Mon.Oct 25, 2021

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Why natural language processing (NLP) is a critical part of your real world data strategy

Bio Pharma Dive

The barrier to knowledge can be eliminated when pharmaceutical companies use natural language processing to analyze unstructured content.

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The future of healthcare?

World of DTC Marketing

SUMMARY: One definitive trend to emerge from the pandemic is that more people are becoming healthcare consumers. They want healthcare to be easier to access and don’t want to wait for necessary medical tests. This could lead to an evolution in urgent care centers, but it will require disruptive thinking. Urgent care centers aren’t new, but they are evolving to become “total care” in some areas.

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Roche's refillable eye implant becomes Eylea's latest threat

Bio Pharma Dive

The FDA has approved Susvimo, a device that continuously administers a version of Roche's Lucentis over several months. It could challenge Regeneron's top-selling drug.

Drugs 305
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Strike two for Novartis’ lung cancer antibody canakinumab

pharmaphorum

Expectations for Novartis’ canakinumab as a therapy for cancer have taken another dive, after a second phase 3 trial in non-small cell lung cancer (NSCLC) failed to meet its primary objectives. Novartis isn’t giving up on the programme yet, as it still has other trials of canakinumab in play, but the latest failure makes prospects for the antibody in oncology look increasingly remote.

Antibody 122
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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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Moderna vaccine safe and spurs immune response in kids, company says

Bio Pharma Dive

The trial results should allow the company to ask the FDA for approval of its vaccine in younger children, just as Pfizer nears a crucial decision for its shot in 5- to 11-year olds.

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Luminopia scores FDA approval for TV-based amblyopia therapy

pharmaphorum

Hard on the heels of some impressive clinical trial results, Luminopia has won FDA approval for its digital therapeutic (DTx) for amblyopia or lazy eye in children that is based on watching TV shows. The DTx is TV watching with a difference, of course – namely specially modified TV shows and movies that are viewed using a virtual reality headset designed to promote use of the weaker eye in amblyopia, which is a leading cause of vision loss in children.

More Trending

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23andMe makes $400m telehealth play, gulping down Lemonaid

pharmaphorum

Consumer DNA testing company 23andMe has signed a deal to acquire privately-held Lemonaid Health in a $400 million deal that marks a move into the online health sector. Lemonaid operates an on-demand platform for remotely accessing medical care and pharmacy services, including online consultations and prescription medicines delivery across the US. 23andMe – which went public earlier this year through a blank cheque company backed by Virgin Group founder Sir Richard Branson – is making 25% of the

DNA 105
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Axcella Launches Long Covid Treatment Trial in the UK

BioSpace

Axcella announced it is initiating a new clinical program to study AXA1125 in patients with Long Covid. The trial will be conducted at the Oxford Centre for Clinical Magnetic Resonance Research.

Trials 106
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COVID-19 vaccines and IP waiver proposals: One year on, where are we now?

BioPharma Reporter

A lot has changed over the last year since IP waiver proposals were first put forward - notably a massive rise in the production of COVID-19 vaccines. Komal Kalha of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) tells us more ahead of her presentation this week during BioPharma-Reporter's Manufacture of Vaccines webinar.

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Kids Up Next: FDA Panel Discussing EUA for Pfizer-BioNTech COVID-19 Vaccine

BioSpace

If the panel votes in favor of the vaccine for children, it will move to the U.S. CDC. If both agencies support the data, children this age would be likely to receive their first shots in early November.

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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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Nature article: SARS-CoV-2 disrupts timing of immune response

Scienmag

Once an infection is under control, the body normally uses a biochemical messenger known as TGF? to downgrade its immune response. In severe COVID-19, however, this messenger is released at the very beginning of the infection, thus blocking the early control of the pathogen by the innate immune system. This was the conclusion of a […].

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Scioto Hopes to Modify Autistic Behaviors by Improving the Gut Microbiome

BioSpace

The concept is based on scientific studies showing that modulating the gut microbiome affects human health in multiple ways, beyond the expected gastrointestinal effects.

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US healthcare system is ‘bottleneck’ to adoption of Biogen’s Alzheimer drug

BioPharma Reporter

Biogen Inc noted delayed uptake of its Alzheimerâs drug, Aduhelm, in the US, but said it continues to believe in the treatmentâs long-term potential.

Drugs 105
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Jennifer Doudna’s Mammoth Links with Vertex in $700 Million Ultra-Small CRISPR Deal

BioSpace

Mammoth Biosciences just announced a collaboration with Vertex to develop in vivo gene-editing therapeutics for patients with either of two serious, but not-yet-disclosed diseases.

