Bio Pharma Dive
MAY 13, 2021
Study results could address concerns raised by FDA advisers who recently voted against approval of Keytruda in patients with early-stage breast cancer.
World of DTC Marketing
MAY 13, 2021
QUICK READ: Reaching physicians with key brand messages isn’t hard, but the online landscape has become crowded with many players. By far, Medscape is still number one in physician reach , and medical journal advertising has been proven to result in more branded Rx’s. Deloitte showed there is a significant trust gap between pharmaceutical companies and people working in healthcare.
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Bio Pharma Dive
MAY 13, 2021
The San Diego-based biotech's drug, which will now be sold as Zynrelef, had perviously been rejected by the agency in 2019 and 2020.
World of DTC Marketing
MAY 13, 2021
It’s 2021. Trends are a whole lot different from what they were a decade ago. This doesn’t just relate to fashion or hobby choices, either. It’s also highly relevant in the marketing world. One of the most essential methods to generate organic traffic is content marketing when it comes to marketing. With the right content marketing strategy in place, a website has the ability to do that all-important climb to the first page of Google.
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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
MAY 13, 2021
With $82 million in hand, Flare Therapeutics is looking to create precision cancer drugs by going after a type of protein called transcription factors.
Pharma Mirror
MAY 13, 2021
Industry specialists working on contaminated land are being urged to use the new British Standard BS 10176 for soil sampling. BS 10176 was introduced in August 2020 but tests using old methods, which do not conform to the new standard, are still being accepted by regulators and assessors, which has led to concerns that its use is still only sporadic.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
MAY 13, 2021
Given that people have spent most of the past year being locked down at home due to the COVID-19 pandemic, it comes as no surprise that much of that time has been spent binging content on TV and through digital streaming services. In light of this, pharma wasted no time throwing some added cash towards TV ads. Taking advantage of the opportunity, the top ten pharma brands spent 17 percent more on TV ads in April 2020 compared to just a month prior, raising their monthly ad expenditures from $156
BioSpace
MAY 13, 2021
Have you ever thought seriously about entrepreneurship? While large organizations appear to dominate the life sciences industry, startups and small businesses have started to compete in the marketplace.
Scienmag
MAY 13, 2021
Credit: Martin Visser, Unsplash Humans in the 21st century spend most of their time indoors, but the air we breathe inside buildings is not regulated to the same degree as the food we eat and the water we drink. A group of 39 researchers from 14 countries, including two from the University of Colorado Boulder, […].
BioSpace
MAY 13, 2021
Pivotal data from Amgen’s and AstraZeneca’s NAVIGATOR Phase III trial show tezepelumab, a potential first-in-class human monoclonal antibody, reduced asthma aggravations and exacerbations requiring hospitalizations better than placebo in patients with severe asthma.
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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
MAY 13, 2021
The first UK patient has enrolled on Pfizer’s phase 3 trial for its Duchenne muscular dystrophy (DMD) gene therapy. Pfizer’s CIFFREO study began in the US in January this year and has now begun enrolling eligible patients in the UK. The first patient was recruited in The Newcastle upon Tyne Hospitals NHS Foundation Trust, one of three UK sites for the clinical trial and part of 55 globally, across 15 countries.
BioSpace
MAY 13, 2021
Shares of Heron Therapeutics climbs after it announced the U.S. FDA approved its non-opioid drug for extended pain relief following some surgeries.
pharmaphorum
MAY 13, 2021
Virtual communications between sales reps and HCPs jumped significantly during 2020, making it more important than ever for pharma companies to maintain up-to-date customer data. Over the 12 months to December 2020 the number of global Veeva CRM Engage Meetings increased sixfold, while those held in Europe saw an eight-fold increase – with 200,000 remote meetings conducted in Europe in November alone.
BioSpace
MAY 13, 2021
Humanigen reported it had held a meeting with the FDA to discuss plans for filing an EUA for its lenzilumab for hospitalized, hypoxic COVID-19 patients by the end of May.
