BioTech 365

SEPTEMBER 28, 2021

This HR+/HER2-VE Breast … Continue reading →

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The Pharma Data

MARCH 25, 2021

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

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Medical Xpress

DECEMBER 8, 2022

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 clinical trial, according to results presented (..)

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Pharmaceutical Technology

JULY 25, 2022

AstraZeneca noted that the sBLA is based on findings from the randomised, open-label Phase III DESTINY-Breast04 clinical trial of Enhertu in priorly treated subjects with HER2-low metastatic breast cancer with hormone receptor (HR)-positive or HR-negative disease.

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Scienmag

SEPTEMBER 20, 2020

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 (..)

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pharmaphorum

AUGUST 17, 2022

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 clinical trial. The post End of the line for Sanofi’s SERD amcenestrant as it fails first-line trial appeared first on.

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The Pharma Data

SEPTEMBER 28, 2021

Data from the IMpower010 trial were published simultaneously within the Lancet. Data from the IMpower010 trial were published simultaneously within the Lancet. In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the danger of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88)

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Drug Discovery World

JUNE 7, 2023

Positive primary endpoint data from Novartis’ pivotal Phase III NATALEE trial has been presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

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Pharmaceutical Technology

MAY 26, 2023

Paxlovid’s approval was based on results from the Phase III EPIC-HR clinical trial (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.

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The Pharma Data

NOVEMBER 8, 2021

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).

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Drug Discovery World

DECEMBER 14, 2023

Antibody drug conjugate MBRC-101 MBrace Therapeutics presented preclinical data demonstrating the potential of its novel antibody drug conjugate MBRC-101 for the treatment of solid tumours including hormone receptor-positive (HR+) and triple negative breast cancers. months in heavily pre-treated patients. “We

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Drug Discovery World

MARCH 24, 2023

Regulatory approval The company and the US Food and Drug Administration (FDA) agreed to the integrated Phase II/III trial design for AIPAC-003 that will help inform a Biologics License Application (BLA). The Phase III will have overall survival as the primary objective and may include a specific patient population.

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The Pharma Data

APRIL 27, 2022

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.

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pharmaphorum

SEPTEMBER 27, 2021

As people have become more conscious and vocal about diversity and inclusion, Page & Page’s Lisa Lishman says pharma should reassess how it conducts clinical trials. To address this problem, businesses operating in this sector should go back to the beginning of the process and look at how they conduct clinical trials.

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The Pharma Data

APRIL 28, 2023

In August 2022, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza based on positive results from the pivotal PROpel trial, also published in NEJM Evidence. maturity, HR of 0.81, 95% CI 0.67-1.00; 0.43) and OS (HR of 0.29, 95% CI, 0.14-0.56). 0.94), and a modest trend for OS (HR of 0.91, 95% CI, 0.73-1.13).

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Drug Discovery World

JUNE 2, 2023

AI-designed monoclonal antibody ‘redirects’ the immune system Immuno-oncology company Aulos Bioscience has revealed interim results from an ongoing Phase I/II trial of monoclonal antibody AU-007 in solid tumours.

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XTalks

NOVEMBER 8, 2021

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.

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VirTrial

OCTOBER 14, 2020

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.”

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The Pharma Data

APRIL 28, 2023

In August 2022, the FDA accepted the supplemental New Drug Application for LYNPARZA plus abi/pred for priority review based on positive results from the pivotal Phase 3 PROpel trial, which were also published in NEJM Evidence. 0.43]) and OS (HR=0.29 [95% CI, 0.14-0.56]) 1.00]; p=0.0544). While the observed 7.4-month

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XTalks

FEBRUARY 17, 2021

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 Clinical Trials for key industry HR insights for jobseekers. This includes hiring practices and HR management.

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Scienmag

SEPTEMBER 29, 2020

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 […].

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The Pharma Data

JUNE 2, 2023

That includes delivering innovative clinical trials 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]

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The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Phase 2 FIGHT Trial: Summary of Efficacy*. Wainberg, M.D., 5% (n=118).

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The Pharma Data

APRIL 16, 2021

Opdivo is the first and only immunotherapy in combination with chemotherapy to deliver superior overall survival versus chemotherapy alone in a trial of this patient population 1. 5 (OS HR 0.71; 95% CI: 0.61 5 (OS HR 0.71; 95% CI: 0.61 5: progression-free survival (PFS) HR 0.68; 95% CI: 0.58 PRINCETON, N.J.–(BUSINESS

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The Pharma Data

AUGUST 30, 2021

Finerenone significantly reduced the risk of the composite primary endpoint of time to first occurrence of CV death or non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization by 13% (relative risk reduction, HR 0.87 [95% CI: 0.76-0.98]; 1.09]) and heart failure hospitalization (HR 0.71 [95% CI: 0.56-0.90])

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XTalks

DECEMBER 4, 2020

Ajay Srivastava, Senior Medical Director, Medical Department, and Carrie Sheil, Senior Director, Clinical Trial 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 clinical trials.

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Pharma Business Blog

AUGUST 15, 2021

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.

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The Pharma Data

DECEMBER 29, 2020

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.,

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The Pharma Data

AUGUST 30, 2021

New Kisqali ® (ribociclib)* overall survival (OS) results from MONALEESA-2 trial in HR+/HER2? Health-related quality of life, pain and safety outcomes from phase III VISION trial of investigational radioligand therapy 177 Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer. 19, 2:10 PM CEST].

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Triage Cancer

APRIL 27, 2021

Accessing clinical trials. 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.

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The Pharma Data

JULY 22, 2021

ARV-471 is currently in a Phase 2 dose expansion clinical trial 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.

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The Pharma Data

JUNE 19, 2023

The findings bolster the idea, which is currently under investigation in at least three clinical trials, that when it comes to treating resistant breast cancer, two drugs may be better than one.

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FDA Law Blog

JUNE 13, 2023

To quote everyone’s favorite flautist (and TikTok sensation) Lizzo, “ it’s about d@mn time! ” (Sorry for the bowdlerization, but we’re trying to make it past everyone’s filter and HR warned us in any event.) Lastly, and we’re unsure why this requires repeating, and yet, here we are, don’t mess with the clinical trial numbers.

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The Pharma Data

JUNE 7, 2023

The secondary endpoint of DMFS, defined as the time from the first dose of KEYTRUDA until the date of first distant recurrence or death from any cause, was pre-specified for statistical testing following the positive primary endpoint of recurrence-free survival (RFS).

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Drug Discovery World

APRIL 4, 2023

Read more: FDA clears in vivo gene editing therapy for trials in US RRx-001, EpicentRx Most recently, the FDA granted Fast Track Designation to RRx-001 for the prevention/attenuation of severe oral mucositis in chemotherapy and radiation-treated head and neck cancer patients.

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XTalks

MARCH 25, 2021

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.

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The Pharma Data

JULY 29, 2021

SYNAPSE showed that there was a 57% reduction in the proportion of patients who had surgery in the group treated with mepolizumab vs. placebo, HR=0.43 (95% CI 0.25, 0.76). With 41 clinical trials, mepolizumab has been studied in over 4,000 patients. The mechanism of action for mepolizumab has not been definitively established.

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