Thu.Nov 11, 2021

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Detailed Roche study results muddy another Alzheimer's hypothesis

Bio Pharma Dive

Data presented at an Alzheimer's meeting raised more questions about the seeming benefit of Roche and AC Immune's drug semorinemab, which they claim is the first of its kind to slow deterioration of memory.

Drugs 316
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University of Oxford begins human trials of Ebola vaccine

Pharma Times

ChAdOxl biEBOV is being tested for safety and immunogenicity, and may protect against multiple species of the virus

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Moderna, escalating dispute with NIH, claims government had no role in key vaccine patent

Bio Pharma Dive

The biotech claimed its NIH partners were involved only after a key discovery was made "by Moderna scientists using Moderna technology." The dispute could end up in court.

Scientist 306
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Valneva gets EU deal for COVID jab, and may sue UK

pharmaphorum

Shares in France’s Valneva leaped after it got an EU order to supply 60 million doses of its COVID-19 vaccine VLA2001 over the next two years, including 27 million next year. The deal for the adjuvanted, inactivated SARS-CoV-2 vaccine still depends on authorisation of the jab by the European Medicines Agency (EMA) which is due to start a rolling review of VLA2001 shortly, but Valneva thinks it could start delivering supplies to the EU in April next year.

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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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World Chicken Day: Is Vegan Chicken Legally Allowed to be Called ‘Chicken?’

XTalks

While chicken is the most common type of poultry consumed around the world, to some, its meaning has changed considerably over the last few years thanks to the growing vegan movement. Today, on World Chicken Day, let’s explore how chicken has evolved throughout the last decade and determine whether vegan chicken can legally be called “chicken.”. Plant-based meat alternatives have helped reshape the landscape of the food industry over the last few years.

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Fishawack Health welcomes expert-led dermatology initiative FIDE to its group

pharmaphorum

KNUTSFORD, United Kingdom — Fishawack Health welcomes FIDE, an independent organization providing its clients with insight from clinical key opinion leaders in inflammatory dermatology. [Image: From left, FIDE Directors Richard GB Langley, MD; Richard Warren, MD, PhD; Kenneth B Gordon, MD; Bruce E Strober, MD, PhD]. November 10, 2021, UK. Fishawack Health, the leading commercialization partner for the life science industry, welcomes FIDE to its group—an independent expert-led consultancy specia

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New positive long-term data for JAK inhibitor Olumiant in RA

Pharma Times

Olumiant maintained a consistent safety profile in a long-term analysis of patients with rheumatoid arthritis

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Monash University study uncovers a new understanding of how mesenchymal stromal cells benefit patients in cell therapy

Scienmag

The therapeutic benefit to patients receiving mesenchymal stromal cell (MSC) therapy is not because the injected cells remain viable, but because of cell death, researchers at the Monash Biomedicine Discovery Institute (BDI) have found. Credit: (C) Professor Tracy Heng The therapeutic benefit to patients receiving mesenchymal stromal cell (MSC) therapy is not because the injected […].

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Valneva receives EU deal for COVID jab, and seeks apology from UK

Pharma Times

Decision follows the UK government’s termination of their deal with Valneva in September

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Competing quantum interactions enable single molecules to stand up

Scienmag

Nanoscale machinery has many uses, including drug delivery, single-atom transistor technology, or memory storage. However, the machinery must be assembled at the nanoscale which is a considerable challenge for researchers. Credit: Credit: University of Warwick Nanoscale machinery has many uses, including drug delivery, single-atom transistor technology, or memory storage.

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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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New AI Collaborations Reflect Rapid Growth in Pharmaceutical Industry

BioSpace

As the capabilities have been proven, AI is establishing a firm foothold in the key areas of R&D, drug development, clinical trials, and, to some extent, patient-facing products.

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IU findings published in New England Journal of Medicine show effectiveness of low-cost medicine in treating high blood pressure in people with advanced kidney disease

Scienmag

INDIANAPOLIS – An all Indiana University School of Medicine team of researchers led by, Rajiv Agarwal, MD, professor of medicine and staff physician at the Roudebush VA, and including Arjun Sinha, MD, associate professor of clinical medicine and renal section chief at the Roudebush VA, and Wanzhu Tu, PhD, professor of biostatistics and health data sciences and research […].

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Adaptimmune Confident T-Cell Therapy Will Hit Efficacy Endpoint

BioSpace

?Adaptimmune said that afamitresgene autoleucel (afami-cel) had a significantly positive effect on patients diagnosed with myxoid/round cell liposarcoma (MRCLS) and advanced synovial sarcoma.

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Black hole found hiding in star cluster outside our galaxy

Scienmag

Using the European Southern Observatory’s Very Large Telescope (ESO’s VLT), astronomers have discovered a small black hole outside the Milky Way by looking at how it influences the motion of a star in its close vicinity. This is the first time this detection method has been used to reveal the presence of a black hole […].

