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The regulatory approval was based on the data obtained from the DESTINY-Breast04 Phase III trial, which was conducted in HR-positive or HR-negative, HER2-low unresectable or metastatic breast cancer patients, who have received one or two prior lines of chemotherapy.
The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinicaltrial. Furthermore, Enhertu’s safety profile was in line with prior clinicaltrials without any new safety concerns detected. months compared with 5.1 months for the chemotherapy arm.
The latest filing is based on non-clinical and clinical data for Paxlovid and also comprised data from the Phase II/III EPIC-HRclinicaltrial. Furthermore, findings from the final trial report showed a relative risk decline of 86%.
The company claimed that the utmost benefit is reported in hormone-receptor positive (HR+) women and those who commence treatment with Nerlynx within a year of receiving trastuzumab-based therapy. In a Phase III ExteNET clinicaltrial, neratinib offered a 34% decline in the risk of recurrence and a 2.3%
Navigating regulatory affairs in the biopharma industry requires a skilled talent pool, according to Benjamin James, HR Leader, Asia-Pacific, Cytiva Lifesciences – a global life sciences (biopharma) company. in 2021 to 5.60 […]
Syros Pharmaceuticals announced that its cancer drug tamibarotene failed to meet its primary endpoint in the SELECT-MDS-1 Phase III trial. The placebo-controlled SELECT-MDS-1 trial involved 190 patients with complete response rate (CRR) being the study’s primary endpoint. percent and 18.8
Verzenio along with endocrine therapy (ET) has received approval as an adjuvant treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) adult patients who are at a high recurrence risk.
AstraZeneca noted that the sBLA is based on findings from the randomised, open-label Phase III DESTINY-Breast04 clinicaltrial of Enhertu in priorly treated subjects with HER2-low metastatic breast cancer with hormone receptor (HR)-positive or HR-negative disease.
As people have become more conscious and vocal about diversity and inclusion, Page & Page’s Lisa Lishman says pharma should reassess how it conducts clinicaltrials. To address this problem, businesses operating in this sector should go back to the beginning of the process and look at how they conduct clinicaltrials.
VIKTORIA-1 is a clinicaltrial aimed at evaluating gedatolisib, a new investigational drug for patients with HR+/HER2-, Stage 3 or 4 breast cancer. This trial explores the potential of gedatolisib, given intravenously, to inhibit the PI3K/mTOR pathway, which is known to regulate cell growth and function.
By; Brooke Kaplan, Director, People Partner- HR Compliance & Human Capital Initiatives In April 2007, at 19 years old, I was a sophomore at the University of Maryland. In 2011, I participated in a Type 1 diabetes clinicaltrial and have continued exploring study opportunities ever since.
In patients with hormone receptor (HR)-positive, HER2-negative tumors resistant to aromatase inhibitors, addition of the investigational AKT inhibitor capivasertib to fulvestrant (Faslodex) doubled the median progression-free survival compared with placebo plus fulvestrant in the phase III CAPItello-291 clinicaltrial, according to results presented (..)
These findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research. months with letrozole alone (HR 0.58: 95% CI, 0.49 months among patients in the letrozole group (HR 0.66: 95% CI, 0.53
Paxlovid’s approval was based on results from the Phase III EPIC-HRclinicaltrial (NCT04960202). However, other studies found that the relapse in symptoms occurs in patients independent of Paxlovid use. In response to the approval news, some pointed concerns about long-term safety.
Decentralized ClinicalTrials, Hybrid Trials & Virtual Trials . Since the beginning of the pandemic, many traditional trials pivoted to a decentralized model and the importance of remote monitoring for clinicaltrials grew exponentially. How to Reinvent and Scale Decentralized ClinicalTrials.
.–(BUSINESS WIRE) December 5, 2020 — Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced new clinical data from its Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RAR?)
(Nasdaq: GILD) today announced results from the Phase 3 TROPiCS-02 study evaluating Trodelvy ® (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. Its safety and efficacy have not been established for this indication.
The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. months for Datroway and 18.3 months for chemotherapy.
Data from latest research presented at the ESMO Virtual Congress 2020 Lugano, Switzerland, 20 September 2020 – Adding abemaciclib to hormonal therapy reduces the risk of cancer recurrence by 25% in patients with high-risk early hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer, according to (..)
Verifiable and accessible in real-time, Investigator sites will also benefit by having employer’s VirTrial certifications as part of their dynamic research ready auditable (HR) GDPRDirectory® commonly used for business and compliance tracking, all from one place.”. That’s why we provide our Virtual Trial Capable training for sites.”
