Bio Pharma Dive
SEPTEMBER 20, 2020
The highly anticipated results could signal a change in how some patients with the most common form of breast cancer are treated — and drive up the costs of care.
BioSpace
SEPTEMBER 20, 2020
Progentec Diagnostics, Inc. just launched a novel blood test to determine the likelihood that a patient with systemic lupus erythematosus (commonly known as both SLE and lupus) will experience an immunologic disease flare during the coming 12 weeks.
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Bio Pharma Dive
SEPTEMBER 20, 2020
Study results unveiled Sunday, if replicated later this year, could be strong enough to garner an approval for Amgen's sotorasib, the first KRAS-blocking drug to get this far.
BioSpace
SEPTEMBER 20, 2020
Swiss pharma giant Roche acquired Ireland’s Inflazome and its NLRP3 inflammasome inhibitors aimed at multiple inflammatory diseases for €380 million (about $451 million) in an upfront payment.
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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
Scienmag
SEPTEMBER 20, 2020
Collaborative research leads to newly approved testing technology Credit: Photo by Andrea Starr | PNNL RICHLAND, Wash. – The nation’s ability to test for COVID-19 has expanded, thanks to work at the U.S. Department of Energy’s Pacific Northwest National Laboratory in collaboration with the University of Washington. At the request of the Federal Emergency Management […].
BioSpace
SEPTEMBER 20, 2020
Last week, HHS Secretary Alex Azar assumed all final authority in deciding new rules regarding food, medical devices and new medications.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
SEPTEMBER 20, 2020
The European Society for Medical Oncology (ESMO) Virtual Congress 2020 was this weekend, with numerous companies presenting clinical trial data and updates.
JAMA Internal Medicine
SEPTEMBER 20, 2020
This randomized clinical trial examines the efficacy of a smartphone application for smoking cessation based on acceptance and commitment therapy vs a National Cancer Institute smoking cessation application based on US clinical practice guidelines.
BioSpace
SEPTEMBER 20, 2020
Genentech, a Roche company, presented data from three Phase III trials of Tecentriq (atezolizumab) in triple-negative breast cancer at the European Society for Medical Oncology Virtual Congress 2020 this weekend.
Scienmag
SEPTEMBER 20, 2020
New research being presented at this year’s Annual Meeting of the European Association for the Study of Diabetes (EASD), held online this year, shows that when one half of a couple shows high levels of certain behaviours that prevent type 2 diabetes, such as good diet or exercise, that behaviour also tends to be high […].
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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
SEPTEMBER 20, 2020
The overall survival benefit of the drug was shared this weekend, four months after the U.S. Food and Drug Administration approved it as a treatment for prostate cancer.
Scienmag
SEPTEMBER 20, 2020
PROfound trial investigators show significantly longer overall survival of mCRPC patients with at least one alteration in BRCA1, BRCA2, or ATM genes, who received treatment with PARP inhibitor olaparib versus enzalutamide or abiraterone plus prednison Credit: VHIO Results from the PROfound phase III study, funded by AstraZeneca and Merck Sharp & Dohme, open up a […].
BioSpace
SEPTEMBER 20, 2020
Yibin Kang, a professor of molecular biology at Princeton University, and his team have set out to make a world where breast cancer cannot easily spread.
Scienmag
SEPTEMBER 20, 2020
Credit: University of Otago People who smoke are increasingly using e-cigarettes to try to quit smoking, a study by researchers at the University of Otago, Wellington, has found. The researchers found that between 2016 and 2018 the level of awareness, as well as the use of e-cigarettes, increased among smokers and those who had recently […].
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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 20, 2020
It was a fairly busy week for clinical trial announcements, with some important and interesting news about COVID-19 treatments and vaccines, as well as numerous stories about non-COVID-19 studies.
The Pharma Data
SEPTEMBER 20, 2020
Related Topics. Coronavirus pandemic. image copyright AFP. image caption Covid-Organics was launched in Madagascar in April after being tested on fewer than 20 people over three weeks. The World Health Organization (WHO) has agreed rules for the testing of African herbal remedies to fight Covid-19. Sound science would be the sole basis for safe and effective traditional therapies to be adopted, it said.