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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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Sanofi, Be the Match, and DiMe to weigh in on patient centricity

Outsourcing Pharma

During our November 17 webinar Patient-centric solutions, a group of professionals representing a range of perspectives will share ideas and innovations.

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It takes more than one mutant copy of the PIK3CA gene to make breast cancer more aggressive

Scienmag

Breast cancers that have an overactive PI3K enzyme, involved in cell growth and division, tend to be more aggressive and to spread and divide more like stem cells. But a new study by Ralitsa Madsen of University College London and colleagues publishing November 11th in the journal PLOS Genetics uncovers a surprising relationship between PI3K […].

Gene 86
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Non-Profit Period for AstraZeneca COVID Vaccine Coming to an End

BioSpace

The total revenue for the quarter was $9.74 billion, a leap of 47%. The COVID-19 vaccine, Vaxzevria, only contributed 1% to the company’s profit.

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Study reveals common loud noises cause fluid buildup in the inner ear and suggests simple possible cure for noise-induced hearing loss

Scienmag

LOS ANGELES — Exposure to loud noise, such as a firecracker or an ear-splitting concert, is the most common preventable cause of hearing loss. Research suggests that 12% or more of the world population is at risk for noise-induced loss of hearing. Credit: Ricardo Carrasco III LOS ANGELES — Exposure to loud noise, such as […].

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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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Moderna: Vaccine mRNA Sequence Was Selected Without NIH Input

BioSpace

Moderna responded to claims that the government should be co-patent owners of the mRNA vaccine developed by the company and said its mRNA sequence was exclusively selected by Moderna scientists.

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Czech scientists become first to observe an inhomogeneous electron charge distribution on an atom

Scienmag

Until now, observing subatomic structures was beyond the resolution capabilities of direct imaging methods, and this seemed unlikely to change. Czech scientists, however, have presented a method with which they became the first in the world to observe an inhomogeneous electron charge distribution around a halogen atom, thus confirming the existence of a phenomenon that […].

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Updated guidelines for managing long-term effects of COVID-19 published

Pharma Times

New guidelines from NICE, SIGN and the RCGP includes an update to original list of common symptoms

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Making a sleep device fit

Scienmag

Experts are working on a way to make dental appliances more effective in reducing the effects of sleep apnea and snoring. Credit: Flinders University Experts are working on a way to make dental appliances more effective in reducing the effects of sleep apnea and snoring. Led by Flinders University, Australian sleep health researchers have combined […].

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Biden Nominates Robert Califf to Lead FDA at Critical Juncture

BioSpace

President Joe Biden has nominated former U.S. Food and Drug Administration Commissioner Robert Califf to reprise his role at the agency’s helm.

Drugs 92
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Humans hastened the extinction of the woolly mammoth

Scienmag

New research shows that humans had a significant role in the extinction of woolly mammoths in Eurasia, occurring thousands of years later than previously thought. Credit: Credit Mauricio Anton ([link] New research shows that humans had a significant role in the extinction of woolly mammoths in Eurasia, occurring thousands of years later than previously thought. […].

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Biogen Says Aduhelm Significantly Lowers Another Top Alzheimer's Biomarker

BioSpace

Boston-based Biogen shared data from two Phase III studies at the Clinical Trials on Alzheimer’s Disease conference that showed the latest efficacy data of Aduhelm (aducanumab).

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PFAS exposure, high-fat diet drive prostate cells’ metabolism into pro-cancer state

Scienmag

CHAMPAIGN, Ill. — Exposure to PFAS – a class of synthetic chemicals utilized in food wrappers, nonstick cookware and other products – reprograms the metabolism of benign and malignant human prostate cells to a more energy efficient state that enables the cells to proliferate at three times the rate of nonexposed cells, a new study […].

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Testimony: Holmes Offered to Buy Out Investor Seeking "Straight Answers"

BioSpace

Houston-based money manager Alan Eisenman testified in the ongoing Elizabeth Holmes fraud trial that he sought “straight answers” about the company’s work for several years.

Trials 80
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Simple silicon coating solves long-standing optical challenge

Scienmag

Quick bursts of laser light, lasting less than a trillionth of a second, are used in a range of applications today. These ultrashort laser pulses have allowed scientists to observe chemical reactions in real-time, image delicate biological samples, build precise nanostructures, and send long-distance, high-bitrate optical communications. Credit: Harvard SEAS Quick bursts of laser light, […].

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Research Roundup: How Age Impacts Post-COVID Antibody Numbers and More

BioSpace

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

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Gut microbiota differences seen in people with autism may be due to dietary preferences

Scienmag

Research suggested that autism spectrum disorder (ASD) may be at least partly caused by differences in the composition of the gut microbiota, based on the observation that certain types of microbes are more common in people with autism. But a paper appearing November 11 in the journal Cell suggests that the link may actually work […].

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.