PharmaFocus Today – Page 173 – media

Schizophrenia Trial Failure Ends Acadia’s Efforts to Expand Use of Its Flagship Drug

With pimavanserin’s Phase 3 failure in schizophrenia, Acadia Pharmaceuticals said it will no longer run clinical trials for the drug, whose lone approval is for treating psychosis from Parkinson’s disease. The FDA previously rebuffed regulatory submissions for the drug in dementia and Alzheimer’s disease. By FRANK VINLUAN An Acadia Pharmaceuticals drug that’s already approved for treating psychosis in Parkinson’s disease patients could not beat a placebo in a pivotal schizophrenia study, spelling the end of efforts to develop a medication the company once envisioned as having potential applications across a range of neurological disorders. The clinical trial failure announced Tuesday evaluated the drug, pimavanserin, as a treatment for negative symptoms of schizophrenia. The main goal was to show a change in score according to an assessment used to measure the disease’s symptoms. According to the preliminary results, the pimavanserin arm achieved a numerical change in score that was similar to ...
- Source: drugdu
- 190
- March 16, 2024
Scientists develop micofluidic chip to make cell therapy safer

The chip removes cells, which could become tumours, before they are implanted in a patient Researchers from the Massachusetts Institute of Technology (MIT) and the Singapore-MIT Alliance for Research and Technology have developed a plastic microfluidic chip to improve the safety and effectiveness of cell therapy treatments for patients living with spinal cord injuries. In cell therapy, clinicians create induced pluripotent stem cells using skin or blood cells from a patient. When treating a spinal cord injury, pluripotent stem cells are transformed into progenitor cells, which differentiate into spinal cord cells, which are transplanted back into the patient. Despite being able to regenerate part of the injured spinal cord, pluripotent stem cells do not completely change into progenitors and can form tumours. Researchers developed a microfluidic cell sorter to remove around half of the undifferentiated cells in a batch to mitigate potential tumours without causing damage to fully-formed progenitor cells. ...
- Source: drugdu
- 191
- March 16, 2024
Phesi’s AI-driven Trial Accelerator platform contains over 100 million patients

The platform delivers digitalised patient data to improve clinical trials and development Phesi has announced that its artificial intelligence (AI)-driven Trial Accelerator platform has reached a critical milestone of now containing global data from more than 100 million patients. The volume will allow sponsors to access data on patients with over 4,000 indications, plan more successful trials and simulate clinical development activity more accurately. Phesi’s Trial Accelerator works to deliver digitalised patient data to enhance or replace those collected from clinical trials. Across the past two decades, data has been collated from product and disease registries, electronic health records, medical claims data and data gathered from around 100,000 dynamically updated sources. The platform powers the Phesi Patient Access Score, Diversity, Equity and Inclusion Data Service and the Digital Patient Profile. “We have been gathering and structuring a wealth of data for sponsors and clinical trial planners,” said Dr Gen Li, ...
- Source: drugdu
- 121
- March 16, 2024
First UK patients receive experimental mRNA therapy for cancer in global trial

The phase 1/2 Mobilize trial is evaluating the safety and efficacy of mRNA-4359 Imperial College Healthcare NHS Trust (ICHT) and Imperial College London (ICL) have announced that the first UK patients have received the experimental mRNA therapy in an ongoing phase 1/2 clinical trial to treat melanoma, lung cancer and other solid tumour cancers. The patients received the treatment at the National Institute for Health and Care Research’s Imperial Clinical Research facility at Hammersmith Hospital. In the UK, around one in two people will be diagnosed with cancer in their lifetime. While a range of therapies, including chemotherapy and immune therapies, have been successful, some cancer cells can become resistant to drugs, making tumours more challenging to treat. Sponsored by Moderna and undertaken through the Moderna-UK strategic partnership, the global Mobilize trial is evaluating the safety and efficacy of an immunotherapy known as mRNA-4359, as well as its ability to ...
- Source: drugdu
- 112
- March 16, 2024
Royal Marsden to implement RaySearch’s online adaptive radiation therapy system

OART is increasingly emerging to assess and adapt treatment for cancer patients The Royal Marsden NHS Foundation Trust is set to implement online adaptive radiation therapy (OART) with RaySearch’s treatment planning system, RayStation, and oncology information system, RayCare. OART is a novel treatment for cancer patients that is increasingly emerging to assess patients’ anatomy, with a treatment plan adapted from an original reference plan with the patient on the treatment couch. The Royal Marsden has been using RayStation for conventional treatment planning since 2016 and most recently acquired two additional Radixact treatment delivery machines from Accuray to be used for OART. Daily-acquired patient images are used by OART to optimise treatment plans by considering the changes in the patients’ anatomy. OART puts high demand on the acquired images and an efficient information flow between the treatment planning system, the oncology information system and the treatment control system. RaySearch and Accuray’s ...
- Source: drugdu
- 116
- March 16, 2024
Swedish researchers develop new AI computer model to detect lymphatic cancer

