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Ardelyx sues CMS over revamped kidney disease drug payment bundle

Ardelyx has declared that it is filing a lawsuit against the US Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) to keep essential phosphate-lowering therapies separate from the CMS’s renal disease payment bundle, claiming that the action could “limit patient choice”. Ardelyx has teamed up with the American Association of Kidney Patients (AAKP) and the National Minority Quality Forum (NMQF) to sue the government organisations regarding the CMS’s renal disease payment bundle. The End Stage Renal Disease (ESRD) Prospective Payment System (PPS) is a bundled payment scheme for renal dialysis services available for Medicare beneficiaries. The ESRD PPS adjusts treatment costs at the patient and facility level for renal dialysis treatment at an ESRD facility or the patient’s home. This payment includes costs for laboratory services, drugs, supplies, and more, as per CMS’s description. The litigation states that the CMS has “violated ...
- Source: drugdu
- 93
- July 20, 2024
FDA launches new rare disease innovation hub

Anew rare disease innovation hub set up by the US Food and Drug Administration (FDA) aims to expedite the development and approval of orphan drugs. Rare disease clinical trials can be tricky to navigate, especially for conditions with very few patients. Moreover, even after clinical success, some therapies for rare diseases have been dropped by companies due to the high development costs. The FDA’s hub will act as a central point of connection and engagement with the rare disease community, aiding the navigation of FDA-related concerns. It will enhance inter-centre collaboration on scientific, clinical, and policy issues in rare disease product development, said the agency. It also aims to advance novel endpoints, biomarkers, trial designs, real-world evidence, and statistical methods. The hub will be co-led by Dr. Patrizia Cavazzoni, director at the Center for Drug Evaluation and Research (CDER), and Dr. Peter Marks, director at the Center for Biologics Evaluation ...
- Source: drugdu
- 91
- July 20, 2024
Bayer eyes Nubeqa’s label expansion in prostate cancer following Phase III win

Bayer is set to pursue a label expansion for Nubeqa (darolutamide) in a distinct subgroup of prostate cancer patients—those with metastatic hormone-sensitive prostate cancer (mHSPC)—after announcing that a Phase III trial with the therapy met its primary endpoint. The company did not disclose detailed trial data, only stating that the combination of Nubeqa and androgen deprivation therapy (ADT) demonstrated “a statistically significant and clinically meaningful increase”, compared to the placebo and ADT combination, in the radiological progression-free survival (rPFS), the study’s primary endpoint. Bayer plans to share the detailed results from the trial at an upcoming scientific conference. Nubeqa has been approved by the US Food and Drug Administration (FDA) to treat patients with mHSPC, but only in combination with docetaxel chemotherapy. The company now plans to seek approval for the drug’s use mHSPC indication sans additional chemotherapy. To that end, Bayer plans to submit the Phase III ARANOTE trial ...
- Source: drugdu
- 68
- July 20, 2024
Novartis reports 43% increase in net income in Q2 2024

Novartis has reported a significant 43% increase in net income from continuing operations, reaching $3.24bn in the second quarter (Q2) of 2024, up from $2.27bn in the same period of 2023. This notable growth in net income was attributed primarily to an increase in core operating income. Operating income for Q2 2024 soared to $4.01bn – a substantial year-on-year increase from $2.80bn. The rise in operating income has been chiefly attributed to higher net sales and reduced impairments, although this was partly offset by a rise in research and development investments. Net sales from continuing operations for the company stood at a robust $12.51bn in Q2 2024, an increase on the $11.43bn recorded in Q2 2023. Alongside the growth in net sales, Novartis also experienced a 40% rise in free cash flow from continuing operations, which amounted to $4.61bn compared to $3.29bn in the corresponding period of 2023. For the ...
- Source: drugdu
- 95
- July 20, 2024
New Analytical Tool Could Replace Traditional Biopsies with Liquid Biopsies for Disease Diagnosis

Biopsies are important clinical tools used to diagnose various diseases or monitor tissues for abnormal growth or transplant rejection. Typically, this involves removing tissue samples from the body for closer examination, which can be invasive depending on the tissue required. Researchers have developed a new analytical method that could enable the use of “liquid biopsies” as an alternative to traditional biopsies for certain patients or diseases. This new tool, developed by researchers from Vanderbilt University’s School of Medicine Basic Sciences (Nashville, TN, USA), is known as EV Fingerprinting, where EV stands for extracellular vesicles. EVs are membrane-bound particles filled with biologically active materials that play a crucial role in cell-cell communication in both health and disease. Although EVs have been studied since the 1980s, their origins and functions have not been fully defined. Research on EVs has intensified over the last two decades, revealing their involvement in processes such as ...
- Source: drugdu
- 98
- July 19, 2024
Early Detection of miRNAs in Maternal Blood Could Predict Preeclampsia

