Bio Pharma Dive
JUNE 16, 2021
The biotech said it will seek an expanded FDA clearance after results from the RECOVERY trial showed its antibody can lower mortality among certain hospitalized COVID-19 patients.
pharmaphorum
JUNE 16, 2021
Developers of mobile health apps are comprehensively failing to safeguard the privacy of users, according to a study by researchers in Australia. The team from Macquarie University compared 15,000 free mobile health (mHealth) apps available on the Google Play store and compared their privacy practices to those found in 8,000 non-health apps, finding “serious problems with privacy and inconsistent privacy practices.” The range of apps put under scrutiny included tools for managing hea
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Bio Pharma Dive
JUNE 16, 2021
The consumer group wants Janet Woodcock, Patrizia Cavazzoni and Billy Dunn to step down over last week's controversial approval of Aduhelm, which is expected to put immense strain on healthcare budgets.
pharmaphorum
JUNE 16, 2021
As biopharmaceutical products have become increasingly complex, both in design and in regulatory requirements, we need a new way of working. Markus Gershater looks at how automation and artificial intelligence (AI) can transform pharma R&D. Due to increasing complexity in R&D, pharma teams are under pressure to drive down costs and speed up time to market whilst improving outcomes, and most recognise that incorporating automation and AI into their workflows will be game-changing.
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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
JUNE 16, 2021
The subsidiary of hospital-owned nonprofit CivicaRx plans to make six to 10 common generic drugs that don't have enough competition to drive down cost.
Pharma Times
JUNE 16, 2021
New antibody tests can detect if an individual has been exposed to COVID-19 variants, including Alpha and Delta variants
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JUNE 16, 2021
People who cannot generate an effective immune response against COVID-19 can be protected with an infusion of Regeneron’s antibody therapy REGN-COV, according to new data from the UK RECOVERY trial. The therapy significantly reduced the risk of death, the length of hospital stay and the need for a ventilator in the study , which involved around 1,000 subjects who were given a blood test to check whether they had made any antibodies of their own to fight the virus.
XTalks
JUNE 16, 2021
Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4 percent, including against variants of concern. The company’s candidate recombinant nanoparticle protein-based COVID-19 vaccine, NVX-CoV2373, is being evaluated in the PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial COVID-19) Phase III tria
Scienmag
JUNE 16, 2021
Credit: Evan Kovacs/©Woods Hole Oceanographic Institution An innovative underwater robot known as Mesobot is providing researchers with deeper insight into the vast mid-ocean region known as the “twilight zone.” Capable of tracking and recording high-resolution images of slow-moving and fragile zooplankton, gelatinous animals, and particles, Mesobot greatly expands scientists’ ability to observe creatures in their […].
XTalks
JUNE 16, 2021
Tyson and JBS, two of the world’s largest meat producers, have recently announced plans to achieve net-zero greenhouse gas (GHG) emissions by 2050 and 2040, respectively. But will this goal be achievable given the fact that livestock account for about 14.5 percent of total GHG emissions, globally, and roughly two-thirds of those emissions come from cattle?
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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
Scienmag
JUNE 16, 2021
Credit: ALMA (ESO/NAOJ/NRAO) Researchers using the Atacama Large Millimeter/submillimeter Array (ALMA) discovered a titanic galactic wind driven by a supermassive black hole 13.1 billion years ago. This is the earliest-yet-observed example of such a wind to date and is a telltale sign that huge black holes have a profound effect on the growth of galaxies […].
pharmaphorum
JUNE 16, 2021
Sage Therapeutics and Biogen’s antidepressant candidate zuranolone has hit its objectives in a phase 3 trial, but a falloff in efficacy over time has raised concerns about the commercial potential of the drug. The WATERFALL trial of zuranolone showed that a two-week course of the oral GABA A receptor modulator significantly reduced symptoms of depression compared to placebo, with a rapid onset of action that started to be seen within three days.
Scienmag
JUNE 16, 2021
The three-year grant targets agricultural productivity, but also can advance ongoing human fertility research Credit: Daniel Miller, The University of Toledo Every time a dairy cow is bred and fails to become pregnant, a farmer loses a month of profits on the cow’s milk. If it grows to two months, that’s a 20% loss in […].
BioSpace
JUNE 16, 2021
The U.S. FDA approved Ayvakit for the treatment of adult patients with advanced sytematic mastocytosis (SM), advanced SM, and mast cell leukemia.