In the study, the Lymphoma Artificial Reader System accurately detected 90% of lymphatic cancersResearchers from Chalmers University of Technology in Sweden have developed a new computer model using artificial intelligence (AI), which successfully identifies signs of lymphatic cancer. The model was developed in collaboration with researchers from Memorial Sloan Kettering Cancer Center, Chalmers University of Technology, Medical University in Vienna, Icahn School of Medicine at Mount Sinai and NYU Langone Health, with results published in The Lancet Digital Health. Lymphoma is a cancer of the lymphatic system, including the lymph nodes, spleen, thymus gland and bone marrow, and can affect other organs throughout the body. The two main subtypes of lymphoma are Hodgkin’s lymphoma and non-Hodgkin’s lymphoma, which is the sixth most common cancer in the UK, responsible for around 14,200 cases every year, according to Cancer Research UK. Using AI-assisted image analysis of lymphoma, researchers developed a deep learning ...
- Source: drugdu
- 170
- March 16, 2024
Roche partners with Cardiff researchers to uncover new research into dementia

Affecting 55 million people globally, dementia impairs the ability to remember, think or make decisionsRoche and the Cardiff University Brain Research Imaging Centre (CUBRIC) have partnered to uncover new research to understand the structural changes of dementia. Using cutting-edge imaging and machine learning (ML), researchers will analyse the brains of patients living with Parkinson’s disease (PD) and Alzheimer’s disease (AD). Dementia is a general term used for the impaired ability to remember, think or make decisions that interferes with day-to-day activities and affects 55 million people globally, according to Alzheimer’s Society. Currently the most common form of dementia, AD is a progressive neurological disease that affects the part of the brain that controls thought, memory and language. PD is a progressive neurodegenerative disorder that affects the body’s nervous system. The main symptoms include shaking, slow movements and stiffness. The study will use advanced MRI to understand the bigger structural changes ...
- Source: drugdu
- 133
- March 16, 2024
Par Pharmaceutical Issues Recall of Single Lot of Treprostinil

Mike Hollan The voluntary recall was ordered due to potential silicon particulate exposure. Endo International plc issued a press release announcing that one of its pharmaceutical companies, Par Pharmaceuticals, is issuing a voluntary recall of a single lot of one of its medications.1 The lot, which is being recalled on the consumer, may potentially be tainted with silicon particulates in the product solution. The recalls order is for one lot of Treprostinil Injection 20mg/20ml (1mg/mL). This specific lot was reportedly distributed to wholesalers between June 16, 2022 and October 17, 2022. According to the company, it has yet to receive any reports of injuries due to the contamination, and the recall appears to be a preemptive move. Endo warns that particulates entering the body through an injected solution may cause of a variety of problems. The particulates may simply cause local irritation or swelling at the site of the injection. ...
- Source: drugdu
- 138
- March 15, 2024
Novartis Pays $90M for Molecules That Could Take STING Out of Inflammation

Placing research in the hands of a large pharmaceutical company is a goal of many biotech companies. IFM Therapeutics has now done it three times and its latest deal is the second time Novartis is the acquirer. By FRANK VINLUANFor more than four years, Novartis has foot the bill for a partner’s preclinical development of molecules with the potential to target a pathway implicated in inflammatory disorders. Now the pharmaceutical giant has seen enough progress to plunk down $90 million to buy the company, IFM Due, and continue its inflammation drug research. The acquisition announced Wednesday is the culmination of a 2019 agreement that Novartis reached with IFM Due’s parent company, IFM Therapeutics. In exchange for fully funding IFM Due’s R&D, Novartis gained an option to acquire all of that biotech’s stock. IFM Due’s research focuses on cGAS, a protein that regulates STING, a pathway in the innate immune system ...
- Source: drugdu
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- March 15, 2024
AbbVie’s Produodopa approved by SMC to treat Parkinson’s disease patients in Scotland

The progressive neurological disorder affects approximately 12,400 people in Scotland AbbVie’s Produodopa (foslevodopa-foscarbidopa) has been accepted by the Scottish Medicines Consortium (SMC) for use within NHS Scotland to treat advanced levodopa-responsive Parkinson’s disease (PD). PD patients with severe motor fluctuations and hyperkinesia or dyskinesia when previous available combinations of PD medicinal products have not provided satisfactory results and who are not eligible for deep brain stimulation will be eligible for the treatment. Affecting around 12,400 people in Scotland, PD is a progressive neurological disorder that results from the loss of dopamine-producing brain cells and is characterised by tremor, muscle rigidity, slowness of movement and difficulty with balance. Patients with advanced PD are marked by more severe and complex symptoms, including severe motor deficits, a risk of falling and cognitive problems. The SMC’s decision is supported by data from two phase 3 clinical trials, M15-741 and M15-736, which demonstrated that Produodopa ...
- Source: drugdu
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- March 15, 2024

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