be consistent with national energy and national planning policy.

"It would extend the wind farms contribution to renewable energy generation and the reduction of greenhouse gas emissions without resulting in any significantly adverse environmental effects or other material considerations which would conflict with the current local development plan.

Energiekontor had initially wanted to build seven 158.5m-high turbines but agreed to reduce that height after Scottish Natural Heritage raised concerns about the aviation safety lighting that would be required.

Continued here:

Bid is made to extend the life of a Borders windfarm - The Southern Reporter

Fullerton officials have agreed to allow restaurants to serve patrons outdoors for another six months, a move business owners said was much needed to maintain revenue and keep customers safe.

Editors Note: This dispatch is part of the Voice of OC Youth Media program, working with student journalists to cover public policy issues across Orange County. If you would like to submit your own student media project related to Orange County civics or if you have any response to this work, contact Digital Editor Sonya Quick atsquick@voiceofoc.org.

The City Council last Tuesday voted unanimously to extend outdoor dining on either private property or public right-of-way with some council members saying the uncertainty of the pandemic and state mandates may require businesses to continue outdoor dining.

Although the vote was unanimous, some council members said there should be changes and additional regulations are warranted. Restaurant owners who attended the council meeting expressed their desire to be able to continue serving patrons outdoors.

As a 35-year professional musician, I really want to recommend that not only do we have outdoor dining but we also have live music in those outdoor areas, Ron Kobayashi, a jazz pianist at Les Amis restaurant, told the council before the vote. Keep art alive, keep revenue pumping into the city and keep citizens happy and enjoying their time.

Before the COVID-19 pandemic, the Fullerton municipal code allowed for outdoor dining as an extension to a businesss operations. According to a city staff report, the city grandfathered and allowed businesses to use the existing outdoor dining areas without amending their permits, while newer businesses had to amend their permits.

When California restricted indoor dining during COVID-19, Fullerton issued more than 60 permits to allow for outdoor dining and retail operations. According to the agenda report, the outdoor dining program was set to end Sept. 30.

Simon Collier, the owner of The Olde Ship Fullerton, voiced his concern about closing down outdoor dining and live music. My customers are scared, and they want to sit outside, Collier told the council. I have immunocompromised people who want to sit outside, please allow it.

Greg Pfost, the citys temporary director of community and economic development, enumerated the pros and cons of extending the outdoor dining program.

The benefits of discontinuing the program include placing all businesses on an equal footing with other businesses that have struggled during the pandemic, he told the council during the meeting.

Other pros of discontinuing the strategy include reducing staff costs associated with code enforcement, restoring access to public spaces, improving public safety, addressing building occupation concerns, and reducing trash production, Pfost said.

However, the uncertainty of the pandemic and state mandates may require businesses to continue offering outdoor dining. The city may suffer a loss in revenue, and the loss of attraction of outdoor dining in the downtown area, according to the staff report.

Pfost added that the extension would allow enough time for businesses to dismantle their outdoor dining or decide if they want to apply for a continuation of the program under normal regulatory conditions and allow outdoor dining to continue through the holiday season.

Mayor Bruce Whittaker was in favor of extending the program.

Theyre (outdoor dining areas) wildly popular and theyre very successful and so I wouldnt like to see anything that would dampen what we have begun in Fullerton, said Whitaker.

Council member Ahmad Zahra pointed to economic benefits that would warrant a continuation but recommended a framework for permanent outdoor dining.

Staff recommended that businesses apply for outdoor dining permits by Oct. 30. If a business does not obtain a permit, staff recommended that the business discontinue and remove its existing outdoor dining area by Nov. 7.

While he did not oppose the extension, Council member Fred Jung cited public safety and overcrowding as reasons why the city should not continue to allow outdoor dining. He instead urged the council to create something more regulated.

Outdoor dining served as a much needed life line for some of them (these businesses) and I would not want to deny them that, Jung said. It certainly needs to be continued but the form its in right now I could not support it because its a free-for-all. There are bad actors that come into any space that isnt regulated and those bad actors are giving everyone thats doing the right thing a terrible name.

Public safety issues that have arisen due to outdoor dining include an overcrowding of patrons in areas, as well as fire hazards related to certain outdoor installations businesses might have.

As part of the extension of outdoor dining, city staff identified certain elements to address with businesses, including maintaining occupancy levels, limiting alcohol to only be sold alongside food in outdoor dining areas, trash disposal upkeep, and ability for the city to revoke a businesss outdoor dining area if dangerous situations arise.

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Fullerton City Council votes to extend outdoor dining for six months, With the Mayor Calling it Wildly Popular - Voice of OC

Australian company Amphibian Aerospace Industries (AAI), which owns the type certificate for the Grumman G-111 amphibious aircraft, has bought Australian aerospace design engineering firm Five Rings Aerospace and the two are working to re-engine the G-111 with Pratt & Whitney PT6 turboprops and put the aircraft type back into production.

