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Henlius Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway Steering Group for Serplulimab in ES-SCLC

Recently, an Innovation Passport designation has been awarded to serplulimab, Henlius’ self-developed anti-PD-1 mAb (trade name in China: HANSIZHUANG), for the treatment of extensive stage small cell lung cancer (ES-SCLC) by the U.K. Innovative Licensing and Access Pathway Steering Group including the Medicines & Healthcare products Regulatory Agency (MHRA). This designation marks serplulimab’s entry into the U.K.’s Innovative Licensing and Access Pathway (ILAP) and is expected to promote the presence of serplulimab in the U.K., benefiting more local SCLC patients. ILAP steering group consists of The All Wales Therapeutics and Toxicology Centre (AWTTC), The Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC). It was launched by the MHRA in order to accelerate the development and access to promising medicines. The designation is open to medicinal product that developed for life-threatening or seriously debilitating condition and meet ...
- Source: drugdu
- 110
- March 18, 2024
SHANGHAI RAAS and Boehringer Ingelheim enter into a major collaboration to develop innovative drugs for hemophilia

SHANGHAI RAAS and Boehringer Ingelheim, one of the world’s leading biopharmaceutical companies, announced today that they have entered into a major collaboration: Boehringer Ingelheim BioPharmaceuticals (China) Ltd. will provide process transfer and clinical manufacturing services for SHANGHAI RAAS’s innovative hemophilia drug, SR604 injection. Boehringer Ingelheim China Biopharmaceutical (“Boehringer Ingelheim China Biopharmaceutical”) will provide process transfer and clinical manufacturing services for SR604 injection, an innovative hemophilia drug under Shanghai Lacey, which will be transformed into a high-quality end-product through the international first-class CDMO platform, helping Chinese innovations to go overseas to benefit patients worldwide. SR604 injection is a humanized monoclonal antibody that binds human activated protein C with high affinity and specifically inhibits the anticoagulant function of human activated protein C. Recently, the State Drug Administration (SDA) has officially approved SR604 injection. Recently, the State Drug Administration formally approved an application for a clinical phase I trial of SR604 injection, to ...
- Source: drugdu
- 123
- March 18, 2024
POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics. Traditionally, exosomes are isolated through ultrasound centrifugation, a process that requires eight hours or more, requires large sample volumes, and often harms the integrity of these delicate structures. Alternative methods also present challenges, including low purity and yield. Now, researchers have devised a diagnostic technique that employs sound waves to spin a single water droplet at speeds reaching 6,000 revolutions per minute, thereby facilitating the separation of tiny biological particles for exosome-based diagnostics. This novel approach involves a lightweight disk atop the spinning droplet and featuring etched channels that incorporate star-shaped nanoparticles designed for the label-free identification of exosomes. This method surpasses traditional techniques in efficiency, requiring less time and smaller sample volumes, and minimizes damage to the exosomes. It represents a significant ...
- Source: drugdu
- 151
- March 16, 2024
Rapid Test Diagnoses Tropical Disease within Hours for Faster Antibiotics Treatment

Melioidosis, a neglected tropical disease, is believed to affect around 165,000 individuals globally each year, with approximately 89,000 succumbing to it. This illness is caused by the bacterium Burkholderia pseudomallei, which thrives in the soil and water of tropical and subtropical areas, gaining entry into humans through skin cuts, consumption, or inhalation. Diagnosing melioidosis poses challenges due to its varying symptoms ranging from localized infections and pneumonia to severe septicemia or prolonged chronic conditions. The disease’s tendency to predominantly affect isolated rural communities contributes to its significant underreporting. Diagnosis traditionally depends on culturing bacterial specimens, a process extending over three to four days. Meanwhile, a large percentage of patients with melioidosis succumb to the disease, often within the initial 24 to 48 hours of hospital admission, while waiting for a diagnosis. Although no vaccine exists for melioidosis, it can be effectively managed with specific intravenous antibiotics if identified promptly. However, ...
- Source: drugdu
- 84
- March 16, 2024
New Study Finds Direct-to-Consumer Pharmaceutical Advertising Can Benefit Public Health Goals When Incentives Align

Don Tracy, Associate Editor Data shows that from 2014-2019, pneumococcal vaccinations in seniors increased by 10%, growing sales for Prevnar 13 due to government recommendation in addition to a high-profile advertising campaign.A 2014 recommendation by the Advisory Committee on Immunization Practices (ACIP) for adults aged 65 years and over to receive Prevnar 13 was followed by Pfizer initiating a high-profile advertisement campaign for the vaccinations. During this time, Medicare and private insurance companies began covering the vaccine as well. According to a new study published in the Journal of Policy Analysis and Management, over the next five years, this resulted in a 10% increase in vaccination among seniors and a corresponding $1 billion annual increase in Prevnar 13 sales. According to the authors of the study, government vaccine recommendations may offer substantial value to pharmaceutical manufacturers, further implying that direct-to-consumer (DTC) advertising can lead to successfully achieving public health goals ...
- Source: drugdu
- 209
- March 16, 2024
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
- 155
- 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
- 154
- 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
- 99
- 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
- 84
- 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
- 107
- March 16, 2024

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