Bio Pharma Dive
FEBRUARY 10, 2021
Using technology from Caribou Biosciences, AbbVie hopes to engineer "off-the-shelf" CAR-T cells that can better withstand attacks from the immune system.
World of DTC Marketing
FEBRUARY 10, 2021
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Bio Pharma Dive
FEBRUARY 10, 2021
In a late-stage study of people recently diagnosed with COVID-19, the dual-antibody drug sharply reduced the risk of hospitalizations and death.
Camargo
FEBRUARY 10, 2021
Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high. Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products.
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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
Bio Pharma Dive
FEBRUARY 10, 2021
More data are needed to support use of the immunotherapy before surgery in triple-negative breast cancer, according to the FDA advisory committee.
BioPharma Reporter
FEBRUARY 10, 2021
BioNTech announced this morning it has started the production of mRNA at its new facility in Marburg, Germany: which will become one of the largest mRNA manufacturing sites in Europe.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
FEBRUARY 10, 2021
Three COVID-19 vaccine manufacturing sites are set to start production in France in the coming weeks: while the French government is seeking to boost further production with a â300m ($363m) initiative announced on Monday.
pharmaphorum
FEBRUARY 10, 2021
Improving the Safety, Efficacy & Predictability of Monotherapy & Combinatorial Therapies to Fast-track the Discovery & Development of TNBC Treatments to Reach Patients in Need. This is the primary industry platform specifically dedicated to providing you insight into the latest developments of safe and efficacious blockbuster therapies to treat triple negative breast cancer.
Pharma Times
FEBRUARY 10, 2021
Trial is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID)
pharmaphorum
FEBRUARY 10, 2021
Don’t panic – that’s the message from one ABPI code expert who tells Amanda Barrell it’s time to take stock and prioritise. Compliance managers have less than six months to rewrite processes and procedures in line with the updated ABPI code of practice before it becomes enforceable in July. But it doesn’t all have to be done at once, says Dr Rina Newton, managing director at code consultancy firm, CompliMed.
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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
NY Times
FEBRUARY 10, 2021
In a clinical trial, participants taking semaglutide lost 15 percent of their body weight, on average.
BioSpace
FEBRUARY 10, 2021
An observational study published in the Proceedings of the National Academy of Sciences suggests there is a strong positive association between the number of coronavirus disease 2019 (COVID-19) aerosol droplets an individual breathes out with age, infection and body weight.
pharmaphorum
FEBRUARY 10, 2021
The pairing of Heat Biologics’ lead drug HS-110 with Bristol-Myers Squibb’s blockbuster checkpoint inhibitor Opdivo has boosted survival in patients with non-small cell lung cancer (NSCLC), sending the biotech’s share price skywards. . Interim data from a phase 2 trial of Heat’s off-the-shelf cell therapy with Opdivo (nivolumab) showed that patients treated with the duo as a second-line therapy had a survival benefit, particularly in patients who hadn’t previously had checkpoint inhibitor therap
BioSpace
FEBRUARY 10, 2021
In the waning weeks of the fourth quarter of the 2020 fiscal year, AstraZeneca terminated several clinical programs, including some oncology and heart-related studies, as well as one COVID-19 related trial.
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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 10, 2021
Credit: Mary Ann Liebert, Inc., publishers New Rochelle, NY, February 10, 2021–It may be safe for COVID-infected mothers to maintain contact with their babies. Keeping them apart can cause maternal distress and have a negative effect on exclusive breastfeeding later in infancy, according to The COVID Mothers Study published in the peer-reviewed journal Breastfeeding Medicine. […].
XTalks
FEBRUARY 10, 2021
The US Food and Drug Administration (FDA) has granted marketing authorization to Signifier Medical Technologies ’ sleep apnea treatment device, called eXciteOSA. The new device is designed to reduce snoring and treat mild obstructive sleep apnea (OSA) in individuals 18 years and older, and is available by prescription only. Getting a restful night’s sleep is important for maintaining good physical and mental health.
