Search Results for “dialysis” – Page 6 – media

Ardelyx Nabs FDA Approval for First Phosphate Absorption Blocker in CKD

Pictured: Test-tube containing a blood sample for measuring serum phosphorus levels/iStock, Md Saiful Islam Khan The FDA on Tuesday gave the greenlight to Ardelyx’s tenapanor, now to be marketed under the brand name Xphozah, indicated to reduce serum phosphorus levels in patients with chronic kidney disease. Tuesday’s approval covers chronic kidney disease (CKD) patients on dialysis who had previously shown an inadequate response to phosphate binders, or who are otherwise intolerant to such therapies. Xphozah’s label bears no boxed warning but carries a precaution against severe diarrhea, the most common observed adverse event during the drug’s development. Ardelyx CEO Mike Raab called Tuesday’s approval an “important milestone” for dialysis patients, their families and the larger nephrology care community. Xphozah “represents a new mechanism and new option for patients who, despite treatment with phosphate binders, continue to have elevated phosphorus.” Xphozah is taken as 30-mg oral tablets twice-daily, before the morning and evening meals. Its ...
- Source: drugdu
- 109
- October 20, 2023
FibroGen CEO Conterno, Who Scrapped Post-Lilly Plans Over Roxadustat Hype, Resigns After Launch Setbacks

Hopes around FibroGen’s anemia drug roxadustat were high in early 2020 when Enrique Conterno arrived as the company’s new CEO. He’d just come off a 27-year-run at Eli Lilly and was, according to an analyst interview at the time, “most impressed” by the commercial opportunity for roxadustat.But the last few years have not been kind to FibroGen and AstraZeneca’s drug, with an FDA rejection, commercial disappointments and a clinical trial flop considerably blunting the oral anemia med’s trajectory. It’s against that backdrop—plus a major layoff round—that Conterno, who’s been chief at FibroGen since January 2020, is now hitting the exit. Conterno has resigned from the FibroGen CEO post for “personal reasons,” the company said Tuesday. As FibroGen looks for a permanent successor, the company’s chief commercial officer Thane Wettig will don the mantle of interim chief executive officer. To support Wettig, Conterno plans to stick around as a special advisor to ...
- Source: drugdu
- 251
- July 27, 2023
Gilead’s COVID-19 Treatment Approved by FDA for Patients with Severe Renal Impairment

Gilead Sciences has announced that its COVID-19 treatment, Veklury (remdesivir), has been approved by the US Food and Drug Administration (FDA) to treat patients with severe renal impairment, including those on dialysis. The drug is already approved in the US to treat COVID-19 in adults and paediatric patients who are hospitalised or have mild-to-moderate COVID-19 and are at high risk for progression to severe illness. However, its use has previously been limited among patients with severe renal impairment due to insufficient data. The FDA’s latest decision makes Veklury the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease. Gilead’s supplemental new drug application was supported by positive results from a phase 1 study as well as data from the phase 3 REDPINE trial that demonstrated the efficacy and safety profile of Veklury among patients with moderately and severely ...
- Source: drugdu
- 118
- July 19, 2023
Clinical Trial Set to Change Kidney Transplant Practice

A major clinical trial has found a simple change to world practice for kidney transplants could deliver real benefits for recipients and reduce their need for dialysis by 25%. The BEST-Fluids trial was conducted by the Australasian Kidney Trials Network (AKTN) in collaboration with researchers from The University of Queensland, The University of Adelaide, and The University of Sydney. The research was published in The Lancet. ATKN chair and UQ Professor David Johnson said the trial assessed the use of an intravenous fluid containing sodium, potassium, magnesium and chloride in proportions similar to human blood—instead of the usual practice of using normal saline (sodium chloride and water). “Of those study participants who received intravenous Plasma-Lyte 148, 30% needed dialysis after their transplants, compared to 40% for those given normal saline,” Professor Johnson said. “This is a significant improvement in outcomes for those undergoing kidney transplant surgery.” Royal Adelaide Hospital Nephrologist ...
- Source: drugdu
- 113
- July 14, 2023
Kidney transplant recipients may benefit from new fluid therapy

A major clinical trial has found a simple change to world practice for kidney transplants could deliver real benefits for recipients and reduce their need for dialysis by 25 per cent. The BEST-Fluids trial was conducted by the Australasian Kidney Trials Network (AKTN) in collaboration with researchers from The University of Queensland, The University of Adelaide, and The University of Sydney. ATKN chair and UQ Professor David Johnson said the trial assessed the use of an intravenous fluid containing sodium, potassium, magnesium and chloride in proportions similar to human blood – instead of the usual practice of using normal saline (sodium chloride and water). David Johnson, UQ Professor, said, “Of those study participants who received intravenous Plasma-Lyte 148, 30 per cent needed dialysis after their transplants, compared to 40 per cent for those given normal saline. This is a significant improvement in outcomes for those undergoing kidney transplant surgery.” Royal ...
- Source: drugdu
- 139
- July 8, 2023
AstraZeneca decries low kidney disease diagnosis rates, finds ‘urgent need’ for better screening

