Bio Pharma Dive
OCTOBER 7, 2021
Founded by former Biogen executive Michael Ehlers and backed by Apple Tree Partners, Intergalactic aims to create non-viral gene therapies delivered via an advanced form of electroporation.
Pharma Mirror
OCTOBER 7, 2021
The history of medical writing began with the rise of the modern clinical trial. A medical writer can be your most pivotal ally in a clinical trial. While clinic directors, data managers, and investigators in the pharmaceutical industry are required for clinical trials, medical writers are the glue that holds clinical trials together. The increase in volume of clinical trials has already put a tremendous strain on journal editors and reviewers.
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Bio Pharma Dive
OCTOBER 7, 2021
Researchers found evidence of a "chromosomal abnormality" in one patient treated with Allogene's CAR-T cell therapy, spurring the clinical hold and an investigation.
Pharma Times
OCTOBER 7, 2021
AstraZeneca has submitted an emergency approval to the US drug regulators for its COVID-19 antibody cocktail, which would be the first non-vaccine protection from the virus to be granted approval.
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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
Bio Pharma Dive
OCTOBER 7, 2021
Neumora Therapeutics launched Thursday with a $100 million investment from Amgen and another $400 million from a long list of venture capital firms, including Arch, which is taking another shot at building a neuroscience company.
pharmaphorum
OCTOBER 7, 2021
The WHO has given a green light to widespread use of GlaxoSmithKline’s malaria vaccine in Africa, in what could be a major turning point in the fight against the disease. The RTS,S/AS01 vaccine – also known as Mosquirix – will be administered to children living in sub-Saharan Africa and other regions with moderate to high malaria transmission in what WHO Director-General Dr Tedros Adhanom Ghebreyesus described as “a historic moment.” Initial clinical trials of the vaccine only
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
OCTOBER 7, 2021
Mirati and Sanofi will assess the combination of adagrasib and SAR442720 in a Phase I/II study in patients with previously treated non-small-cell lung cancer who express KRASG12C mutations.
Bio Pharma Dive
OCTOBER 7, 2021
The biotech company expects to make its coronavirus vaccine and mRNA shots for other diseases at the planned plant, into which it will invest $500 million.
pharmaphorum
OCTOBER 7, 2021
Moderna has said it plans to invest $500 million in a new facility for manufacturing mRNA vaccines in Africa, and has kicked off a search to find a suitable country and location. The factory will be able to supply up to 500 million doses of mRNA shots a year, and cover the full spectrum of manufacturing from drug substance production through to full/finish and packaging, according to the company.
Bio Pharma Dive
OCTOBER 7, 2021
The failure of the pharma's TYK2 blocker in the first of two ulcerative colitis studies is a setback for a treatment that's expected to become a top-seller.
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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
Pharma Times
OCTOBER 7, 2021
Leading RNA intereference (RNAi) therapeutics company, Alnylam, has been welcomed as the latest partner in the Medicines Manufacturing Innovation Centre, to transform the manufacturing process of oligonucleotide therapies.
Scienmag
OCTOBER 7, 2021
Credit: Carlos Jones/ORNL, U.S. Dept. of Energy Journal PRX Quantum DOI 10.1103/PRXQuantum.2.040304 Method of Research Experimental study Subject of Research Not applicable Article Title Reconfigurable Quantum Local Area Network Over Deployed Fiber Article Publication Date 6-Oct-2021.
BioSpace
OCTOBER 7, 2021
Acting FDA Commissioner Janet Woodcock’s days as interim head of the agency are numbered due to federal regulations. Speculations are rampant on a number of potential choices.
Scienmag
OCTOBER 7, 2021
Yellow warblers are hosts to brood parasitic brown-headed cowbirds, which rely on other species to raise their offspring. Warblers use referential “seet” calls to warn female warblers specifically of the brood parasitic brown-headed cowbirds that may try to lay eggs in their nests. When exposed to experimental playbacks of seet calls one day, female warblers […].
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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
OCTOBER 7, 2021
Patients and patient organizations, which have detailed insights in the natural history of a rare disease, should be integral, too.
Scienmag
OCTOBER 7, 2021
CORVALLIS, Ore. – Microbiology researchers at Oregon State University have shed new light on the mechanisms of carbon cycling in the ocean, using a novel approach to track which microbes are consuming different types of organic carbon produced by common phytoplankton species. Credit: Oregon State University CORVALLIS, Ore. – Microbiology researchers at Oregon State University […].
