World of DTC Marketing
MAY 2, 2021
SUMMARY: A new survey from the Kaiser Family Foundation and the Purchaser Business Group on Health shows signs that corporate executives might be warming to the idea of government getting more involved to rein in the excesses of the healthcare system. It’s affecting their bottom lines, and they won’t stand for that. Big changes are coming.
Camargo
MAY 2, 2021
Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. These therapies frequently target diseases in patients that are rare (affecting fewer than 200,000 people in the US), serious, and representing an unmet medical need.
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BioSpace
MAY 2, 2021
Grabbing a fast-tracked novel enzyme replacement therapy for a rare pediatric disease, new biopharma Aceragen launched with $35 million in hand for product financing.
Scienmag
MAY 2, 2021
Automated search for “various situations” encountered in automated driving Credit: © National Institute of Informatics The research team led by Fuyuki Ishikawa at the National Institute of Informatics (NII, Japan) developed a technique to search automatically for simulation configurations that test various behaviors of automated driving systems.
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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
BioSpace
MAY 2, 2021
If actually administered to these patients, this could represent the first recorded attempt to manage dementia that uses an injectable gene therapy technique.
Scienmag
MAY 2, 2021
Review in The American Journal of Psychiatry The legacy of systemic racism in the U.S impacts psychosis risk at the individual and neighborhood level, according to a definitive review published online today. Researchers examined U.S. based evidence connecting social and environmental factors with outcomes relating to psychotic experiences, including schizophrenia.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
MAY 2, 2021
New research shows that planned cesarean deliveries on maternal request are safe for low-risk pregnancies and may be associated with a lower risk of adverse delivery outcomes than planned vaginal deliveries. The study is published in CMAJ (Canadian Medical Association Journal). The study used province-wide data from the Better Outcomes Registry & Network (BORN), Ontario’s […].
BioSpace
MAY 2, 2021
The regulatory nod marks the first time the FDA approved an SGLT2 inhibitor for the treatment of CKD regardless of diabetes status.
Scienmag
MAY 2, 2021
Can increase organ availability by 20% Boston, MA (May 2, 2021) – A new study, presented today at the AATS 101st Annual Meeting, found that heart transplantation using donation after cardiac death (DCD) with normothermic regional perfusion (NRP) is feasible in the United States. Broader application of DCD heart transplantation has the potential to increase […].
BioSpace
MAY 2, 2021
Although clinical trial news related to COVID-19 was slow last week, there’s quite a bit of news on studies for other indications.
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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
MAY 2, 2021
New research has shown that COVID-19 infections in healthcare workers during the first wave of the pandemic provided an accurate sample of the general population, suggesting that data from healthcare workers could be used to estimate the severity of future viruses more quickly. The study, led by researchers from RCSI University of Medicine and Health […].
BioSpace
MAY 2, 2021
As Tenaerts takes the scientific helm at Medable, she will leverage the company’s proprietary platform to advance decentralized research methodologies with evidence-based best practices for patient-centric clinical trials.
Scienmag
MAY 2, 2021
Study from Bocconi University shows that negative campaigning with electoral attacks on opponents backfires and, in multicandidate races, ends up having positive spillover effects on third candidates Credit: Paolo Tonato Candidates often give in to temptation to attack opponents in electoral campaigns through negative ads (more than 55% of the ads aired by the Clinton […].
BioSpace
MAY 2, 2021
There are seven stages of Alzheimer’s disease, and understanding each stage is a useful aid in setting your expectations whether you might have the disease or you’re caring for someone with the illness.
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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.
JAMA Internal Medicine
MAY 2, 2021
This cohort study compares patterns of childbirth among physicians vs nonphysicians.
BioSpace
MAY 2, 2021
One year after Astellas and California-based Cytokinetics extended an agreement to develop Skeletal Sarcomere Activators, the Japanese pharma company is walking away from the deal.
Scienmag
MAY 2, 2021
Diatoms are tiny unicellular plants — no bigger than half a millimeter — which inhabit the surface water of the world’s oceans where sunlight penetration is plenty. Despite their modest size, they are one of the world’s most powerful resources for removing carbon dioxide (CO2) from the atmosphere. They currently remove, or “fix,” 10-20 billion […].
