Tag: Week

Bayer to Present Results From Phase III FIDELIO-DKD Study with Finerenone in Patients with Chronic Kidney Disease and Type 2 Diabetes during Late-Breaker Session at the American Society of Nephrology’s Kidney Week 2020

WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer will present detailed results from the Phase III FIDELIO-DKD study assessing the use of the investigational drug finerenone on kidney and cardiovascular outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) during scientific sessions of the upcoming American Society of Nephrology’s (ASN) Kidney Week, October 22-25, 2020. Additional data evaluating use of finerenone will also be presented.

The FIDELIO-DKD study, which evaluated the efficacy and safety of finerenone versus placebo when added to standard of care in patients with CKD and T2D, is the first large contemporary positive outcomes study in patients with CKD and T2D with a primary composite endpoint exclusively consisting of kidney-specific outcomes. Bayer announced earlier this year that FIDELIO-DKD met its composite primary renal endpoint and its composite key secondary cardiovascular endpoint.

Full data from the FIDELIO-DKD study will be presented as part of the live-streamed, late-breaker oral abstract session High-Impact Clinical Trials:

  • “Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes” – October 23, 2020, 10:30 –10:45 am (EDT) (Abstract FR-OR51)

Additional scientific presentations include:

About the Finerenone Phase III Clinical Program

Finerenone (BAY 94-8862) is an investigational, non-steroidal, selective mineralocorticoid receptor antagonist.1 The Phase III clinical program with finerenone in CKD and T2D is the largest Phase III clinical trial program to date in CKD and T2D having 13,000 randomized patients across a broad range of disease severity including those with early kidney damage and more advanced stages of kidney disease. The clinical program comprises two studies (FIDELIO-DKD and FIGARO-DKD), evaluating the effect of finerenone versus placebo in addition to the standard of care in both renal and cardiovascular outcomes.

FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study that investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D from more than 1,000 sites across 48 countries worldwide.

FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) is still ongoing and is investigating the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and T2D across 47 countries including sites in Europe, Japan, China and the U.S.

Bayer also recently announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III study which will investigate finerenone compared to placebo in more than 5,500 symptomatic heart failure patients (New York Heart Association class II-IV) with a left ventricular ejection fraction of ≥40%. The primary objective of the study is to demonstrate superiority of finerenone over placebo in

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Tricida Announces Twelve Data Presentations on Veverimer and Metabolic Acidosis to be Given at the Virtual American Society of Nephrology Kidney Week 2020

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the development and commercialization of its investigational drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today that it has authored or sponsored 12 presentations at the upcoming American Society of Nephrology (ASN) Kidney Week 2020 being held virtually October 22-25, 2020. Data to be presented at multiple sessions at the meeting will expand the breadth of information about the implications of metabolic acidosis and CKD. All Tricida presentations will be available on Thursday, October 22, 2020 at 10:00am ET. Session and presentation titles are listed below:

Session Title: CKD Risk Factors: Diet, Environment, Lifestyle

Title:

Relationship Between Metabolic Acidosis and Chronic Kidney Disease Progression is Evident Across United States Racial and Ethnic Groups

Author:

N. Tangri et al.

ePoster #:

PO0468

 

 

Title:

Metabolic Acidosis is Associated with Chronic Kidney Disease Progression: A Longitudinal Analysis of >100,000 United States Community-Based Patients

Author:

V. Mathur et al.

ePoster #:

PO0469

 

 

Title:

Metabolic Acidosis and Progression to Renal Replacement Therapy (Encore Presentation)

Author:

V. Mathur et al.

ePoster #:

PO0467

Session Title: Advances in Geriatric Nephrology

Title:

Effects of Veverimer on Serum Bicarbonate and Physical Function in Elderly Patients with Metabolic Acidosis in Chronic Kidney Disease

Author:

D. Wesson et al.

ePoster #:

PO1685

 

 

Title:

Correlation Between Patient-Reported Physical Limitation and Objective Physical Performance on the Repeated Chair Stand Test Among Patients with Non-Dialysis Dependent Chronic Kidney Disease and Metabolic Acidosis

Author:

V. Mathur et al.

ePoster #:

PO1687

Session Title: CVD, BP, and Kidney Diseases: Exploring the Link

Title:

No Adverse Effects of Veverimer on Volume Status or Blood Pressure in Patients with Chronic Kidney Disease and Metabolic Acidosis

Author:

D. Wesson et al.

ePoster #:

PO2116

Session Title: Women’s Health and Kidney Diseases

Title:

Effects of Veverimer on Serum Bicarbonate and Physical Function in Women with Chronic Kidney Disease: A Subgroup Analysis from a Randomized Controlled Trial