NY Times
OCTOBER 7, 2021
The agency has promised to move quickly on the request and has tentatively scheduled a meeting at the end of the month to consider it.
Scienmag
OCTOBER 7, 2021
Multisystem inflammatory syndrome in children (MIS-C) is a serious condition associated with a recent COVID-19 infection. The syndrome is rare, and it remains unclear how the viral infection leads to MIS-C and why it only develops in some children. Credit: UC San Diego Health Sciences Multisystem inflammatory syndrome in children (MIS-C) is a serious condition […].
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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.
BioPharma Reporter
OCTOBER 7, 2021
Moderna will build a state-of-the-art mRNA facility in Africa, with the goal of producing up to 500 million vaccine doses a year.
Scienmag
OCTOBER 7, 2021
BIRMINGHAM, Ala. – The mix of microbes in the gut can shape a person’s immune response. In immunotherapy for melanoma, for example, the composition of the gut microbiota correlates with efficacy of anti-PD-1 therapy in animal models and cancer patients. Credit: UAB BIRMINGHAM, Ala. – The mix of microbes in the gut can shape a […].
BioSpace
OCTOBER 7, 2021
Of these six patients, three had a partial response (PR) with their tumors shrinking by more than 30%.
Scienmag
OCTOBER 7, 2021
The malaria parasite Plasmodium vivax (P. vivax) causes frequent, chronic infections that represent a major unrecognized burden on global health, according to a review by Kevin Baird of the Eijkman-Oxford Clinical Research Unit in Indonesia and Katherine Battle of the Institute for Disease Modeling in the United States publishing October 7th in the open access […].
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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.
pharmaphorum
OCTOBER 7, 2021
A drug originally developed for high blood pressure could find a new use in the treatment of Huntington’s disease, thanks to an artificial intelligence-based drug discovery programme at Spain’s SOM Biotech. SOM3355 (bevantolol hydrochloride) hit its objectives in a phase 2 trial in patients with Huntington’s disease , improving the involuntary, jerky movements known as chorea that are a key symptom of the neurodegenerative disease.
Scienmag
OCTOBER 7, 2021
We regularly hear warnings that climate change may lead to ‘tipping points’: irreversible situations where savanna can quickly change into desert, or the warm gulf stream current can simply stop flowing. These cautions often refer to spatial patterns as early-warning signals of tipping points. An international team of ecologists and mathematicians has studied these patterns […].
BioSpace
OCTOBER 7, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Scienmag
OCTOBER 7, 2021
MINNEAPOLIS/ST. PAUL (10/07/2021) – In a first-of-its-kind study, researchers from the University of Minnesota Medical School led a large, multicenter investigation on whether cardiovascular magnetic resonance (CMR) is the best approach in evaluating patients with suspected cardiac tumors. Their results prove that CMR provides high accuracy and prognostic value for this purpose.
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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.
pharmaphorum
OCTOBER 7, 2021
If there’s one take-home message about working during a pandemic, it is the enormous value that virtual events, webinars and e-learning can bring when face-to-face meetings and presentations are impossible. COVID-19 raised the profile of these digital interactions, becoming a key resource for pharma during the pandemic almost overnight and leaving companies scrambling to develop and refine their engagement with their target audience.
Scienmag
OCTOBER 7, 2021
Coughs and colds spread quickly within wild mountain gorilla groups but appear less likely to spread between neighboring groups, a new study published in Scientific Reports shows. Credit: Dian Fossey Gorilla Fund Coughs and colds spread quickly within wild mountain gorilla groups but appear less likely to spread between neighboring groups, a new study published in Scientific Reports shows. […].
BioSpace
OCTOBER 7, 2021
The FDA approved ChemoCentryx’s Tavneos (avacopan) as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).
Scienmag
OCTOBER 7, 2021
FOR IMMEDIATE RELEASE Credit: Images courtesy of David Kass FOR IMMEDIATE RELEASE Researchers at Johns Hopkins Medicine have found that a drug first developed to treat Alzheimer’s disease, schizophrenia and sickle cell disease reduces obesity and fatty liver in mice and improves their heart function — without changes in food intake or daily activity.
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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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