Fri.Apr 16, 2021

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Lilly asks FDA to revoke clearance of first COVID-19 antibody drug

Bio Pharma Dive

The request comes less than six months after the FDA authorized Lilly's bamlanivimab, reflecting the spread of virus variants that can elude the drug.

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Pharma agency challenges and opportunities

World of DTC Marketing

QUICK READ: According to Setup 30% of Brand marketers say they’re likely/somewhat likely to switch Agencies in the next 6 months. While the consolidation of agencies may be a priority for some pharma companies a good digital agency can add a lot of value. There is a lot of downside to letting your main ad agency do your digital work. Setup also found that one third of brand marketers want their agencies to better understand their business + seek greater transparency and communication between Age

Branding 203
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Relay buys AI startup to aid unorthodox drug discovery quest

Bio Pharma Dive

The $85 million acquisition is an unusual and early step for a company like Relay, which went public last July and only just began clinical testing of its lead drugs last year.

Drugs 306
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Medical Equipment: Should You Buy, Lease, or Just Wait?

Pharma Mirror

Running a healthcare business is a tricky thing. Certain equipment is often being requested by physicians who are insisting it’s needed to improve patient diagnosis and care. Yet, it’s not always affordable. Other times, it’s preferred, but the business should be mindful of the cost and look at how best to afford it. Should medical equipment be purchased outright, leased, and then acquired or delayed until it’s more affordable?

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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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US clears AstraZeneca buyout of Alexion amid closer scrutiny of biopharma M&A

Bio Pharma Dive

FTC authorization of the $39 billion deal — the sector's largest in 2020 — may ease concerns over the agency's plans to more intently inspect pharma deals.

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Rising Demand for Customized Medication To Transform Compounding Pharmacies Market Outlook

Pharma Mirror

Compounding pharmacies, which involve the preparation and selling of prescribed medicines are gaining massive popularity across the healthcare sector owing to the rising awareness regarding the benefits of compounded medications. Besides, the shortfall of various drugs such as cancer medicines and other lifesaving drugs is fostering the demand for compounding pharmacy services.

Pharmacy 130

More Trending

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Inside Intouch: Building a Diverse Employee Community

Intouch Solutions

Learn how and why the organization keeps inclusion and diversity top of mind, and how this affects not only our employees, but the work we do for clients every day. The post Inside Intouch: Building a Diverse Employee Community appeared first on Intouch Solutions.

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Risk of brain clots higher with COVID than vaccine, study suggests

pharmaphorum

A study has suggested that the risk of getting a serious brain clot is eight to 10 times higher in people with COVID-19 than those who get a vaccine. There are some big caveats with the research from Oxford University – it was based on data from people in the US who had received either a Pfizer or Moderna vaccine – but the team said findings could reassure people about the safety of vaccines.

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Best throat numbing lozenges | Get rid of sore throat

Druggist

For many customers, throat numbing lozenges are the first choice in the management of sore and irritated throat. Throat numbing lozenges contain a local anaesthetic which numbs the area and hence help with pain and irritation. This post list all sore throat lozenges containing a local anaesthetic available in the UK. You may also be interested in a related post listing variety of sore throat lozenges.

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Scientists may detect signs of extraterrestrial life in the next 5 to 10 years

Scienmag

Telescope launching this autumn could spot biosignatures on other planets within three days Credit: ESA / Hubble, M. Kornmesser, CC BY 4.0 Research shows that a new telescope could detect a potential signature of life on other planets in as little as 60 hours. “What really surprised me about the results is that we may […].

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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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Three pillars of post-pandemic launch excellence

pharmaphorum

IQVIA’s Sarah Rickwood reviews the launch of innovative medicines in 2020 and outlines three key pillars of activity for companies to focus on and address in 2021. It is undeniable that 2020 was a particularly challenging year to launch non-COVID innovative prescription medicines. The launch environment was directly impacted by the COVID-19 pandemic, which hit two key drivers of launch uptake particularly hard: the dynamic market, i.e. new and switch prescriptions, and face-to-face interac

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The fate of the planet

Scienmag

Unconventional takes on pandemics and nuclear defense could protect humanity from catastrophic failure Credit: U.S. Navy From engineered pandemics to city-toppling cyber attacks to nuclear annihilation, life on Earth could radically change, and soon. Scientists will forecast the fate of the planet at a press conference during the 2021 APS April Meeting. “Our Earth is […].

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Microsoft puts AI at heart of digital health strategy with Nuance deal

pharmaphorum

Microsoft has made its aspirations in digital health clear with a whopping $19.7 billion deal to buy Nuance Communications and its artificial intelligence platform for speech recognition that is increasingly being used for clinical applications. . The $56 per share deal is all about increasing Microsoft’s position in digital health, and represents a hefty multiple on Nuance’s current revenue stream, which was running at around $350m in the fourth quarter of 2020.

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Study identifies new targets in the angiogenesis process

Scienmag

Credit: Universidad de Sevilla Angiogenesis is a process of new vessel formation that is activated both in physiological (tissue repair, reproduction, etc.) and pathological (myocardial infarction, diabetic retinopathy, cancer, etc.) conditions. The process is carried out by endothelial cells and includes their proliferation, migration and arrangement in tubes.

