The agreement builds on the companies’s existing partnership Elligo Health Research has announced it is expanding its IntElligo Study Marketplace platform with Syneos Health. The platform aims to make sales, site selection and application processes more transparent and efficient for clinical trial sponsors, clinical research organisations and sites, while also tracking progress. As part of the agreement, Syneos will utilise Study Marketplace to expand access to clinical trials, increase efficiencies for sites and sponsors across over 500 of Elligo’s US site networks and cover a broad range of therapeutic areas. Launched in 2022 by the healthcare-enabling research organisation, Study Marketplace is a one-stop platform that aims to accelerate participation in clinical research and allows sites to manage their entire pipeline process on a single, user-friendly portal. Updated in June this year, IntElligo Study Marketplace allows sites to easily access and browse available studies and study documents, apply for those of ...
KYV-101 designed as a CD19 CAR T-cell therapy. Image Credit: Adobe Stock Images/Trsakaoe Kyverna Therapeutics revealed in a company press release that FDA has approved an investigational new drug (IND) application for KYV-101 for the treatment of scleroderma. It marks the third IND clearance for the drug candidate. Reportedly, this will result in a multicenter study of KYV-101, an autologous fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for the treatment of diffuse cutaneous systemic sclerosis (scleroderma). “We are immensely proud of being able to bring KYV-101 to patients suffering from scleroderma,” said Peter Maag, PhD, CEO, Kyverna Therapeutics. “We are keen to initiate our KYSA-5 trial in this new patient population and generate data to support our KYV-101 design goals. With the deep B cell depletion from KYV-101 treatment, patients with scleroderma may have a full reset of their immune system to stop the vicious cycle of their ...
Cancer and pharmacy services are driving up costs for employers. One Mercer exec recently laid out several recommendations for employers to manage these costs. By MARISSA PLESCIA Employers have a long list of concerns when it comes to healthcare, and at the top of that list is cost, one expert said. “Employers are extremely concerned about cost. They are focused on most of their top cost drivers,” said Agnes Quiggle, principal health transformation collaborative leader at Mercer, a consulting firm. Quiggle made these comments Tuesday during an interview at HLTH 2023 in Las Vegas. The top cost driver for employers is cancer, she noted. Cancer overtook musculoskeletal conditions in this category last year, according to Business Group on Health. Quiggle said that cancer diagnoses are “increasing rapidly” and people are living longer with the disease. Pharmacy spending is also a key driver of healthcare costs, Quiggle stated. “Our clients are ...
Dive Brief Best Buy plans to start selling continuous glucose monitors in the next few weeks, in the tech retailer’s first foray into prescription-based medical device sales. The company plans to sell the Dexcom G7 CGM at launch, and is looking to offer additional CGM systems from other manufacturers, according to the company. Customers who want to buy a CGM will be routed to virtual care platform Wheel, where clinicians will determine a patient’s eligibility and write a prescription. Pharmacy tech provider HealthDyne will receive and process prescriptions, and consumers can then purchase the CGMs on Best Buy’s website for delivery to their homes. Dive Insight Best Buy has been increasingly active in healthcare as it angles to solidify itself as a valuable partner for hospitals and health plans looking for ways to help consumers manage their health at home. The company has sold medical devices for at-home use for ...
Genes may be responsible for third of complex regional pain syndrome cases. But the condition is less common in men, even though they are more likely to have the 4 genetic variations implicated in heightened risk, suggesting that there may be sex specific causes, say the researchers. Most cases of CRPS are usually triggered by an injury, with the skin of the affected body part hypersensitive to the slightest touch or temperature change. CRPS is difficult to treat, and while it often improves with time, some people experience intense pain for many years. But why some people develop CRPS yet others don’t after the same injury, isn’t clear. A heritable component to CRPS has been suggested, sparking the theory that some people might be genetically predisposed to the condition. To explore this further, the researchers looked for variations in genes, formally known as single nucleotide polymorphisms, or SNPs for short, ...
Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Now, as BlueRock Therapeutics advances its lead prospect, its parent company Bayer is ready to kick production into high gear.Bayer on Tuesday opened its first Cell Therapy Launch Facility in Berkeley, California, which is expected to create capacity to bring cell therapies to patients worldwide. Bayer has invested $250 million to build the plant, which will initially crank out materials for late-stage clinical trials across 100,000 square feet of space, the drugmaker said in a release. The plant is also equipped to support the potential commercial launch of BlueRock’s experimental cell therapy for Parkinson’s disease, bemdaneprocel. At the moment, BlueRock says planning is underway for its phase 2 study of bemdaneprocel, which is expected to start enrolling patients in the first half of 2024. The plant features flexible, modular space ...
What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer (NSCLC) could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Keytruda. Using Keytruda both before and after surgery significantly extended the lives of patients with stage 2 to 3b NSCLC in a phase 3 trial, Merck said Tuesday. The Keytruda regimen was pitted against presurgical chemo alone, while Keytruda recipients also received chemotherapy before surgery. The Keynote-671 trial marks the first time an immunotherapy has shown a statistically significant overall survival benefit for certain patients with early-stage NSCLC, Marjorie Green, M.D., head of late-stage oncology development at Merck Research Laboratories, said in a statement. The positive readout comes right before the FDA is expected to decide—by Monday—on Keytruda’s perioperative use as a continuous neoadjuvant-plus-adjuvant therapy in early-stage NSCLC. The trial previously met its other dual primary endpoint, showing Keytruda could reduce ...
The study will offer new insights into the immune system’s response to iGAS Spencer Dayman Meningitis Research has announced that scientists at the University of Bristol have begun a research project to aid in the development of a vaccine against invasive group A streptococcus (iGAS). The study will offer new and unique insights into the adaptive immune response to iGAS. iGAS is a severe infection caused by bacteria invading parts of the body, including the blood, deep muscle, fat tissues or lungs, which can lead to diseases such as meningitis and sepsis. Since April 2023, there have been 3,287 cases of iGAS in the UK, 761 of which occurred in children aged 18 years and under. There is currently no vaccine to protect individuals from group A streptococcus, which can also cause rheumatic fever and scarlet fever. Funded by Spencer Dayman Meningitis Research, scientists Dr Ana Goenka, Dr Alice Halliday ...
Swedish company Salipro Biotech has entered into a multi-target antibody research agreement with biotech company Icosagen. The agreement leverages Salipro’s proprietary platform technology for membrane proteins to identify drugs that target specific G protein-coupled receptors (GPCRs) and solute carrier (SLC) transporters, as per a 10 October announcement. These membrane proteins play a role in different areas such as oncology and autoimmune diseases. Estonian company Icosagen has CRO [contract research organisation] and CDMO [contract development and manufacturing organisation] capabilities, with expertise in protein production and analytics, which contributes to the drug development of monoclonal antibodies. Icosagen will utilise its QMCF technology to advance the project, based on the 10 October press release. The company’s QMCF technology is based on a proprietary mammalian expression system for producing recombinant proteins. Monoclonal antibodies have been identified by GlobalData as a key innovation area for cancer therapy, with Johnson & Johnson being the leading patent ...
Mike Hollan Klein discusses how recent FDA draft guidelines will impact the use of SaMD in the life sciences industry. David Klein CEO and co-founder Click Therapeutics FDA recently released draft guidelines regarding the use of software as a medical device (SaMD), which determines when the software should be included on the drug’s label. David Klein, CEO of Click Therapeutics, spoke with Pharmaceutical Executive about the impact these guidelines could have on the industry. Pharmaceutical Executive: What work are you doing with SaMD? David Klein: We are a science led biotech and tech company developing SaMD to be prescription treatments. That includes prescription digital therapeutics and discovering developing them in a way where they could potentially work independently or in conjunction with pharmacotherapies in order to lead to better clinical and economic outcomes. PE: The FDA just issued some updated guidelines regarding SaMD, how do you think the industry will ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.