Bio Pharma Dive
JANUARY 12, 2022
Analysts expect that deal engines are ready to start firing again following the recent quiet period. Still, uncertainty remains about how biopharma acquisitions could play out in the coming months.
World of DTC Marketing
JANUARY 12, 2022
The word influencer was added to the Merriam-Webster dictionary in 2019, but influencer marketing is nothing new. Scandals, fake followers, bot technologies, and the pandemic crisis converged have put a halt to influencer marketing growth and tarnished the public view of influencers as a whole. Can pharma leverage influencer marketing? Across the board, influencer marketing was worth around $9.7 billion in 2020, according to Influencer Marketing Hub , which estimated the mark
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Bio Pharma Dive
JANUARY 12, 2022
A restrictive Medicare decision on Alzheimer's drugs sent Lilly shares tumbling, while the CEO of Editas brushed off competitive threats to his company's gene editing technology.
Camargo
JANUARY 12, 2022
As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases. However, the anticipated impact of PDUFA VII will extend well beyond those industry segments.
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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
Outsourcing Pharma
JANUARY 12, 2022
The company plans to launch a Phase Ib/II study of its compound NVG-291 in collaboration with researchers at Northwestern Universityâs Shirley Ryan AbilityLab.
pharmaphorum
JANUARY 12, 2022
Roche has launched what it says is a first-of-its kind handheld glucose management device, backed up by a digital platform that aims to simplify the work of doctors and nurses as they deliver care to patients. The cobas pulse system is a point-of-care device that combines a glucose test strip reader with a touch screen that is used for displaying patient information and data, as well as analysing and sharing clinical results.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
JANUARY 12, 2022
Speaking at the JP Morgan Healthcare Conference, being held virtually this year, on Monday, Pfizer CEO Albert Bourla said the company has plans to boost manufacturing of its COVID-19 treatment Paxlovid by up to 50 percent this year. Bourla said the company would achieve the scale-up by expanding its manufacturing capacity. Paxlovid was granted emergency use authorization (EUA) by the US Food and Drug Administration (FDA) late last month, making it the first authorized antiviral treatment for COV
Scienmag
JANUARY 12, 2022
University of Texas at Arlington computer scientist Jacob Luber has earned a five-year, $2 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to create a database that contains every publicly available cancer dataset from the National Cancer Institute (NCI). Credit: UT Arlington University of Texas at Arlington computer scientist Jacob Luber […].
pharmaphorum
JANUARY 12, 2022
The development of gene therapies for Duchenne muscular dystrophy has proved to be challenging, but one of the key players – Sarepta – thinks it may have the clinical data needed to file for regulator approval. The new data from the mid-stage Study 102 of SRP-9001 (delandistrogene moxeparvovec) comes from 21 patients who were initially in the placebo group of the study but crossed over to receive the gene therapy later.
Scienmag
JANUARY 12, 2022
Flat materials that can morph into three-dimensional shapes have potential applications in architecture, medicine, robotics, space travel, and much more. But programming these shape changes requires complex and time-consuming computations. Credit: (Credit: Bertoldi Lab/Harvard SEAS) Flat materials that can morph into three-dimensional shapes have potential applications in architecture, medicine, robotics, space travel, and much more. […].
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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
JANUARY 12, 2022
Prospects for Aldeyra’s dry eye disease candidate reproxalap were hit last month after the drug failed to hit its primary objective in a phase 3 trial, but the company isn’t giving up and has new data showing an improvement over Novartis rival therapy Xiidra. Patients treated with reproxalap reported significantly less eye discomfort and itching than those using Xiidra (lifitegrast) in the new phase 2 trial, which Aldeyra said backs up early tolerability comparisons between the drugs
XTalks
JANUARY 12, 2022
A team of scientists from Harvard T.H. Chan School of Public Health and Nanyang Technological University (NTU) Singapore recently unveiled a biodegradable, waterproof and antibacterial food packaging. The “smart” packaging kills harmful microbes and can extend the shelf life of fresh foods for multiple days. So, how does it work? The innovative food packaging is made from a type of corn protein called zein , starch and other naturally-derived biopolymers, which have been found to be sustainable
pharmaphorum
JANUARY 12, 2022
EMA “lags behind” other international regulators when it comes to approval timelines, finds EFPIA analysis. Only a regulatory framework that “embraces a culture of excellence and innovation” will make Europe a world leader in life sciences and ensure people can reap the benefits of life-changing new treatments. That’s according to the EFPIA’s analysis of the region’s regulatory framework, which compares the timelines of national regulatory agencies, and suggests key areas for change as the Europ
Scienmag
JANUARY 12, 2022
EMBARGOED FOR RELEASE UNTIL 4 P.M. ET, WEDNESDAY, JANUARY 12, 2022 MINNEAPOLIS – A new study suggests that people with early-stage Parkinson’s disease who regularly got one to two hours of moderate exercise twice a week, like walking or gardening, may have less trouble balancing, walking and doing daily activities later. The research is published […].
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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.
pharmaphorum
JANUARY 12, 2022
The pandemic has given us a surge of opportunities to take fresh looks at how we live, work and play with huge changes of pace and direction being funnelled through technology. Digital muscled its way to centre stage as we plunged into lockdowns and its life and sanity-saving qualities were immediately clear. It also helped most businesses to function but two years on we need to re-focus.
