Bio Pharma Dive
APRIL 12, 2022
Pfizer and Shionogi could receive 10 million pounds, or about $13 million, a year for new antibiotics. International participation might be needed further to spur development, however.
Pharma Mirror
APRIL 12, 2022
There are so many ways to get into the healthcare industry these days. There are a lot of changes happening in the industry which means that there are a lot of niche services that you can provide and make a lot of money while also serving your communities needs. For instance, telehealth is a burgeoning field these days and is a good place to start. Another area that has a lot of potentials is starting a medical lab facility.
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Bio Pharma Dive
APRIL 12, 2022
The FDA's OK is a needed reprieve for Gilead, whose dealmaking strategy in oncology has come under scrutiny from analysts and investors.
pharmaphorum
APRIL 12, 2022
The UK is poised to become the first country in the world to launch a new payment model for antibiotics that could reverse decades of decline in the category. The Department of Health, NHS England and NICE have completed an evaluation of two new antibiotics – Pfizer’s Zavicefta (ceftazidime/avibactam) and Shionogi’s Fetcroja (cefiderocol) – that will be paid for using the new subscription-like model likened to a Netflix account.
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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
XTalks
APRIL 12, 2022
Ferrero U.S.A., Inc., the owner of Kinder Chocolate, Nutella and Tic Tacs, among other brands, is voluntarily recalling its Kinder Happy Moments Chocolate Assortment and Kinder Mix Chocolate Treats basket, due to possible Salmonella contamination. “While there are no reports of illness in the United States to date, Ferrero is voluntarily recalling the products out of an abundance of caution due to reported cases of Salmonella in consumers that consumed products in Europe that were manufactured a
pharmaphorum
APRIL 12, 2022
Cate Evans, SVP group director, strategy at Havas Media Group, and Nick Lapolla, research director at MedSurvey tell us about a two-phase research study the companies recently performed to understand a patient’s prescription journey and who influences prescription-based decisions. The healthcare landscape has shifted dramatically due to the pandemic.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
APRIL 12, 2022
Novartis has joined the select cadre of drugmakers developing KRAS inhibitors for cancer, opening its account with phase 1b data on JDQ443 showing efficacy in KRAS-mutated non-small cell lung cancer (NSCLC). The results – presented at the American Association of Cancer Research (AACR) congress – set Novartis off in pursuit of Amgen, whose Lumakras (sotorasib) is already on the market, and Mirati Therapeutics which has adagrasib under review by the FDA.
Drug Channels
APRIL 12, 2022
The econowonks at the Centers for Medicare & Medicaid Services (CMS) recently released the latest projections for U.S. spending on healthcare. (See links below.) These data provide our first official look at post-pandemic U.S. healthcare spending. As you will see below, outpatient prescription drugs dispensed by retail and mail pharmacies are projected to remain a small share (8.4%) of total U.S. healthcare spending.
Scienmag
APRIL 12, 2022
Renewable energy prices have fallen by more than 70 percent in the last decade, driving more Americans to abandon fossil fuels for greener, less-polluting energy sources. But as wind and solar power continue to make inroads, grid operators may have to plan for large swings in availability. Credit: Yash Amonkar and Upmanu Lall, Columbia Engineering Renewable energy […].
Pharma Times
APRIL 12, 2022
Novacyt’s second direct-to-PCR test is the third product to be added to the Coronavirus Test Device Approvals (CTDA) register of approved products
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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
APRIL 12, 2022
In two new papers, a team of Massachusetts researchers examined the implementation of a groundbreaking opioid use disorder medication treatment program in seven jails across the state – part of a $155 million national effort to address the opioid crisis in criminal justice settings. The research was published in Drug and Alcohol Dependence (“Legislatively mandated implementation of […].
Pharma Times
APRIL 12, 2022
Engetix and Takeda will extend existing agreement to collaborate extensively in the development of therapeutics in IBD
Scienmag
APRIL 12, 2022
After water, sand is the most exploited natural resource on the planet. However, its extraction from seas, rivers, beaches and quarries has an impact on the environment and surrounding communities. A new study by researchers from the University of Geneva (UNIGE) and the University of Queensland’s Sustainable Minerals Institute (SMI) has found that a step-change […].
Outsourcing Pharma
APRIL 12, 2022
A recent online event hosted by the patient services company invited a number of women to share their experience and insights working in the research field.
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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
APRIL 12, 2022
Treating pollutants, such as endocrine disruptors, is an effective way to protect the environment. Endocrine disruptors are chemicals that alter the hormonal systems and the development of organisms that are exposed to them, even in small quantities. Doctoral student Julie Robitaille and Professor Valérie Langlois of the Institut national de la recherche scientifique (INRS) are […].