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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.
Scienmag
JUNE 16, 2021
Credit: Prof Jon Blount Chemical additives used in plastic production have been found in herring gull eggs, new research shows. Phthalates are a group of chemicals added to plastics to keep them flexible. The study, by the universities of Exeter and Queensland, looked for evidence of phthalates in newly laid herring gull eggs – and […].
BioSpace
JUNE 16, 2021
New research shows T cells can be engineered to migrate more effectively inside tumor microenvironments, raising hopes of reproducing the remarkable outcomes seen for certain hematological cancer patient subsets in broader populations and indications.
Scienmag
JUNE 16, 2021
Films made of shellfish shells, essential oils, and nanoparticles to protect fruit from microbes Credit: Christian Fleury (INRS) Québec produces more strawberries than any other Canadian province. Strawberries are delicate and difficult to keep fresh. In response to this challenge, Monique Lacroix, a professor at at the Institut national de la recherche scientifique (INRS), and […].
BioSpace
JUNE 16, 2021
Biopharma and life sciences companies from across the globe provide updates on their business operations and pipelines.
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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.
Scienmag
JUNE 16, 2021
Researchers show a graphene-based sensor can detect SARS-CoV-2 Credit: Vikas Berry Researchers at the University of Illinois Chicago have successfully used graphene — one of the strongest, thinnest known materials — to detect the SARS-CoV-2 virus in laboratory experiments. The researchers say the discovery could be a breakthrough in coronavirus detection, with potential applications in […].
BioSpace
JUNE 16, 2021
The new findings likely throw a wrench in the company's plans to deliver millions of much-needed vaccine doses to the European Union soon.
Scienmag
JUNE 16, 2021
Credit: Takao Yasui & Atsushi Natsume A recent study by Nagoya University researchers revealed that microRNAs in urine could be a promising biomarker to diagnose brain tumors. Their findings, published in the journal ACS Applied Materials & Interfaces, have indicated that regular urine tests could help early detection and treatment of brain tumors, possibly leading […].
BioSpace
JUNE 16, 2021
XTX101 is a tumor-selective anti-CTLA-4 monoclonal antibody designed to improve upon the safety of current therapies in the same class.
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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.
BioPharma Reporter
JUNE 16, 2021
Decentralized trials and remote monitoring, long discussed, but never really taking off until COVID-19 disrupted studies last year, will be under the spotlight at the DIA 2021 Annual Meeting at the end of this month.
BioSpace
JUNE 16, 2021
The FDA granted it to Lu-PSMA-617, an investigational radioligand therapy to treat metastatic castration-resistant prostate cancer.
pharmaphorum
JUNE 16, 2021
With the first patient set to receive Biogen’s new Alzheimer’s drug Aduhelm in Rhode Island today, US consumer advocacy organisation Public Citizen is deeply unhappy about the FDA’s approval of the drug – and it wants the scalps of those responsible. In a letter to Secretary of Health and Human Services Xavier Becerra, the director of Public Citizen’s Health Research group – Michael Carome – calls the FDA’s approval “reckless” and “one of the most
BioSpace
JUNE 16, 2021
Research shows that cancer can fool immune cells, which normally repair the body, into actually helping develop the disease.
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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
JUNE 16, 2021
The primary endpoint of the study is a 50% reduction in monthly migraine headache days
BioSpace
JUNE 16, 2021
Global science and technology innovator Danaher Corporation is adding another company to its ever-growing global operation.
Scienmag
JUNE 16, 2021
Ozone is a pollutant at ground level, but very high in the atmosphere’s “ozone layer,” it absorbs damaging ultraviolet radiation. Past studies have examined ozone levels in the Southern Hemisphere, but little is known about levels of the molecule in Antarctica over long periods. Now, researchers reporting in ACS’ Environmental Science & Technology have analyzed […].
pharmaphorum
JUNE 16, 2021
UK-based artificial intelligence pioneer Exscientia has made a play to stay at the forefront of the field, acquiring Austrian rival Allcyte with the help of its recent $525 million financing. The €50 million ($61 million) deal – in cash and stock – will give Exscientia ownership of a technology platform that takes patient samples and tests them against a library of approved or experimental drugs, using an AI-enabled imaging system to determine which compounds are having an effect.
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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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