This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
As the CEO of iOnctura, an innovative oncology biopharmaceutical company she co-founded in 2017, Catherine has played a key role in advancing the development of highly targeted small molecules aimed at revolutionising cancer treatment. I went on to complete my MBA and PhD at The Institute of Cancer Research (ICR) in drug development.
Compounds useful as kinase inhibitors (WO 2017/103611 A1). “FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma” Clinical Cancer Research. 1] [2] [4] It inhibits B cell lymphocyte proliferation and survival by binding and inhibiting Bruton’s tyrosine kinase (BTK). [5] August 2023).
Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. Mr Ho has worked in the biotechnology industry for almost 20 years.
Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally. Source link:[link].
Merck will fund research and development on the program, according to the collaboration. Under the terms of the agreement, Merck received an exclusive worldwide license to products and intellectual property developed from this collaboration. Janux, which was founded in 2017, is still largely a preclinical company.
05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. .
The companies will use ViGeneron’s proprietary vgAAV technology to efficiently transduce target cells via intravitreal injections.
MUNICH, Germany, Jan.
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. Senior Vice President and Global Head of Cardiometabolic Diseases Research, Boehringer Ingelheim. About Gubra.
Alternative methods will require significant research investment to demonstrate their utility for a particular context of use and inform regulatory decision-making. In 2019, FDA formed an agency-wide Alternative Methods Working Group indicating that it viewed the applicable scope of alternative methods to go beyond just toxicology research.
of the Net Proceeds is originally intended to be used for the Group’s research and development of ASC21, which is an IND-approved NS5B polymerase nocleot(s)ide inhibitor licensed from Medivir AB under the exclusive licensing agreement executed in June 2017. b) The Prospectus stipulates that approximately 10.0%
“With AbbVie’s acquisition of Syndesi, we aim to advance the research of a novel, first-in-class asset for the potential treatment of cognitive impairment associated with neuropsychiatric and neurodegenerative disorders.” The lead molecule, SDI-118, was discovered by UCB before being out-licensed to Syndesi as of 2018.
Alzprotect co-owns or has an exclusive worldwide license from the French National Institute of Health and Medical research (Inserm) and the University of Lille (France) on a total of 58 patents related to Ezeprogind in 39 countries. The company employs 8 people and is supported by BPI France, the National Research Agency and Eurasanté.
In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys’ antibody technology to receive regulatory approval.
Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. Of the 4,819 facilities in the Site Catalog, 60% manufacture drugs approved under a New Drug Application (NDA), Abbreviated NDA (ANDA), or Biologics License Application (BLA).
In December 2017, Roche licensed the investigational molecule from Ionis Pharmaceuticals. Neuroscience is a major focus of research and development at Roche. Survival ranges from approximately 10-20 years following motor onset of the disease. About Roche in Neuroscience.
We hear recurring pain points among R&D leaders: Companies lack a systematic way to discover researchers and technologies outside of their geography, industry and existing relationships. In two months, Halo connected Oldcastle with sixty interested researchers. We had one researcher in mind.
Researchers are aware of more than 80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. The researchers regulated the abnormal immunological memory processes found in these patients. However, if the immune system malfunctions, it can attack healthy cells, tissues and organs.
director of research programs for the Foundation for Prader-Willi Research, said, “With a focus on individuals with PWS and their caregivers, our mission is to accelerate research and support the development of therapies that will eliminate the challenges of PWS.” Theresa Strong, Ph.D., ” Clinical Highlights.
Astellas and iota previously entered into a Research and Development Agreement in August 2019 (the “R&D Agreement”) to jointly conduct research and development activities associated with iota’s ultrasonic-powered bioelectronic devices (also known as “neural dust”) in a number of indications. and Jose Carmena, Ph.D.,
With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. Inozyme Pharma was founded in 2017 by Joseph Schlessinger, Ph.D., Demetrios Braddock, M.D.,
In 2017 we bet on refocusing our strategy on medical dermatology to best address patients’ unmet needs.
Investment in Research & Development remained at c. 10% of its Net Sales in R&D and also invests significantly in business development and in-licensing.
