Bio Pharma Dive
OCTOBER 2, 2020
Under his leadership, Merck developed a once overlooked cancer drug into Keytruda, now a top-selling medicine and foundational treatment for more than a dozen types of tumors.
pharmaphorum
OCTOBER 2, 2020
Psychedelic therapy company Field Trip Psychedelics has announced that it will soon join the growing list of psychedelic companies going public. . Through a direct listing on the CSE, the company expects trading to begin on 7 October after entering into an amalgamation agreement in August with Newton Energy Corp. Field Trip aims to “take a personalised approach to mental wellness” by blending legal psychedelic-enhanced therapy, mindfulness, and self-care with a series of sessions with trained ps
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Bio Pharma Dive
OCTOBER 2, 2020
The company is now cleared to resume testing of its experimental shot in multiple countries, but a Phase 3 trial in the U.S. remains halted as an FDA investigation reportedly widens.
pharmaphorum
OCTOBER 2, 2020
New research shows that the COVID-19 pandemic is encouraging people to take their health into their own hands, and experts say this trend towards self-care could be a significant boon for healthcare systems – one the pharma industry should be encouraging. We often hear how early detection and disease prevention will be key for the future of healthcare – alleviating pressure on already over-stressed health systems by nipping costly and preventable diseases in the bud before they can drain healthc
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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
Scienmag
OCTOBER 2, 2020
Credit: Georgia State University ATLANTA–A combination of two substances secreted by the immune system can cure and prevent rotavirus infection, as well as potentially treat other viral infections that target epithelial cells, which cover body surfaces such as skin, blood vessels, organs and the urinary tract, according to researchers in the Institute for Biomedical Sciences […].
pharmaphorum
OCTOBER 2, 2020
European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines Agency did not say how long the process will take.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
OCTOBER 2, 2020
Sweden’s Orexo says its opioid use disorder (OUD) digital therapeutic – now christened Modia – is on course for a launch before the end of the year in the US. Like its earlier digital therapies for alcohol misuse and depression , Modia’s earlier-than-expected rollout stems from legislation that has made it possible to secure reimbursement for certain digital products for psychiatric disorders during the COVID-19 pandemic.
Scienmag
OCTOBER 2, 2020
Credit: Columbia University Irving Medical Center Columbia University will award the 2020 Louisa Gross Horwitz Prize to three scientists: Robert Fettiplace, University of Wisconsin-Madison, Madison, Wisconsin, USA A. James Hudspeth, Howard Hughes Medical Institute, Chevy Chase, Maryland, and the Rockefeller University, New York, New York, USA Christine Petit, Collège de France, Paris, and Institut Pasteur, […].
Pharma Tutor
OCTOBER 2, 2020
About Author. Nrusingha Panda. Department of Quality Assurance, Mankind Pharma Ltd., Bermiok Elaka, South Sikkim, Sikkim, Zip Code- 737126, India. ABSTRACT. Regulatory authorities expect from pharmaceutical industries that there should be written and approved procedures of sampling to collect samples for testing before approval of components of drug products, container and closure of drug products and drug product itself to assure patient safety in all respects whether chemical, physical and bio
pharmaphorum
OCTOBER 2, 2020
The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinical trials in the UK by offering new ways to conduct late-phase, large-scale research projects. One of the Sector Deal 2 commitments within the Government’s Life Sciences Industrial Strategy, the NPRCs are the first NIHR-funded research infrastructure that is 100% dedicated to delivering commercial research.
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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
OCTOBER 2, 2020
Credit: Provided by Indiana University A study conducted at 19 universities by IU researchers and their colleagues in the U.S. and Canada, found that a brief social belonging exercise, administered online before students arrive on campus, boosts the performance and persistence of students in STEM disciplines – science, technology, engineering and math – who speak […].
Pharma Times
OCTOBER 2, 2020
Fast track designation is based on promising phase Ib results
Scienmag
OCTOBER 2, 2020
Credit: Virginia Tech Renowned tick immunobiologist Utpal Pal wants to ad apt the rabies vaccination platform to produce antibodies that can protect against Borrelia burgdorferi, the bacteria responsible for Lyme disease. The intention is to apply this work to other tick-borne diseases in the future. “Borrelia infection is treatable with antibiotics, but it is often […].
Pharma Times
OCTOBER 2, 2020
NHS Confederation director responds to latest figures
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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
OCTOBER 2, 2020
Kessler Foundation and University of New Hampshire nTIDE Report–featuring more on the 2020 Kessler Foundation National Employment and Disability Survey and the experiences of college graduates with disabilities who came of age under the ADA Credit: Kessler Foundation East Hanover, NJ – October 2, 2020 – The downshift in the September job numbers sparks concerns […].
