Sat.Oct 24, 2020

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5 takeaways from the FDA's closely watched coronavirus vaccine meeting

Bio Pharma Dive

Experts convened by the regulators debated how much data would warrant an approval, while pressing government officials on their distribution plans.

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Cause of Alzheimer’s disease traced to mutation in common enzyme

Scienmag

Mutation to MARK4 makes proteins stickier and more likely to clump in brain Credit: Tokyo Metropolitan University Tokyo, Japan – Researchers from Tokyo Metropolitan University have discovered a new mechanism by which clumps of tau protein are created in the brain, killing brain cells and causing Alzheimer’s disease. A specific mutation to an enzyme called […].

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New patent expiration for Novartis drug TYZEKA

Drug Patent Watch

Annual Drug Patent Expirations for TYZEKA Tyzeka is a drug marketed by Novartis and is included in two NDAs. There are three patents protecting this drug. This drug has fifty-five…. The post New patent expiration for Novartis drug TYZEKA appeared first on DrugPatentWatch - Make Better Decisions.

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New model predicts which patients with kidney disease may develop heartbeat irregularities

Scienmag

Highlights * A new model that incorporates a type of artificial intelligence can accurately predict which individuals with chronic kidney disease face a high risk of developing atrial fibrillation. * Results from the study will be presented online during ASN Kidney Week 2020 Reimagined October 19-October 25. Washington, DC (October 24, 2020) — A new […].

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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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Knowing What to Expect May Help After Sexual Assault

The Pharma Data

SATURDAY, Oct. 24, 2020 — Sexual assault is common in America, with an attack occurring every 73 seconds. But having supportive care at the emergency department and afterwards can help heal the trauma, Penn State doctors say. One in five women is raped during their lifetime, yet only 25% report it, according to the National Sexual Violence Resource Center.

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Oncotarget: Evaluation of cellular alteration & inflammatory profile of cells

Scienmag

Oncotarget recently published “Evaluation of cellular alterations and inflammatory profile of mesothelial cells and/or neoplastic cells exposed to talc used for pleurodesis” Credit: Correspondence to – Milena Marques Pagliarelli Acencio – milena.acencio@incor.usp.br Oncotarget recently published “Evaluation of cellular alterations and inflammatory profile of mesothelial cells and/or neoplastic cells exposed to talc used for pleurodesis” which […].

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Birthrates, marriage will change dramatically in post-pandemic world, say scientists

Scienmag

Credit: Jeff Berlin COVID-19 and America’s response to it are likely to profoundly affect our families, work lives, relationships and gender roles for years, say 12 prominent scientists and authors who analyzed 90 research studies and used their expertise to evaluate our reaction to the pandemic and predict its aftermath. The group, which included several […].

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Turning Point Therapeutics Presents Initial Clinical Data From Phase 1 SHIELD-1 Study of Novel MET/SRC/CSF1R Inhibitor TPX-0022 at 2020 EORTC-NCI-AACR Symposium

BioTech 365

Preliminary Clinical Activity and Safety Profile Support Advancing to Dose Expansion in Multiple Tumor Types Recommended Phase 2 Dose Determination Ongoing Preclinical Combination Data for Lead Drug Candidate Repotrectinib in both KRAS Tumor Models and Pediatric Neuroblastoma Tumor Models Also … Continue reading →

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Model predicts acute kidney injury requiring dialysis in patients with COVID-19

Scienmag

Highlights In a recent study, a new algorithm achieved good performance for predicting which hospitalized patients will develop acute kidney injury requiring dialysis. Results from the study will be presented online during ASN Kidney Week 2020 Reimagined October 19-October 25. Washington, DC (October 24, 2020) — A new artificial intelligence-based algorithm may help clinicians predict […].

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Syros Presents Initial Data from Phase 1 Clinical Trial of SY-5609, Its Selective Oral CDK7 Inhibitor, at EORTC-NCI-AACR Meeting

BioTech 365

Early Dose-Escalation Data Demonstrate Proof of Mechanism and Support Ongoing Development of SY-5609 for Difficult-to-Treat Cancers On Track to Report Additional Data, including Clinical Activity Data, in Mid-2021 CAMBRIDGE, Mass.

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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 companies have the most drug patents in Sweden?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Sweden. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Sweden? appeared first on DrugPatentWatch - Make Better Decisions.

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#news #biotech KSQ boosts PARP inhibition in animal models of ovarian and breast cancers with USP1 inhibitor

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: KSQ boosts PARP inhibition in animal models of ovarian and breast cancers with USP1 inhibitor.

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U.S. Daily COVID-19 Case Count Sets New Record for the Pandemic

The Pharma Data

SATURDAY, Oct. 24, 2020 — The United States broke a bleak record on Friday, logging the highest daily number of new coronavirus cases since the pandemic began. The tally of over 80,000 new infections eclipses the previous record of 76,533 new cases set on July 17, during a surge in cases across the Sun Belt, the Washington Post reported. The country could soon be facing its worst stretch of the pandemic, with some hospitals in the West and Midwest already overwhelmed and death counts begin

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Aileron Therapeutics Announces Proof-of-Concept Clinical Data from Ongoing ALRN-6924 Phase 1b Trial Presented in Late-Breaking Presentation at the EORTC-NCI-AACR Annual Symposium

BioTech 365

First and only chemoprotective therapy in clinical development that utilizes a biomarker strategy designed to protect patients with p53-mutated cancers from chemotherapy-induced toxicities and side effects Treatment with ALRN-6924 prior to topotecan administration resulted in a protective effect against severe … Continue reading →

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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.