Search Results for “Clinical Trial” – Page 88 – media

AbbVie Passes on License Option for Harpoon’s TriTAC Multiple Myeloma Program

By Tristan Manalac Pictured: AbbVie corporate office in California/iStock, vzphotos AbbVie will not exercise its exclusive licensing option for Harpoon Therapeutics’ HPN217 program, being developed for the treatment of multiple myeloma, the immuno-oncology biotech announced Wednesday. Harpoon will retain exclusive ownership over HPN217, for which it is running a Phase I clinical trial. The company will complete the study and plans to advance the candidate through its next phases of development. Despite AbbVie’s decision, Harpoon CEO Julie Eastland said in a statement that the biotech remains “confident in HPN217’s potential” to offer multiple myeloma patients “a differentiated treated option.” The company will share interim results from the candidate’s Phase I study at the upcoming International Myeloma Society (IMS) Annual Meeting, scheduled for Sept. 28, Eastland said. Developed using Harpoon’s proprietary TriTAC technology, HPN217 targets the B-cell maturation antigen, a protein highly and specifically expressed on myeloma cells. TriTAC, which stands ...
- Source: drugdu
- 106
- September 16, 2023
FDA to start review of subcutaneous Entyvio for Crohn’s disease

The US Food and Drug Administration (FDA) has accepted Takeda’s biologics license application (BLA) for the company’s investigational subcutaneous administration of Entyvio (vedolizumab) for the treatment of Crohn’s disease. The BLA, which is for maintenance therapy of moderate to severe active forms of the disease after induction therapy with IV vedolizumab, will now be reviewed by the FDA alongside a separate BLA submitted by Takeda for the same formulation indicated for ulcerative colitis treatment. Dr Vijay Yajnik, vice president and head of US Medical for Gastroenterology at Takeda said in a statement: “With two applications for a subcutaneous option of Entyvio now under FDA review, we remain firm in our commitment to the inflammatory bowel disease community—adults with ulcerative colitis or Crohn’s disease—and the healthcare professionals actively managing their care.” Takeda submitted the most recent BLA with data from a Phase III clinical trial demonstrating that Entyvio led to a ...
- Source: drugdu
- 127
- September 15, 2023
Alnylam Wins Adcomm’s Support for Heart Disease Drug Despite FDA Concerns

By Hayley Shasteen Pictured: FDA headquarters, iStock, GrandbrothersT he FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday voted 9-3 in favor of Alnylam Pharmaceuticals’ patisiran on whether its benefits outweigh its risks for the treatment of adults with cardiomyopathy induced by transthyretin amyloidosis. In the company’s announcement on Wednesday, Alnylam CMO Pushkal Garg said the “positive outcome” of the adcomm meeting is “supported by the efficacy and safety data observed in the APOLLO-B Phase III study and is another step toward bringing patients with the cardiomyopathy of ATTR amyloidosis a novel treatment option that addresses the underlying cause of disease and has the potential to meaningfully benefit patients’ functional capacity and quality of life.” The decision came after the panel’s day-long meeting in which adcomm members discussed whether the treatment effects demonstrated by data from Alnylam’s Phase III APPOLLO-B clinical trial were clinically meaningful for patients with cardiomyopathy induced ...
- Source: drugdu
- 113
- September 15, 2023
Coherus acquires immuno-oncology company Surface

Coherus BioSciences has concluded the acquisition of clinical-stage immuno-oncology (I-O) company Surface Oncology in a deal totalling nearly $66.9m. The deal value comprises $40m, along with Surface’s net cash at deal closing of $26.9m. Surface Oncology focuses on the development of immunotherapies that act on the microenvironment of the tumour. With the deal closing, Surface became a completely owned Coherus subsidiary. Following the takeover, Coherus expanded its I-O pipeline by adding clinical-stage antibody immunotherapy candidates of Surface, Casdozokitug (SRF388 / casdozo) and CHS-114 (SRF114). These product candidates can boost the innate and adaptive immune responses to facilitate a strong immunologic response and disease outcomes in cancer patients. Casdozokitug is a new antibody targeting IL-27 and is presently being analysed in Phase I/II clinical trials for lung and liver cancer. An anti-CCR8 antibody, CHS-114 is being evaluated in Phase I/II study as a single agent in advanced solid tumour patients. Coherus ...
- Source: drugdu
- 202
- September 13, 2023
Click Expands to Substance Use Disorder With Indivior Digital Therapeutics Pact

Click Therapeutics, a developer of prescription digital therapeutic products, is adding substance use disorder to its pipeline through a new partnership with addiction medicines maker Indivior. Like other products in the Click pipeline, the new substance use disorder treatment, codenamed CT-102, will be a mobile software app. This app will be designed to work alongside drugs used to treat addiction. The Indivior portfolio includes the opioid addiction products Sublocade and Suboxone. Click said the partnered app will combine evidence-based behavioral therapy with tailored interventions intended to have an effect on the brain. Privately held Click is part of a cohort of companies developing software as treatments for various medical conditions. The company has mapped the entire brain to discover faulty brain circuits that are implicated across a variety of diseases. To treat these diseases, the company designs apps that present users with tasks that have the effect of retraining and ...
- Source: drugdu
- 175
- September 12, 2023
NICE recommends Lilly’s tirzepatide to treat T2D