Khoa Hoang, chairman of the Amphibian Aerospace Group of Companies, says they are reengining the aircraft with Pratt & Whitney PT6 turboprops using a supplemental type certificate (STC) they are developing under the Australia Civil Aviation Safety Agency (CASA) and US FAA regime. The latter is important so the new production aircraft, the G-111T, can be more readily sold internationally.

AAI has selected the PT6A-67F, a more powerful variant of the PT6. It has 1,700 shaft horse power and is the same variant used on the AirTractor AT-802, an aircraft that carries large payloads.

The aircrafts spec sheet lists maximum take-off weight as 15.2 metric tons (15,200kg). The aircraft will have endurance of 12hrs and a range of 1458nm (2,700km), with a standard load, and a maximum operating altitude of 21,500ft, it says.

The aircraft has a large cabin: 6.23ft high, 7.55ft wide and 26.25ft long.

AAI and Five Rings Aerospace are based in the Australian city of Melbourne. AAI acquired Five Rings Aerospace in 2016, which is now a wholly-owned subsidiary.

The Amphibian Aerospace Group of Companies is negotiating with an undisclosed state/territory government to confirm the place to carry out the STC and manufacture the new aircraft, says Hoang.

The company has a Grumman G-111, local registration VH-NMO and manufacturers serial number 148329, which will be converted to a PT6-powered aircraft and used for obtaining the STC.

VH-NMO is one of the very last G-111 manufactured, says Hoang, adding that a total of 466 Albatross seaplanes were built by Grumman Aircraft from 1947 to 1961. The Albatross includes the G-111 civil aircraft as well as the HU-16 (variants A to E) which is a military aircraft.

The G-111 and HU-16 are both powered Wright Aeronautical piston engines, but Hoang says reengining with the PT6A-67F gives the aircraft more range, power, payload capability and greater fuel efficiency.

He says they chose the PT6 because it is a proven engine platform in a maritime environment. There are many seaplanes, such as the Viking Air DHC-6 Twin Otter, that are powered by the PT6, says Hoang.

The other reason they chose the PT6 is because the engine type is ubiquitous in the market, says Hoang, adding that it is on so many aircraft platforms Beechcraft KingAir, Twin Otter, Cessna Caravan, Pilatus PC-12, Quest Kodiak, etc that it means there is strong spare parts and customer support for the engine around the world.

AAI is very happy with the support we have been receiving from Frank Nel and the team at Pratt & Whitney Canada, says Hoang.

He says the first STC will purely be for reengining the aircraft. The only other significant modification under that STC will be upgrading the cockpit to support the new powerplants. He says it will remain largely an analogue cockpit, but there will be some digital flight instrument displays incorporated.

Hoang says they aim to receive the STC in two years from now and have the first production aircraft come off the assembly line in three to four years from now.

He says the bought Five Rings Aerospace because it gave them immediate aerospace design capability.

Five Rings Aerospace, which is led by its founder and CEO Greg Hanlon, has done previous projects such as: an airframe life-extension program for the Dornier 228-201 that it certified with CASA for Australian operator GAM Air, a bariatric stretcher leading device for the Royal Flying Doctor Service and an ATR 42-320 passenger-to-freighter cargo conversion program for Hevilift Australia.

Amphibian Aerospace Group of Companies also includes Amphibian Aircraft Maintenance, which it created by buying a general aviation maintenance company in New South Wales called Copper Sky that was already maintaining G111 aircraft. It also has Amphibian Air which it created by acquiring air operator certificate holder De Bruin Air, a charter operator based in South Australia. While Hoang is founder and chairman the Amphibian Aerospace Group of Companies, the CEO of AAI is Dan Webster the former managing director of the Australian arm of Elbit Systems.

Hoang says the G-111 may have first been developed in the late 1940s, but an upgraded version of the aircraft has a valuable role to play in the current aviation landscape because it has unique capabilities.

It is the only FAA-certified transport category seaplane that can carry 28 passengers, says Hoang.

Many of the planes operating today are not really seaplanes, they are float planes, which means they can only cope with waves that are 30-40cm high, says Hoang, adding that the G-111T is certified for and has proven capability take off and land in 1.37m-high waves.

He also says most float planes have no toilet, which really limits in practical terms the flight time which you would have to keep within 45mins.

Hoang says he was inspired to develop a seaplane program after attending a conference in Singapore which discussed humanitarian assistance and the need for a platform to rescue refugees at sea in the Mediterranean.

He says he realised there was a need for an amphibious aircraft that could do search and rescue out at sea and also deliver aid shipments onshore.

He says the new G-111T will target five segments: search and rescue, medevac, VIP transport, regular passenger transport (RPT) and cargo.

Theres countries such as India and those in Southeast Asia, Africa, South America and parts of northeast Asia where the economy has developed. People are no longer poor in many of these places so they can afford to fly but the infrastructure has failed to keep up, so they need an amphibious aircraft, says Hoang.

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Australia's Amphibian Aerospace Industries, Type Certificate Holder Of The Grumman G-111 Amphibious Aircraft, To Re-Engine With Pratt & Whitney...