Mon.May 03, 2021

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Roivant valued at $7B in blank-check merger, bucking SPAC slowdown

Bio Pharma Dive

Vivek Ramaswamy's unusual biotech holding company will go public through a deal with Montes Archimedes Acquisition Corp. that nets Roivant $611 million.

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Revealing the secret cocoa pollinators

Scienmag

International research team led by Göttingen University investigates landscape and farm-level man-agement in cocoa agroforests in Indonesia Credit: Manuel Toledo The importance of pollinators to ensure successful harvests and thus global food security is widely acknowledged. However, the specific pollinators for even major crops – such as cocoa – haven’t yet been identified and there […].

Research 113
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Sarepta's second-gen Duchenne drug shows signs of topping its first

Bio Pharma Dive

An experimental Duchenne drug developed with a newer technology may be more potent than Sarepta's marketed treatment Exondys 51. But early data also brought new safety concerns.

Drugs 236
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Expansions and Hirings Spark Surge of Growth in BioCapital Region

BioSpace

Fueled by billions of dollars invested by the federal government to battle the ongoing COVID-19 pandemic, companies across the BioCapital region have expanded their footprint and number of employees.

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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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Avrobio changes course after FDA closes path for speedy gene therapy approval

Bio Pharma Dive

The FDA recently converted its clearance for a standard Fabry treatment to a full approval, complicating Avrobio's plans to seek an accelerated OK for its rare disease therapy.

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NurOwn: A Study in the Complexity of ALS Trials

BioSpace

There is also a tacit acknowledgment in the industry that the ALSFRS-R (revised) scale needs to evolve.

Trials 141

More Trending

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Explore vital drug delivery innovations at online event

Outsourcing Pharma

On May 5, a panel of experienced industry experts will discuss recent developments during Innovations in Drug Delivery, a free one-hour industry webinar.

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Social cognition plays a key role in everyday lives of people with multiple sclerosis

Scienmag

Longitudinal study by international MS research team shows that people with relapsing-remitting MS performed significantly lower in several social cognition domains, despite being classified as “cognitively normal.” Credit: Kessler Foundation/Jody Banks East Hanover, NJ. May 3, 2021. An international team of multiple sclerosis (MS) researchers showed that longitudinal changes in social cognition are associated with […].

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AbCellera-Eli Lilly Antibody Shows Potency Against All Current COVID-19 Variants

BioSpace

Should this antibody continue to prove to be safe and effective in clinical studies, it will replace the previously authorized bamlanivimab, which has since been sidelined due to the rise of viral variants that diminished its effectiveness.

Antibody 102
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Chemical ‘nose’ sniffs critical differences in DNA structures

Scienmag

Detection innovation could enhance drug development and cancer research Credit: Richard Hooley/UCR Small changes in the structure of DNA have been implicated in breast cancer and other diseases, but they’ve been extremely difficult to detect — until now. Using what they describe as a “chemical nose,” UC Riverside chemists are able to “smell” when bits […].

DNA 98
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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 Sunrise’s Sleep Apnea Test Could Be A Game Changer For At-Home Testing

XTalks

Sunrise, a Belgium-based biotech start-up, has developed an innovative new at-home sleep apnea test. The test consists of a lightweight, wireless device placed on the chin that measures mandibular (lower jaw) movement to assess interruptions in breathing during sleep. The design of the device is far less invasive than current conventional sleep apnea tests, which involve the placement of different electrodes on the body.

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The neural mechanism of autonomous learning uncovered by researchers at IBEC

Scienmag

The brain can teach artificial intelligence a lesson or two Credit: Brainx3.com, SPECS lab. Thanks to the so-called deep learning, a subset of artificial intelligence (AI) algorithms inspired by the brain, machines can match human performance in perception and language recognition and even outperform humans in certain tasks. But do these synthetic biologically inspired systems […].

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FDA Set to Authorize Pfizer Vaccine for Adolescents by Early Next Week

NY Times

The U.S. vaccination campaign will soon expand to millions more people, but public health experts say the move raises complicated questions about supply and access.

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Landmark study launched to detect liver cancer early in Singapore

Scienmag

Study aims to recruit 2,000 participants at high risk of developing HCC from 6 healthcare institutions and 8 polyclinics across Singapore Credit: Image credit: Mole DJ et al. Plos One. 2020;15(12):e0238568 Only 20% of primary liver cancer or hepatocellular carcinoma (HCC) are diagnosed at an early stage, which makes early detection an urgent, unmet healthcare […].

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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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Is the Dream of COVID-19 “Herd Immunity” Dead?

BioSpace

In 2020, “herd immunity” was the mythical goal set forth in the hearts and minds of a struggling population, waiting on a vaccine to return us to normal. Now experts are saying herd immunity with COVID-19 may well be impossible.

