Wed.Dec 30, 2020

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UK authorizes AstraZeneca, Oxford coronavirus vaccine, but questions linger

Bio Pharma Dive

The first public vaccinations with AstraZeneca and Oxford’s shot will begin early in the New Year. But it’s still unclear how effective the vaccine is, or the best way to use it.

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New and Emerging Drug Classes That Will Outlast the Pandemic

BioSpace

From synthetic polymer-based anti-infectives to antiviral conjugates and DNA vaccines, the past year has given new and emerging drug classes an opportunity to shine.

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Good Judgement; Bad Judgment on Personal Drug Imports

Pharmacy Checkers

Here’s a kind of funny story to end the year with. I make a big deal on these pages about the decriminalized reality of personal drug importation. Federal law prohibits under most circumstances importing prescription drugs for your own use, but people are never busted for it. I’ve been around this a long time and I mean never. But that’s for personal use only.

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Axsome’s Migraine Drug Provides Relief in Phase III Trial

BioSpace

Axsome Therapeutics reported positive data from the long-term, open-label Phase III MOVEMENT trial of AXS-07 for the treatment of acute migraine.

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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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Largest study of Asia’s rivers unearths 800 years of paleoclimate patterns

Scienmag

The SUTD study will be crucial for assessing future climatic changes and making more informed water management decisions. Credit: SUTD 813 years of annual river discharge at 62 stations, 41 rivers in 16 countries, from 1200 to 2012. That is what researchers at the Singapore University of Technology and Design (SUTD) produced after two years […].

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10 Biopharma Stories to Look Forward to in 2021

BioSpace

If 2020 taught us anything, it was that unexpected things happen. That said, there are some stories we’ll be watching for. Here’s a look.

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AstraZeneca Vaccine Not Likely to Receive U.S. EUA Until April, Warp Speed Chief Says

BioSpace

The U.K authorized AstraZeneca’s COVID-19 vaccine on Wednesday, but it could be April at the earliest before the drug will likely be administered in the United States, Operation Warp Speed’s chief said.

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Don’t Worry Too Much About Covid Vaccine Allergic Reactions

NY Times

We should expect some people to experience side effects. The shot is still safer than the disease.

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Madrona Venture Group Nets $500 Million in Oversubscribed Funds

BioSpace

Seattle-based Madrona Venture Group closed $500 million in new funds that will be used to accelerate startup tech and life science companies primarily in the Pacific Northwest.

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AstraZeneca's COVID-19 vaccine gets the green light in the UK

BioPharma Reporter

The UK has authorized emergency supply of AstraZeneca's COVID-19 vaccine: with the first vaccinations set to begin early in the new year.

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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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How to choose a reliable CTMS

Cloudbyz

+1 (312)-763-8040. Follow us to get daily updates : Linkedin. Twitter. Products. Enterprise IT. Project Portfolio Management (PPM). Resource Management. Agile Portfolio Management. IT Business Management (ITBM). Healthcare & Lifesciences. Clinical Trial Management (CTMS). R&D Portfolio Management. Clinical Trial Budget Management. Study Start-up.

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FYR Diagnostics Partners with The State of Montana to Expand COVID-19 Testing

The Pharma Data

MISSOULA, Mont. , Dec. 31, 2020 /PRNewswire/ — FYR Diagnostics , a Missoula -based biotech company, has executed a contract with the State of Montana that will increase statewide COVID-19 testing capacity and reduce the time patients must wait to receive results. Adding FYR as a primary testing resource will keep test processing within Montana and alleviate pressure on the state laboratory in Helena. “Even with the roll-out of vaccines, the need for fast, accurate,

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New patent for Kala Pharms drug EYSUVIS

Drug Patent Watch

Annual Drug Patent Expirations for EYSUVIS Eysuvis is a drug marketed by Kala Pharms Inc and is included in one NDA. The generic ingredient in EYSUVIS is loteprednol etabonate. Additional…. The post New patent for Kala Pharms drug EYSUVIS appeared first on DrugPatentWatch - Make Better Decisions.

