Bio Pharma Dive
FEBRUARY 28, 2022
The findings build on early evidence that gene editing inside the body could safely and effectively treat disease, and suggest the effects of Intellia's medicine might last.
World of DTC Marketing
FEBRUARY 28, 2022
Advertising is meant to “sell” your product, but the pharma industry is unique because people don’t just see an ad for a prescription drug and run to their doctor. There is a path between awareness and asking for/receiving an Rx. It’s more than just about understanding; it’s about being relevant to the needs of online health seekers.
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Bio Pharma Dive
FEBRUARY 28, 2022
The CAR-T treatment is the second to be approved in the U.S. for the blood cancer, following Bristol Myers Squibb and 2Seventy bio's Abecma.
BioPharma Reporter
FEBRUARY 28, 2022
Medicago and GlaxoSmithKline (GSK) have gained approval for Covifenz, the companiesâ plant-based COVID-19 vaccine, from Health Canada.
Bio Pharma Dive
FEBRUARY 28, 2022
Arbutus and partner Genevant claim Moderna's coronavirus shot uses delivery technology covered by six patents they hold, an allegation Moderna denies.
pharmaphorum
FEBRUARY 28, 2022
UK Health Secretary Sajid Javid has said he wants to accelerate the rollout of electronic patient records (EPR) in the NHS, with 90% of NHS trusts using them by the end of 2023. Javid laid out the new target in a speech to the HSJ Digital Transformation Summit, in which he said that current estimates are that one in five NHS trusts still do not have EPR, and so are missing out on a key technology to deliver better, safer care for patients.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
FEBRUARY 28, 2022
With over 40% of all medicines in the pipeline aimed at rare diseases, the future looks positive for increasing the number of treatments available. However, as Ben Hargreaves discovers, research into the area has only scratched the surface, amid calls for greater funding and greater collaboration to accelerate progress. There are approximately 7,000 different types of rare disease and researchers estimate that there are more than 300 million people worldwide living with such a condition.
Bio Pharma Dive
FEBRUARY 28, 2022
Self-care and the resulting increased use of over-the-counter (OTC) medications is a growing global trend.
pharmaphorum
FEBRUARY 28, 2022
India’s Biocon has expanded its pipeline of biosimilars with a $3.3 billion deal to acquire a portfolio of drugs from Viatris, the parent of its longstanding partner Mylan, which will boost its position on the international stage. . Biocon is paying $2.3 billion in cash and providing another $1 billion in stock under the terms of the deal, which has been approved by the boards of both companies and is expected to close in the second half of this year.
Bio Pharma Dive
FEBRUARY 28, 2022
While expected, the decision raises questions about the treatment's prospects in other settings. Reata may have better luck with another drug it's submitting to the FDA for a movement disorder.
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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
pharmaphorum
FEBRUARY 28, 2022
A new study has suggested that the economic burden posed by rare diseases is around 10 times higher than for common “mass market” conditions. The analysis by IQVIA and pharma company Chiesi looked at the per patient, per year (PPPY) direct, indirect and mortality-related costs associated with 24 rare diseases, and compared them to 24 chronic ailments like diabetes, heart disease, arthritis and cancers.
Bio Pharma Dive
FEBRUARY 28, 2022
The sale to Biocon represents the first major step Viatris has taken to reshape itself, following a strategic review that took place throughout 2021.
pharmaphorum
FEBRUARY 28, 2022
Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare and debilitating skin disease epidermolysis bullosa (EB). Shares in the Ireland-based rare disease specialist fell sharply after news of the complete response letter (CRL) from the FDA emerged, with the agency asking for “additional confirmatory evidence of effectiveness” for cutaneous manifestations of dystrophic and junctional EB.
XTalks
FEBRUARY 28, 2022
Today is Rare Disease Day, which is celebrated annually on the rarest day of the year, February 28 (or February 29 in leap years). Rare Disease Day is a global movement that strives to foster equity in access to diagnosis, care and therapies, as well as social opportunity for people with rare diseases. The theme of this year’s Rare Disease Day is “Share Your Colours,” which is a call to shine light on individuals with rare diseases to hear about their stories, experiences and aspirations.
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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
FEBRUARY 28, 2022
The new clinical trials regulation makes it easier to conduct clinical trials in the EU, according to an EU Commission representative.
