Bio Pharma Dive
JUNE 25, 2021
A key committee of the EMA gave a positive review of Astellas and Fibrogen's roxadustat, as well as Bristol Myers Squibb's cell therapy Abecma and UCB's psoriasis drug Bimzelx.
pharmaphorum
JUNE 25, 2021
Former Cognoa executive Andy Molnar has been appointed chief executive of the Digital Therapeutics Alliance, a global trade association for companies developing evidence-based DTx products. Molnar, who served as vice president of market access and government affairs at Cognoa, joins the four-year-old trade association at a time when the potential of using DTx to deliver remote healthcare has been thrust into the spotlight by the coronavirus pandemic.
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Bio Pharma Dive
JUNE 25, 2021
The committee voted 13-4 to recommend the FDA wait for more clinical trial data from Incyte, which is aiming to win approval for what would be the eighth PD-1 or PD-L1 inhibitor.
pharmaphorum
JUNE 25, 2021
Sanofi and Regeneron’s checkpoint inhibitor Libtayo has tripled its approved uses in Europe, after getting the nod for the treatment of advanced basal cell carcinoma (BCC) and advanced non-small cell lung cancer (NSCLC). The approval of Libtayo (cemiplimab) in advanced NSCLC is for first-line treatment of patients with 50% or more PD-L1 expression and no EGFR, ALK or ROS1 aberrations, taking the drug into a large market dominated by Merck & Co/MSD’s rival checkpoint inhibitor Key
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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
JUNE 25, 2021
Catalent is to acquire German company, RheinCell Therapeutics, a developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs) for the next generation of cell therapies.
pharmaphorum
JUNE 25, 2021
Amarin’s Craig Granowitz discusses the impact of COVID on cardiovascular disease treatment and explains why there’s still a long way to go till we can truly tackle these diseases. COVID-19 has shone a light on the dangers of cardiovascular disease (CVD), with patients with these underlying conditions at much higher risk of dying from the virus. But Dr Craig Granowitz, chief scientific officer of cardiology drug developer Amarin, says that this is only the tip of the iceberg when it comes to the
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JUNE 25, 2021
In this episode of our Health Innovators series, Paul Tunnah is joined by tech entrepreneur Fredrik Debong. Fredrik is the founder of Hi.Health app which enables customers of private health insurance to submit their bills and prescriptions for medical services digitally. He discusses his career in tech and how he built the digital health company mySugr, which became one of the largest European digital health exits when it was sold to Roche in 2017.
Pharma Times
JUNE 25, 2021
Findings of the latest study assessing the test back its use as a screening tool, researchers say
BioPharma Reporter
JUNE 25, 2021
Augmenta Bioworks and TFF Pharmaceuticals Inc have selected their first lead monoclonal antibody (mAb) for clinical development against COVID-19 as part of their collaborative alliance.
Scienmag
JUNE 25, 2021
Credit: UTHSC Liza Makowski, PhD, professor in the Department of Medicine and the UTHSC Center for Cancer Research, has long been interested in how the immune system is altered by obesity and how this impacts cancer risk and treatment. “Obesity is complex, because it can cause both inflammation and activate counter-inflammation pathways leading to immunosuppression,” […].
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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
Pharma Times
JUNE 25, 2021
Genetic changes could be used to guide treatment for the rare and aggressive cancer type
Scienmag
JUNE 25, 2021
Seven graduate students in 3 departments including Department of Emerging Materials Science Credit: DGIST Graduate school students of DGIST were selected for the Ph.D. Student Research Promotion Fund Category of the ‘2021 Research Program for Cultivating Follow-up Generation of Science and Engineering’ funded by the National Research Foundation of Korea.
Pharma Times
JUNE 25, 2021
Study of self-reported data found a sizeable portion of individuals reporting persistent COVID-19 symptoms
Scienmag
JUNE 25, 2021
Assistant Professor Wei Xiong honored with inaugural CALPHAD Young Leader Award Credit: Wei Xiong PITTSBURGH (June 25, 2021) … CALPHAD (CALculation of PHAse Diagrams) is one of the genomic toolkits for material design and more recently is widely used in alloy innovation, ceramic design, processing optimization, and microstructure engineering. Its high-performance, time reducing capabilities are […].
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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.
The Pharma Data
JUNE 25, 2021
Ethicon*, part of the Johnson & Johnson Medical Devices Companies,**today announced the launch of the ENSEAL X1 Curved Jaw Tissue Sealer, a new advanced bipolar energy device that increases procedural efficiency [1] and provided stronger sealing [2] and better access to more tissue than LigaSure Maryland. [3] The device is indicated for colorectal, gynecological, bariatric surgery and thoracic procedures.
Scienmag
JUNE 25, 2021
Credit: UNIST Sung-Deuk Choi, Professor of Urban and Environmental Engineering at UNIST, received a certificate of commendation from the Ministry of Environment in commemoration of the 26th Environment Day on Saturday, June 5, 2021. As an expert in measuring and analyzing air pollutant emissions, Professor Choi received credit for carrying out a number of research […].
