PharmaFocus Today – Page 110 – media

Enhanced Rapid Syndromic Molecular Diagnostic Solution Detects Broad Range of Infectious Diseases

GenMark Diagnostics (Carlsbad, CA, USA), a member of the Roche Group (Basel, Switzerland), has rebranded its ePlex® system as the cobas eplex system. This rebranding under the globally renowned cobas name underscores Roche’s dedication to ongoing enhancement across its entire product line, encompassing everything from raw materials and manufacturing to quality control. The cobas eplex system has been redesigned with new features that enhance usability, reliability, and serviceability. Notable improvements include onboard quality control tracking and monitoring, eSignature capabilities, onboard epidemiology reports, email alerts, and customizable comments to support clinical decisions. Additionally, GenMark has refined its cartridge manufacturing processes, ensuring an adequate supply and enhanced validity. The system offers tests for infectious diseases, focusing on panels for respiratory and bloodstream infections, which can progress to sepsis, and the company is developing panels for gastrointestinal infections, meningitis, and encephalitis. The cobas eplex system integrates the entire order-to-report process to maximize the ...
- Source: https://www.labmedica.com/microbiology/articles/294801045/enhanced-rapid-syndromic-molecular-diagnostic-solution-detects-broad-range-of-infectious-diseases.html
- 93
- May 4, 2024
AstraZeneca’s Lynparza to dominate PARP inhibitors market with $4 bn in sales by 2027

In 2014, the FDA approved the first (adenosine diphosphate-ribose) polymerase (PARP) inhibitor AstraZeneca/Merck’s Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients who have received three or more prior lines of chemotherapy. Since then, the PARP inhibitors market has made significant strides, but Lynparza maintains its dominance with projected global sales of $4 billion by 2027, according to an analyst consensus forecast by GlobalData. GlobalData’s analyst consensus reveals that high sales projections underscore Lynparza’s role in treating multiple cancer types, including ovarian, pancreatic, prostate, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Expected revenues in these indications will reach over 68 per cent of the global PARP inhibitors market by 2027. GlaxoSmithKline’s (GSK) Zejula (niraparib) holds the second position with over $1.6 billion in sales and 28 per cent of the market share. Most of Lynparza’s sales come from ovarian and HER2-negative breast cancer treatment. Biswajit Podder, ...
- Source: https://www.expresspharma.in/astrazenecas-lynparza-to-dominate-parp-inhibitors-market-with-4-bn-in-sales-by-2027-globaldata/
- 165
- May 4, 2024
BD India’s Venous Summit focus on best practices for better patient care

Attended by 200+ delegates with 13 case-presenters who drove 8.5 hours of scientific discussions each day, the end-objective of the Summit was to discuss best domestic and international practices in order to drive better patient care in venous domain in India To create awareness and enable knowledge-sharing around Venous diseases, in order to drive better patient care, BD (Becton, Dickinson, and Company) conducted roadshows across New Delhi, Mumbai and Bangalore recently. Venous disease is a condition where the veins in the body have difficulty returning blood to the heart, thereby resulting in blood clot forming in a vein, typically in the legs. If left untreated, these clots can break loose and travel to the lungs, causing serious complications. Delayed detection and intervention can lead to worsened clinical outcomes and a multitude of problems for both patients and healthcare professionals. The 3-day Venous Summit witnessed a series of Technology Innovation Forums ...
- Source: https://www.healthpartners.com/ucm/groups/public/@hp/@public/documents/documents/entry_191059.pdf
- 113
- May 4, 2024
Senseonics gets FDA clearance to pair CGM implant with insulin pumps

Dive Brief Senseonics has received an integrated continuous glucose monitoring (iCGM) designation from the Food and Drug Administration, the company said Tuesday. The designation, which the FDA granted via its de novo pathway, clears Senseonics to integrate its implantable CGM with pumps as part of automated insulin delivery systems. Senseonics’ sales are small compared to the CGM leaders Abbott and Dexcom, but BTIG analysts said the iCGM designation and planned one-year sensor could help the device appeal to a broader patient population. Dive Insight Senseonics’ Eversense device is a CGM implant that replaces fingerstick blood glucose measurements. The current device continually measures glucose levels for up to 180 days but requires daily calibrating with a fingerstick after day 21 and when symptoms do not match CGM information. Abbott and Dexcom sell shorter-lasting patches that dominate the CGM space. The iCGM designation allows Eversense to integrate with ...
- Source: https://www.medtechdive.com/news/senseonics-fda-clearance-integrated-cgm/714804/
- 80
- May 3, 2024
Asimov achieves 10x improvement in lentiviral production, launches new stable cell line development service

Asimov, the synthetic biology company advancing the design and manufacture of therapeutics, today announced the expansion of its LV Edge System with the launch of a fully stable cell line development service. There are now two ways for customers to access Asimov’s cell line technology to minimize cost and manufacturing risk, depending on their needs: The LV Edge Packaging System, launched earlier this year, which enables a single plasmid transfection that achieves E8 TU/mL. The new, fully-stable LV Edge Producer cell line development service, which generates clones that achieve E9 TU/mL with no transient transfection required. The LV Edge Producer System completely eliminates GMP plasmid cost and greatly reduces process complexity and variability by stably integrating all the genes for lentiviral production into the host cell. Current processes for lentiviral production are inherently scale-limited and variable due to the need for multi-plasmid transient transfection. Furthermore, the ...
- Source: https://www.news-medical.net/news/20240430/Asimov-achieves-10x-improvement-in-lentiviral-production-launches-new-stable-cell-line-development-service.aspx
- 92
- May 3, 2024
DP Technology DevDay 2024 Showcases Large Science Models and Announces Open Science Initiative