Author:

V. Mathur et al.

Session:

Women’s Health and Kidney Diseases

ePoster #:

PO2612

Session Title: Diabetic Kidney Disease: Clinical – 2

Title:

Effects of Veverimer on Serum Bicarbonate and Physical Function in Patients with Diabetes and Chronic Kidney Disease: Subgroup Analysis from a Randomized Trial (Encore presentation)

Author:

D. Wesson et al.

ePoster #:

PO1033

Session Title: Fluid, Electrolyte, and Acid-Base Disorders: Clinical – 2

Title:

Metabolic Acidosis is a Predictive Factor for All-Cause Mortality in Patients with Chronic Kidney Disease (Encore presentation)

Author:

N. Tangri et al.

ePoster #:

PO1483

Session Title: Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)

Title:

Action of Veverimer on Gastrointestinal Acid Binding is Not Affected by Omeprazole

Author:

D. Parsell et al.

ePoster #:

PO2374

 

 

Title:

Evaluation of Veverimer Drug Interaction Potential (Encore presentation)

Author:

J. Shao et al.

ePoster #:

PO2373

Session Title: Informational Posters

Title:

Understanding the Long-Term Impact of Metabolic Acidosis in Chronic Kidney Disease: Design of the ULTIMA-CKD Patient Registry

Author:

V. Mathur et al.

ePoster #:

INFO16

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Valentine is Your Rancho Coastal Humane Society Pet of The Week

This post was contributed by a community member. The views expressed here are the author’s own.

Valentine is pet of the week at your Rancho Coastal Humane Society. He’s an 8-month-old, 12- pound, male, Domestic Short Hair cat with a Brown Tabby coat.

Valentine was a two-month-old kitten when he was taken to another shelter. After that he was transferred to Rancho Coastal Humane Society through the FOCAS (Friends of County Animal Shelters) program. He spent a few weeks in foster care before returning to Rancho Coastal Humane Society, where he was quickly adopted.

Five months later, his adopter returned Valentine, saying that he was too active for their home situation.

Valentine is still very much a kitten. He’s outgoing and social with people. He might do best in a home where the owners have had cats in the past.

The $100 adoption fee for Valentine includes medical exams, vaccinations, neuter, and registered microchip. For information about Adoption by Appointment or to become a Virtual Foster log on to www.SDpets.org.

Special Notes:

Act now. There are just a few openings left for the first week of Fall Animal Camp at your Rancho Coastal Humane Society. Safe, socially distanced Fall Camp has openings for October 19 – 23 from 9 AM to 2 PM at 389 Requeza Street in Encinitas. Ages are 6 to 12 years. Campers enjoy hands-on experiences with animals. For more information or to reserve space for your campers log on to www.sdpets.org.

Join “Team Rancho Coastal Humane Society” to “Strut Your Mutt.” Now through October 24 you can take a walk and raise funds that support pets. The virtual Strut Your Mutt Walk is in partnership with Best Friends Animal Society. Teams across the country are walking to raise money for animal-related charities. You can join Team RCHS, form your own team, or support someone else. Visit www.sdpets.org and click on Strut Your Mutt.

“Fund a Need” at your Rancho Coastal Humane Society now through October 30th. Rancho Coastal Humane Society’s Celebration of Second Chances fundraiser was cancelled, but the animals still need your help. To Fund A Need and help save lives visit www.SDPets.org/FundANeed2020

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Dicerna to Present Nedosiran Data at American Society of Nephrology (ASN) Kidney Week 2020

Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) (the “Company” or “Dicerna”), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced that clinical data on nedosiran, an investigational candidate for the treatment of primary hyperoxaluria (PH), will be presented during the American Society of Nephrology (ASN) Kidney Week taking place Oct. 22-25, 2020. In addition, a commercial claims analysis of clinical and economic burden associated with PH will also be presented.

The following poster presentations will be available during the “Genetic Diseases of the Kidneys: Non-Cystic – 1” session taking place on Thursday, Oct. 22, 2020 at 10:00 a.m. ET:

  • Title: PHYOX™3: A Long-Term, Open-Label Extension Trial of Nedosiran in Patients With Primary Hyperoxaluria Type 1, 2 or 3
    Poster #: PO1625