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BioSpace Global Roundup: Companies Slash Prices to Meet China’s Health Coverage

The Pharma Data

Multiple drugmakers agreed to cut prices of some of their newest drugs by as much as 50% in order to receive coverage from China’s national insurance program. This week, Bloomberg reported companies agreed to slash the prices of 119 new therapies that treat a range of illnesses, including pulmonary disease, lupus, diabetes and cancer. Some of the drugs included on the list are AstraZeneca’s cancer medication Zoladex; BeiGene’s Brukinsa; GlaxoSmithKline’s lupus drug Benlysta and Volibris, which t

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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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Maritime Strategy and Naval Innovation

Scienmag

Technology, Bureaucracy, and the Problem of Change in the Age of Competition Credit: US Naval Institute Press The essays in this book highlight the connective tissue between maritime strategy and naval innovation. The cases and perspectives in this collection of essays by some of today’s foremost strategic thinkers are both retrospective and prospective and carry […].

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AstraZeneca Vaccine Not Likely to Receive U.S. EUA Until April, Warp Speed Chief Says

The Pharma Data

rafapress/Shutterstock. The United Kingdom authorized AstraZeneca ’s COVID-19 vaccine on Wednesday, but it could be April at the earliest before the drug will likely be administered in the United States, Operation Warp Speed’s chief said. During a call with reporters following the U.K. approval, Moncef Slaoui, head of the government’s effort to support the development of COVID-19 vaccine programs, pointed to questions about the amount of protection the vaccine could provide to the elderly, as we

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NIH study uncovers blood vessel damage & inflammation in COVID-19 patients’ brains but no infection

Scienmag

Results from a study of 19 deceased patients suggests brain damage is a byproduct of a patient’s illness Credit: Courtesy of NIH/NINDS. In an in-depth study of how COVID-19 affects a patient’s brain, National Institutes of Health researchers consistently spotted hallmarks of damage caused by thinning and leaky brain blood vessels in tissue samples from […].

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Top 2020 Biopharma M&A Deals

The Pharma Data

The year 2020 will certainly go down in history as the year of COVID-19. And while a large portion of the biopharmaceutical world pivoted their pipelines to address the novel coronavirus, that didn’t halt a number of high profile mergers and acquisitions. BioSpace highlights a number of the key M&A deals struck over the past 12 months. Gilead Sciences Makes Multiple Bets : When Gilead Sciences wasn’t working on remdesivir in COVID-19, the company seemed to be constantly flexing its M&A m

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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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Scientists explore deficits in processing speed in individuals with spinal cord injury

Scienmag

Research team finds persons with spinal cord injury and older healthy individuals have similar brain activation during processing speed tasks. Findings support the theory of accelerated cognitive aging following spinal cord injury Credit: Kessler Foundation/Jody Banks East Hanover, NJ. December 30, 2020. A team of rehabilitation researchers has studied processing speed deficits in individuals with […].

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Ensysce Biosciences, a California Based Biotech With a Mission to Solve the Opioid Crisis, Secures $60 Million Capital Commitment From Global Emerging Markets

The Pharma Data

Dec. 31, 2020 13:00 UTC. Ensysce revolutionizing analgesia: tackling the biggest crises in US healthcare. SAN DIEGO–( BUSINESS WIRE )– Ensysce Biosciences Inc. is a clinical phase company launching two new classes of novel opioids designed to treat severe pain, and eliminate opioid misuse, abuse and overdose. Today Ensysce announced that it has signed an agreement with GEM Global Yield LLC SCS, (GEM) a Luxembourg-based private, alternative investment group.

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Wrapping Up 2020: What We’ve Accomplished This Year

Olympian Clinical Research

2020 has been an incredibly difficult year, and we’ve seen firsthand the physical, emotional, and financial struggles that COVID has caused for our patients, our loved ones, and the healthcare industry as a whole over the past several months. Despite the difficulties of this year, we can’t help but be grateful as we look back over 2020 and reflect on all the things we were able to accomplish in spite of the trials and tribulations of this pandemic!

