Sat.Sep 19, 2020

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AstraZeneca, Under Fire for Vaccine Safety, Releases Trial Blueprints

NY Times

Experts are concerned that the company has not been more forthcoming about two participants who became seriously ill after getting its experimental vaccine.

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UC study sheds light on cancer treatment, COVID-19

Scienmag

Death rates spike for patients with cancer and COVID-19 who are treated with certain anti-cancer therapies at certain times Credit: Colleen Kelley/UC Creative + Brand University of Cincinnati researchers have found that certain treatments for cancer may increase the chance of death if they contract COVID-19. These findings from a multicenter study, presented at the […].

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Russia Is Slow to Administer Virus Vaccine Despite Kremlin’s Approval

NY Times

After announcing the first government clearance for a coronavirus vaccine, Russia delayed distributing it. It remains unclear how many people have received it.

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New first-line treatment option for metastatic kidney cancer

Scienmag

Data from latest research presented at the ESMO Virtual Congress 2020 Lugano, Switzerland, 19 September 2020 – The results of the phase 3 CheckMate 9ER trial have provided a new first-line treatment option for patients with metastatic kidney cancer. The late breaking results are presented at ESMO 2020. (1) The trial took two drugs used […].

Trials 75
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Cancer taskforce aims to reduce patient backlog

The Pharma Data

Image copyright. Getty Images. A new taskforce will meet next week to kick-start the recovery of cancer services across the NHS in England. Charities believe the pandemic has led to a significant reduction in people being referred for urgent cancer treatment. Cancer Research UK says three million people have missed cancer screenings since March. The taskforce aims to investigate how to ensure more people are referred, tested and checked.

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Size and sleep: New research reveals why little things sleep longer

Scienmag

Why does the mouse sleep five times longer than the elephant? Why do babies sleep longer than adults? If these sound like riddles, that’s because they have been. Sleep, in spite of its ubiquity, holds mysteries that have perplexed scientists for decades. Now, using data from humans and other mammals, a team of scientists including […].

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Complex phonological tests are useful for diagnosing reading dysfunction

Scienmag

HSE University researchers have confirmed that the level of phonological processing skills in children can impact their ability to master reading. Complex phonological tests are best suited to detect phonological impairment. The study was published on September 6, 2020, in the Journal of Research in Reading. Phonological processing is the ability to distinguish phonemes (minimal […].

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Covid: PM considering new restrictions amid second coronavirus wave

The Pharma Data

Media playback is unsupported on your device. Media caption Newcastle pub-goers adapt to new coronavirus measures. Boris Johnson is spending the weekend considering whether to tighten Covid-19 measures in England, after saying the UK was “now seeing a second wave” The government is understood to be looking at a ban on households mixing, and reducing opening hours for pubs.

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Research organizations announce joint commitment to advancing scholarly study of racism

Scienmag

Washington, September 18, 2020–The American Educational Research Association (AERA), the Society of Research on Adolescence (SRA), and the Society for Research in Child Development (SRCD) have announced that they are jointly committing to advancing scholarly inquiry related to racism and its impact on education- and youth development-related settings, processes, and outcomes, and promoting the use […].

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Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Significant Survival Benefits in Patients with Advanced Renal Cell Carcinoma in Pivotal Phase 3 CheckMate -9ER Trial

BioTech 365

Opdivo in combination with CABOMETYX showed superior overall survival and doubled median progression-free survival and objective response rate with a favorable safety profile vs.

Trials 52
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Which pharmaceutical drugs have the most drug patents in Switzerland?

Drug Patent Watch

This chart shows the drugs with the most patents in Switzerland. 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 Switzerland? appeared first on DrugPatentWatch - Make Better Decisions.