BioSpace
MAY 2, 2021
The U.S. FDA approved Chiesi Global Rare Diseases’ Ferriprox for treatment of transfusional iron overload caused by sickle cell disease (SCD) or other anemias in adults and children ages three years and older. This approval expands the use of the drug for patients with SCD or other anemias.
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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
MAY 2, 2021
More than 40 percent of recipients received multiple NIH grants Boston, MA (May 2, 2021) – A new study, presented today at the AATS 101st Annual Meeting, finds that AATS Foundation fellowships support success in academic surgery career tracks. The AATS Foundation has two primary grant funding mechanisms: the AATS Foundation Scholarship and the Surgical […].
BioSpace
MAY 2, 2021
BioSpace takes an in-depth look at the Top 25 of Q1.
Scienmag
MAY 2, 2021
Levels of potentially health-threatening chemicals rise with years of service, Rutgers study finds Volunteer firefighters — who comprise more than 65 percent of the U.S. fire service — have higher levels of “forever chemicals,” per- and polyfluoroalkyl substances (PFAS), in their bodies than the general public, according to a Rutgers study.
BioTech 365
MAY 2, 2021
Advanced Clinical Continues Global Expansion into Asia-Pacific with New Singapore Office Advanced Clinical Continues Global Expansion into Asia-Pacific with New Singapore Office CHICAGO–(BUSINESS WIRE)–Advanced Clinical, a global clinical research services organization, is pleased to announce that the company’s global expansion … Continue reading →
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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
MAY 2, 2021
Proportion of patients with segmental disease has increased dramatically over the last 15 years; 76% of patients with segmental disease treated with PEA were highly functional within 12 months of procedure Boston, MA (April 30, 2021) – A new study, presented today at the AATS 101st Annual Meeting, found that patients treated surgically for segmental […].
BioTech 365
MAY 2, 2021
Addex Therapeutics to Release Q1 2021 Financial Results and Host Conference Call on May 5, 2021 Addex Therapeutics to Release Q1 2021 Financial Results and Host Conference Call on May 5, 2021 Geneva, Switzerland, May 3, 2021 – Addex Therapeutics Ltd … Continue reading →
Scienmag
MAY 2, 2021
Boston, MA (May 2, 2021) – A new study, presented today at the AATS 101st Annual Meeting, shows an association between decreased survival at five years and leaving an atrial communication at biventricular repair of unbalanced AVSD after adjusting for other known risk factors. During repair of atrioventricular septal defect (AVSD), surgeons may leave an […].
BioTech 365
MAY 2, 2021
Santhera Announces Settlement of Convertible Bond Exchange Offer on May 4, 2021 Santhera Announces Settlement of Convertible Bond Exchange Offer on May 4, 2021 NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN ANY JURISDICTION IN WHICH IT WOULD BE UNLAWFUL TO … Continue reading →
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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.
The Pharma Data
MAY 2, 2021
Sandoz to begin enrolling patients with neovascular age-related macular degeneration in MYLIGHT Phase lll confirmatory efficacy and safety study 1. Neovascular age-related macular degeneration accounts for 10% of age-related macular degeneration cases, but is responsible for 90% of AMD-related blindness 2. With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems.
BioTech 365
MAY 2, 2021
GenSight Biologics Announces Publication of Results from the REALITY LHON Natural History Study in the Journal Eye GenSight Biologics Announces Publication of Results from the REALITY LHON Natural History Study in the Journal Eye Confirms that untreated ND4 LHON patients … Continue reading →
Drug Patent Watch
MAY 2, 2021
This chart shows the patent expirations for capsule dosed drugs over the next decade. The term of drug patents varies. The basic term for a patent is 20 years from…. The post Capsule dosed drug patent expirations by year appeared first on DrugPatentWatch - Make Better Decisions.
BioTech 365
MAY 2, 2021
Study Investigates the Ability of Masimo PVi® to Predict Preload Responsiveness in Patients On Nasal High-Flow Therapy Study Investigates the Ability of Masimo PVi® to Predict Preload Responsiveness in Patients On Nasal High-Flow Therapy Researchers Found That PVi May Be … Continue reading →
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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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