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Personalised follow-up care needed to address varying health burdens in breast cancer pts

Scienmag

ESMO Breast Cancer 2021 Virtual Congress, 5-8 May Credit: ESMO LUGANO, Switzerland, 3 May 2021 – As breast cancer becomes a largely curable disease, with more than 70% of women surviving at least 10 years after diagnosis across most of Europe thanks to early detection and treatment, (1) the quality of life after cancer has […].

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Two Biotechs Gear Up for Nasdaq Debut

BioSpace

Two weeks after announcing plans for initial public offerings, Gyroscope Therapeutics and Talaris Therapeutics have now set the terms for their debut on the Nasdaq.

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Review outlines approaches to deliver radiation to tumors while sparing healthy tissue

Scienmag

Credit: UNC Health CHAPEL HILL, North Carolina–A comprehensive review by University of North Carolina researchers and colleagues highlights the optimal ways that focused, high-dose radiation can be delivered to various types of tumors while sparing normal tissue and mitigating long-term side effects. The review was reported as a special issue in the International Journal of […].

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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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CPhI survey: pharma leaders optimistic about the future

Outsourcing Pharma

According to a recent survey of executives conducted by CPhI, COVID-19âs impact is driving manufacturing and CDMOs are fueling industry growth.

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Natural immunity to malaria provides clues to potential therapies

Scienmag

WEHI researchers have identified how natural human antibodies can block malaria parasites from entering red blood cells, potentially indicating how new protective therapies could be developed against this globally significant disease. Credit: WEHI National Health and Medical Research Council, the European Research Council and the Victorian Government.

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New patent expiration for Gilead Sciences drug ATRIPLA

Drug Patent Watch

Annual Drug Patent Expirations for ATRIPLA Atripla is a drug marketed by Gilead Sciences and is included in one NDA. It is available from two suppliers. There are nine patents…. The post New patent expiration for Gilead Sciences drug ATRIPLA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 90
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Electric vehicle batteries: The older they get, the safer they are

Scienmag

Credit: © Lunghammer – TU Graz As part of the project “SafeBattery”, a team from Graz University of Technology (TU Graz) has been investigating the behaviour of lithium-based batteries in electric cars under crash loads for the past four years. “The performance of new battery cells is largely known, so we dealt with the entire […].

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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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Touting 100% Efficacy, Pfizer Vaccine Expects Approval This Week for Younger Teens

BioSpace

The U.S. FDA is expected to give the go-ahead for Pfizer and BioNTech’s COVID-19 vaccine for adolescents ages 12 and older within the week.

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UM professor awarded $430,000 NASA grant

Scienmag

Credit: UM News Service MISSOULA – A University of Montana geosciences professor who studies the structure and evolution of the Earth has received a prestigious grant from NASA’s Earth Surface and Interior Division. Hilary Martens, assistant professor in the Department of Geosciences, housed in UM’s College of Humanities and Sciences, recently was awarded a $443,000 […].

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Changing of the Guard: Four Biopharma Companies Appoint New CEOs

BioSpace

Companies across the biotech and biopharma industries recently reported a slew of new leadership appointments, several of which have been explicitly focused on the fields of oncology and precision medicine.

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Biden Confronts Coronavirus Vaccine Patents

NY Times

President Biden and drugmakers are facing demands from liberal activists and global leaders to suspend intellectual property rights on the vaccines as the pandemic surges.

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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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Neuroelectrics Bags $17.5 Million for At-Home, Personalized Brain Stimulation Platform

BioSpace

Neuroelectrics, based in Barcelona, Spain with offices in Cambridge, Massachusetts, announced it had raised $17.5 million in a Series A financing round. It was led by Morningside Ventures.

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Reduction in wetland areas will affect Afrotropical migratory waterbirds

Scienmag

Study points to need for an integrated approach to fighting impacts of climate change Migratory waterbirds are particularly exposed to the effects of climate change at their breeding areas in the High Arctic and in Africa, according to a new study published in Bird Conservation International. The research team came to this conclusion after modelling […].

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Australian Researchers Say Best COVID-19 Vaccines 58% Effective at 250 Days

BioSpace

Next year, people are likely to need an annual COVID-19 vaccination just like they need an annual flu shot.

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Understanding aromaticity in catalysis to unlock new opportunities

Scienmag

Aromaticity, a concept usually used to explain the striking stability and unusual reactivity of certain carbon-based molecules, could inspire the design of new catalysts with novel uses, KAUST researchers have shown. Chemists first came upon the anomalous behavior of aromatic molecules in the nineteenth century while studying benzene. The unexpected stability of this six-carbon cyclic […].

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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.