About Primary Hyperoxaluria

Primary hyperoxaluria (PH) is a family of ultra-rare, life-threatening genetic disorders that initially manifest with complications in the kidneys. There are three known types of PH (PH1, PH2 and PH3), each resulting from a mutation in one of three different genes. These genetic mutations cause enzyme deficiencies that result in the overproduction of a substrate called oxalate. Abnormal production and accumulation of oxalate leads to recurrent kidney stones, nephrocalcinosis and chronic kidney disease that may progress to end-stage renal disease, requiring intensive dialysis. Compromised renal function eventually results in the accumulation of oxalate in organs ranging from skin, bones, eyes and heart. In the most severe cases, symptoms start in the first year of life. A combined liver-kidney transplantation may be undertaken to resolve PH1 or PH2, but it is an invasive solution with limited availability and high morbidity that requires lifelong immune suppression to prevent organ rejection. There are currently no approved medications for the treatment of PH. Patients are limited to using hyperhydration and medication to attempt to increase solubility of oxalate in urine. Despite these interventions, oxalate may continue to accumulate in the kidneys and other organs, causing damage.

About Nedosiran

Nedosiran is the only RNAi drug candidate in development for primary hyperoxaluria (PH) types 1, 2 and 3 and is Dicerna’s most advanced product candidate utilizing the proprietary GalXC™ RNAi technology platform. Nedosiran is designed to reduce the levels of hepatic lactate dehydrogenase (LDH) enzyme – an enzyme that catalyzes the final step in a common pathway resulting in oxalate overproduction in patients with PH1, PH2 and PH3. Dicerna is evaluating the safety and efficacy of nedosiran in patients with all known forms of PH as part of its PHYOX™ clinical development program.

About Dicerna Pharmaceuticals, Inc.

Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) is a biopharmaceutical company focused on discovering, developing and commercializing medicines that are designed to leverage ribonucleic acid interference (RNAi) to selectively silence genes that cause or contribute to disease. Using our proprietary RNAi technology platform called GalXC™, Dicerna is committed to developing RNAi-based therapies with the potential to treat both rare and more prevalent diseases. By silencing disease-causing genes, Dicerna’s GalXC platform has the potential to address conditions that are difficult to treat with other modalities.

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UK government expands its job support program with stricter virus lockdowns due next week

The U.K. government has expanded its jobs support program as the country gears up for tighter coronavirus restrictions set to be announced next week.



a man wearing a suit and tie: Chancellor of the Exchequer Rishi Sunak leaves 10 Downing Street after attending a Cabinet meeting on 14 February, 2020.


© Provided by CNBC
Chancellor of the Exchequer Rishi Sunak leaves 10 Downing Street after attending a Cabinet meeting on 14 February, 2020.

Finance Minister Rishi Sunak said Friday that firms whose premises have to shut over the winter period as part of local or national restrictions will receive grants to pay the wages of staff who cannot work.

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Two weeks ago, Sunak announced the Job Support Scheme — a new emergency package of measures to contain unemployment, replacing the U.K.’s furlough scheme which is due to expire at the end of October.

It will directly top up the wages of employees working fewer hours due to suppressed business demand, enabling workers to keep their jobs on shorter hours rather than being made redundant.

The original furlough scheme in the summer had subsidized 80% of wages for millions of workers furloughed as a result of the pandemic. But Sunak confirmed in July that it would be wound down as the country began to emerge from coronavirus lockdown measures.

—CNBC’s Elliot Smith contributed to this article.

This is a breaking news story, please check back for more

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Pound falls on reports UK could quit Brexit talks next week

Britain's Prime Minister Boris Johnson as fears grow Brexit talks could collapse. Photo: Justin Tallis/AFP via Getty Images
Britain’s Prime Minister Boris Johnson as fears grow Brexit talks could collapse. Photo: Justin Tallis/AFP via Getty Images

The pound slid on Wednesday, after a report that the UK government could pull out of Brexit talks as soon as next week if not enough progress has been made towards a deal.

Sterling had lost 0.8% against the dollar (GBPUSD=X) by mid-afternoon in the UK, trading just below $1.29. It shed 0.7% against the euro (GBPEUR=X), with the pound selling for $1.09.

The flight from sterling reflects investors fears’ Britain could face severe economic upheaval if no deal is reached. It would likely spark disruption and sudden new barriers to long-standing trade and other ties with most of Europe when the Brexit transition period expires at the end of the year.

Talks between negotiators are ongoing in London this week. The pound’s decline came after a source told Bloomberg the UK government was serious about threatening to walk out of talks over a trade deal next week.

READ MORE: Stocks mixed as US stimulus hopes endure despite Trump ditching talks

Last month UK prime minister Boris Johnson set a deadline of 15 October for reaching an agreement, in order for it to be signed off and put into place by the start of next year.