Outsourcing Pharma
FEBRUARY 28, 2022
With a specific focus on clinical trials involving treatments for rare diseases, Orphan Reach seeks to build upon the services that conventional CROs offer.
Pharma Times
FEBRUARY 28, 2022
Unmet need among over 7000 rare diseases is being addressed in a comprehensive action plan
Outsourcing Pharma
FEBRUARY 28, 2022
The recent Outsourcing-Pharma webinar hosted a trio of industry experts highlighting challenges, opportunities, and innovations in the rare disease realm.
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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
FEBRUARY 28, 2022
A research team from New York Institute of Technology College of Osteopathic Medicine (NYITCOM), led by Biomedical Sciences Instructor Satoru Kobayashi, Ph.D., has secured a grant from the National Institutes of Health (NIH) National Heart, Lung, and Blood Institute. The three-year $428,400 grant will support innovative research that may deliver life-saving treatments for diabetic heart failure. […].
Pharma Times
FEBRUARY 28, 2022
Quviviq can be used on a long-term basis, addressing a key limitation of existing therapies
Scienmag
FEBRUARY 28, 2022
Scientist Prof. Dr. Svetlana Berdyugina, Professor of Astrophysics at the University of Freiburg and Director of the Leibniz Institute for Solar Physics (KIS), together with an international team of astronomers, has reliably measured for the first time a large difference between the rotation axis of the black hole and the axis of the orbit of […].
BioPharma Reporter
FEBRUARY 28, 2022
Eyebiotech Limited, which was only founded in August last year, has just completed a successful US$65m Series A funding round.
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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
FEBRUARY 28, 2022
The impacts of climate change are pushing electrical grids around the world to their limits. Last year, an unprecedented polar vortex caused consumers in Texas to crank up their thermostats and overwhelm the power grid, resulting in days-long power outages. And in California, power is preemptively shut off during high fire-risk weather conditions. Credit: Holy […].
pharmaphorum
FEBRUARY 28, 2022
It looks like GlaxoSmithKline’s concerns about its respiratory syncytial virus (RSV) vaccine in pregnant women aren’t going to be resolved quickly. After suspending three trials of the much-anticipated vaccine earlier this month to investigate a safety signal, the pharma group has now gone a step further, stopping all enrolment and vaccination in the studies.
Scienmag
FEBRUARY 28, 2022
The innate immune system plays a crucial role in regulating host-microbe interactions, and especially in providing protection against pathogens that invade the mucosa. Using an intestinal infection model, scientists from the Institut Pasteur and Inserm discovered that innate effector cells – group 3 innate lymphoid cells – act not only during the early stages of […].
pharmaphorum
FEBRUARY 28, 2022
Johnson & Johnson and the ‘big three’ US pharm wholesalers say they are close to finalising a $26 billion settlement that could allow them to finally put years of litigation over their role in fuelling the opioid crisis behind them. The settlement is the largest to date among thousands of opioid-related lawsuits brought against pharma companies and distributors.
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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
FEBRUARY 28, 2022
FOR IMMEDIATE RELEASE Credit: Public domain images FOR IMMEDIATE RELEASE In early 2021, researchers at Johns Hopkins Medicine and NORC at the University of Chicago showed that the Agency for Healthcare Research and Quality (AHRQ) Safety Program for Improving Antibiotic Use — a comprehensive system they developed to assist health care institutions with establishing and […].
Drug Patent Watch
FEBRUARY 28, 2022
Annual Drug Patent Expirations for GALAFOLD Galafold is a drug marketed by Amicus Therap Us and is included in one NDA. There are twenty-seven patents protecting this drug. This drug…. The post New patent for Amicus Therap drug GALAFOLD appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
FEBRUARY 28, 2022
A team from the University of Illinois has revamped the popular crop growth simulation software BioCro, making it a more user-friendly and efficient way to predict crop yield. The updated version, BioCro II, allows modelers to use the technology much more easily and includes faster and more accurate algorithms. Credit: Justin McGrath and Ed Lochocki/RIPE […].
Drug Patent Watch
FEBRUARY 28, 2022
Annual Drug Patent Expirations for PRISTIQ Pristiq is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from four suppliers. There are two…. The post New patent expiration for Pf Prism drug PRISTIQ appeared first on DrugPatentWatch - Make Better Decisions.
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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.
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