Bio Pharma Dive
JUNE 11, 2021
The latest results from the companies' trials give support to hopes that CRISPR gene editing could functionally cure sickle cell disease and beta thalassemia.
World of DTC Marketing
JUNE 11, 2021
Key Points: Trust in the CDC and FDA has decreased dramatically during the COVID-19 pandemic among health care professionals, according to a new WebMD/Medscape poll. Out of nearly 450 U.S. doctors surveyed in the same time period, 77% said their trust in the CDC has decreased and 48% said their trust in the FDA has decreased. Health care professionals have been critical of these agencies’ decisions during the pandemic, with some concerned that their work has been politicized and now wit
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Bio Pharma Dive
JUNE 11, 2021
An advisory panel could not reach consensus on how long or large trials in young children should be. Some experts argued falling infection rates might mean vaccination of kids under 12 is unnecessary.
Pharma Mirror
JUNE 11, 2021
In the new normal scenario of Healthcare, where the approaches are patient-centric and no longer product-centric, traditional and integrative medicinal practices are rooting to the greater extent so does the ‘Ethno-pharmacy’ At the intersection of social and natural sciences, Ethno-pharmacy is a field that focuses on the traditional medicines (and pharmaceuticals) and the cultural determinants to investigate the possible use/perception of traditional medicines (and also pharmaceutica
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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
pharmaphorum
JUNE 11, 2021
A digital therapeutic aimed at people with chronic lower back pain based on virtual reality (VR) has shown encouraging results in a clinical trial, helping patients manage the fear of movement that can reduce their activity and impede recovery. The therapy uses a VR headset to guide people with chronic pain through a series of cognitive behavioural therapy (CBT) exercises that are designed to help them overcome the fear of movement – also known as kinesiophobia.
Pharma Times
JUNE 11, 2021
The approval is based on results from the Phase III VIALE-A study as well as the Phase Ib M14-358 clinical trial
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Patent Watch
JUNE 11, 2021
Annual Drug Patent Expirations for INJECTAFER Injectafer is a drug marketed by Am Regent and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent for Am Regent drug INJECTAFER appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
JUNE 11, 2021
The fallout over the FDA’s decision to approved Biogen’s Alzheimer’s therapy Aduhelm continues to be felt, with a third member of its advisory committee resigning in protest. . The latest to depart the FDA’s Peripheral and Central Nervous System Drugs panel is Aaron Kesselheim of Harvard Medical School, joining fellow committee members Joel Perlmutter and David Knopman who quit earlier this week.
Scienmag
JUNE 11, 2021
Credit: Image provided by Abdullah Metebi, PhD Student at the Institute for Quantitative Health Science and Engineering, Michigan State University. Reston, VA (Embargoed until 11:00 a.m. EDT, Friday, June 11, 2021)–Preclinical trials of a new radiopharmaceutical to treat ovarian cancer have produced successful results, dramatically limiting tumor growth and decreasing tumor mass.
Pharma Times
JUNE 11, 2021
Stirred has been launched this week by former senior Pegasus colleagues Jo Spadaccino and Stuart Hehir
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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
JUNE 11, 2021
Sanofi’s hopes of a speedy approval of first-in-class C1s inhibitor sutimlimab in rare disorder cold agglutinin disease (CAD) were dashed by the FDA, but new phase 3 data keep the drugmaker on track for a resubmission before year-end. The results of the 42-subject CADENZA study – reported at the ongoing European Haematology Association (EHA) – showed that sutimlimab was able to reduce the destruction of red blood cells (haemolysis) seen in patients with CAD within one week of starting trea
Pharma Times
JUNE 11, 2021
New guidance enables earlier access to certain treatments, including biologics
Scienmag
JUNE 11, 2021
Jan Hoeijmakers to present new research in the biology of aging at the world’s largest aging research for drug discovery conference Credit: Insilico Medicine Hong Kong Limited Friday, 11th of June, 2021, London — Jan Hoeijmakers, Ph.D., will present the latest research on the topic DNA damage induced transcription stress and its connection with aging […].
Pharma Times
JUNE 11, 2021
Majority of patients were transfusion-free through 12 weeks of study, according to the new data
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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
JUNE 11, 2021
Credit: Yu Wang The Fenton reaction is a chemical transition involving hydrogen peroxide (H2O2) and the ferrous (iron) ion, which acts as a catalyst. This process is used to destroy hazardous contaminants in wastewater through oxidation. In the atmosphere, a similar reaction, or “Fenton-like” reaction, occurs continuously with ferric oxalate([Fe(III)(C2O4)3]3-) and aerosols suspended in the […].
pharmaphorum
JUNE 11, 2021
Lucid Group has acquired US strategic brand consultancy DiD to expand its presence in the US. Founded in 2007, Lucid Group is a strategic healthcare communications company based in London. In recent years the group has made a number of acquisitions including Bluedog , a digital and creative consultancy, and HealthCare21 , a specialised medical communications team.