Chronic kidney disease (CKD) affects around 37 million Americans, but this disease, which does not get the attention other conditions often do, can go undetected for years, boosting the risks of organ failure and even death.AstraZeneca, maker of blockbuster diabetes drug Farxiga that recently nabbed an expanded label in CKD, wants more to be done to find those who have this disease. The pharma cited new, real-world evidence that shows the prevalence of undiagnosed stage 3—moderate—CKD is 85% to 97% across Australia, Brazil, Canada and Spain. The study was shared this month at the European Renal Association 2023 Congress in Milan, Italy. This is a “staggeringly low rate” of diagnosis in CKD, according to an accompanying release from AstraZeneca, with these data showing “that an urgent need exists for improved screening.” Improved screening can lead to earlier diagnosis and thus potentially better outcomes, given that once kidney damage sets in ...
- Source: drugdu
- 172
- June 28, 2023
Novartis to acquire Chinook Therapeutics for approximately $3.5bn

Novartis has entered into an agreement to acquire Chinook Therapeutics for approximately $3.5bn, marking a notable expansion to the Swiss drugmaker’s renal pipeline. The deal grants Novartis access to the US biopharma’s two late-stage candidates in development for Immunoglobulin A Nephropathy (IgAN), a rare and progressive kidney disease that mostly affects young adults. IgAN, which Novartis says currently lacks targeted treatment options, affects up to 21 people per million per year in the US, with a higher rate among Asian populations. The most advanced of the two assets is atrasentan, an oral endothelin A receptor antagonist that Chinook bought from AbbVie at the beginning of 2020. The candidate is currently in phase 3 development for IgAN, with a readout from the study expected in the fourth quarter of this year. The second candidate, zigakibart (BION-1301), is a subcutaneously administered anti-APRIL monoclonal antibody that is expected to enter phase 3 development ...
- Source: drugdu
- 119
- June 16, 2023
Novartis to acquire Chinook Therapeutics for approximately $3.5bn

Novartis has entered into an agreement to acquire Chinook Therapeutics for approximately $3.5bn, marking a notable expansion to the Swiss drugmaker’s renal pipeline. The deal grants Novartis access to the US biopharma’s two late-stage candidates in development for Immunoglobulin A Nephropathy (IgAN), a rare and progressive kidney disease that mostly affects young adults. IgAN, which Novartis says currently lacks targeted treatment options, affects up to 21 people per million per year in the US, with a higher rate among Asian populations. The most advanced of the two assets is atrasentan, an oral endothelin A receptor antagonist that Chinook bought from AbbVie at the beginning of 2020. The candidate is currently in phase 3 development for IgAN, with a readout from the study expected in the fourth quarter of this year. The second candidate, zigakibart (BION-1301), is a subcutaneously administered anti-APRIL monoclonal antibody that is expected to enter phase 3 development ...
- Source: drugdu
- 108
- June 14, 2023
FDA OKs Injectafer for Iron Deficiency Anemia in Heart Failure

Megan Brooks The US Food and Drug Administration (FDA) has expanded the indication for ferric carboxymaltose injection (Injectafer, Daiichi Sankyo/American Regent) to include treatment of iron deficiency in adults with New York Heart Association (NYHA) class II/III heart failure (HF). “This new indication for Injectafer marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure,” Ravi Tayi, MD, MPH, chief medical officer at American Regent, said in a news release. Ferric carboxymaltose injection is also indicated for the treatment of iron deficiency anemia in adults and children as young as 1 year of age who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have nondialysis dependent chronic kidney disease. The new indication in HF was supported by data from the CONFIRM-HF randomized controlled trial that evaluated the efficacy and safety of ferric carboxymaltose injection ...
- Source: drugdu
- 135
- June 7, 2023
Pfizer’s Paxlovid approved by FDA and Gilead’s Veklury recommended by CHMP

Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) has been approved by the US Food and Drug Administration (FDA), and Gilead Science’s Veklury (remdesivir) recommended by the European Medicines Agency’s human medicines committee to treat certain COVID-19 patients. Pfizer’s oral antiviral, which has now been granted full approval to treat mild-to-moderate COVID-19 in adults at a high risk for progression to severe disease, has been available in the US since December 2021 under the FDA’s accelerated approval pathway. The agency’s latest decision is supported by the totality of evidence submitted by Pfizer, the company said, including efficacy data from the phase 2/3 EPIC-HR study showing an 86% reduction in risk of COVID-19-related hospitalisation or death from any cause in patients who took Paxlovid within five days of symptom onset. The drugmaker said in a statement that at this time, the US government will continue to oversee the distribution of Paxlovid, and eligible ...
- Source: drugdu
- 105
- May 30, 2023

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