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Ambulnz and Rapid Reliable Testing Partner with NYC Test & Trace Corps to Launch Rapid COVID-19 Testing on Mobile Units

The Pharma Data

. NEW YORK , Dec. 31, 2020 /PRNewswire/ — As COVID-19 cases increase this holiday season, the NYC Test & Trace Corps announced the launch of rapid testing on mobile units to reach more communities in need of testing at no cost. The partnership with Rapid Reliable Testing (RRT), a subsidiary of Ambulnz , is introducing rapid antigen testing in two mobile testing units, with plans to expand to additional units in the coming weeks. “New Y

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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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Anti-transpirant products unnecessary in cycad propagation

Scienmag

Credit: University of Guam In a first-of-its-kind study within cycad horticulture literature, University of Guam researchers have found that the use of anti-transpirants neither help nor hinder successful propagation of cycad stem cuttings. The Guam-based study, published Oct. 22 in the journal Tropical Conservation Science, investigated whether retaining leaves during the propagation of cycad stem […].

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FDA In Brief: Certain Lots of Sportmix Pet Food Recalled for Potentially Fatal Levels of Aflatoxin

The Pharma Data

SILVER SPRING, Md. , Dec. 30, 2020 /PRNewswire/ — The following quote is attributed to Amber McCoig , D.V.M., M.P.H., deputy director of the FDA’s Center for Veterinary Medicine (CVM) Division of Compliance: “Although this pet food recall is still unfolding, we are sharing the facts we have so far because the levels of aflatoxin found in the recalled pet food are potentially fatal.

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Alcohol Use Disorder (AUD): When Drinking Becomes A Headache

Delveinsight

Alcohol use is a serious health problem worldwide, leading to many physical, mental, and behavioral health problems. Besides physical health, it also leads to a significant number of mortality every year. As per the WHO, worldwide, harmful use of alcohol results in 3 million deaths every year which is about 5.3 % of all the deaths. Alcohol abuse or alcoholism is often referred to as AUD by the general population.

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Ongoing Exposure to Stressors Harms Health

The Pharma Data

News. Professional. Ongoing Exposure to Stressors Harms Health. WEDNESDAY, Dec. 30, 2020 — Chronic exposure to stressors leads to an erosion of health, as measured by allostatic load, which is particularly severe among foreign-born Black and Latino individuals, according to a study published online Dec. 14 in the American Journal of Preventive Medicine.

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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.

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The Future of Clinical Research?!

Clinical Trial Gurus

The future of clinical is heading towards several key areas of medicine which are mentioned in this video. Site owners should consider entering or expanding into these areas. Likewise CRAs and coordinators in these areas should also expect an increased demand in their skills.

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More Dangerous Mouthwashes and Hand Sanitizers Recalled

The Pharma Data

WEDNESDAY, Dec. 30, 2020 — A hand sanitizer has been recalled because it may contain methanol, a toxic chemical known as wood alcohol, according to the U.S. Food and Drug Administration. In addition, a mouthwash is being recalled because it may be tainted with bacteria that are particularly dangerous for people with COVID-19. Shane Erickson Inc. is recalling three brands of hand sanitizer because they may contain methanol, which can cause nausea, vomiting, headache, blurred vision, permane

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BioSpace Global Roundup: Companies Slash Prices to Meet China's Health Coverage

BioSpace

Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.

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U.K. Is First Country to Approve Oxford-AstraZeneca COVID-19 Vaccine

The Pharma Data

News. Professional. U.K. Is First Country to Approve Oxford-AstraZeneca COVID-19 Vaccine. WEDNESDAY, Dec. 30, 2020 — Britain became the first country to give authorization to the COVID-19 vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. The British government also decided to start giving as many people as possible a first dose of vaccines, rather than keeping supplies for second shots, expanding the number of people who will be vaccinate

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.