Drug Discovery Today
OCTOBER 2, 2020
Faecal transplants could one day be used as a therapy to restore cognitive function in the elderly – according to new research from the University of East Anglia, the University of Florence and the Quadram Institute
Scienmag
OCTOBER 2, 2020
Breast cancers that are detected in the interval between national screening programme mammograms have a worse prognosis than those detected at the time of a screening, even if they have the same biology, according to research presented at the 12th European Breast Cancer Conference on Saturday. Analysis of results from over eight years’ follow-up of […].
Pharma Times
OCTOBER 2, 2020
Diagnostics: Recovery and Renewal report identifies a number of key actions
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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
OCTOBER 2, 2020
New funding from the NIH’s rapid acceleration of diagnostics program supports social network strategy to encourage COVID-19 testing in disenfranchised populations The Chicago Center for HIV Elimination, housed at the University of Chicago, has been awarded $5 million over two years through the National Institute of Health’s (NIH) RADx Underserved Populations program.
pharmaphorum
OCTOBER 2, 2020
In a world producing more content than ever before, getting information to time-poor HCPs can be incredibly difficult – even if they want to find it. Ian Daley and Jonathan Macdonald from EPG Health tell us how pharma can take cues from digital publishing and companies like Amazon to make sure their messages get heard. We’re a long way from the times when doctors would get most of their medical information from print journals and medical meetings.
Scienmag
OCTOBER 2, 2020
Credit: University of California San Diego Patients receiving care for advanced cancer at Moores Cancer Center at UC San Diego Health were more likely to survive or experience a longer period without their disease progressing if they received personalized cancer therapy, report University of California San Diego School of Medicine researchers. Led by Razelle Kurzrock, […].
pharmaphorum
OCTOBER 2, 2020
Roche’s Genentech unit has paid $200 million to develop an individualised cancer vaccine with Norwegian biotech Vaccibody, which focuses on targets known as neoantigens that spring up as tumours grow and mutate. The deal with the Oslo-based company is worth up to $715 million, with potential milestone payments worth up to $515 million on top of the $200 million in near-term payments.
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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
OCTOBER 2, 2020
Developed by Innova Therapeutics, IVT-8086 is the first potential new treatment for osteosarcoma in over 30 years Credit: Medical University of South Carolina Innova Therapeutics Inc., a biotechnology company dedicated to developing innovative cancer therapies for patients who have inadequate treatment options, recently announced that the U.S. Food and Drug Administration (FDA) has granted rare […].
NY Times
OCTOBER 2, 2020
Scientists are looking at the medicinal potential of plants and animals in the region’s vast tropical forests.
Scienmag
OCTOBER 2, 2020
Credit: Will Kirk/Johns Hopkins University When a baby reaches for one stuffed animal in a room filled with others just like it, that seemingly random choice is very bad news for those unpicked toys: the baby has likely just decided she doesn’t like what she didn’t choose. Though researchers have long known that adults build […].
Drug Patent Watch
OCTOBER 2, 2020
Annual Drug Patent Expirations for OFEV Ofev is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent expiration for Boehringer Ingelheim drug OFEV appeared first on DrugPatentWatch - Make Better Decisions.
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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
OCTOBER 2, 2020
Dual-energy CT adds value to routine interpretation of emergency department imaging studies by increasing radiologists’ diagnostic confidence, leading to a reduction in downstream imaging and associated costs Credit: American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR) Leesburg, VA, October 2, 2020–According to an open-access article in ARRS’ American Journal of Roentgenology (AJR), dual-energy […].
pharmaphorum
OCTOBER 2, 2020
A significant proportion of the clients we work with know that KOLs well. They also recognise that this in itself is the problem! When you have been in a therapy area for a while and have done your KOL identification and KOL mapping previously, you may get used to working with the same people over and over again. It’s after all easy (and very natural) to keep working with the same KOLs and using the same small group of people that you know well for all your activities and initiatives.
Scienmag
OCTOBER 2, 2020
Credit: (Photo courtesy of the NavalX Agility Cell) ARLINGTON, Va.–A mobile app allowing Sailors and Marines to collaborate with leadership to solve problems. A Wikipedia-style platform for the entire Navy–which can be shared in a Cloud environment and serve as a repository of institutional knowledge. Streamlining the use of Microsoft SharePoint and Teams to reduce […].
pharmaphorum
OCTOBER 2, 2020
The five new NHS Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinical trials in the UK by offering new ways to conduct late-phase, large-scale research projects. One of the Sector Deal 2 commitments within the Government’s Life Sciences Industrial Strategy, the NPRCs are the first NIHR-funded research infrastructure that is 100% dedicated to delivering commercial research.
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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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