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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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Ferritin-based nanomedicine developed for targeted leukemia therapy

Scienmag

Researchers from the Institute of Process Engineering (IPE) of the Chinese Academy of Sciences, Peking University and Zhujiang Hospital of Southern Medical University have developed a ferritin (Fn)-based nanomedicine for targeted delivery of arsenic (As) and efficient therapy against diverse leukemia types. Credit: IPE Researchers from the Institute of Process Engineering (IPE) of the Chinese […].

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Lilly, Merck and Bayer Back a New Composer for Autoimmune Therapies

BioSpace

Seattle-based Mozart Therapeutics closed on a $55 million Series A financing round. The company focuses on developing treatments for celiac disease and other immune-related conditions.

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New synthesis process paves way for more efficient lasers, LEDs

Scienmag

Researchers from North Carolina State University have developed a new process that makes use of existing industry standard techniques for making III-nitride semiconductor materials, but results in layered materials that will make LEDs and lasers more efficient. Credit: Salah Bedair Researchers from North Carolina State University have developed a new process that makes use of […].

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Novartis Considers Sale or Spinoff of Generics Unit

BioSpace

Novartis is reviewing its Sandoz division to determine the best moves to maximize value for shareholders. The strategic review will explore all options for the Swiss pharma giant.

Sales 101
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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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RWD from community registries adds long COVID understanding: IQVIA

Outsourcing Pharma

An epidemiologist from the healthcare data specialist offers perspective on how real-world data can help get to the heart of long-lasting COVID research.

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Avian Flu Spike in Humans Creates Concern

BioSpace

?Scientists are scrambling to find the cause for the sudden spike in human cases of avian influenza A (H5N6) in China to 21 this year, from only five in 2020.

Scientist 104
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New project helps people who are blind safeguard private visual content

Scienmag

People who are blind take pictures and videos and share them with others but face a unique challenge—they cannot independently review their pictures and videos to identify unnecessary private or sensitive content. A set of new algorithmic and interactive techniques being developed by researchers at the iSchool and partner institutions will empower people who are […].

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10x Genomics Expands Global Reach with New Singapore Facility

BioSpace

10X Genomics is continuing to increase its presence outside of the United States, this time with its first manufacturing facility outside of the country.

Genome 104
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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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An international team of scientists, lead by researchers at UC Santa Barbara, will investigate how elephants shape their environment even after death

Scienmag

Big animals have a big impact on the environment. Whales, elephants, bison: They’re the movers and shakers of their ecosystems. But what happens when they die? Credit: Deron Burkepile Big animals have a big impact on the environment. Whales, elephants, bison: They’re the movers and shakers of their ecosystems. But what happens when they die? […].

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Merck gets EU approval for Keytruda in triple-negative breast cancer

pharmaphorum

Merck & Co has claimed EU approval for Keytruda in triple-negative breast cancer (TNBC), a particularly hard-to-treat form of the disease. The European Commission has cleared Keytruda (pembrolizumab) in combination with chemotherapy as a first-line treatment for locally recurrent, unresectable or metastatic TNBC involving tumours with a PD-L1 expression score of 10 or more.

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Sajid Javid: NHS likely to have mandatory vaccinations

Pharma Times

Javid also announced the government’s ‘five pillar’ plan for addressing COVID-19 during the challenging winter months

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Aquatic fungus has already wiped amphibians off the map and now threatens survival of terrestrial frogs

Scienmag

A water-borne fungus that has led to the extinction of several species of amphibians that spend all or part of their life cycle in water is also threatening terrestrial amphibians. In Brazil, researchers supported by FAPESP detected unprecedented mortality among a genus of tiny frogs known as pumpkin toadlets that live in the Atlantic Rainforest […].

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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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Rishi Sunak promises £6 billion package for health service

Pharma Times

Package was announced during a speech at the annual Conservative Party Conference in Manchester, UK

Packaging 115
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That primate’s got rhythm!

Scienmag

Songbirds share the human sense of rhythm, but it is a rare trait in non-human mammals. An international research team led by senior investigators Marco Gamba from the University of Turin and MPI’s Andrea Ravignani set out to look for musical abilities in primates. “There is longstanding interest in understanding how human musicality evolved, but […].

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FDA Vaccine Panel Recommends Pfizer-BioNTech Vaccine for Kids Ages 5-11

BioSpace

In documents prepared for the meeting, the vaccine demonstrated 90.7% effectiveness for the children in this age group.

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Groundbreaking electroceutical research on spleen function

Scienmag

An international team of researchers, led by University of Houston Cullen Endowed Professor of biomedical engineering Mario Romero-Ortega, has progressed electroceutical research for treatment of diseases including rheumatoid arthritis, colitis and sepsis. Romero-Ortega partnered with the ARC Centre of Excellence for Electromaterials Science (ACES) at the University of Wollongong in Australia.

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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.