Pharmaceutical Technology

MARCH 6, 2023

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.

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Pharmaceutical Technology

JULY 1, 2022

The latest filing is based on non-clinical and clinical data for Paxlovid and also comprised data from the Phase II/III EPIC-HR clinical trial. The safety data currently available for the therapy is in line with over 3,500 Paxlovid-treated subjects across the EPIC clinical development programme.

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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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HR Hormones Drugs Research 45

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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Hormones HR Clinical Trials Clinical Trials 73

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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HR Hormones Clinical Trials Clinical Trials 130

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

SEPTEMBER 28, 2021

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) 0.88) in people with Stage II-IIIA NSCLC whose tumours express PD-L1?1%,

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Clinical Trials Clinical Trials Trials HR 52

Drug Discovery World

JUNE 7, 2023

in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer. There was a consistent, clinically meaningful invasive disease-free survival (iDFS) benefit across key pre-specified subgroups.

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HR Drugs Hormones Trials 52

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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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

NOVEMBER 8, 2021

placebo donors (HR = 0.64; 95 CI0.41-0.995; The effect of finerenone on the compound order issues was reflected by a 36 relative threat reduction of end- stage order complaint (ESKD). ESKD passed in0.9 of finerenone versus1.3 0.995; p = 0.046).

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Clinical Trials Clinical Trials Trials HR 52

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.

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Trials HR Hormones Development 52

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 of additional follow-up and 78.3% The results show a 25.1%

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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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Life Science HR Clinical Research Clinical Trials 97

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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Clinical Trials Clinical Trials Trials Vaccination 122

The Pharma Data

APRIL 28, 2023

Results from the PROpel trial showed a statistically significant and clinically meaningful 34% reduction in the risk of radiographic disease progression or death with Lynparza plus abiraterone with prednisone or prednisolone, versus abiraterone alone in patients with mCRPC (hazard ratio [HR] 0.66; 95% confidence interval [CI] 0.54-0.81;

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Drug Discovery World

JUNE 2, 2023

Syros to present new clinical data at ASCO 2023 Biopharmaceutical company Syros Pharmaceuticals has announced new clinical data from the Phase I/Ib clinical trial evaluating SY-5609 in patients with relapsed/refractory pancreatic ductal adenocarcinoma (PDAC), HR+ breast cancer and other solid tumours.

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Drugs HR Antibody Clinical Trials 52

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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The Pharma Data

APRIL 28, 2023

Results from the PROpel trial showed a statistically significant and clinically meaningful 34% reduction in the risk of radiographic disease progression or death with LYNPARZA plus abi/pred (HR=0.66 [95% CI, 0.54-0.81]; 0.43]) and OS (HR=0.29 [95% CI, 0.14-0.56]) months versus 16.6 months, respectively. 1.00]; p=0.0544).

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XTalks

NOVEMBER 8, 2021

Pfizer’s results come from an interim analysis of the Phase II/III EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) randomized, double-blind study of non-hospitalized adult patients with COVID-19 at risk of developing severe disease. The EPIC-HR study began enrolling participants in July 2021.

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HR Trials Drugs Development 98

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.”.

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Compliance Clinical Research Clinical Trials Clinical Trials 98

The Pharma Data

APRIL 16, 2021

In the trial of this patient population, Opdivo plus chemotherapy demonstrated superior overall survival (OS) compared to chemotherapy alone, both in all randomized patients (OS HR 0.80; 95% CI: 0.71 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

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HR Dermatology Trials Clinical Trials 52

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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HR Hormones Medicine Trials 52

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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HR Life Science Clinical Trials Clinical Trials 52

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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HR Clinical Trials Clinical Trials Nurses 52

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 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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Protein Development HR Hormones 52

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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HR Production Trials Containment 52

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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The Pharma Data

NOVEMBER 19, 2021

About the Phase2/3 EPIC-HR Study Interim Analysis In July 2021, Pfizer initiated the Phase2/3 EPIC-HR ( Evaluation of Protease Inhibition for COVID-19 in High- Threat Cases) randomized, double-eyeless study ofnon-hospitalized adult cases with COVID-19, who are at high threat of progressing to severe illness.

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The Pharma Data

JANUARY 14, 2021

“The FIGHT trial results demonstrate that treatment with bemarituzumab in combination with chemotherapy can deliver a significant reduction in the risk of disease progression and death in gastric cancer patients whose tumors overexpress FGFR2b.”. HR (95% CI): 0.68. HR (95% CI): 0.54 (0.33, 0.87).

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Trials HR Containment Development 52

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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FDA Approval In-Vivo Gene Editing Drugs 52

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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Clinical Trials Clinical Trials HR Drugs 40

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). The safety profile of KEYTRUDA was consistent with findings from previous studies.

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Clinical Trials Clinical Trials HR Medicine 40

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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The Pharma Data

MARCH 17, 2022

The study found that adjuvant treatment with KEYTRUDA significantly improved disease-free survival (DFS), one of the dual primary endpoints, reducing the risk of disease recurrence or death by 24% compared to placebo (hazard ratio [HR]=0.76 [95% CI, 0.63-0.91]; 0.91]; p=0.0014) in patients with stage IB (?4

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Clinical Trials Clinical Trials Research Trials 52

pharmaphorum

JUNE 17, 2022

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 clinical trials, 5.6 Paxlovid can be prescribed for anyone age 12 and older who weighs at least 88 pounds.

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