The UK National Institute for Health and Care Excellence (NICE) has recommended Eli Lilly’s tirzepatide (Mounjaro) for the treatment of adult patients with inadequately controlled type 2 diabetes. According to NICE’s final draft guidance, the injection is indicated for weekly usage in combination with diet and exercise. Clinical trials show that tirzepatide usage resulted in a substantial decline in both blood sugar levels and body weight, in comparison with insulin therapy, semaglutide or a placebo. Data also showed that tirzepatide aided between 81% and 97% of individuals in attaining improved glucose control, and 54% to 88% also showed a 5% or greater reduction in body weight. These figures were substantially higher than the comparators. The independent NICE committee provided a positive recommendation for tirzepatide after conducting additional assessments and modelling on clinical and cost-efficiency data provided by Lilly. NICE noted that 180,000 individuals with poorly managed type 2 diabetes will ...
- Source: drugdu
- 103
- September 12, 2023
Veracyte and Gustave Roussy announce partnership for cancer therapies

Veracyte has announced a multi-year partnership with Gustave Roussy to support biopharmaceutical companies in expediting the development of new cancer therapies. They will combine their abilities to offer new insights into the biology of metastatic tumours, helping to develop new cancer treatments. The collaboration will utilise Gustave Roussy’s extensive collection of tumour samples and related data, along with Veracyte’s Biopharma Atlas, a machine learning-powered, multi-omic solution aimed at enhancing the effectiveness and efficacy of clinical studies. Gustave Roussy’s department of therapeutic innovation and early clinical trials will deliver metastatic tumour samples and information for several cancer indications. These are derived from research projects, specifically for new immunotherapies. Veracyte intends to combine these resources with its multi-omics testing and machine learning capabilities, resulting in the development of a Veracyte Biopharma Atlas reference database for genomic and immunomic biomarkers. Using the comprehensive understanding of each tumour’s biology, especially its immune context, the ...
- Source: drugdu
- 141
- September 11, 2023
Researchers receive $2.5 million award to develop a tailored treatment for glioblastoma

A multidisciplinary team of investigators from the UCLA Jonsson Comprehensive Cancer Center was awarded a $2.5 million Translational Team Science Award from the Department of Defense to develop a tailored treatment for glioblastoma, a deadly brain tumor with limited treatment options. The team -; including David Nathanson, associate professor of molecular and medical pharmacology at the David Geffen School of Medicine at UCLA, Benjamin Ellingson, director of the UCLA Brain Tumor Imaging Laboratory and professor of radiological sciences, and Dr. Timothy Cloughesy, professor of neuro-oncology -; plan to target the epidermal growth factor receptor, a protein that is mutated in about 60% of people diagnosed with glioblastoma. Previous attempts have had limited success improving patient outcomes due to drugs’ inability to cross the blood-brain barrier and target genetic alterations in the protein that are unique to glioblastoma. To overcome these obstacles, the researchers have developed ERAS-801, a brain-penetrant inhibitor that ...
- Source: drugdu
- 107
- September 7, 2023
New Biomarker Tests Aid Quick, Accurate Diagnosis of Alzheimer’s Disease

By Claire Jarvis Pictured: Close-up of an arm receiving a blood draw/iStock, montiannoowong Prior to the approval of effective therapies for Alzheimer’s disease, there was little need for biomarker tests. Now, with Eisai and Biogen’s anti-amyloid drug Leqembi on the market and approval of Eli Lilly’s donanemab expected to follow soon, the pipeline of Alzheimer’s drugs is expanding and the development of tests to detect the disease is accelerating. With Leqembi’s full approval, the Centers for Medicare and Medicaid Services (CMS) has instituted broader coverage of the drug—with stipulations. To ensure reimbursement, physicians must participate in a qualified registry and patients must be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia with evidence of beta-amyloid deposits. To help facilitate this, CMS proposed in July 2023 to increase its coverage of PET scans to detect these amyloid plaques—however, cheaper and faster diagnostic methods are still being developed. The past ...
- Source: drugdu
- 186
- September 6, 2023
Centogene finds diagnostic and predictive biomarker for Gaucher disease

Centogene has published data about the use of lyso-Gb1 (glucosylsphingosine) as a sensitive diagnostic and predictive biomarker for Gaucher disease. The study was published in the open-access MDPI journal, Diagnostics, and showed that lyso-Gb1 could be used to predict the clinical course of patients with Gaucher disease. Gaucher disease is a rare inherited metabolic disorder caused by mutations in the beta-glucocerebrosidase (GBA1) gene, responsible for producing a fat-breaking enzyme, glucocerebrosidase. Decreased activity of the enzyme causes fat accumulation in the cells causing symptoms such as liver enlargement, anaemia, bone pain, and spleen enlargement. Multiple biomarkers have been identified for the disease. However, these were present in other diseases and not exclusively in Gaucher disease. Lyso-Gb1 is a more specific biomarker for Gaucher’s, and it can be used to both diagnose the disease and monitor its progression. The confirmation of the biomarker serves as an important step forward in rare disease ...
- Source: drugdu
- 173
- September 6, 2023

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