media – Page 162 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

Philips restricted from selling respiratory machines in DOJ consent decree

Dive Brief The Department of Justice filed a consent decree of permanent injunction against Philips on Tuesday in response to the company’s ongoing recall of sleep apnea and respiratory devices. The settlement would restrict Philips from producing or selling new continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines and other devices in the U.S. until the company meets certain requirements. Philips also faces restrictions on exporting devices that are being provided to patients impacted by the recall “to help ensure remediation of U.S. patients is prioritized over export for commercial distribution.” Philips is required to implement a recall remediation plan that the Food and Drug Administration must agree on, including providing patients with new or reworked devices, or a partial refund. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Tuesday statement that the finalization of the decree is a ...
- Source: drugdu
- 89
- April 12, 2024
3D Printed Point-Of-Care Mass Spectrometer Outperforms State-Of-The-Art Models

Mass spectrometry is a precise technique for identifying the chemical components of a sample and has significant potential for monitoring chronic illness health states, such as measuring hormone levels for hypothyroidism patients. However, the high cost of mass spectrometers, often reaching several hundred thousand dollars, restricts them to labs that require the transportation of blood samples for analysis, thereby complicating chronic disease management. Now, researchers have taken a big step towards building inexpensive hardware that could make mass spectrometry local. The team has used 3D printing to create a low-cost ionizer, a vital component of the mass spectrometer, that can deliver twice as good a performance as its high-end counterparts. The device developed at MIT (Cambridge, MA, USA) spans just a few centimeters and is designed for mass production, enabling its integration into mass spectrometers through robotic assembly method. This also makes it more economical than traditional ionizers which often ...
- Source: drugdu
- 157
- April 12, 2024
Bio-Rad and Alleghany Health Network partner for patients with solid tumour cancer

Bio-Rad Laboratories and Alleghany Health Network (AHN) have partnered to advance clinical evidence for monitoring solid tumour cancers using Bio-Rad’s Droplet Digital PCR (ddPCR) technology. The collaboration will use ddPCR technology for molecular residual disease (MRD) monitoring of patients across a range of solid tumour types. Accounting for approximately 90% of all adult human cancers and half of childhood malignancies, solid tumour cancers can develop in many parts of the body, including the breast, lung, prostate and colon. Used to provide a critical indication of both remission and potential relapse in patients, MRD testing has been widely adopted for monitoring haematological malignancies and is now being implemented for solid tumour diseases. As part of the agreement, the collaboration will combine Bio-Rad’s digital PCR technology and expertise in molecular oncology, assay design and development with AHN’s cancer-care expertise, clinical data and patient samples collected via its Cancer Institute’s Moonshot programme, which ...
- Source: drugdu
- 91
- April 12, 2024
Study reveals shorter scans for prostate cancer could improve diagnosis

A clinical trial led by researchers from University College London (UCL) and University College London Hospitals NHS Trust Foundation (UCLH) has revealed that removing a step from a three-part MRI scan could make prostate cancer diagnosis quicker, cheaper and more accessible. The PRIME study was funded by Prostate Cancer UK and the John Black Charitable Foundation. Currently the most common form of cancer in men, prostate cancer is responsible for around 52,000 new cases and 12,000 deaths every year in the UK. In the UK, a three-part multiparametric MRI of the prostate is the current standard of care for patients suspected of having prostate cancer, which includes a dye injection as its third step to identify abnormalities to be seen on the MRI scan. In the study, cancer experts from 22 hospitals from 12 different countries recruited 555 patients and performed full-three-part multiparametric scans on them. Radiologists then assessed the ...
- Source: drugdu
- 151
- April 12, 2024
AstraZeneca, Daiichi Sankyo Drug Enhertu Becomes First Tumor-Agnostic ADC Cancer Med

The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.The AstraZeneca and Daiichi Sankyo targeted cancer drug Enhertu is now the first therapy in its class approved for treating solid tumors regardless of either the cancer type or where the disease started in the body. Enhertu had previously won FDA approvals for treating certain advanced cases of breast, gastric, and lung cancers that express a protein called HER2. Late Friday, the FDA expanded the drug’s approval to broadly include the treatment of adults who have HER2-expressing solid tumors. These patients must have a cancer that cannot be removed surgically or has advanced following a prior systemic treatment. The expanded approval came nearly two months ahead of the May 30 ...
- Source: drugdu
- 93
- April 11, 2024
Bristol Myers Squibb Reveals Promising Data for KarXT, a Potential Treatment for Schizophrenia

