Bio Pharma Dive
APRIL 27, 2021
Biogen plans to start a compassionate use program in July that would let a small group of patients with rapidly progressing disease access its drug.
World of DTC Marketing
APRIL 27, 2021
QUICK READ: Patients are returning to their doctor’s office, and it’s not uncommon for appointments, or routine visits, to be scheduled weeks or months in advance. I talked to some thought leaders, and they said that they don’t have time for either virtual patient visits or online pharma detailing. About this time, every year, I get my annual physical, which is more like a request for a blood workup.
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Bio Pharma Dive
APRIL 27, 2021
Gilead will donate at least 450,000 vials of Veklury, while Merck licensed its experimental antiviral molnupiravir to five generic drugmakers in India.
Pharma Mirror
APRIL 27, 2021
Scivita Medical Technology Co., Ltd. (“Scivita Medical”) announced that it has raised nearly RMB0.4 Billion in Series A funding round, which has become one of the highest financing projects in the field of endoscope in China in recent years. The investment was jointly led by GL Ventures and Lilly Asia Ventures, with contribution from Matrix Partners China, Medtronic, Chengwei Capital and Shanghai Innochip Investment.
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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
BioPharma Reporter
APRIL 27, 2021
Medicago has started a rolling submission with Health Canada for its plant-derived adjuvanted COVID-19 vaccine candidate: championing a unique and versatile platform that can also be scaled up easily.
pharmaphorum
APRIL 27, 2021
Cognoa has filed for FDA approval of a digital device that could be used to diagnose autism, which the company argues could redefine care standards. . Autism can be difficult to diagnose as there are no medical markers to show its presence – instead doctors look at the child’s developmental history and behaviour to make a diagnosis. Cognoa hopes to change this with an efficient and accurate approach that could allow diagnosis in primary care that won’t require a lengthy referral to a specialist.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
APRIL 27, 2021
Researchers are continuing to develop next-generation therapeutics and oral vaccines that could overcome some vaccine hesitancy. Here are some of the top producers.
pharmaphorum
APRIL 27, 2021
Protracted diagnostic odysseys don’t only block access to rare disease treatments, they also leave people facing emotional turmoil all alone. Growing up in Glasgow, Linsey Brady “felt like a freak” and did everything she could to hide what she was told was a vascular deformation on her leg from the rest of the world. She was in her late 20s when, after years of struggling with her mental health and self-medicating with alcohol, she was finally diagnosed with Klippel Trenaunay Syndrome (KTS).
BioSpace
APRIL 27, 2021
Launched in January 2020 by Flagship Pioneering, Ohana was being dubbed a “first-in-category reproductive health company” focused on the industry’s first sperm biology platform.
Scienmag
APRIL 27, 2021
Seeing the unseen: HKU scientists develop a new chemical tool that sheds light on how proteins recognise and interact with each other Credit: The University of Hong Kong A research group led by Professor Xiang David LI from the Research Division for Chemistry and the Department of Chemistry, The University of Hong Kong, has developed […].
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
BioSpace
APRIL 27, 2021
As a devastating pandemic increased scientific collaboration globally, CSL was already ahead of the curve with teams spanning the continents, working together to advance lifesaving treatments and technologies.
Scienmag
APRIL 27, 2021
Credit: HI-SEAS MUNICH — Imagine trying to pick up a pebble or scrape microbes off a cave wall in a bulky spacesuit with puffy gloves on, under a time constraint because you don’t want to run out of oxygen. That’s what the analog astronauts do daily at the HI-SEAS moonbase habitat in Hawaii as they […].
BioSpace
APRIL 27, 2021
Figuring out how to become a more qualified, competitive job candidate can seem overwhelming. Often it feels as if you only have a handful of options to build your resume in any meaningful way – like earning additional degrees or simply gaining several more years of experience in your role.
Pharma Times
APRIL 27, 2021
Medicine recommended for the treatment of visual impairment in Leber’s Hereditary Optic Neuropathy
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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.
BioSpace
APRIL 27, 2021
Levitt has practiced law for over 20 years in the FDA regulatory space. Previously chief regulatory counsel for Pfizer Inc., Levitt has had extensive experience working with an interdisciplinary team of scientists, executives and lawyers to push a candidate to market.