Drug Patent Watch
JUNE 25, 2021
Annual Drug Patent Expirations for OXBRYTA Oxbryta is a drug marketed by Global Blood Theraps and is included in one NDA. There are eight patents protecting this drug. This drug…. The post New patent for Global Blood drug OXBRYTA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 25, 2021
Researchers from the University of Tsukuba use time-resolved photoemission electron microscopy to probe the electron dynamics of solid-state film OLEDs Credit: University of Tsukuba Tsukuba, Japan – Organic light-emitting diodes (OLEDs) are widely used in display technology and are also being investigated for lighting applications. A comprehensive understanding of these devices is therefore important if […].
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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.
pharmaphorum
JUNE 25, 2021
The Cannes Lions Health awards took place this week from 21-25 June, celebrating creativity across industries including pharma. Gold, Silver and Bronze Lions were shared among winners from the U.S, U.K, Italy and Romania, with one pharma Grand Prix and two in health & wellness. There were 509 total entries in pharma, three were awarded Gold, eight Silver and 10 Bronze.
Scienmag
JUNE 25, 2021
Credit: Dr Maya Wardeh A new University of Liverpool study could help scientists mitigate the future spread of zoonotic and livestock diseases caused by existing viruses. Researchers have used a form or artificial intelligence (AI) called machine-learning to predict more than 20,000 unknown associations between known viruses and susceptible mammalian species.
Pharma Marketing Network
JUNE 25, 2021
Dynamic Global Events (“DGE”) is the Life Science Leader in providing B2B Events. Our name is derived from our Goal – to serve the dynamic informational and networking needs of the Pharmaceutical, Biotechnology, Healthcare, Medical Device and allied industries. DGE Virtual, Hybrid and Live Events: Engage Audiences. Facilitate Information Exchange. Accelerate Partnerships.
Scienmag
JUNE 25, 2021
Credit: Dr. Michael Roy (WEHI), using UCSF ChimeraX. WEHI has partnered with Boehringer Ingelheim, a leading research-driven pharmaceutical company, in a collaboration to discover and develop anti-cancer therapeutics using a promising new technology called targeted protein degradation. The partnership builds on more than 25 years of pioneering discoveries at WEHI, into a family of proteins […].
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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.
Clinical Trial Gurus
JUNE 25, 2021
It is not a regular occurrence for your first clinical research job to come with a six figure salary, but that is exactly what happened to recent CRA Academy graduate and we discuss just how that occurred in this interview.
Scienmag
JUNE 25, 2021
A paper appeared in Chemical Physics Credit: Kazan Federal University The contemporary materials industry raises the problem of creating a microscopic theory that allows to describe the observed physicochemical properties of a wide class of substances which are in demand in modern industry, medicine, and agriculture. A general and consistent theory will help to obtain […].
XTalks
JUNE 25, 2021
NeuraLace Medical’s peripheral nerve stimulation Axon Therapy System for treating chronic pain has been granted 510(k) clearance by the US Food and Drug Administration (FDA). Axon offers a non-invasive and non-pharmaceutical option for treating chronic pain. In contrast to other neuromodulatory devices, which work to impede the transmission of pain signals in the nervous system, NeuraLace’s technology applies external nerve stimulation at the source of pain caused by damaged peripheral nerves.
Scienmag
JUNE 25, 2021
Led by Katie Baldwin, Ph.D., research published in Neuron shows how the loss of the protein hepaCAM drives brain development dysfunction and plays an important role in neurological disorders Credit: Baldwin Lab, UNC School of Medicine CHAPEL HILL, NC – When we think of the brain, we think of neurons. But much of the brain […].
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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
JUNE 25, 2021
KEYNOTE-564 is the First Phase 3 Study to Show Positive Results for Adjuvant Immunotherapy in RCC. First-Time Disease-Free Survival Data to be Presented During Plenary Session at the 2021 ASCO Annual Meeting. KENILWORTH, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced first-time results from the pivotal Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, for the potential adjuvant treatment of patients
Scienmag
JUNE 25, 2021
The new system streamlines the process of fermenting plant sugar to fuel by helping yeast survive industrial toxins Credit: Photo courtesy of Felix Lam More corn is grown in the United States than any other crop, but we only use a small part of the plant for food and fuel production; once people have harvested […].
The Pharma Data
JUNE 25, 2021
Global Phase 3 TOPAZ-1 study will evaluate the efficacy and safety of BIIB059, as compared to placebo, in active systemic lupus erythematosus (SLE) , a debilitating autoimmune disease which has limited treatment options Positive Phase 2 LILAC study efficacy results support the further evaluation of BIIB059 in SLE. Biogen today announced that the first patient has been dosed in the global clinical study, TOPAZ-1.
Scienmag
JUNE 25, 2021
Vera Gorbunova 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, June 25, 2021, London — Vera Gorbunova, PhD., will present the latest research on the topic Mechanisms of Longevity: from naked mole rat to bowhead whale at […].
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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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