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Machine learning is a subset of AI that identifies patterns in large datasets, leveraging identifiable conditions or attributes that are needed to inform sample selection for trials and other prospective data. It identifies cases in instances where diagnosis codes and other information available in each database are too non-specific to do so.
2 Unmet needs in lung cancer treatment Recent decades have seen significant advancements in lung cancer treatment, especially with the introduction of targeted therapies and immunotherapies, which have notably improved survival rates. 18 Indeed, early-phase clinical studies exploring TsAbs in solid tumours have recently commenced.
AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinicaldevelopment of ATX01. About AlgoTherapeutix
AlgoTx was founded in 2018 by Stéphane Thiroloix and Olivier Bohuon to develop topical treatments for complex pain and was incubated by Paris Biotech Santé. 15, 2020 07:15 UTC.
Instead of the standard approach where studies are designed to address a primary focus, a parallel study method — a format that incorporates multiple endpoints and objectives, modifications, treatment arms and dose selections into a single protocol — is being rapidly adopted.
Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Bioanalysis to support drug development requires meticulous attention to detail across many clinic and laboratory disciplines.
To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinicaldevelopment.
The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). ADUHELM is indicated for the treatment of Alzheimer’s disease. Please see the full Prescribing Information. INDICATION.
UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinicaldevelopment qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,
Sandoz, a Novartis division, today announced progress in the late-stage clinicaldevelopment program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Aflibercept is a key treatment in ophthalmology.
Our skepticism was based on our understanding of the biology of those pathways and informed by observations made by the Antonia lab, several Roche groups and others that TGF- expression is sufficient to prevent T cell activation. The lead program here was bintrafusp alfa, now terminated. No chemotherapy regimen is used in the trial.
Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. iii Current treatment options have limited efficacy in terms of weight loss or are often associated with adverse events. “We
Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. Harpoon has four drug product candidates in clinicaldevelopment for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. “I About Harpoon Therapeutics.
Prior to joining Gannex, Dr. Palmer was Head of Liver Disease ClinicalDevelopment at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. . ” About Ascletis.
The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., Chief Medical Officer and Head of Global Product Development, Roche. Actemra/RoActemra is not U.S.
With all this experience, I was very excited to take on the CEO role for Alzinova, a company developing a vaccine and other treatments against Alzheimer’s disease. I have built up this biopharma company from being a university science focused company to a biopharma company with all skills and focused on drug development and partnering.
PRA Health Sciences selected for the study which will position Awakn at the Forefront of Psychedelic Research for Addiction Treatment. While there are current treatment methods available, which are effective for some segments of the population, relapse rates are high. For more information, please visit awaknlifesciences.com.
As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. Our approach is informed by our combined 30+ years in rare disease clinicaldevelopment and our time in various stakeholder roles, such as scientists, CRAs, and project managers.
This multi-layered mechanism contributes to the development of immunoresistance against current standard-of-care treatments such as checkpoint inhibitors, chemotherapy, or antibody-drug conjugates (ADCs). Visugromab is a monoclonal antibody – a treatment modality that has been extensively studied and de-risked.
to advance the development of a subcutaneous delivery for Sarclisa ® with the goal of offering a unique patient-centric treatment experience. for the treatment of patients with RRMM who have received 1–3 prior lines of therapy and in the European Union for patients with MM who have received at least 1 prior therapy.
– Second Product Candidate Expected to Enter Clinic in First Half of 2021. Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. PHILADELPHIA, Jan.
Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. Selva Therapeutics is a privately held biotechnology company dedicated to the development of therapeutics for infectious diseases.
This targeted approach provides readers interested diseases or applications with tailored information and insights that align with their specific interests. By exploring the latest advancements and potential treatment approaches for their areas of interest, readers can deepen their understanding of disease-specific applications.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].
To complement the internal capabilities, Aruvant is partnering with world-leading contract development manufacturing organizations. The strategic long-term manufacturing agreement with Lonza is a critical step to advancing the clinicaldevelopment of ARU-1801 for sickle cell patients.
FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.
Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinicaldevelopment program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. About Sandoz.
a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, today announced dose administration for the first patient in a Phase 2a clinical study of the company’s lead drug candidate, STP705, for the treatment of cutaneous basal cell carcinoma.
The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Sage Therapeutics, Inc.
In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development. What sets RADR ® apart is its robust data-driven approach.
Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. Visit FDA’s website for more information. A list of sites, contact information and more details on the study are available on: [link]. Vivet’s lead program, VTX-801, is currently under clinicaldevelopment. About VTX-801.
The European Commission (EC) has approved Sanofi and Regeneron’s PD-1 inhibitor Libtayo ® (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have ?50% 50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. Libtayo is now approved for three advanced cancers in the European Union.
Cancer Research UK has partnered with Hummingbird Bioscience to advance this novel antibody drug into clinical trials for the treatment of HER3-driven cancer. Hummingbird Bioscience is an innovative clinical-stage biotech company focused on developing revolutionary therapies against hard-to-drug targets for improved treatment outcomes.
Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Roche’s Chief Medical Officer and Head of Global Product Development. “If
Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). Top-tier capsid candidates from this effort demonstrated significant improvements over benchmark AAVs currently in clinicaldevelopment. Forward Looking Statements.
for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. .–(BUSINESS WIRE) January 15, 2021 — Daiichi Sankyo Company, Ltd. In the U.S., Sammons Cancer Center and the W.W. Caruth, Jr.
How have advancements in antibody-drug conjugates (ADCs) expanded treatment options for different types of cancer? The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinicaldevelopment.
Food and Drug Administration (FDA) has granted a rare pediatric disease designation (RPDD) to its lead product candidate VS-01, an ammonia clearance enhancer, for the treatment of Urea Cycle Disorders (UCD). Current treatment options are associated with poor outcomes. For additional information, visit: www.versantis.ch.
For instance, AI algorithms could facilitate patient-trial matching, encompassing medical records, genetic information, demographics, and personal preferences. Furthermore, the incorporation of response biomarkers offers early insight into a drug’s effectiveness, preventing the continuation of a treatment.
Additional data to be presented include trials-in-progress on the use of Yescarta in FL versus standard of care (ZUMA-22), as a first-line treatment in high-risk LBCL (ZUMA-23) and in the outpatient setting (ZUMA-24).
Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. For more information, please visit www.inozyme.com.
BOSTON, Jan.
executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinicaldevelopment process to bring this potential new innovative treatment to patients as quickly as possible.”. For additional information, please visit www.lexpharma.com.
As a second and more challenging test, the researchers reconfigured the BOC by placing a multi-drug resistant vulva cancer cell line in one chamber and, in another, a breast cancer cell line that responded to drug treatment. Both tamoxifen alone and the combination treatment showed some off-target effects on heart cells.
Performance data on principal investigators and clinical trial sites provides invaluable insights to pharma companies, helping them leverage successful sites and patient populations to maximize their clinicaldevelopment feasibility and operations. There is a tendency to want to measure everything.”
HK), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG). For more information, please visit: www.harbourbiomed.com. CAMBRIDGE, Mass.
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