Meanwhile Britain’s chief Brexit negotiator David Frost told MPs on Wednesday that barriers had not yet been overcome on one of the key stumbling blocks of state aid policy, according to Reuters.

WATCH: Boris Johnson says he can live with a no-deal Brexit

“I feel we’re some way from a deal at the moment, if I’m honest, but we are at least having a decent discussion of this, you know, what is possible and what isn’t possible,” he said.

Ireland’s foreign minister Simon Coveney also said on Wednesday that a “landing zone was hard to envisage” at present on another thorny issue, fishing rights.

“This is a big obstacle and I don’t think the British government should underestimate the strength of feeling on fishing of many of the Atlantic member states,” he said.

Susannah Streeter, senior investment and markets analyst at Hargreaves Lansdown, said fishermen’s demands on either side of the Channel “risk skewering a Brexit deal,” hitting sterling on Wednesday.

“Throughout the Brexit process, flotillas of British boats have made regular protest appearances, demanding priority catches for the fish in UK waters. But the EU’s determination not to throw the Common Fisheries Policy completely overboard, and instead netting continued access for its boats, is casting serious doubts that a trade deal will be reached,” she said.

“The EU stance appears to be hardening, leading to speculation that negotiations will now be forced to extend into November.”

Any concessions by either side are likely to “cause a stink for domestic politics,” but negotiators will be “highly conscious” of the economic damage from failure to secure a deal, she added.

READ MORE: UK and EU agree to ‘intensify talks’

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Lebanon’s President Says Consultations on New Government Start Next Week | World News

BEIRUT (Reuters) – Lebanon’s President Michel Aoun said on Wednesday parliamentary consultations to choose a new prime minister who will form the country’s next government will begin on Oct. 15.

Lebanon’s government resigned on Aug. 10 in the wake of a devastating blast that killed nearly 200 people and wrecked swathes of the capital, Beirut.

Mustapha Adib, the country’s former ambassador to Berlin, was picked on Aug. 31 to form a cabinet after French President Emmanuel Macron intervened, securing a consensus on naming him in a country where power is shared out between Muslim and Christian sects.

He quit in late September, however, after trying for almost a month to line up a non-partisan cabinet. His resignation dealt a blow to a French plan aimed at rallying sectarian political leaders to tackle the worst crisis since the nation’s 1975-1990 civil war.

Under the French roadmap, the new government would take steps to tackle corruption and implement reforms needed to trigger billions of dollars of international aid to fix an economy that has been crushed by a mountain of debt.

But Adib’s efforts stumbled in a dispute over appointments, particularly the post of finance minister, who will have a key role in drawing up economic rescue plans.

Macron admonished Lebanon’s leaders following Adib’s resignation, saying the failed efforts amounted to a collective “betrayal”, but vowed to push ahead with his efforts.

The country’s leaders bristled at Macron’s accusations, but there has been little movement since.

(Reporting by Raya Jalabi; Editing by Dominic Evans)

Copyright 2020 Thomson Reuters.

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Lebanon’s president says consultations on new government start next week

BEIRUT (Reuters) – Lebanon’s President Michel Aoun said on Wednesday parliamentary consultations to choose a new prime minister who will form the country’s next government will begin on Oct. 15.

Lebanon’s government resigned on Aug. 10 in the wake of a devastating blast that killed nearly 200 people and wrecked swathes of the capital, Beirut.

Mustapha Adib, the country’s former ambassador to Berlin, was picked on Aug. 31 to form a cabinet after French President Emmanuel Macron intervened, securing a consensus on naming him in a country where power is shared out between Muslim and Christian sects.

He quit in late September, however, after trying for almost a month to line up a non-partisan cabinet. His resignation dealt a blow to a French plan aimed at rallying sectarian political leaders to tackle the worst crisis since the nation’s 1975-1990 civil war.

Under the French roadmap, the new government would take steps to tackle corruption and implement reforms needed to trigger billions of dollars of international aid to fix an economy that has been crushed by a mountain of debt.

But Adib’s efforts stumbled in a dispute over appointments, particularly the post of finance minister, who will have a key role in drawing up economic rescue plans.

Macron admonished Lebanon’s leaders following Adib’s resignation, saying the failed efforts amounted to a collective “betrayal”, but vowed to push ahead with his efforts.

The country’s leaders bristled at Macron’s accusations, but there has been little movement since.

(Reporting by Raya Jalabi; Editing by Dominic Evans)

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New Michigan law lets ballot processing start early, but don’t expect results until Friday of election week

Michigan officials expect record-breaking turnout for the Nov. 3 election and Gov. Gretchen Whitmer has signed a few last-minute bills into law to speed the process and ensure every ballot is counted.

