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In the rapidly evolving field of cell and gene therapy (CGT), the ability to manage complex biological data, optimise manufacturing processes, and accelerate drug discovery is crucial. How AI is solving CGTs biggest challenges Cell and gene therapy is inherently complex. Kosten Digital was established to bridge this gap.
As a result, drug developers make better decisions more quickly (removing 50% of study timeline whitespace) to bring new therapies to market faster. Ready to learn more about how to leverage AI and machine learning to maximize your clinical trial efficiency?
The investigational ADC is built using Daiichi Sankyo’s proprietary DXd technology and represents one of the newest generation of targeted cancer therapies. Building on Early Clinical Success The Phase 3 IDeate-Prostate01 trial is based on encouraging results from the earlier IDeate-PanTumor01 Phase 1/2 study.
“As our science has advanced, so has the need for tighter alignment across Research and Development to ensure that we continue to scale our impact and transform the lives of patients across a growing number of diseases,” Greenstreet stated.
Oncology remains a core priority, reflecting the rising global burden of cancer and the need for more effective, targeted therapies. By aligning their research priorities, Bayer and Tsinghua are aiming to bridge the gap between academic research and industrial development. Source link
Importantly, the treatment effect emerged early in the course of therapy and continued to increase over time. Despite existing therapies, many PAH patients remain at substantial risk. Patients were randomized 1:1 to receive either WINREVAIR or placebo, both in combination with maximum-tolerated background therapy. Source link
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This expansion is creating opportunities for clinical trials related to a range of new therapy areas and their subpopulations. Expertise that accelerates your clinicaldevelopment success The PPD clinical research business of Thermo Fisher Scientific has significant experience in customized Phase I-IV metabolic clinical trials.
Within cell therapyclinical trials, apheresis collections contribute to the specific constituents of the given therapy. Whether this is via an allogeneic (healthy donors) or autologous (patient) approach, the material collected is then manufactured and returned to patients for infusion therapy.
The FDA has approved a request from American Gene Technologies to begin a clinical study into its HIV gene therapy. The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases. Conor Kavanagh.
Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. Perlmutter, President, Merck Research Laboratories. “We About A2 Biotherapeutics.
Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994, 1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors. – If Approved, Investigational TAK-994 May Provide a Future Treatment Option Targeting the Orexin Deficiency Underlying NT1.
15, 2020 /PRNewswire/ — Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapydevelopment and manufacturing.
CARLSBAD, Calif. ,
Why Partnering with Genetic Counselors May Benefit Your Clinical Program The American College of Medical Genetics (ACMG) has issued a statement that geneticists should be involved in the development of genetic therapies. Enrolling adequate populations will be required to advance these programs.
By: Sarah Bly and Aman Khera, Regulatory Science and Innovation The journey of bringing a new therapeutic agent from the laboratory to the marketplace is fraught with challenges, not least of which is navigating the complexities of regulatory feedback, which do not always converge but can diverge.
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These data also support the potential first-line use of LENVIMA plus everolimus, which is already approved in advanced RCC following prior antiangiogenic therapy,” said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. Source link.
today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. Source link: [link].
Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy. These compounds were later licensed to the pharmaceutical industry for clinicaldevelopment.
A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St. Louis is being advanced toward Phase I human clinical trials to treat COVID-19. Hunt, a graduate research fellow in Jewett’s laboratory, is the paper’s co-first author.
Cadavid will be responsible for the strategy, direction and execution of the company’s clinicaldevelopment programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinicaldevelopment group.
As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.
The company hopes to raise $140 million of common stock, which will be used to advance its clinical and earlier stage programs and for R&D, working capital and general corporate purposes. TCR 2 is developing novel T-cell therapies for solid tumors and hematological cancers. The company is based in Suzhou and Shanghai, China.
Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. Data on the efficacy of deucravacitinib, no matter prior psoriasis treatment (Presentation FC03.06), were featured as an public speaking today from 2:30 – 3:30 p.m.
Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. prostate cancer is the second most common cancer in men, and despite an increase in the number of available therapies for patients with mCRPC, five-year survival remains low. 0.45]) and overall survival (OS) (HR=0.30 [95% CI, 0.15-0.59])
Consider the potential for drug interactions prior to and during PREVYMIS therapy; review concomitant medications during PREVYMIS therapy; and monitor for adverse reactions associated with PREVYMIS and concomitant medications. See additional Selected Safety Information below. Source link: [link]
Prior to joining Labcorp, she held multiple appointments with The Children’s Hospital of Philadelphia, including Patient Safety Officer, chief of the Division of Transfusion Medicine and Vice-Chief of Pathology and Laboratory Medicine. Abbott Laboratories and TAP Pharmaceuticals. a company previously known as miRagen Therapeutics.