Scienmag
FEBRUARY 10, 2021
Credit: NASA/Goddard/Barbara Lambert/Desiree Stover With less than a year to launch, NASA’s Lucy mission’s third and final scientific instrument has been integrated onto the spacecraft. The spacecraft, which will be the first to explore the Trojan asteroids—a population of small bodies that share an orbit with Jupiter—is in the final stages of the assembly process. […].
pharmaphorum
FEBRUARY 10, 2021
MEDSIR , a global company dedicated to independent clinical research in oncology, has initiated the PHERGain II clinical trial to demonstrate that in patients with HER2-positive early breast cancer with a good prognosis, a chemotherapy-free therapeutic approach can be as effective as the current standard of care, which involves the use of this generally more toxic treatment.
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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 10, 2021
Pitt and CMU researchers develop high-torque light-powered actuator Credit: Mahnoush Babaei If you watch the leaves of a plant long enough, you may see them shift and turn toward the sunlight through the day. It happens slowly, but surely. Some man-made materials can mimic this slow but steady reaction to light energy, usually triggered by […].
pharmaphorum
FEBRUARY 10, 2021
Harness the Maternal-Infant Microbiome, Establish New Mechanisms of Action, and Develop Breakthrough Health Products that Proactively Prevent Disease Risk. Returning for another year, the 3rd Microbiome Movement – Maternal & Infant Health Summit will unite industry and academics in the exploration of preventative and therapeutic treatment of the microbiome during pregnancy and early life.
Scienmag
FEBRUARY 10, 2021
Credit: Phil Jones, freelance photographer A tiny population of neurons known to be important to appetite appear to also have a significant role in depression that results from unpredictable, chronic stress, scientists say. These AgRP neurons reside exclusively in the bottom portion of the hypothalamus called the arcuate nucleus, or ARC, and are known to […].
BioSpace
FEBRUARY 10, 2021
It’s easy to feel guilty about taking time off when you’re working from home and not physically going on vacation. But your brain needs that vacation.
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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
FEBRUARY 10, 2021
Psychology: publication in Nature Communications Credit: HHU / Luca Franziska Kaiser As indicated by other studies, different parts of the brain are responsible for different types of decisions. A research team led by Luca Franziska Kaiser and Prof. Dr. Gerhard Jocham from the HHU working group ‘Biological Psychology of Decision Making’, and Dr.
BioSpace
FEBRUARY 10, 2021
There are some big surprises among the list of major players in the vaccine space who either dropped their programs or have been significantly delayed.
Scienmag
FEBRUARY 10, 2021
Credit: DFKI Three award winners earned their doctorates under Philipp Slusallek at Saarland University. The university professor and DFKI researcher has significantly advanced the award-winning ray tracing technology over the past two decades. Today, this technology provides many Hollywood movies and computer games with the perfect images and can also recently be found in almost […].
BioPharma Reporter
FEBRUARY 10, 2021
In recent months we have seen companies investing in capacity and technology around pre-fillable systems for both new injectable drugs and vaccines.
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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.
Outsourcing Pharma
FEBRUARY 10, 2021
This monthâs announcements about industry hires, promotions, alliances and other important events includes Merck, Lonza, Medable and other key firms.
BioSpace
FEBRUARY 10, 2021
Immunai today announced it has received $60 million in Series A funding, bringing its total funding since inception in December 2018 to $80 million.
Scienmag
FEBRUARY 10, 2021
New research and analysis examine how alcohol exposure impacts many aspects of neuroplasticity in a special issue of Brain Plasticity Credit: Steven P. Guerin Amsterdam, NL, February 10, 2021 – Neuroplasticity, the remarkable ability of the brain to modify and reorganize itself, is affected by or in response to excessive alcohol, whether through individual consumption […].
BioSpace
FEBRUARY 10, 2021
Let’s review the six tips for finding work during the coronavirus pandemic.
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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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