BioSpace
SEPTEMBER 20, 2020
San Diego-based Mirati Therapeutics, a clinical-stage biotechnology company, is currently developing sitravatinib to address unmet medical needs in cancer care.
The Pharma Data
SEPTEMBER 20, 2020
Charities are using tailored music to bring back memories for dementia patients from ethnic minorities. To mark World Alzheimer’s Day, the BBC has created a catalogue of world music to help people from all cultures living with dementia. Music producer Naughty Boy is supporting the. BBC Music Memories project, his mother has dementia. Source link.
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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.
Drug Patent Watch
SEPTEMBER 20, 2020
Annual Drug Patent Expirations for MEGACE+ES Megace Es is a drug marketed by Endo Pharms Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent expiration for Endo Pharms drug MEGACE ES appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
SEPTEMBER 20, 2020
Image copyright. Reuters. The UK is at a “critical point” in the coronavirus pandemic and “heading in the wrong direction”, the government’s chief medical officer will warn later. Prof Chris Whitty believes the country is facing a “very challenging winter period” and will hold a televised briefing at 11:00 BST.
Drug Patent Watch
SEPTEMBER 20, 2020
Annual Drug Patent Expirations for TRICOR Tricor is a drug marketed by Abbvie and Abbvie Inc and is included in three NDAs. It is available from five suppliers. There are…. The post New patent expiration for Abbvie drug TRICOR appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
SEPTEMBER 20, 2020
Image copyright. PA Media. Covid restrictions in England will get tougher if rules are not followed, Matt Hancock has warned, as the government introduces £10,000 fines for people who fail to self-isolate. The health secretary told the BBC’s Andrew Marr show the country was facing a “tipping point and we have a choice” “If everybody follows the rules then we can avoid further national lockdown.” The prime minister is understood to be considering a ban on households
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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 20, 2020
Data from latest research presented at the ESMO Virtual Congress 2020 Lugano, Switzerland, 20 September 2020 – Post-operative radiotherapy (PORT) used in patients with non-small-cell lung cancer (NSCLC) following complete resection and after (neo) adjuvant chemotherapy shows no statistically significant difference in 3-year disease-free survival (DFS), according to data presented at ESMO 2020.
BioSpace
SEPTEMBER 20, 2020
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 21, 2020.
Scienmag
SEPTEMBER 20, 2020
A study of approximately 200,000 blood samples from the UK Biobank has identified more than 2,000 undiagnosed cases of type 2 diabetes. The study, presented at this year’s Annual Meeting of the European Association for the Study of Diabetes (EASD), also shows that, because UK Biobank data is not reported back to participants, patients found […].
BioTech 365
SEPTEMBER 20, 2020
LONDON–(BUSINESS WIRE)–#FluidicsforPreclinicalLifeScienceResearchandClinicalApplicationsMarket–The global fluidics for preclinical, life science research, and clinical applications market is expected to grow by USD 1.38 billion as per Technavio.
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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
SEPTEMBER 20, 2020
Data from latest research presented at the ESMO Virtual Congress 2020 Lugano, Switzerland, 20 September 2020 – Adding abemaciclib to hormonal therapy reduces the risk of cancer recurrence by 25% in patients with high-risk early hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer, according to results from a study […].
BioTech 365
SEPTEMBER 20, 2020
DÜSSELDORF, Germany–(BUSINESS WIRE)–#chronic—Algiax Pharmaceuticals, a clinical-stage biotechnology company focused on development of GABAA receptor modulators for neuropathic pain and other indications with unmet medical need, announced that the first patient has been enrolled in the “CURE” study.
Scienmag
SEPTEMBER 20, 2020
A new study presented at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), held online this year, shows that rheumatoid arthritis (RA) is associated with a 23% increased risk of type 2 diabetes (T2D), and may indicate that both diseases are linked to the body’s inflammatory response. The research […].
BioTech 365
SEPTEMBER 20, 2020
Customer health is an indoor air quality priority Riverdale, NJ, Sept. 20, 2020 (GLOBE NEWSWIRE) — In recent years, the conversation about indoor air quality (IAQ) has been focused largely on the harmful health impacts of airborne pollution.
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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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