Outsourcing Pharma
APRIL 12, 2022
Miruna Sasu has been named president and CEO of the company, which uses RWD and analytics in advancing oncology drug development and clinical trial diversity.
Scienmag
APRIL 12, 2022
Rather than digging to identify unmarked mass grave sites or evidence to locate missing persons, new technologies are helping law enforcement agents, forensic scientists and historians uncover attempts to hide victims. Credit: Daniel Miller, The University of Toledo Rather than digging to identify unmarked mass grave sites or evidence to locate missing persons, new technologies […].
BioPharma Reporter
APRIL 12, 2022
Germany has made a series of contracts with vaccine manufacturers to reserve mRNA manufacturing capacity in the country as part of its pandemic preparedness plans.
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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
APRIL 12, 2022
One way in which scientists are studying how the human body grows and ages is by creating artificial organs in the laboratory. The most popular of these organs is currently the organoid, a miniaturized organ made from stem cells. Organoids have been used to model a variety of organs, but brain organoids are the most […].
pharmaphorum
APRIL 12, 2022
In today’s competitive global market, pharmaceutical companies cannot afford to waste time or resources on strategies that do not fit patient needs or generate scripts. Interconnectivity between all stakeholders and a 360° view of everything that touches the patient are essential when mapping each patient’s and HCP’s unique and differentiated journey.
Scienmag
APRIL 12, 2022
Superresolution structured illumination microscopy (SR-SIM) is an outstanding method for visualizing the subcellular dynamics in living cells. SR-SIM can achieve rapid, optically sectioned (OS), superresolution (SR) observation with hundreds to thousands of time points, which are the number of superresolution frames for continuous imaging. Credit: Zhaojun Wang and Ming Lei, Xi’an Jiaotong University Superresolution structured […].
The Pharma Data
APRIL 12, 2022
Navitoclax is being studied in myelofibrosis, a rare, difficult-to-treat blood cancer – Results are from an exploratory analysis of 34 myelofibrosis patients who received at least one dose of navitoclax in combination with ruxolitinib after suboptimal response or disease progression with ruxolitinib monotherapy – Median overall survival was not reached for patients who had a ?
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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
APRIL 12, 2022
As negotiations before the 15th Conference of the Parties to the Convention on Biological Diversity (COP-15) take place, international research has quantified the impact of human consumption on species extinction risk. Credit: Joe Townsend As negotiations before the 15th Conference of the Parties to the Convention on Biological Diversity (COP-15) take place, international research has […].
The Pharma Data
APRIL 12, 2022
– U.S. Pivotal Studies to Restart Enrollment Immediately –. – Decision Based on Review of the Comprehensive Safety Data from Each Trial –. Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine.
Scienmag
APRIL 12, 2022
A meadow’s lush array of flowers needs a full phalanx of bees to pollinate them—far more than just the honeybees and bumblebees that most people are familiar with, according to a new study by a team of researchers including University of Maryland entomologist Michael Roswell. A postdoctoral associate in the Department of Entomology, Roswell helped […].
The Pharma Data
APRIL 12, 2022
WHO welcomes the establishment of a new Heads of State and Government Group to accelerate progress towards the SDG target for noncommunicable diseases ? a one-third reduction in “premature” deaths from diseases like diabetes, cancer, heart and lung disease and the promotion of mental health and well-being. The decision was taken at the inaugural International Strategic Dialogue on Noncommunicable Diseases (NCDs) and the Sustainable Development Goals, held today in Accra, Ghana, where a new Globa
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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
APRIL 12, 2022
LA JOLLA, CA—Scientists at Scripps Research and the National Institute of Dental and Craniofacial Research have discovered a special type of cell that resides in salivary glands and is likely crucial for oral health. Credit: Scripps Research LA JOLLA, CA—Scientists at Scripps Research and the National Institute of Dental and Craniofacial Research have discovered a […].
FDA Law Blog
APRIL 12, 2022
By Michelle L. Butler & Josephine M. Torrente — On March 28, 2022, FDA transmitted its justification to Congress for its Fiscal Year 2023 budget. This document contains a number of legislative proposals, including three proposed amendments to the accelerated approval statutory provisions in section 506(c) of the Federal Food, Drug, and Cosmetic Act.
Scienmag
APRIL 12, 2022
Preventing the formation of a sticky, web-like substance that can form in blood vessels after a stroke could protect the brain and lead to better outcomes for patients, studies in mice suggest. The research was reported in the Journal of Clinical Investigation and led by scientists at University of Utah Health. Credit: Christian Con Yost, […].
Drug Patent Watch
APRIL 12, 2022
Annual Drug Patent Expirations for ZERBAXA Zerbaxa is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from one supplier. There are thirteen…. The post New patent for Cubist Pharms drug ZERBAXA appeared first on DrugPatentWatch - Make Better Decisions.
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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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