Don Tracy, Associate Editor New methods allow the antiseizure treatment to be crushed and mixed with water for oral suspension or for use through a nasogastric tube. SK Life Science announced that the FDA has approved two new ingestion methods for Xcorpi (cenobamate tablets) CV, an antiseizure medication. As of today, the medication can be crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube. These new methods of administration were approved as a result of the results of an open-label, randomized, single-center, three-period, six-sequence, crossover study showing biochemical similarity between three administration routes, including the aforementioned methods.1 “The approval addresses the needs of patients living with epilepsy who are currently taking, or who may benefit from starting XCOPRI, but are unable to swallow the tablets whole,” said Louis Ferrari, BS, RPh, MBA, VP, medical affairs, SK Life Science, in ...
Seaport Therapeutics’ drug candidates are delivered through the lymphatic system, an approach that could overcome some limitations of neuropsychiatric medicines, including products from Sage Therapeutics. The startup stems from the research of PureTech Health.Even when depression drugs address known and validated targets, their commercial potential can be constrained by dosing or safety limitations. Seaport Therapeutics’ drugs use a novel delivery approach to overcome those limitations. The startup launched on Tuesday, backed by $100 million in financing. Boston-based Seaport was formed by PureTech Health, a company that creates startups, typically around a platform technology. One notable example is neuropsychiatric drugs developer Karuna Therapeutics, which grew and eventually spun out of PureTech as a publicly traded company with a lead drug taking a novel approach to schizophrenia. Bristol Myers Squibb last year struck a $14 billion deal to acquire Karuna, whose schizophrenia drug is currently under FDA review. Former Karuna CEO Steven ...
Don Tracy, Associate Editor Collaboration aims to advance the development of treatments for multiple neurodegenerative conditions, including amyotrophic lateral sclerosis. Lonza and NeuroSense Therapeutics have announced a collaboration focused on evaluating biological markers in neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS). According to both companies, the joint venture intends to utilize Lonza’s expertise in extracellular vesicles in combination with NeuroSense’s experience in biomarker utilization for neurodegenerative diseases. The overall goal of this partnership is to enhance development of neurodegenerative disease treatments. This deal comes amid NeuroSense revealing positive results from the Phase IIb PARADIGM trial for PrimeC, focused on treating adults living with ALS. Under terms of the agreement, Lonza will focus on utilizing neuron-derived exosomes (NDEs) for assimilation into the development of PrimeC.1 “We believe this collaboration could be a game-changer for the ALS and neurodegeneration field, as findings in such biomarkers may advance early diagnosis and treatment, ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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