Bio Pharma Dive
JUNE 24, 2021
The lack of specific data frustrated analysts, but shares in Arcus rose by double digits Thursday. Partner Gilead is expected to make a decision on whether to license the drug later this year.
World of DTC Marketing
JUNE 24, 2021
SUMMARY: Consumers don’t real pay attention to fair balance in TV ads. Pharma TV ads drive people online to search for more information. Safety pages on Pharma product websites continue to have high utility. Only requirement in TV ads should be for “boxed” products. As we have seen over the past few years, Pharma companies are a business, a regulated business, but still a business.
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Bio Pharma Dive
JUNE 24, 2021
The pharmaceutical giant is spending $80 million for an exclusive license to an experimental drug developed by Prothena.
Pharma Mirror
JUNE 24, 2021
There are widespread misunderstandings about pharmacists’ job that make many prospective students give up on their dreams. But we are here to bring some light about what pharmacists do and don’t do. If you ask 10 different people “What do pharmacists do?”, they will all reply “They sell medications in drug stores”. But if you ask us, we have a far cry from that answer.
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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
JUNE 24, 2021
The drugmaker said it will file an application with the FDA later this year for accelerated approval of donanemab, a change of plans that comes weeks after the FDA's controversial clearance of Biogen's Aduhelm.
Pharma Mirror
JUNE 24, 2021
By Dr Ash Ramzan, founder and principal consultant, Woodley BioReg During a pharmaceutical product’s lifetime, it’s widely known and accepted that manufacturing processes will drift within their specified ranges — typically due to equipment wear-and-tear and operator variance. To maintain the ‘validated state’, diligent producers spend a lot of time and effort in ensuring validation and periodic re-validation of processes to ensure that any process drift is accounted for and controlled.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JUNE 24, 2021
Poor medication adherence is both a costly issue for pharma manufacturers – with some estimating a loss of $600 billion each year – and a deadly issue for patients, with more than 100k preventable deaths estimated from patients not taking medications correctly, or at all. Tara Herington explores why medication non-adherence is a complex issue. Communication is ever evolving and comes with distinct challenges for the pharma industry.
Scienmag
JUNE 24, 2021
Credit: UCSF Researchers at UCSF have found that extreme caloric restriction diets alter the microbiome in ways that could help with weight loss but might also result in an increased population of Clostridiodes difficile, a pathogenic bacterium that can lead to severe diarrhea and colitis. Such diets, which allow people only 800 calories per day […].
pharmaphorum
JUNE 24, 2021
The FDA has started a review of a new implant version of Roche’s ranibizumab therapy for wet age-related macular degeneration, that could offer patients with the sight-robbing disorder an alternative to monthly eye injections. . The port delivery system (PDS) formulation of ranibizumab – a VEGF inhibitor already approved as Lucentis to treat wet AMD – was able to extend the time between treatments for six months or more in 98% of patients in a phase 3 trial, with no loss of efficacy.
BioSpace
JUNE 24, 2021
The analysis showed that the Pfizer and Oxford/AstraZeneca vaccines can protect patients from being hospitalized by as much as 90 percent.
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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
pharmaphorum
JUNE 24, 2021
Armed with a positive mid-stage trial readout in lung cancer, Arcus Biosciences will expand a phase 3 programme for domvanalimab, its anti-TIGIT antibody. Details from the ARC-7 study of domvanalimab as a first-line treatment for PD-L1-positive, advanced non-small cell lung cancer (NSCLC) remain scanty, but Arcus said that the results were “encouraging” enough to warrant more pivotal trials.
BioSpace
JUNE 24, 2021
Last summer, claims that the deadly SARS-CoV-2 virus emerged from a virology lab in Wuhan were generally dismissed by the scientific community as right-wing conspiracy theories. A year later, the theory isn’t sounding so far-fetched.
Pharma Times
JUNE 24, 2021
Collaboration aims to accelerate Novartis’ use of data and digital technologies
BioSpace
JUNE 24, 2021
New data continues to emerge that seems to add to the possibility of COVID-19 originating from a lab leak at China’s Wuhan Institute of Virology.