Normalized net income was €74.2
The Pediatric Research Equity Act (PREA) was signed into law in 2003 to increase pediatric use information in product labeling and close knowledge gaps regarding the safety, efficacy, and appropriate dosing of drugs to treat children.
4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. 20] Research Phase II Clementia submitted a new drug application for palovarotene for the treatment of fibrodysplasia ossificans progressiva after observing positive phase II results. [21]
The road to research on psychedelic products is paved with obstacles. This means that research programs are subject to additional oversight from U.S. FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances.
FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. 15, 2017), [link]. [18] 22] FDA, Financial Report to Congress: Medical Device User Fee Amendments of 2017 FY 2022, at 27, [link]. [23] 15, 2017), [link]. [18]
These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).
2017 Apr; 81(4):479-484.
The Company may occasionally disseminate material, nonpublic information on the company website. References.
Gooch CL, Pracht E, Borenstein AR. The burden of neurological disease in the United States: A summary report and call to action. Ann Neurol.
Horizon Therapeutics – Karin Rosén joined Ireland-based Horizon Therapeutics as executive vice president, research and development and chief scientific officer. Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies. medical affairs at GlaxoSmithKline.
The FDA requires extensive testing to support the approval of a biosimilar product, including comparative clinical studies and other human research. BsUFA was first authorized in 2012, and BsUFA I ran from FY2013-2017. Featuring previous research by Rachel Coe.
In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. December 21, 2015. link] 9.
Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives approval of a biologics license application (BLA) for a rare pediatric disease product application may be eligible for a voucher which can be redeemed to obtain priority review for a subsequent marketing application for a different product.
executive vice president of Research and Development at Amgen. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2017; 377 (10): 936-946.
and RESEARCH TRIANGLE PARK, N.C. ,
Research and development expense. The table below summarizes research and development expense by major category (dollars in millions):
.
Research and development projects.
SILVER SPRING, Md.
.
executive vice president of Research and Development at Amgen. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2017; 377 (10): 936-946.
The Merkin Prize recognizes novel technologies that have improved human health and is administered by the Broad Institute, one of the worlds leading biomedical research institutes. Some researchers suspected that the body would attack and destroy the CAR T cells. Their work puts us on the doorstep of finding cures to help millions.
Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. Dive Insight: Since the FDA’s approval of Novartis’ Kymriah for leukemia in 2017, six more CAR-T therapies have reached market. Its new CEO has to figure out what’s next.
GeneTx was launched by FAST, a patient advocacy organization and the largest non-governmental funder of Angelman syndrome research. GeneTx licensed the rights to antisense technology intellectual property from the Texas A&M University System in December 2017. About Ultragenyx.
So while not specific to medical devices and diagnostics, parts of the regulations will affect healthcare products and their legislation – the European medical device (MDR; Regulation (EU) 2017/745) and diagnostics regulations (IVDR; Regulation (EU) 2017/746).
Introduction Globally, early-stage biopharma research suffers from chronic underfunding leading to discontinued research in the early stages of the pharma development cycle. This is happening so regularly that academia has coined the phase of research up until clinical trials the “Valley of Death”.
C-Founder of Ascentage Pharma and Chairman of its Scientific Advisory Board, and Warner-Lambert/Parke-Davis Professor in Medicine, Professor of Internal Medicine, Pharmacology and Medicinal Chemistry, Director of Michigan Center for Therapeutic Innovation, University of Michigan , is a leading researcher in the field. 2017, 16 , 101-114.
At last year’s American Association for Cancer Research meeting, Richard Pazdur, director of FDA’s Oncology Center of Excellence, said the agency would consider accepting applications based on China-only clinical data. Lilly first licensed Tyvyt from Innovent in 2015. leveraging existing data where possible,” he said. Source link.
Discovered at Takeda’s Shonan, Japan research center, soticlestat is a potent, highly selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H). President of Research and Development at Takeda. Under the new exclusive agreement, all global rights to soticlestat have been secured by Takeda from Ovid.
Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. How Can Research Professionals Mitigate Risks with Engineered Genetic Materials?
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content