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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.
Pharma Times
MAY 13, 2021
Heart attack patients offered treatment with new technology at the Royal Free Hospital in London
Scienmag
MAY 13, 2021
Credit: John Innes Centre The first frost of autumn may be grim for gardeners but the latest evidence reveals it is a profound event in the life of plants. The discovery may affect how we grow crops in a fluctuating climate and help us better understand molecular mechanisms in animals and humans. Much of our […].
BioSpace
MAY 13, 2021
Merck announced positive results from the late-stage KEYNOTE-522 study that should support its previous attempt that was stymied by a regulatory advisory committee in February and rejected by the U.S. FDA in March.
Pharma Times
MAY 13, 2021
The 2021 Sales Awards have opened their doors for entry, continuing its legacy of uncovering and rewarding exceptional talent within the pharma sales sector.
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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
MAY 13, 2021
Credit: Dr Amelia Wesselink Higher levels of ozone from air pollution are linked to an increased risk of developing fibroids among Black American women according to a large study published today (Friday) in Human Reproduction [1], one of the world’s leading reproductive medicine journals. Fibroids are non-cancerous growths that develop in and around the womb. […].
Pharma Times
MAY 13, 2021
New results from a Phase IIIa study demonstrate benefits of drug for people with obesity 'beyond weight loss'
pharmaphorum
MAY 13, 2021
AstraZeneca and Daiichi Sankyo have revealed new data from datopotamab deruxtecan in triple negative breast cancer (TNBC) – and although it’s from a small patient group results look impressive. To recap, AZ shelled out $1bn for rights to datopotamab last year, an antibody-drug conjugate (ADC) consisting of an antibody that targets tumours and a lethal payload that kills cancer cells.
Pharma Times
MAY 13, 2021
The CIFFREO study is expected to enrol 99 ambulatory male patients aged four to seven years old
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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
MAY 13, 2021
Iconic great apes in Borneo lost muscle during fruit shortages Credit: Kristana Parinters Makur/Tuanan Orangutan Research Project Wild orangutans are known for their ability to survive food shortages, but scientists have made a surprising finding that highlights the need to protect the habitat of these critically endangered primates, which face rapid habitat destruction and threats […].
Outsourcing Pharma
MAY 13, 2021
A leader from clinical-stage pharma firm NuCana shares promising results for its ProTides therapies and hopes the drugs can elevate outcomes for patients.
Scienmag
MAY 13, 2021
Keeping a daily gratitude journal for as little as two weeks can help keep students motivated for months Credit: Ritsumeikan University and the National Institute of Information and Communications Technology (NICT), Japan It is difficult for us to succeed in whatever we set out to do if we lack motivation. We usually need it as […].
BioSpace
MAY 13, 2021
Biogen reported that its gene therapy, cotoretigene toliparvovec, failed to hit the primary endpoint of the Phase II/III XIRIUS trial for X-linked retinitis pigmentosa (XLRP).
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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
MAY 13, 2021
Proteins that enable the sense of touch in humans have an evolutionary cousin that helps plants grow their root systems Credit: Seyed Ali Reza Mousavi, PhD / Scripps Research LA JOLLA, CA–A family of proteins that sense mechanical force–and enable our sense of touch and many other important bodily functions–also are essential for proper root […].
BioSpace
MAY 13, 2021
Foresite Labs-incubated company Interline Therapeutics announced Thursday that it had raised $92 million in a financing round co-led by Foresite Capital and ARCH Venture Partners.
Scienmag
MAY 13, 2021
Researchers at Osaka University use deep learning to reduce noise in the electrical current data collected from nanopores, which may lead to higher precision measurements when working with very tiny experiments or medical diagnostics Credit: Osaka University Osaka, Japan – Scientists from the Institute of Scientific and Industrial Research at Osaka University used machine learning […].
Outsourcing Pharma
MAY 13, 2021
The UK-based development and research firm hopes to accelerate patient access to psychedelic therapies for treatment of various mental health conditions.
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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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