HK) (“Pharmaron”), a fully integrated contract research and manufacturing organization offering laboratory, CMC and clinicaldevelopment services for the life science industry, announced today that it has acquired 100% of the equity of Absorption Systems for up to US$137.5 Limited (Stock Code: 300759.SZ/3759.HK) million in cash.
While peripherally acting COMT inhibitors are currently used as an adjunctive therapy in the treatment of neurological conditions, including Parkinson’s disease, this new collaboration is investigating centrally acting COMT inhibitors in neuropsychiatric disorders. “We Our mission is to create breakthrough therapies that change lives.
Currently available BTK inhibitors irreversibly inhibit BTK and the long-term efficacy of these therapies can be limited by acquired resistance, most commonly through BTK C481 mutations. In rapidly growing tumors with inherently high rates of BTK turnover, resistance to covalent BTK therapies may be the result of incomplete target inhibition.
Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinicaldevelopment, such as priority review and accelerated approval. Brilacidin antiviral research to date has been limited to laboratory-based experiments.
In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinicaldevelopment. Here’s how we do it. Recruitment and talent management are critical to FSP performance.
Libtayo is the first immunotherapy to show a clinical benefit in patients with advanced BCC after HHI therapy in a pivotal trial, and with this first-in-class approval has the potential to transform treatment for patients in Europe whose cancer has progressed despite HHI treatment ,” said Israel Lowy, M.D.,
Under her leadership, Pfizer advanced into clinicaldevelopment or approval bacterial vaccine programs directed at the prevention of diseases due to Streptococcus pneumoniae, Group B Streptococcus, Neisseria meningitidis, Staphylococcus aureus, and Clostridium difficile. Dr. Anderson joined Pfizer via Wyeth in 2007.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinicaldevelopment program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. If appropriate, initiation of anti-HBV therapy may be warranted.
Unraveling the complexity of manufacturing next-gen biologics is critical to the shared mission of accelerating patient access to new therapies,” said Chad Clark, President of Precision for Medicine. This convergence is driving faster clinicaldevelopment and approval. For more information, visit projectfarma.com.
“When choosing the right CRO partner, clinical innovators cannot make decisions based on assumptions of our capabilities because there is far too much at stake—significant financial investment, jobs for their people, and most importantly, the lives of patients that may view these therapies as a last hope for their future.
1] It is being developed by Mirati Therapeutics. [1] 1] It is being developed by Mirati Therapeutics. [1] Identification of the ClinicalDevelopment Candidate MRTX849, a Covalent KRASG12C Inhibitor for the Treatment of Cancer.” 2] Research It is undergoing clinical trials. [5] 1] It is taken by mouth. [1]
Senior Vice President, Early ClinicalDevelopment, Hematology/ Oncology and Cell Therapy and San Francisco point head. “ LabCentral offers completely permitted laboratory and office space for as numerous as 70 startups comprising roughly 500 scientists and entrepreneurs. AboutBioLabs@NYULangone( New York, NY).
Monitor blood pressure after 1 week, at least monthly thereafter, and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Laboratory abnormalities (all grades; Grade 3-4) ?20% Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR.
“As our industry continues to innovate, it is imperative that we continue to advance our portfolio of enterprise solutions to enable scale and connectivity in support of our ultimate goal – delivering therapies to patients. This convergence of trials, labs and data sciences is driving faster clinicaldevelopment and approval.
Senior Vice President and Head of Global ClinicalDevelopment at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinicaldevelopment program.” and Roche will develop, manufacture and distribute it outside of the U.S.
3] While MET inhibitors have recently received accelerated approval in this setting in some regions, the vast majority of patients eventually acquire resistance to these therapies, thus underscoring the need for new treatment options. [4] Vice President, ClinicalDevelopment, Solid Tumors, Janssen Research & Development, LLC. “We
However, developing an accelerated IND application requires that good laboratory practice (GLP) toxicological data must be generated, collected, interpreted and integrated in the IND-enabling data package.
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