Therefore, the role of HR is critical at any organization. And on February 19, join An Insider’s Look: How Syneos Health is Shortening the Distance from Lab to Life in ClinicalTrials for key industry HR insights for jobseekers. This includes hiring practices and HR management.
After co-developing one of the world’s most widely used COVID-19 vaccines, Pfizer announced positive trial results on Friday for its investigational antiviral pill, revealing that the pill could cut the risk of hospitalization and death by 89 percent. The EPIC-HR study began enrolling participants in July 2021.
Sanofi has called time on breast cancer candidate amcenestrant – at one time one of its top pipeline prospects – after it missed the mark in another clinicaltrial. The post End of the line for Sanofi’s SERD amcenestrant as it fails first-line trial appeared first on.
placebo donors (HR = 0.64; 95 CI0.41-0.995; Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and top investigator of the FIDELIO-DKD trial. “ ESKD passed in0.9 of finerenone versus1.3 0.995; p = 0.046).
Since joining Xtalks in 2015, she has written over 1,000 articles on diverse topics from remote clinicaltrials and rare disease to medical device sterilization and drug pricing. She focuses on news relating to the food industry and writes blogs on recruitment and HR in the life sciences.
20-year research breakthrough offers new hope for high risk patients with HR+ breast cancer A new treatment for breast cancer patients with hormone receptor (HR+) early stage disease who are at a high risk of recurrence has been shown to reduce the risk by 25%, according to a study led by The Royal Marsden NHS […].
1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease. 6 Currently chemotherapy remains the only treatment option for patients with HR-positive tumours following progression on endocrine (hormone) therapy. 7 Few targeted options are available for those who are HR-negative.
HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options. months vs. 11.2
She focuses on news relating to the food industry and writes blogs on recruitment and HR in the life sciences. She also writes informative blogs on topics including drug development, life science company profiles and HR content pertaining to the pharma and biotech industries.
Oddly,” she adds, at a recent meeting she attended of human resources (HR) leaders in the New Jersey biopharmaceutical sector, “there was no discussion on the actual merits of employees returning to the office. Senior leadership and HR are not included in the vast majority of remote teams, Mahoney-Jewels notes.
Ajay Srivastava, Senior Medical Director, Medical Department, and Carrie Sheil, Senior Director, ClinicalTrial Management, both from Medpace, shared changes to the CKD treatment paradigm and offered advice on optimizing study design for CKD trials. GFR also forms a basis of eligibility requirements for clinicaltrials.
Developed by Pfizer, Paxlovid was granted emergency use authorization (EUA) to treat COVID-19 patients based on the EPIC-HR study which showed it reduced the risk of hospitalization or death by almost 90 percent. In clinicaltrials, 5.6 Paxlovid can be prescribed for anyone age 12 and older who weighs at least 88 pounds.
Takeda has decided that there is a future for its aurora kinase A inhibitor alisertib after it failed a phase 3 trial in lymphoma – but the company won’t be taking the drug forward itself. Takeda is also in line for just over $287 million in potential milestone payments, plus royalties on net sales if it reaches the market.
The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 The monarchE trial is ongoing and patients will continue to be followed to assess safety, PROs and other endpoints.
As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e.,
This webinar is not only addressed to tax and regulatory specialists, but also to R&D, supply chain, HR and other operational people interested in understanding how ESG can drive value creation. Date Monday, 20 September 2021. Time 8:30 – 10:00am CEST.
That includes delivering innovative clinicaltrials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. chief medical officer, Loxo@Lilly. chief medical officer, Loxo@Lilly. Source link: [link]
Accessing clinicaltrials. FREE continuing education credits/contact hours for social workers and nurses, 7 FREE continuing education credits for patient advocates, and 6 FREE PDCs for HR professionals. The latest updates in the American Rescue Plan, as well as new consumer programs and financial help available due to Covid-19.
ARV-471 is currently in a Phase 2 dose expansion clinicaltrial for the treatment of patients with estrogen receptor (ER) positive / human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer. “We The estrogen receptor is a well-known disease driver in most breast cancers.
In the clinical research sector, the successes achieved in running virtual clinicaltrials have demonstrated that it’s possible to conduct all-important drug research without requiring patients to make as many in-person visits to sites. Supporting Diversity to Strengthen Business.
KEYTRUDA is approved for the treatment of patients with PD-L1-positive, hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative, inoperable or recurrent breast cancer, based on the results of the Phase 3 KEYNOTE-355 trial. months (95% CI, 7.6-11.3) months (95% CI, 5.3-7.5), months [95% CI, 5.4-32.4]
Patients treated with this combination had a decrease in risk of disease progression or death by 48% (HR=0.52, p=0.000002) compared to patients treated with placebo and rituximab, with a median PFS of 21.5 Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.
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