Bio Pharma Dive
SEPTEMBER 2, 2020
Data published Wednesday describe what one study investigator deems a milestone in the fight against ALS, a deadly and progressive neurological disorder.
Camargo
SEPTEMBER 2, 2020
Sponsors and regulators use surrogate endpoints to predict the long-term benefits of drug products that. The post Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020 appeared first on Camargo.
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Bio Pharma Dive
SEPTEMBER 2, 2020
The expert panel's determination appears to conflict with a controversial decision by the FDA last week to clear the blood-derived treatment for emergency use.
Pharma Mirror
SEPTEMBER 2, 2020
Jacobson Pharma Corporation Limited (“Jacobson Pharma” or the Group”; Stock Code: 2633.HK), a leading company engaged in the research, development, production, marketing and sale of essential medicines and branded healthcare products in Hong Kong, announced the signing of a letter of intent (“Letter of Intent”) with Fosun Industrial Co.
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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
SEPTEMBER 2, 2020
In late June, the FDA rejected Intercept's obeticholic acid for the liver disease, asking for more data that could take the biotech some time to collect.
BioSpace
SEPTEMBER 2, 2020
A study published in the journal npj Precision Oncology on Sept. 1 featured data that suggested honeybee venom can potentially destroy triple-negative breast cancer and HER2-enriched breast cancer cells.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
SEPTEMBER 2, 2020
Amylyx Pharmaceuticals published data from its Phase II/III CENTAUR clinical trial evaluating AMX0035 in amyotrophic lateral sclerosis (ALS) which met its primary endpoint.
pharmaphorum
SEPTEMBER 2, 2020
The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. This would see the UK mirroring decisions made by the European Medicines Agency, while also laying out a process should companies wish to file for a separate approval in the UK.
BioSpace
SEPTEMBER 2, 2020
Biospace recently analyzed key emerging cell and gene therapy companies to get a handle on how this evolving science is beginning to make its way from research into clinical applications.
pharmaphorum
SEPTEMBER 2, 2020
Digital health firm Mobio Interactive has closed a $1.8 million seed fund to advance development of its meditation app Am Mindfulness. Mobio said that the app, known as Am for short, is the first and only meditation app to outperform placebo in randomised controlled trials. MI’s Seed raise was led by the Singapore-based Verge HealthTech Fund along with Atlas Asset Management , Creative Ventures and VC giant SOSV.
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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
XTalks
SEPTEMBER 2, 2020
At the Digital International Liver Congress 2020, which was held virtually from August 27 – 29, 2020, Viking Therapeutics, Inc. presented promising results from a 12-week Phase II study of its small molecule compound VK2809 in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C). The release of the data was presented as the flagship event for the annual meeting of the European Association for the Study of the Liver (EASL).
pharmaphorum
SEPTEMBER 2, 2020
Cancer immunotherapy has set new standards in care, with some impressive responses in those patients lucky enough to respond. But many patients still do not respond to therapies such as Merck & Co’s anti PD-1 therapy Keytruda (pembrolizumab), or go on to develop progressive disease, and pharma companies are looking for new second-line therapies.
BioSpace
SEPTEMBER 2, 2020
No matter what stage you’re entering in your professional career, life sciences offer endless opportunities, job satisfaction and security, and competitive pay, making the switch a great career move you don’t want to miss out on.
NY Times
SEPTEMBER 2, 2020
A study of their therapy and clinical trials of other experimental treatments are offering glimmers of hope that paralysis from the disorder can be slowed.
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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
SEPTEMBER 2, 2020
The U.S. Centers for Disease Control and Prevention (CDC) notified the public health departments in all 50 states and five large cities to prepare for the possibility of distribution of a COVID-19 vaccine by November 1.
Find Me Cure
SEPTEMBER 2, 2020
As part of our patient advocacy efforts, at FindMeCure we are dedicated to creating a bridge between patients and the world of clinical research. This includes spreading clinical trial awareness, connecting patients to the trials they are interested in but also speaking up about the issues in the clinical research industry. . Low levels of trust in Pharma companies combined with a lack of sufficient understanding of the clinical trial process, broken communication between all parties involved, a
Scienmag
SEPTEMBER 2, 2020
Study shows potential negative effects of disrupted sleep Credit: Mark Mershon/University of Illinois Chicago In the first study of its kind, University of Illinois Chicago researchers have found associations among disrupted sleep, elevated blood pressure and changes in the gut microbiome. The research aimed to determine whether a 28-day period of disrupted sleep changed the […].
BioSpace
SEPTEMBER 2, 2020
Privately-held Rain Therapeutics closed a $63 million Series B financing round that will be used to advance the company’s pipeline of targeted cancer therapies, including RAIN-32, its recently acquired asset from Daiichi Sankyo.
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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
SEPTEMBER 2, 2020
The decision allows use of the therapy in the EU in children as young as six years of age
BioSpace
SEPTEMBER 2, 2020
Months after forging a development partnership for a COVID-19 vaccine, GlaxoSmithKline and Sanofi are moving their adjuvanted vaccine candidate into the clinic.
Scienmag
SEPTEMBER 2, 2020
Credit: José Manuel Reyes Mendoza Breeding programs for crops with limited per-plant seed yield require one or more generations of seed increase to generate sufficient quantities for sowing replicated yield trials. The ability to accurately discard low potential lines at these early stages may reduce spending on costly yield testing. Breeders typically rely on visual […].
Pharma Times
SEPTEMBER 2, 2020
Over 400 participants are being enrolled in the Phase I/II study after promising preclinical safety and immunogenicity data
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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
SEPTEMBER 2, 2020
Credit: UTHSC Memphis, Tenn. (September 2, 2020) – Liza Makowski, PhD, a professor in the Department of Medicine-Hematology-Oncology at the University of Tennessee Health Science Center, and Joseph F. Pierre, PhD, an assistant professor in the Department of Pediatrics-Obesity at UTHSC, have received $2.1 million from the National Cancer Institute for a five-year study to […].
Pharma Times
SEPTEMBER 2, 2020
The test can typically identify SARS-CoV-2 infection within 15 minutes
Scienmag
SEPTEMBER 2, 2020
The populations of common animals are just as likely to rise or fall in number in a time of accelerating global change as those of rare species, a study suggests. Credit: Gergana Daskalova, University of Edinburgh The populations of common animals are just as likely to rise or fall in number in a time of […].
BioSpace
SEPTEMBER 2, 2020
The use of structured data and automation can accelerate antibody engineering as much as 50%, Prem Mohanty, product marketing manager and life sciences product specialist for Benchling, told BioSpace.
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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.
Pharma Times
SEPTEMBER 2, 2020
The oral therapy can be used as continued treatment for adults in first remission with acute myeloid leukaemia (AML)
Scienmag
SEPTEMBER 2, 2020
Credit: Robert Goodwin, Michigan State University AUSTIN, Texas — A team of scientists from nine universities and research facilities hope to find out how to make switchgrass — a fast-growing perennial native to the U.S. — into a biofuel powerhouse. It’s part of new project from the U.S. Department of Energy. In nature, switchgrass sequesters […].
Pharma Times
SEPTEMBER 2, 2020
Merck and Pfizer's drug will now be available on the NHS in combination with axitinib as a first-line treatment for kidney cancer
Scienmag
SEPTEMBER 2, 2020
Credit: (photo by Susan Urmy) Vanderbilt University Medical Center (VUMC) is launching a clinical trial of promising treatments for COVID-19 in the outpatient setting. The trial is part of the national ACTIV-2 protocol to evaluate the safety and efficacy of new potential therapeutics in adult patients who have COVID-19 illness but are not hospitalized.
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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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