Scienmag
JUNE 11, 2021
JAMA Internal Medicine What The Study Did: Editorial team composition by gender, race, ethnicity and sexual orientation was assessed at 25 leading medical and scientific journals in this survey study. Authors: James W. Salazar, M.D., M.A.S., of the University of California San Francisco, is the corresponding author. To access the embargoed study: Visit our For […].
NY Times
JUNE 11, 2021
The agency has not decided whether to allow a troubled vaccine factory in Baltimore to reopen.
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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
JUNE 11, 2021
What The Study Did: International medical graduates often practice as physicians in locations and specialties less preferred by U.S. medical graduates. This study reports on physician mortality from COVID-19, and on the mortality of international medical graduates in particular. Authors: Abraham Verghese, M.D., of Stanford University in California, is the corresponding author.
pharmaphorum
JUNE 11, 2021
Bristol-Myer Squibb has only just won FDA approval for its CAR-T Breyanzi in large B-cell lymphoma (LBCL), but is already eyeing an expansion into earlier-line therapy that could overtake rival therapies from Novartis and Gilead Sciences. Breyanzi (lisocabtagene maraleucel or liso-cel) was approved in February for use in LBCL patients after two prior systemic therapies, making it a third CD19-targeting CAR-T option for these patients after Novartis’ Kymriah (tisagenlecleucel) and Gilead
Scienmag
JUNE 11, 2021
Human health records and studies of lab mice suggest that vitamin D levels influence the desire for opioids and sun-seeking behavior BOSTON – Vitamin D deficiency strongly exaggerates the craving for and effects of opioids, potentially increasing the risk for dependence and addiction, according to a new study led by researchers at Massachusetts General Hospital […].
pharmaphorum
JUNE 11, 2021
Ocugen is the first company to be affected by the FDA’s recent decision to raise the bar on emergency use authorisations for COVID-19 medicines, and will have to file for full approval of its vaccine candidate. That will hold back the biotech’s Covaxin shot by several months, and the delay put pressure on Ocugen’s share price, which fell more than 25% after the announcement.
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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
JUNE 11, 2021
Four planets locked in a perfect rhythm around a nearby star are destined to be pinballed around their solar system when their sun eventually dies, according to a study led by the University of Warwick that peers into its future Credit: University of Warwick/Mark Garlick Astronomers from University of Warwick and University of Exeter modelling […].
Pharma Times
JUNE 11, 2021
Collaboration will research the effects of Modus' drug sevuparin in patients with severe malaria
Scienmag
JUNE 11, 2021
Credit: Image created by Singh et al., Cedars-Sinai Medical Center, Los Angeles, CA. Reston, VA (Embargoed until 6:15 p.m. EDT, Friday, June 11, 2021)–An advanced artificial intelligence technique known as deep learning can predict major adverse cardiac events more accurately than current standard imaging protocols, according to research presented at the Society of Nuclear Medicine […].
Drug Channels
JUNE 11, 2021
Today’s guest post comes from Jan Nielsen, Division President of AssistRx Patient Solutions. Jan provides five criteria that manufacturers can use when evaluating the capabilities of a Patient Solutions Provider (PSP), a.k.a. a hub vendor. To learn more, register for AssistRx's new, four-part webinar series: “Leading the Market in a Rapidly Changing Patient Solutions Landscape.”.
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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
JUNE 11, 2021
Credit: IPK/ Christoph Martin The enormous potential of Big Data has already been demonstrated in areas such as financial services and telecommunications. An international team of researchers led by the IPK Leibniz Institute has now tapped the potential of big data for the first time on a large scale for plant research. To this end, […].
Clinical Trial Gurus
JUNE 11, 2021
World renowned Principal Investigator and oncologist, Dr. Aljazayrly discusses common terminology criteria for adverse events, specifically as they pertain to cancer clinical trials.
Scienmag
JUNE 11, 2021
In a discovery that challenges long-held dogma in biology, researchers show that mammalian cells can convert RNA sequences back into DNA, a feat more common in viruses than eukaryotic cells PHILADELPHIA – Cells contain machinery that duplicates DNA into a new set that goes into a newly formed cell. That same class of machines, called […].
BioTech 365
JUNE 11, 2021
Ascendis Pharma A/S Announces Extension of U.S. Food and Drug Administration Review Period for TransCon™ hGH (Lonapegsomatropin) for Pediatric Growth Hormone Deficiency Ascendis Pharma A/S Announces Extension of U.S.
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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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