Bio Pharma Dive
JULY 26, 2021
With the decision by Bristol Myers, each of the two accelerated cancer drug approvals an FDA advisory panel voted to overturn in April have now been voluntary withdrawals.
pharmaphorum
JULY 26, 2021
You’ve had your two COVID-19 jabs, but are you actually protected against infection? That’s a question that a fingerprick test launched today in the UK and Ireland could help to answer. The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood.
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Bio Pharma Dive
JULY 26, 2021
Approximately 79% of patients look to connect through social media to find answers to their health questions.
BioSpace
JULY 26, 2021
Biotech jobs are one of the most promising career paths for people who are into life sciences and those who dream of creating change in the world through developing breakthrough medicines and therapeutics.
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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
JULY 26, 2021
Responding to criticism, the German biotech plans to develop a malaria shot and build manufacturing infrastructure on the continent.
pharmaphorum
JULY 26, 2021
A lack of racial diversity in clinical trials is a long-standing, well-documented problem that contributes to the stark health inequalities that have been brought into sharp focus by COVID-19. Tackling it, however, has not been easy, thanks in no small part to the reasons being as complex as they are multi-faceted. But, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), the country’s biopharmaceutical companies are “committed to learning and leading” in a bid to “addr
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JULY 26, 2021
Bryan Dechairo, newly appointed president and CEO of Sherlock Biosciences, learned early in his career to fill gaps and seize opportunities. “When you see a gap, jump in and solve those problems, and you’ll be at the forefront of science rather than following others,” he told BioSpace.
Bio Pharma Dive
JULY 26, 2021
New data from an early-stage study of Denali's drug for Hunter syndrome look "noisy" and even "uninterpretable," according to some analysts. Company shares fell by 15% Monday morning.
BioSpace
JULY 26, 2021
Merck's Keytruda won FDA approval for the treatment of patients with high-risk, early-stage triple-negative breast cancer. The approval marked the 30th for Keytruda.
Pharma Times
JULY 26, 2021
Combo therapy includes carflizomib administered alongside lenalidomide, dexamethasone and cyclophosphamide
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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
BioSpace
JULY 26, 2021
Several biotech and biopharmaceutical companies have announced new wins with the U.S. Food and Drug Administration (FDA), with these wins ranging from Investigational New Drug (IND) application approvals for cancer treatment candidates to Fast Track Designations for investigational agents aimed t.
XTalks
JULY 26, 2021
Plant-based meat has been in the spotlight in recent years thanks to its professed health, safety and environmental benefits over its animal-based counterpart. But several researchers and experts have brought to light some food safety concerns of plant-based meat, and why it must be treated differently than that of animal protein. While public discourse tends to focus on the notable achievements in plant-based meat, there is much less discussion surrounding the inherent safety challenges it must
BioSpace
JULY 26, 2021
While modern-day science has provided the world with highly effective vaccines to fight the COVID-19 pandemic, researchers have had less luck finding effective treatment options for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Scienmag
JULY 26, 2021
Credit: Hidekazu Sumi Citrus fruits from the mandarin family have important commercial value but how their diversity arose has been something of a mystery Researchers analyzed the genomes of the East Asian varieties and found a second center of diversity in the Ryukyu Islands along with the previously known center in the mountains of southern […].
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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.
BioSpace
JULY 26, 2021
?The companies will co-finance a clinical study to test the combination of SHP2 inhibitor BBP-398 and OPDIVO in treating patients with advanced solid tumors KRAS mutations.
Scienmag
JULY 26, 2021
Credit: Rebecca Gourley/University of Washington Government officials and policymakers have tried to use numbers to grasp COVID-19’s impact. Figures like the number of hospitalizations or deaths reflect part of this burden. Each datapoint tells only part of the story. But no one figure describes the true pervasiveness of the novel coronavirus by revealing the number […].
BioSpace
JULY 26, 2021
Just as it was beginning to appear safe to return to maskless, pre-pandemic life, the Delta variant of the SARS-CoV-2 virus emerged. It is fast-spreading, more likely to lead to hospitalizations, and accounts for most of the breakout infections among fully vaccinated individuals.
Scienmag
JULY 26, 2021
Credit: Alzheimer’s Association DENVER, JULY 26, 2021 — Improving air quality may improve cognitive function and reduce dementia risk, according to several studies reported today at the Alzheimer’s Association International Conference® (AAIC®) 2021 in Denver and virtually. Previous reports have linked long-term air pollution exposure with accumulation of Alzheimer’s disease-related brain plaques, but this is […].
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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.
Pharma Times
JULY 26, 2021
European drug regulator has recommended Ultomiris for use in children and adolescents with PNH
Scienmag
JULY 26, 2021
Collaboration signifies strong commitment by all stakeholders to maintain the journal’s high standards and expand its global prominence Credit: ACMG New York, July 26, 2021 – The American College of Medical Genetics and Genomics (ACMG), the only nationally recognized US medical professional organization solely dedicated to improving health through the practice of medical genetics and […].
Delveinsight
JULY 26, 2021
Uncomplicated Urinary Tract Infections are one of the most commonly diagnosed infections in the US, with the maximum prevalence in women who are sexually active. A wide range of pathogens can be a reason behind the manifestation of the condition; however, Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis , Enterococcus faecalis , and Staphylococcus saprophyticus are some of the most common causes.
Scienmag
JULY 26, 2021
Credit: TIAN Ying and ZHANG Fan Researchers from the Institute of Process Engineering (IPE) of the Chinese Academy of Sciences, Beijing Chaoyang Hospital and the University of Queensland have developed a new formulation based on regulatory T-cell exosomes (rEXS) to deliver vascular endothelial growth factor (VEGF) antibodies for choroidal neovascularization therapy.
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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.
BioPharma Reporter
JULY 26, 2021
A new UK eLearning program is targeted at healthcare and academic professionals to support their learning on advanced therapy medicinal products (ATMPs).
BioSpace
JULY 26, 2021
Regeneron and AstraZeneca are looking to research, develop, and eventually commercialize a new drug that targets GPR75, the gene associated with obesity.
Pharma Times
JULY 26, 2021
Eight weeks between doses is the 'sweet spot' according to researchers
Outsourcing Pharma
JULY 26, 2021
A clinical trial logistics expert discusses specialized concerns involved in transporting cell and gene products and other personalized medicine items.
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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.
NY Times
JULY 26, 2021
The F.D.A. wants Pfizer and Moderna to increase the number of 5- to 11-year-olds who participate in trials of their coronavirus vaccines to ensure there is enough data about rare side effects.
Outsourcing Pharma
JULY 26, 2021
A clinical trial logistics expert discusses specialized concerns involved in transporting cell and gene products and other personalized medicine items.
BioSpace
JULY 26, 2021
The company announced its Malaria project, part of the “eradicateMalaria” initiative led by the kENUP Foundation.
Scienmag
JULY 26, 2021
New Study in Nature Genetics uses SPARK database to investigate variants that are less damaging than de novo mutations, but contribute almost as much risk New York, NY (July 26, 2021) – Researchers have identified a rare class of genetic differences transmitted from parents without autism to their affected children with autism and determined that […].
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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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