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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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New subcutaneous formulation of Tysabri approved in UK

Pharma Times

Multiple sclerosis treatment can now be administered subcutaneously or intravenously

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New understanding of the deleterious immune response in rheumatoid arthritis

Scienmag

Credit: (C) Erica Tandori Researchers within the Biomedicine Discovery Institute at Monash University have made a breakthrough in understanding the role played by high-risk immune genes associated with the development of rheumatoid arthritis (RA). The findings, published in Science Immunology, were the result of a seven-year collaboration led by Monash University, involving Janssen Research and […].

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Activist investor Elliott builds stake in GSK after fresh trial upset

pharmaphorum

Activist investor Elliott Management has built a significant stake in GlaxoSmithKline, after a poor run of clinical trial results this year raised questions about management’s strategy to turn around the company’s fortunes. The news follows another trial disappointment this week, where GSK’s feladilimab, combined with Merck & Co’s Keytruda (pembrolizumab), came up short in a trial of patients with head and neck cancer.

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Neural plasticity depends on this long noncoding RNA’s journey from nucleus to synapse

Scienmag

Credit: Credit: Jenna Wingfield and Yibo Zhao of the Puthanveettil lab at Scripps Research in Jupiter, Florida. JUPITER, FL–Making memories involves more than seeing friends or taking photos. The brain constantly adapts to new information and stores memories by building connections among neurons, called synapses. How neurons do this–reaching out arm-like dendrites to communicate with […].

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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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EMA begins review of GSK/Vir’s COVID-19 antibody

Pharma Times

The review will include an interim analysis of efficacy and safety data from the Phase III COMET-ICE trial

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Quality and quantity of enrichments influence well-being of aquaculture fishes

Scienmag

Credit: Pekka Hyvärinen/Luke Collaborative research of the University of Jyvaskyla and Natural Research Institute Finland presents new evidence of the effects of enriched rearing on well-being of aquaculture fishes. The research demonstrates that stone enrichments that have been previously conditioned in lake water significantly improve survival of fish compared to clean stones.

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NICE recommends Alexion’s PNH treatment Ultomiris

Pharma Times

C5 complement inhibitor approved to treat PNH in adult patients with haemolysis

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New tech builds ultralow-loss integrated photonic circuits

Scienmag

Credit: Jijun He, Junqiu Liu (EPFL) Encoding information into light, and transmitting it through optical fibers lies at the core of optical communications. With an incredibly low loss of 0.2 dB/km, optical fibers made from silica have laid the foundations of today’s global telecommunication networks and our information society. Such ultralow optical loss is equally […].

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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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Breaking News: Thermo Fisher Scientific Buys PPD

ECRG Media's Clinical Research Podcast

Breaking News: Thermo Fisher Scientific Buys PPD This is Big!! Breaking News: Thermo Fischer Scientific Buys PPD Don't forget to Subscribe for new content! Merch: [link] Subscribe: [link] Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Resear

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New nanoscale device for spin technology

Scienmag

Spin waves could unlock the next generation of computer technology, a new component allows physicists to control them Credit: Matt Allinson, Aalto University Researchers at Aalto University have developed a new device for spintronics. The results have been published in the journal Nature Communications, and mark a step towards the goal of using spintronics to […].

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Breaking News: Thermo Fisher Scientific Buys PPD

ECRG Media's Clinical Research Podcast

Breaking News: Thermo Fisher Scientific Buys PPD. This is Big!! Breaking News: Thermo Fischer Scientific Buys PPD Don't forget to Subscribe for new content! Merch: [link]. Subscribe: [link]. Email: eliteclinicalgroup@gmail.com. Podcast: [link]. Steemit: [link]. Advertise: eliteclinicalgroup@gmail.com. Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical

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Simulations reveal how dominant SARS-CoV-2 strain binds to host, succumbs to antibodies

Scienmag

Dominant G-form Spike protein ‘puts its head up’ more frequently to latch on to receptors, but that makes it more vulnerable to neutralization Credit: Los Alamos National Laboratory. LOS ALAMOS, N.M., April 16, 2021 — Large-scale supercomputer simulations at the atomic level show that the dominant G form variant of the COVID-19-causing virus is more […].

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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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Hyman, Phelps & McNamara, P.C. Seeks a 2nd to 4th Year Associate

FDA Law Blog

Hyman, Phelps & McNamara, P.C. seeks a 2nd to 4th year associate to join our team and work on a wide variety of FDA-related matters. The ideal candidate must have a demonstrated interest in FDA law, possess strong research and writing skills, and fit into the collegial culture of a boutique law firm. A science background and previous private practice experience are preferred, but not required.

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A new guide for communicating plant science

Scienmag

Credit: Iowa State University News Service AMES, Iowa – A lot is riding on the continued advancement of plant sciences. Take the food supply, for starters. Climate change and population growth will continue to pose challenges in the future, and crop production will require innovation and progress by plant scientists in order to keep pace. […].

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bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

The Pharma Data

– Final step in Lilly’s planned transition to provide only bamlanivimab and etesevimab together in the U.S. – Bamlanivimab and etesevimab together now fully available across the U.S. – Lilly, in collaboration with Amgen, expects to manufacture sufficient supply for complete global transition by June Eli Lilly and Company (NYSE: LLY) has requested the U.S.

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University of Colorado inter-campus collaboration wins R01 award for salivary gland cancer

Scienmag

Antonio Jimeno, MD, Ph.D., received a grant of nearly $500K from the National Institutes of Health (NIH) to investigate a potential drug treatment for salivary gland cancer, in collaboration with researcher Tin Tin Su, Ph.D. Credit: Antonio Jimeno, MD, PhD, and Tin Tin Su, PhD Two University of Colorado Cancer Center researchers have received a […].

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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.