Bio Pharma Dive
JUNE 5, 2022
A quarter century after Roche's Herceptin became an option for HER2-positive breast cancer, positive study results for Enhertu could push doctors to consider a new classification of "HER2 low" disease.
NY Times
JUNE 5, 2022
The study was small, and experts say it needs to be replicated. But for 18 people with rectal cancer, the outcome led to “happy tears.”.
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BioSpace
JUNE 5, 2022
In a small study of 14 rectal cancer patients, researchers at Memorial Sloan Kettering Cancer Center published results where 100% of the 12 patients who completed treatment went into remission.
Scienmag
JUNE 5, 2022
CHAPEL HILL, NC—UNC Lineberger Comprehensive Cancer Center’s Hanna K. Sanoff, MD, MPH, is the author of a viewpoint in the New England Journal of Medicine that provides a perspective on the evolving treatment of rectal cancer. She offers prospects for future treatment of the disease in light of encouraging findings from a study published in […].
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
BioSpace
JUNE 5, 2022
GSK's MMR vaccine is only the second to be approved in the United States for protection against measles, mumps and rubella. The first, licensed to Merck, was approved in 1971.
Scienmag
JUNE 5, 2022
BOSTON – Patients with multiple myeloma who have been treated with a three-drug combination therapy have a growing number of choices for subsequent treatment. Results of a new study led by researchers at Dana-Farber Cancer Institute can help patients and their physicians weigh benefits and risks of each option. Credit: Dana-Farber Cancer Institute BOSTON – […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
JUNE 5, 2022
Background:Patients with advanced pancreatic neuroendocrine tumors (NETs) have few treatment options that yield objective tumor response. Retrospective and small, prospective studies suggest that the combination of capecitabine and temozolomide is associated with high response rates (RR) and relative long progression-free survival (PFS). This trial was conducted to establish a role for the combination of capecitabine […].
BioSpace
JUNE 5, 2022
Data presented at the ASCO meeting this weekend show that treatment with Enhertu demonstrated a 49% improvement in median overall survival by more than six months.
JAMA Internal Medicine
JUNE 5, 2022
This JAMA Internal Medicine Patient Page describes use of aducanumab for treatment of Alzheimer disease, including potential benefits, harms, and concerns about use.
Scienmag
JUNE 5, 2022
New Haven, Conn. — Very few treatment options are available to patients with advanced pancreatic neuroendocrine tumors (NETs), but researchers at the Yale Cancer Center and Yale New Haven Health’s Smilow Cancer Hospital found that patients treated with a combination of capecitabine and temozolomide had longer progression-free survival rates than those treated with temozolomide alone. […].
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
BioSpace
JUNE 5, 2022
Data presented in bladder and pancreatic cancer at ASCO underscore the company’s vision of using NK cells and T cells to target difficult-to-treat cancers.
FDA Law Blog
JUNE 5, 2022
By Allyson B. Mullen — On June 3, FDA announced, via email to industry, that it plans to withdraw the guidance “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised).” This guidance did two things: (1) automatically extended hold times for additional information requests (e.g., PMA major deficiency letters, 510(k) additional information requests) by 180 days; and (2) communicated that all advisory committ
BioSpace
JUNE 5, 2022
The early data demonstrated a favorable safety profile and encouraging indications of clinical activity. BNT122 is being developed in multiple solid tumor indications.
Drug Patent Watch
JUNE 5, 2022
This chart shows the drugs with the most patents in Norway. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Norway? appeared first on DrugPatentWatch - Make Better Decisions.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
BioSpace
JUNE 5, 2022
The study revealed that Yescarta was both safe and effective in adult patients regardless of race and ethnicity.
BioSpace
JUNE 5, 2022
The Phase II/III Aria Study was unsuccessful in achieving statistical significance on the primary endpoint or any secondary objectives, according to Praxis.
BioSpace
JUNE 5, 2022
Finding the most cost-effective school for your undergraduate pharmaceutical degree can allow you to start working in the field without incurring astronomical student debt.
BioSpace
JUNE 5, 2022
The results demonstrated that Jardiance reduced the risk of hospitalization for heart failure compared to two other classes of glucose-lowering drugs in adults with type 2 diabetes.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
BioSpace
JUNE 5, 2022
Primary seven-year data from Janssen's (Johnson & Johnson) Phase III trial of Imbruvica (ibrutinib) in lymphoma demonstrated positive survival outcomes.
BioSpace
JUNE 5, 2022
The combination of Opdivo plus Yervoy in addition to chemotherapy demonstrated additional benefits in patient populations who usually have poor prognoses.
BioSpace
JUNE 5, 2022
A combination study of CG Oncology’s oncolytic immunotherapy and a checkpoint inhibitor is showing promise.
BioSpace
JUNE 5, 2022
June is starting off with a number of important dates for the FDA, including an advisory committee meeting to discuss COVID-19 vaccines in children as young as six months.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
BioSpace
JUNE 5, 2022
Gilead Sciences shared what seemed to be good news regarding Trodelvy in HR+/HER2- breast cancer at the 2022 American Society of Clinical Oncology's annual meeting.
BioSpace
JUNE 5, 2022
Ibrance, a first-line treatment for ER+, HER2- metastatic breast cancer, did not improve the overall survival rate in patients.
BioSpace
JUNE 5, 2022
It was a busy, busy week for clinical trial news and updates, largely driven by the annual ASCO meeting taking place June 3-7 in Chicago.
BioSpace
JUNE 5, 2022
Legend Biotech and J&J, Adicet Bio, Curis and Immutep present optimistic early and mid-stage results at ASCO.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
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