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Novartis reports late-breaking data from Phase III COMBI-i trial of spartalizumab (PDR001) with Tafinlar® and Mekinist® in advanced melanoma

BioTech 365

Based on unprecedented progression-free survival results, Tafinlar (dabrafenib) + Mekinist (trametinib) confirmed as standard-of-care, targeted therapy for advanced BRAF-mutated melanoma1-4 Data show positive durable responses and progression-free survival benefit for patients treated with Tafinlar + Mekinist in the comparator arm … Continue reading →

Trials 40
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Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020

BioTech 365

Data from the Phase III IMpassion031 study demonstrated that Tecentriq in combination with chemotherapy improved pathological complete response for patients with early triple-negative breast cancer (TNBC), when compared to placebo plus chemotherapy Final overall survival data from the Phase III … Continue reading →

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Novartis Piqray® data show survival benefit for patients with HR+/HER2- advanced breast cancer with a PIK3CA mutation

BioTech 365

In SOLAR-1 final analysis, Piqray (alpelisib) plus fulvestrant demonstrated 8 months clinically relevant improvement in overall survival (OS) in HR+/HER2- advanced breast cancer (aBC) patients with a PIK3CA mutation compared to fulvestrant alone1 14+ months OS improvement was achieved in … Continue reading →

HR 40
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Genentech Presents New Data From Multiple Phase III Studies of Tecentriq in Triple-Negative Breast Cancer at ESMO Virtual Congress 2020

BioTech 365

— Data from the Phase III IMpassion031 study demonstrated that Tecentriq in combination with chemotherapy improved pathological complete response for patients with early triple-negative breast cancer (TNBC), when compared to placebo plus chemotherapy — — Final overall survival data from … Continue reading →

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Merck’s KEYTRUDA® (pembrolizumab) Reduced the Risk of Distant Metastasis or Death by 40% Versus Placebo as Adjuvant Treatment in Resected, High-Risk Stage III Melanoma

BioTech 365

Long-Term Findings From EORTC1325/KEYNOTE-054 Show Adjuvant KEYTRUDA Demonstrated a Sustained Recurrence-Free Survival Benefit Versus Placebo Across Stage IIIA (>1 mm Lymph Node Metastasis), IIIB and IIIC Melanoma Merck Is Advancing a Broad Clinical Program Evaluating KEYTRUDA for the Early Treatment … Continue reading →

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#news #biotech ESMO: Novartis posts data from failed spartalizumab phase 3, reaffirms commitment to PD-1 combos

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: ESMO: Novartis posts data from failed spartalizumab phase 3, reaffirms commitment to PD-1 combos.

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ESMO 2020: Cabometyx® (cabozantinib) in Combination With Opdivo® (nivolumab) Demonstrates Significant Survival Benefits in Patients With Advanced Renal Cell Carcinoma in Pivotal Phase III CheckMate -9ER Trial

BioTech 365

Cabometyx® in combination with Opdivo® showed superior overall survival and doubled median progression-free survival and objective response rate versus sunitinib, and had a favorable safety profile Efficacy benefits were observed across key patient subgroups, including all International Metastatic Renal Cell … Continue reading →

Trials 40
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The New Age of Decentralized Clinical Trials

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.

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TAGRISSO Reduced the Risk of Disease Recurrence in the Brain by 82% in the Adjuvant Treatment of Early-Stage EGFR-Mutated Lung Cancer

BioTech 365

ADAURA Phase III trial data at ESMO reinforce the proven clinical activity of TAGRISSO in treating central nervous system metastases WILMINGTON, Del.

Trials 52
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Immunomedics Announces Positive Results from Pivotal Phase 2 TROPHY U-01 Study of Trodelvy™ in Metastatic Urothelial Cancer

BioTech 365

Trodelvy achieves a 27 percent overall response rate and a 5.

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Trodelvy™ Significantly Extends Survival in Phase 3 ASCENT Study of Metastatic Triple-Negative Breast Cancer

BioTech 365

Trodelvy significantly reduced the risk of death by 52 percent, with a median overall survival (OS) of 12.1 months compared to 6.

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