Preeclampsia (PE) significantly contributes to increased maternal morbidity and mortality globally, with notably high incidences in the United States where it impacts 2–8% of pregnancies. This condition often leads to premature births and subsequent health issues for infants. Now, a new study indicates that early detection of specific microRNAs (miRNAs) contained in vesicles could enable the prediction of preeclampsia in pregnant individuals before the appearance of clinical symptoms. Conducted by researchers at UCLA Health (Los Angeles, CA, USA), this study highlights the potential of a distinct set of miRNAs within extracellular vesicles (EVs)—small particles that facilitate cellular communication—as a noninvasive biomarker for preeclampsia. The analysis involved 33 participants, including a control group of seven non-pregnant women and a subgroup of 12 women with healthy pregnancies. The study also included 14 women exhibiting symptoms of preeclampsia, emphasizing early detection and prediction. Women with preeclampsia exhibited different levels of miRNAs in EVs ...
- Source: drugdu
- 75
- July 19, 2024
FDA Grants Fast Track Designation to Abdera Therapeutics’ Treatment for Extensive-Stage Small Cell Lung Cancer

By Don Tracy, Associate Editor The novel therapy, ABD-147, uses advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, a protein found on neuroendocrine tumors. The FDA has granted Fast Track Designation to Abdera Therapeutics’ ABD-147, a next-generation precision radiopharmaceutical therapy designed for patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed following platinum-based chemotherapy. According to the company, ABD-147 implements advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, which is a protein commonly found on neuroendocrine tumors but rarely expressed on the surface of normal cells or tissues.1 “Aggressive neuroendocrine cancers such as SCLC carry a poor prognosis and new treatment options are urgently needed,” said Lori Lyons-Williams, president, CEO, Abdera Therapeutics, in a press release. “These cancers have the most aggressive clinical course of any type of pulmonary tumor and often rapidly metastasize to other parts of the body. We are ...
- Source: drugdu
- 111
- July 19, 2024
Roche Weighs In With Encouraging Early Clinical Data for Oral GLP-1 Drug

Roche reported its oral GLP-1 agonist led to an average 6.1% weight loss at four weeks, according to preliminary results from part of a Phase 1 study. The small molecule comes from Roche’s $2.7 billion acquisition of Carmot Therapeutics last year. By Frank VinluanRoche is a relative latecomer to GLP-1 metabolic disorder drugs, but an oral drug candidate that came as part of a $2.7 billion acquisition last year now has preliminary early-stage clinical data that keep the pharmaceutical giant in contention to bring patients a pill to tap into this increasingly popular mechanism for weight loss. The results reported Wednesday are from a Phase 1 test of CT-996, a once-daily pill designed to activate the GLP-1 receptor to treat type 2 diabetes and obesity. Roche said treatment of patients who are obese and do not have type 2 diabetes lost a placebo-adjusted average of 6.1% of body weight within ...
- Source: drugdu
- 98
- July 19, 2024
KCL leads first guidelines on immune monitoring for hard-to-treat blood cancer

Myelodysplastic syndromes are a group of blood cancers that currently affect more than 7,000 people in the UK King’s College London (KCL) has led the publication of first-in-their-kind guidelines that aim to standardise how clinicians measure the immune response of patients living with a hard-to-treat form of blood cancer. The new guidelines will help identify which patients could respond to certain types of therapies, as well as better categorise patients based on whether their immune response is autoimmune or autoinflammatory to determine the choice of therapy and clinical outcome. Affecting more than 7,000 people in the UK, myelodysplastic syndromes (MDS) are a group of blood cancers in which immature blood cells in the bone marrow do not mature or become healthy blood cells, causing them to die in the bone marrow or just after entering the bloodstream. Risks associated with MDS can include an increased likelihood of infections, anaemia, bleeding ...
- Source: drugdu
- 83
- July 19, 2024
Study finds Parkinson’s disease SLT more effective than one used in NHS

The progressive neurodegenerative condition affects around 153,000 people in the UK Researchers from the Universities of Nottingham and Birmingham have revealed that a new form of speech therapy was more effective than the speech and language therapy (SLT) currently used in the NHS for Parkinson’s disease (PD). Published in the British Medical Journal, the PD-COMM trial has been evaluating the effectiveness and cost-effectiveness of two forms of SLT for people living with the neurological disease who have self-reported problems with voice or speech. Affecting around 153,000 people in the UK, PD is a neurodegenerative condition in which parts of the brain become progressively damaged, causing problems such as shaking and stiffness. Due to changes in the brain in people with PD, movements in the muscles to generate speech become smaller and less forceful than before, leading to speech and communication problems. Carried out across the UK by NHS Speech and ...
- Source: drugdu
- 78
- July 19, 2024

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