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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
JUNE 24, 2021
Study shows dentists need to be aware of medication history even in younger patients Credit: Regenstrief Institute INDIANAPOLIS — A new study demonstrates that many younger adult dental patients are taking medications and highlights the importance of dental providers reviewing medication histories regardless of age. The study from Regenstrief Institute and the Indiana University School […].
BioSpace
JUNE 24, 2021
The U.S. Food and Drug Administration (FDA) has made the decision to grant Breakthrough Therapy Designation to Mirati Therapeutics’ adagrasib for the potential treatment of non-small cell lung cancer (NSCLC) in patients harboring the KRASG12C mutation after systemic therapy.
Scienmag
JUNE 24, 2021
NIH scientists discover that bacteria may drive activity of many hallmark aging genes in flies Credit: Courtesy of the Giniger lab NIH/NINDS. To better understand the role of bacteria in health and disease, National Institutes of Health researchers fed fruit flies antibiotics and monitored the lifetime activity of hundreds of genes that scientists have traditionally […].
pharmaphorum
JUNE 24, 2021
Biogen has hinted that it may consider altering the price of its controversially-approved Alzheimer’s therapy Aduhelm – but only if its assumptions on population size and uptake are different from what it expects. In a joint statement with Aduhelm (aducanumab) development partner Eisai, Biogen said it is expecting slow take-up of the drug and an eligible patent population of around 1-2 million people with mild Alzheimer’s in the US, saying it has no data on more advanced cases.
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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
JUNE 24, 2021
Dario Valenzano 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 Thursday, June 24, 2021, London — Dario Riccardo Valenzano, PhD., will present the latest research on the topic African turquoise killifish shed light on evolution and modulation of […].
Pharma Times
JUNE 24, 2021
PharmaTimes are proud to confirm that we will be partnering with the Meningitis Research Foundation for the 2021 Communications Awards Charity Challenge.
Outsourcing Pharma
JUNE 24, 2021
The project will use the artificial intelligence specialistâs cell-centered models and deconvolutions to gain insights for each individual asthma endotype.
Scienmag
JUNE 24, 2021
Test can detect over 50 types of cancer, often before symptoms show Credit: Annals of Oncology Final results from a study of a blood test that can detect more than 50 types of cancer have shown that it is accurate enough to be rolled out as a multi-cancer screening test among people at higher risk […].
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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.
BioSpace
JUNE 24, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Scienmag
JUNE 24, 2021
Credit: Elodie Vandelle Over the last decade, severe outbreaks of bacterial canker have caused huge economic losses for kiwi growers, especially in Italy, New Zealand, and China, which are among the largest producers. Bacterial canker is caused by the bacterial pathogen Pseudomonas syringae pv. actinidiae (Psa) and more recent outbreaks have been particularly devastating due […].
BioSpace
JUNE 24, 2021
A new class of compounds currently in development against acute myeloid leukemia has been discovered to block coronavirus reproduction in human lung cells.
BioPharma Reporter
JUNE 24, 2021
Iksuda Therapeutics, a developer of a new generation of antibody drug conjugates (ADCs), has expanded its research collaboration and license agreement with LegoChem Biosciences Inc (LCB).
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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.
pharmaphorum
JUNE 24, 2021
Novartis and Hewlett Packard Enterprise (HPE) have agreed to collaborate on the development of digital health technologies, starting with a project to develop a disease surveillance system for dengue fever. There are currently around 390 million cases of dengue each year, leading to 500,000 hospitalisations and 40,000 deaths, making it one of the World Health Organization’s top 10 global health threats.
Scienmag
JUNE 24, 2021
Novel analysis suggests much earlier, more rapid spread than confirmed cases imply Credit: Roberts DL et al., 2021, PLOS Pathogens Using methods from conservation science, a new analysis suggests that the first case of COVID-19 arose between early October and mid-November, 2019 in China, with the most likely date of origin being November 17. David […].
BioSpace
JUNE 24, 2021
Multiple biopharma companies make their first appearance on the Nasdaq this morning to advance the next-generation therapeutics. BioSpace takes a look at some of these IPOs.
Outsourcing Pharma
JUNE 24, 2021
The annual event (scheduled July 12-16 online) will feature educational sessions, presentations, and networking opportunities for drug manufacturing pros.
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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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