Scienmag
APRIL 27, 2021
Credit: Brian Persinger/WVU For more than 30 years, the world’s largest collection of arbuscular mycorrhizal fungi – the “good” kind essential for sustaining plant life – has been rooted at West Virginia University. Over the next several years, the tiny, soil-dwelling residents of the International Culture Collection of (Vesicular) Arbuscular Mycorrhizal Fungi will be relocated […].
BioSpace
APRIL 27, 2021
Alpha-9 Theranostics announced the closing of an $11 million Series A financing today, while Engage Technologies also announced it has raised money in a Series A round, funding that came in at a tune of $15 million.
Scienmag
APRIL 27, 2021
Credit: Nigel Michki Neurons result from a highly complex and unique series of cell divisions. For example, in fruit flies, the process starts with stem cells that divide into mother cells (progenitor cells), that then divide into precursor cells that eventually become neurons. A team of the University of Michigan (U-M), spearheaded by Nigel Michki, […].
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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.
BioSpace
APRIL 27, 2021
Novartis AG Chief Executive Officer Vas Narasimhan believes that the hybrid of remote and on-site office work is the future.
Scienmag
APRIL 27, 2021
Credit: Lilian Lieber, Queen’s University Belfast The foraging behaviour of seabirds is dramatically affected by turbulence caused by natural coastal features and manmade ocean structures, new research has shown. In a first-of-its-kind study, scientists from the UK and Germany used drones to provide a synchronised bird’s eye view of what seabirds see and how their […].
pharmaphorum
APRIL 27, 2021
FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . The Oncologic Drugs Advisory Committee (ODAC) is scheduled to look at the data for the three drugs – Merck & Co’s Keytruda (pembrolizumab), Bristol-Myers Squibb’s Opdivo (nivolumab) and Roche’s Tecentriq (atezolizumab) – across six types of cancer.
Scienmag
APRIL 27, 2021
New ancient DNA-based study on Madagascar crocodile suggests that modern crocodiles likely originated in Africa Credit: M. Ellison/©AMNH A study led by scientists at the American Museum of Natural History has resolved a long-standing controversy about an extinct “horned” crocodile that likely lived among humans in Madagascar. Based on ancient DNA, the research shows that […].
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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.
Pharma Times
APRIL 27, 2021
Therapy wins a positive CHMP opinion for the adjuvant treatment of early-stage EGFR-mutated NSCLC
Scienmag
APRIL 27, 2021
Credit: UT Southwestern Medical Center DALLAS – April 27, 2021 – Researchers with the Peter O’Donnell Jr. Brain Institute at UT Southwestern have identified a new protein implicated in cell death that provides a potential therapeutic target that could prevent or delay the progress of neurodegenerative diseases following a stroke. Scientists from the departments of […].
BioSpace
APRIL 27, 2021
Takeda’s non-small cell lung cancer treatment Mobocertinib is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application.
Scienmag
APRIL 27, 2021
This is a unique method to diagnose pathogenic areas in the heart in a minute Credit: Front. Physiol. 10:1138. Researchers from Belgium, the Netherlands, Russia, and Italy have developed a breakthrough method for quickly, accurately, and reliably diagnosing cardiac arrhythmias. They called it Directed graph mapping (DGM). The technology principles are published in JACC: Clinical […].
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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.
Pharma Times
APRIL 27, 2021
The Christie NHS Foundation Trust will offer the breast cancer treatment Phesgo to patients in their own homes
Scienmag
APRIL 27, 2021
Credit: Zayda Morales Moreira Just as humans receive the first members of their microbiomes from their mothers, seeds may harbor some of the first microorganisms plants encounter. While these initial microbes could become influential players in the plants’ microbiomes, the microbial communities that colonize seeds have not received as much attention as root, shoot, or […].
JAMA Internal Medicine
APRIL 27, 2021
This disproportionality analysis uses the World Health Organization pharmacovigilance database to explore the potential safety signal of facial paralysis after COVID-19 vaccination.
Scienmag
APRIL 27, 2021
Credit: © Grameen Foundation Smallholders produce two thirds of all food worldwide. Yet the majority of these approximately 500 million farmers lives in poverty. Their production is susceptible to the impacts of climate change. At the same time, they have poor access to information on agricultural practices that could help them increase production, conserve resources, […].
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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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