Bio Pharma Dive
JANUARY 18, 2022
The FDA has extended by three months its review of Bluebird's treatments for beta thalassemia and a rare brain disorder, the latest delay in the company's lengthy road to market in the U.S.
World of DTC Marketing
JANUARY 18, 2022
A Mediabistro survey showed that social networks influence more than 40% of people’s health choices. Tik-Tok, Instagram, and other social media channels may soon be overwhelmed with pharma companies’ content, but is it a good idea? People between 18 and 24 years of age tend to discuss health and wellness issues on social networks twice as much as those between the ages of 45 and 54 (getpushing.com), and of those between 18 and 24 years of age, 90% say they trust medical informatio
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Bio Pharma Dive
JANUARY 18, 2022
Ten months after Roche stopped giving the drug to patients in a Phase 3 trial, the pharma is planning a new study on the belief the medicine may help younger adult patients with less advanced disease.
Pharma Mirror
JANUARY 18, 2022
ADELAIDE, Avance Clinical, the largest premium Australian Contract Research Organisation (CRO) for international biotechs, has secured a significant investment from global private equity firm, The Riverside Company (Riverside), to support further regional and global expansion. The investment values the company in excess of $200m. Avance Clinical is taking meetings with biotechs to discuss the benefits of conducting trials in Australia, including no IND requirement and an attractive 43.5% rebate,
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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
JANUARY 18, 2022
AbbVie's Rinvoq and Pfizer's Cibinqo are both JAK-inhibiting drugs that are taken orally, a convenience which could help them compete against injectable treatments like Sanofi and Regeneron's Dupixent.
Pharma Mirror
JANUARY 18, 2022
BARCELONA, Spain, a global biopharmaceutical company focused on skin health, and IRB Barcelona (the Institute for Research in Biomedicine), an independent, international research centre engaged in fundamental and applied biomedical science, announced today a research collaboration to identify new oral treatments for immune-inflammatory skin diseases with remaining high unmet medical needs using molecular glue degraders, a novel therapeutic modality.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JANUARY 18, 2022
Microsoft and CVS Health have announced a new strategic alliance focusing on personalised care and accelerating digital transformation for the benefit of CVS customers and its employees. David Rhew, MD, global chief medical officer and VP of healthcare at Microsoft, tells us, “Using Microsoft technology, CVS Health will develop a more agile, digital-first technology foundation.” Digital innovation and implementation have skyrocketed within healthcare due to the need to adapt quickly
BioPharma Reporter
JANUARY 18, 2022
Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.
FDA Law Blog
JANUARY 18, 2022
By McKenzie E. Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing.
BioPharma Reporter
JANUARY 18, 2022
Orgenesis and The Johns Hopkins University will construct a cell and gene therapy processing facility for point of care treatment of patients at Johns Hopkins.
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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
JANUARY 18, 2022
Cancer Research UK announces clinical trial for most common type of lung cancer
pharmaphorum
JANUARY 18, 2022
Targeted agents and immunotherapies are two of the most promising areas for significant advancements in cancer treatment. Envision Pharma’s scientific solutions division lead Rebecca Goldstein, discusses this topic and other developments that cancer patients and their loved ones should be paying attention to. People with cancer and their caregivers have long been active participants in discussions of how they are treated, but in the current digital information age, it is becoming more common for
Scienmag
JANUARY 18, 2022
In ecological terms, coniferous formations represent the biggest terrestrial carbon sink, they play an essential part in the pollination of the ecosystems where they grow and, moreover, help improve agricultural production. At the same time, from an economic point of view, they are the main source of raw material for wood industries. Credit: University of […].
pharmaphorum
JANUARY 18, 2022
According to Rock Health’s annual digital health funding report, US-based digital health companies enabling life sciences research and development raised $5.8 billion (£4.3 billion) in 2021, making it the top funded category of the sector. This is the first time R&D has topped the chart since Rock Health began tracking US digital health funding in 2011, although it nabbed the number two slot in 2018 and 2020.
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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
JANUARY 18, 2022
What The Study Did: Researchers examined whether there were differences by insurance type in the return to expected rates of use of ambulatory care services in the first year of the COVID-19 pandemic. Authors: John N. Mafi, M.D., M.P.H., of the David Geffen School of Medicine at UCLA in Los Angeles, is the corresponding author. To access […].