On Tuesday, Whitmer signed Senate Bill 757, passed by the House and Senate in September, to allow clerks in cities and townships with at least 25,000 people to start processing absentee ballots Nov. 2. The ballots can’t be tabulated until 7 a.m. on election day, however.

While the move is a “step in the right direction” per Secretary of State Jocelyn Benson, it’s not enough, she said. States like Kentucky, Ohio, North Carolina and Florida allow more time for processing – sometime weeks more, Benson said.

The change won’t significantly alter when the results will be ready, Benson said.

“We still expect that it will be the Friday of election week that we expect every ballot will be tabulated,” Benson said, noting it could be sooner.

This is the first presidential election in Michigan since voters passed a proposal allowing absentee voting without needing a specific reason.

The law also requires clerks to notify absentee voters if their ballot won’t be counted within 48 hours of receiving it – like for a missing signature, for example. This helps make sure every vote is counted, Whitmer said.

Senate Bill 117 was also supposed to be signed Tuesday, but Whitmer said Republican leadership didn’t send her the bill yet – despite it passing through both chambers of the Legislature.

The bill allows military members and their spouses to return ballots electronically through a secure portal if they can’t be returned in person. Benson’s husband served with the military in Afghanistan in 2004 and attempted to vote, she said, but couldn’t because a law like this wasn’t on the books.

“For some reason, the Republican leaders in the Legislature chose not to send me this bill yet,” Whitmer said. “I’m not sure what’s going on there, but this is crucial for our brave folks and their families who serve in the military. Elections are no time to play partisan games.”

More than 2.7 million ballots have been requested in Michigan so far, and 2.6 million of them have been issued to voters. Nearly 400,000 have been filled out and received back.

Here’s a look at which cities have the most requests for ballots, along with how many have been issued and how many have been submitted:

  1. Detroit: 124,400 (108,065 issued, 12,426 received)
  2. Grand Rapids: 51,711 (51,124 issued, 11,633 received)
  3. Ann Arbor: 47,645 (43,827 issued, 3,108 received)
  4. Livonia: 35,722 (35,457 issued, 8,071 received)
  5. Sterling Heights: 34,815 (33,670 issued, 3,836 received)

More than 450 communities have had at least 1,000 people request an absentee ballot so far.

Michigan residents can check their voter registration, register to vote and track the status of their absentee ballot at Michigan.gov/vote.

The state is also launching an advertising effort this week to put ads on social media, the internet, TV and the back of ATM receipts to

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Fluorine is Your Rancho Coastal Humane Society Pet of The Week

This post was contributed by a community member. The views expressed here are the author’s own.

Fluorine is pet of the week at your Rancho Coastal Humane Society. She’s a 1 year old, 53 pound, female, Husky mix.

Fluorine was a stray in the Imperial Valley when she and her brother were picked up with two other dogs. They went to a local animal shelter then transferred to Rancho Coastal Humane Society through the FOCAS (Friends of County Animal Shelters) program.

Fluorine’s brother was adopted. Now she needs a new home.

She’s timid. Her new family will need to help her build confidence as she settles into her new home. She might like living with another dog.

The $145 adoption fee for Fluorine includes medical exams, vaccinations, spay, registered microchip, and a one-year license if her new home is in the jurisdiction controlled by San Diego Humane Society’s Department of Animal Services. For information about Adoption by Appointment or to become a Virtual Foster log on to www.SDpets.org.

Special Notes:

Join Team Rancho Coastal Humane Society (RCHS) to “Strut Your Mutt.” Now through October 24 you can take a walk and help raise funds that support pets and pet parents who need a helping paw.

The virtual Strut Your Mutt Walk is in partnership with Best Friends Animal Society. Teams across the country are walking to raise money for their favorite animal-related charities. You can join Team RCHS, form your own team, or support someone else. Visit www.sdpets.org and click on Strut Your Mutt.

Now through October 30th you are invited to “Fund a Need” at your Rancho Coastal Humane Society.

Due to COVID 19, Rancho Coastal Humane Society’s 19th annual Celebration of Second Chances fundraiser was cancelled. But the animals still need your help. You can Fund A Need at the shelter and help save lives. To see the Fund A Need list visit www.SDPets.org/FundANeed2020

The views expressed in this post are the author’s own. Want to post on Patch?

The rules of replying:

  • Be respectful. This is a space for friendly local discussions. No racist, discriminatory, vulgar or threatening language will be tolerated.
  • Be transparent. Use your real name, and back up your claims.
  • Keep it local and relevant. Make sure your replies stay on topic.
  • Review the Patch Community Guidelines.

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