BEIJING, April 29, 2024 /PRNewswire/ — In recent years, the rapid development of artificial intelligence has introduced new possibilities across numerous scientific disciplines. As an AI for Science pioneer, DP Technology is continually collaborating with partners to explore the transformative impact AI can bring to science. During its DevDay held in Beijing on April 12th, DP Technology showcased a series of large science models, including the DPA large atomic model[1], Uni-Mol 3D molecular model[2], Uni-Fold protein folding model[3], Uni-RNA ribonucleic acid model[4], and Uni-SMART large language model for multimodal scientific literature[5] among others. About DP Technology DP Technology is a global leader in the “AI for Science” research paradigm, where AI learns scientific principles and data, then tackles key challenges in scientific research and industrial R&D. DP’s commitment to interdisciplinary research has led to the creation of the “DP Particle Universe,” an array of pre-trained large science ...
- Source: https://en.prnasia.com/releases/global/dp-technology-devday-2024-showcases-large-science-models-and-announces-open-science-initiative-445188.shtml
- 107
- May 3, 2024
FDA approves X4 Pharmaceuticals’ WHIM syndrome drug

The US Food and Drug Administration (FDA) has approved X4 Pharmaceuticals‘ XOLREMDI (mavorixafor) capsules for patients aged 12 and above with warts, hypogammaglobulinemia, infections and myelokathexis (WHIM) syndrome. This marks a significant advancement in the treatment of WHIM syndrome, a rare combined primary immunodeficiency and chronic neutropenic disorder. XOLREMDI is a selective CXC chemokine receptor 4 (CXCR4) antagonist. It is the first drug specifically indicated to treat patients with WHIM syndrome. X4 Pharmaceuticals president and CEO Paula Ragan stated: “The approval of XOLREMDI is a transformational milestone both for X4 and, more importantly, for the WHIM syndrome community. “We are incredibly grateful to the people living with WHIM syndrome, their families, and the investigators who took part in our clinical programme, to US regulators for their continued focus on rare-disease treatment development, and to our dedicated employees for making this targeted breakthrough therapy a reality.” ...
- Source: https://www.pharmaceutical-technology.com/news/fda-x4-syndrome-drug/?cf-view
- 103
- May 3, 2024
Lupin receives EIR from USFDA for its Aurangabad manufacturing facility

The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI) Lupin has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Aurangabad manufacturing facility. The inspection was conducted from March 6 to March 15, 2024. The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). Nilesh Gupta, Managing Director, Lupin said, “We are pleased to receive the EIR with VAI status from the USFDA as an outcome of the recent inspection of our Aurangabad facility. It is a testament to our commitment to consistently upholding the highest standards of compliance and providing high-quality healthcare solutions to patients worldwide.”
- Source: https://www.lupin.com/lupin-receives-eir-from-us-fda-for-its-aurangabad-manufacturing-facility/
- 94
- May 3, 2024
New Drug Application of Zydus’ Desidustat tablets by China Medical System Holdings accepted in China

Zydus Lifesciences announced that the New Drug Application (NDA) of Desidustat Tablets has been accepted by the National Medical Products Administration of China (NMPA). CMS International Development and Management, a wholly-owned subsidiary of China Medical System Holdings (CMS) obtained an exclusive license for the Product from Zydus in 2020. Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients. CKD involves the gradual loss of functioning of kidneys and eventually leads to kidney failure. Healthy kidneys naturally secrete a hormone called Erythropoietin (EPO), which stimulates red blood cell production also known as erythropoiesis. When kidneys are impaired as in patients suffering from Chronic Kidney Disease, EPO production is impaired, leading to development of anaemia. HIF-PHI promotes erythropoiesis through increasing endogenous erythropoietin, reducing hepcidin thereby improves iron availability. Discovered and developed by Zydus, Desidustat is being marketed by the group ...
- Source: https://www.biospace.com/article/releases/china-medical-system-new-drug-application-of-desidustat-tablets-accepted-in-china/
- 126
- May 3, 2024
Pioneer Institute study finds IRA discourages non-opioid drug innovation

Astudy from a US-based public policy research firm has highlighted that the US Inflation Reduction Act (IRA) is likely to stifle research efforts into non-opioid pain medications. The ongoing opioid crisis in the US demands alternatives to addictive pain medications. Several pharma companies have been accused of fuelling the opioid crisis by downplaying the addiction risks of their prescription pain drugs, contributing to the out-of-control opioid addiction problem in many American cities. The majority of heroin and fentanyl addictions stem from initial use of prescription drugs. According to a report on GlobalData’s Pharma Intelligence Center, there were 1,038,938 diagnosed cases of opioid use disorder in the US in 2022. This number is expected to increase to 1,062,610 in 2027. Introduced in 2022, the IRA allows Medicare to negotiate prices and rebates for certain drugs from drug makers in a pursuit to curb inflation. Critics have said the IRA may discourage ...
- Source: drugdu
- 127
- May 3, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.