Search Results for “EC” – Page 221 – media

Rona Therapeutics gains Series A+ funds for siRNA pipeline expansion

Rona Therapeutics has secured $35m in its Series A+ financing round to advance its metabolic small interfering RNA (siRNA) pipeline in clinical settings. The company will also use the investment proceeds to develop next-generation RNA platforms. LongRiver Investments spearheaded the financing round, which saw contributions from Zhaode Investment, Zhongqi Capital, BioTrack Capital and Lilly Asia Ventures. LongRiver Investments will become part of Rona’s board. The company focuses on developing siRNA programmes, with its first product, RN0191, having completed Phase I clinical studies in Australia and China. In December 2023, Rona received clinical trial application clearance from the National Medical Products Administration in China to assess RN0191 injection to treat hypercholesterolemia, mixed hyperlipidemia and atherosclerotic cardiovascular disease, to reduce the risk of cardiovascular events. The asset is set to enter Phase II clinical development for hypercholesterolemia. Rona’s second programme, RN0361, is scheduled to enter clinical trials in the second quarter of ...
- Source: drugdu
- 73
- July 22, 2024
US FDA grants priority review for Pierre Fabre’s EBV+ PTLD

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) and granted priority review for Pierre Fabre Pharmaceuticals’ Tabelecleucel (Tab-cel) to treat Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). Tabelecleucel is being developed as a monotherapy for EBV+ PTLD treatment in adult and paediatric patients aged two years and above who have undergone a minimum of one previous therapy. It is an allogeneic, EBV-specific T-cell immunotherapy and acts on EBV-infected cells. The company’s BLA is supported by the outcomes of 430 subjects who received Tab-cel. For patients who have received solid organ transplants, previous therapy typically includes chemotherapy, except in cases where this is deemed inappropriate. No FDA-approved therapies are currently available for this treatment setting. A decision by the US regulator under the Prescription Drug User Fee Act (PDUFA) is anticipated by 15 January 2025. In November 2023, Pierre Fabre Laboratories obtained marketing rights to ...
- Source: drugdu
- 81
- July 22, 2024
Meitheal gains rights to CONTEPO from Nabriva in North America

Meitheal Pharmaceuticals has expanded its biopharmaceutical portfolio through the acquisition of rights to CONTEPO (fosfomycin for injection) from Nabriva Therapeutics for the North American region. Meitheal gains access to the rights to CONTEPO, including development and regulatory works, intellectual property rights, technology and related know-how. Nabriva will receive payment upon the agreement closing in addition to royalties on net sales of the injection in the US. An intravenous broad-spectrum antibiotic, CONTEPO has shown activity against multi-drug resistant strains causing complicated urinary tract infections (cUTI). Fosfomycin for intravenous administration is already marketed outside the US and has been approved for nine indications, including cUTI and other serious bacterial infections. CONTEPO’s new dosing approach aims to optimise the compound’s pharmacokinetics and pharmacodynamics. It met the primary endpoint in the ZEUS trial enrolling patients with cUTI. Nabriva filed a new drug application with the US Food and Drug Administration (FDA) seeking approval for ...
- Source: drugdu
- 61
- July 22, 2024
Automated Benchtop System to Bring Blood Testing To Anyone, Anywhere

Almost all medical decisions are dependent upon laboratory test results, which are essential for disease prevention and the management of chronic illnesses. However, routine blood testing remains limited worldwide. Many adults avoid routine blood tests due to their complexity and the long wait times for results, which can lead to delayed interventions or missed diagnoses, resulting in substantial avoidable costs. Now, a groundbreaking diagnostic platform is set to transform the existing global infrastructure by providing lab-accurate, actionable test results that aid in the early detection and prevention of chronic conditions. Truvian Health (San Diego, CA, USA) has developed an automated benchtop system that allows simple, accurate, and comprehensive routine blood tests to be conducted directly in clinics, doctor’s offices, and pharmacies. Utilizing patented technologies and intelligent integration, Truvian’s compact device offers a convenient and economical alternative to traditional off-site labs, delivering quick, lab-accurate results from just a small blood sample, ...
- Source: drugdu
- 82
- July 20, 2024
Q&A with Amy Ripston

By Mike Hollan Ripston discusses the Biospecimen Management Consortium and how its working to develop best practices for driving sample excellence. Slope recently announced the launching of the Biospecimen Management Consortium (BMC), and new group focused on ensuring sample excellence in clinical trials. The group’s executive director, Amy Ripston, spoke with Pharmaceutical Executive about the group, it’s goals, and the importance of this work in the modern world. Pharmaceutical Executive: What are the goals of the BMC? Amy Ripston: The Biospecimen Management Consortium (BMC) was formed to elevate industry-wide excellence in sample management, raise the bar for data integrity and quality, and enable the future of complex clinical research. To accomplish this, the BMC will drive a variety of initiatives aimed at developing best practices and industry standards, streamlining biospecimen lifecycle operations and data management, and influencing regulatory policy. These initiatives will take a critical look at existing processes including, ...
- Source: drugdu
- 93
- July 20, 2024
FDA Clears Positrigo’s NeuroLF Brain PET System for the Diagnosis of Multiple Brain Disorders

By Don Tracy, Associate Editor Clearance of the NeuroLF Brain PET system marks Positrigo’s first device of its kind to be approved in the United States.The FDA has granted clearance to Positrigo’s NeuroLF brain positron emission tomographic (PET) system, which the company said represents a major advancement in functional brain imaging. The device is designed to diagnose and monitor brain disorders such as Alzheimer disease, brain tumors, epilepsy, and Parkinson disease. As the company’s first brain PET system approved in the United States, Positrigo is currently preparing for global market expansion, with European regulatory approval anticipated later this year.1 “It is not the first device of its kind which receives market clearance in the US, but we believe that our patient-centric and customer-driven design and development efforts over the last couple of years, brought us into the pole position to offer the best imaging solution to address the increased demand ...
- Source: drugdu
- 76
- July 20, 2024
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
- 86
- 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
- 88
- 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
- 65
- 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
- 85
- July 20, 2024

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