Drug Channels
JANUARY 18, 2022
Join Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI), for three live video webinars during 2022. These live, interactive events will be broadcast via Zoom from the Drug Channels Video studio in beautiful downtown Philadelphia. Click here to order the Drug Channels 2022 Video Webinar Series. During these events, Dr. Fein will address the latest issues confronting the U.S. drug channel.
Scienmag
JANUARY 18, 2022
Recent advances in brain imaging techniques facilitate accurate, high-resolution observations of the brain and its functions. For example, functional near-infrared spectroscopy (fNIRS) is a widely used noninvasive imaging technique that employs near-infrared light (wavelength >700 nm) to determine the relative concentration of hemoglobin in the brain, via differences in the light absorption patterns of hemoglobin. […].
Pharma Times
JANUARY 18, 2022
The NHS launches world-first study investigating genetic testing for common diseases
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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
JANUARY 18, 2022
The biological intracellular microenvironment is complex, made up of various cell compartments and intracellular substances. To fully characterize the physiological function of living cells, one of the key factors is the development of micro/nanoprobes for subcellular measurement. Current nanoprobe techniques commonly rely on dyes and quantum dot-doped photoelectric materials as sensors or calibration objects, combined […].
Outsourcing Pharma
JANUARY 18, 2022
The pharmaceutical company reports studies have demonstrated the main protease inhibitor of Paxlovid maintains in vitro efficiency against the variant.
Scienmag
JANUARY 18, 2022
Inspired by their own experiences, representatives of a data-driven initiative to aid the COVID-19 response have outlined what they view as major obstacles to the successful use of novel data released by technology companies in times of crisis. Caroline Buckee of the Harvard T.H. Chan School of Public Health in Boston, Massachusetts, and colleagues present […].
Outsourcing Pharma
JANUARY 18, 2022
The Medicines and Healthcare Products Regulatory Agency has released proposals to bolster trials legislation, asking citizens for input on the suggestions.
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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.
Scienmag
JANUARY 18, 2022
A pair of University of Houston engineers has discovered that they can create upward fountains in water by shining laser beams on the water’s surface. Jiming Bao, professor of electrical and computer engineering at UH, and his postdoctoral student Feng Lin, attribute the finding to a phenomenon known as the Marangoni effect, which causes convection and […].
BioPharma Reporter
JANUARY 18, 2022
Charles River and La Jolla Institute for Immunology (LJI) are collaborating on a new project to uncover how different cells in the human immune system respond to SARS-CoV-2 in early, acute infection.
Scienmag
JANUARY 18, 2022
CLEVELAND—Researchers from Case Western Reserve University have identified a new mechanism by which a protein known for repairing damaged DNA also protects the integrity of DNA by preserving its structural shape. Credit: Case Western Reserve University CLEVELAND—Researchers from Case Western Reserve University have identified a new mechanism by which a protein known for repairing damaged […].
FDA Law Blog
JANUARY 18, 2022
By McKenzie E. Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing.
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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.
Scienmag
JANUARY 18, 2022
HOUSTON – (Jan. 18, 2022) – A new experimental platform developed at Rice University promises to speed up the discovery of how infectious bacteria become resistant to antibiotics. Credit: Jeff Fitlow/Rice University HOUSTON – (Jan. 18, 2022) – A new experimental platform developed at Rice University promises to speed up the discovery of how infectious […].
pharmaphorum
JANUARY 18, 2022
Cancer Research UK’s Centre for Drug Development, working with the Ludwig Institute for Cancer Research and Vaccitech, has begun a phase I/IIa clinical trial of a new lung cancer vaccine. The novel immunotherapeutic, VTP-600, is not a preventative vaccine — it’s intended for patients who have recently been diagnosed with non-small cell lung cancer. The initial trial will enrol 86 patients, across 10 specialist hospitals in the UK, testing for safety and efficacy in patients who are also receivin
Scienmag
JANUARY 18, 2022
As the COVID-19 pandemic continues, the development of antiviral drug treatments has become a critical weapon in our arsenal against the virus. Credit: Marc Roseboro – CNSI at UCLA As the COVID-19 pandemic continues, the development of antiviral drug treatments has become a critical weapon in our arsenal against the virus. Harnessing the research and […].
pharmaphorum
JANUARY 18, 2022
Poolbeg Pharma has licenced a candidate for nasal immunotherapy, developed by the University of Warwick, targeting respiratory infections, such as influenza and coronavirus. The RNA-based immunotherapy drug was developed at the University of Warwick and drew on 20 years of research, led by prominent virologists Professor Andrew Easton and Professor Nigel Dimmock.
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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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