Don Tracy, Associate Editor A combination of data from the EMERGENT-4 trial and pooled data from the EMERGENT program showed the promise of KarXT (xanomeline-trospium) in providing symptom improvement for people with schizophrenia. Bristol Myers Squibb announced results from its Phase III EMERGENT-4 trial analyzing the long-term efficacy, safety, and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia, which was showcased at the Annual Congress of the Schizophrenia International Research Society (SIRS). Additionally, the company revealed promising pooled data from EMERGENT-4 and EMERGENT-5 for the long-term safety, tolerability, and metabolic effects of KarXT in schizophrenia over 52 weeks. EMERGENT-4 is a 52-week, open-label extension trial assessing long-term efficacy, safety, and tolerability of KarXT in adults who completed earlier phases of the trial for schizophrenia. Investigators found that over 75% of patients administered KarXT achieved a 30% improvement in symptoms.1 “We are pleased to see a continued and consistent meaningful reduction ...
- Source: drugdu
- 177
- April 11, 2024
Next Generation Instrument Screens for Hemoglobin Disorders in Newborns

Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations ranges from mild cases with minimal symptoms to severe disorders like sickle cell disease and Hb Bart’s hydrops fetalis, which can cause extensive organ damage and necessitate lifelong blood transfusions. Capillary electrophoresis has been established as a reliable method for newborn screening of hemoglobin disorders, offering high-quality outcomes. Now, a next-generation instrument dedicated to newborn hemoglobin screening offers a smooth workflow and excellent analytical capabilities. Sebia’s (Lisses, France) CAPILLARYS 3 DBS instrument is an automated, multitasking capillary electrophoresis instrument that uses 12 capillaries simultaneously for hands-free electrophoretic separation at high throughput. Designed to detect both standard (F and A) and abnormal hemoglobins (S, C, E, D, and Bart’s) in dried blood samples collected on filter paper from newborns, this instrument provides ...
- Source: drugdu
- 87
- April 11, 2024
New Diagnostic System Achieves PCR Testing Accuracy

While PCR tests are the gold standard of accuracy for virology testing, they come with limitations such as complexity, the need for skilled lab operators, and longer result times. They also require complex chemical reactions which are crucial for amplifying viral DNA or RNA, a process that involves generating multiple copies of the genetic material that can also create and amplify error. Additionally, PCR tests can detect only nucleic acids, the material comprising DNA and RNA, but can be of great use in detecting other biomarkers such as proteins in the case of certain diseases. Now, a groundbreaking diagnostic system offers the ability to accurately identify SARS-CoV-2 and Zika virus with a precision matching or surpassing that of PCR tests, but significantly reducing the time and complexity involved in diagnosis. The new system developed at UC Santa Cruz (Santa Cruz, CA, USA) in collaboration with the Texas Biomedical Research Institute ...
- Source: drugdu
- 131
- April 11, 2024
Pfizer meets Phase III primary endpoints for RSV vaccine Abrysvo

Pfizer has reported positive top-line results from its Phase III MONeT study (NCT05842967) evaluating the efficacy of single-dose Abrysvo for adults at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD). As per the 9 April press release, Abrysvo met its co-primary immunogenicity and safety endpoints, with patients demonstrating non-inferior RSV-A and RSV-B neutralising responses compared to the Phase III RENOIR study (NCT05842967) where the vaccine previously showed efficacy. Compared to pre-vaccination, the vaccinated patients also demonstrated a minimum of a four-fold increase in serum-neutralising titers for RSV-A and RSV-B a month after being vaccinated. The MONeT trial did not identify any new safety signals for Abrysvo. The pharma giant plans to publish the findings in a peer-reviewed journal and submit the results to regulatory agencies in a bid to expand the vaccine’s label from its current indication to include adults 18 years and older, the ...
- Source: drugdu
- 131
- April 11, 2024
Oryzon wins FDA approval to begin SCLC treatment trial

Oryzon Genomics is set to commence a Phase I/II clinical trial of iadademstat (ORY-1001) plus immune checkpoint inhibitors (ICI) in patients with first-line small cell lung cancer (SCLC). The development comes after the US Food and Drug Administration (FDA) cleared the Spain-based biotech’s investigational new drug application (IND) to initiate the study. The Phase I/II trial (NCT06287775) will be conducted and sponsored by the National Cancer Institute (NCI), enrolling 45-50 patients. In the first phase, patients will receive iadademstat on days 1, 8, 15, and 22 or days 1 and 15 of each cycle. Patients will also continue to receive their initial ICI treatment, Tecentriq (atezolizumab) intravenously (IV), or Imfinzi (durvalumab) IV over 60 minutes on day one of each cycle. Cycles will repeat every 28 days in the absence of disease progression or unacceptable toxicity. In the second phase of the study, patients are randomised to two different arms ...
- Source: drugdu
- 84
- April 11, 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.