Outsourcing Pharma
JANUARY 12, 2022
The pharma firm and collaborator Molecular Partners reported positive data out of their Phase II study for ensovibep, an antiviral for treating the virus.
pharmaphorum
JANUARY 12, 2022
Just over a decade after being acquired by Daiichi Sankyo, US biotech Plexxikon will be shuttered at the end of March, with its R&D projects transferred to other areas of the Japanese group. It’s the end of the road for the South San Francisco-based company, which became part of the Daiichi Sankyo in a $935 million deal in 2011 and since then has contributed two approved cancer therapies – Zelboraf (vemurafenib) for melanoma and Turalio (pexidartinib) for tenosynovial giant cell tumour
Scienmag
JANUARY 12, 2022
EVANSTON, Ill. — For those who rarely forget a face, but struggle with names, the remedy for boosting learning may as near as your pillow. Credit: Nathan Whitmore, a Ph.D. candidate in the Interdepartmental Neuroscience Program at Northwestern University. EVANSTON, Ill. — For those who rarely forget a face, but struggle with names, the remedy […].
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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
JANUARY 12, 2022
The test is hoped to provide patients with a more convenient means of access to treatment for respiratory issues.
Scienmag
JANUARY 12, 2022
Teaching younger children through ‘guided’ play can support key aspects of their learning and development at least as well, and sometimes better, than traditional, direct instruction, according to a new analysis. The research, by academics at the University of Cambridge gathered and assessed data from numerous, widespread studies and information sources, which collectively documented guided […].
Eye on FDA
JANUARY 12, 2022
Each year we look back to take stock of how the agency has been communicating in the course of the previous year and assess how that might compare to years gone by. In fact from year to year, there is a good deal of change that occurs. When Dr. Scott Gottlieb took the reins of FDA as Commissioner, the amount of communications material put out jumped enormously.
Scienmag
JANUARY 12, 2022
Leesburg, VA, January 12, 2022—According to an article in ARRS’ American Journal of Roentgenology (AJR), whole-spine MRI commonly demonstrates isolated thoracolumbar injuries in children with suspected abusive head trauma. Credit: American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR) Leesburg, VA, January 12, 2022—According to an article in ARRS’ American Journal of Roentgenology (AJR), […].
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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.
Pharma in Brief
JANUARY 12, 2022
Amendments to the Federal Courts Rules (the Amended Rules ) were registered on December 13, 2021 and officially published in the Canada Gazette Part II on December 22, 2021. The Amended Rules come into force on January 13, 2022. Key Changes and Additions. As we previously reported , in April 2021 the Rules Committee of the Federal Court of Appeal and the Federal Court proposed amendments to the Federal Courts Rules (the Rules ) to address proportionality, abuse of process, and Federal Court of A
Scienmag
JANUARY 12, 2022
Eyes are crucial players in the evolution of organisms. They allow an animal to find food, a mate, potential prey, to avoid predators and aid in regulating the internal clock by differentiating day from night. Eyes are also delicate features that tend to be not well preserved in fossil crustaceans. Credit: Credit: Masato Hattori Eyes […].
XTalks
JANUARY 12, 2022
In this episode, Ayesha discussed a new blood test developed by researchers at the University of Oxford that can identify cancers and even detect if they’ve metastasized. The test is based on measuring metabolites produced by tumor cells in blood samples using nuclear magnetic resonance (NMR) spectroscopy. The researchers found that the test could identify cancer among healthy people, those with localized cancer and individuals with cancer that has metastasized.
Scienmag
JANUARY 12, 2022
An international team of researchers, led by postgraduate student Alexis Andrés, has found that the black hole at the centre of our galaxy, Sagittarius A*, not only flares irregularly from day to day but also in the long term. The team analysed 15 years’ worth of data to come to this conclusion. The research was initiated […].
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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
JANUARY 12, 2022
Formedix and CDISC Join Forces to Provide Free Access to Ready-to-Use, CDASH-Compliant eCRFs for Accelerated Clinical Trial Set-Up. Formedix, a leading provider of clinical trial software solutions, has collaborated with CDISC, the global clinical research data standards development organization, to create a novel portal providing free access to ready-to-use, CDASH-compliant, annotated electronic case report forms (eCRFs).
Scienmag
JANUARY 12, 2022
Scientists from Wageningen University and Research (WUR) and Indiana University discovered that the increasing irrelevance of factual truth in public discourse is part of a groundswell trend that started decades ago. Credit: Marten Scheffer Ingrid van de Leemput Johan Bollen Scientists from Wageningen University and Research (WUR) and Indiana University discovered that the increasing irrelevance […].
pharmaphorum
JANUARY 12, 2022
Rewind to late 2019. If you had been told that within a few months, you’d be living in the middle of the biggest pandemic since the 1918 global flu outbreak, but that thanks to new mRNA technology, vaccine prototypes would be ready for trials within weeks and the first shots would go into arms before the end of 2020, what would you have thought? You could be forgiven for assuming that people would marvel in unison about the miracle of modern medical science.
Scienmag
JANUARY 12, 2022
No one likes when their favorite clothes develop holes or unravel after many laundry cycles. But what happens to the fragments of fabric and stitching that come off? Although it’s known that washing clothes releases microfibers into wastewater, it’s unclear how drying impacts the environment. Now, a pilot study in ACS’ Environmental Science & Technology […].
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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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