Bio Pharma Dive
OCTOBER 19, 2021
A closely watched competitor to Merck's molnupiravir failed a Phase 2 study, prompting its makers to change their strategy in a move that could delay an answer on the drug's efficacy until late next year.
pharmaphorum
OCTOBER 19, 2021
The work of the UK’s HTA body, the National Institute for Health and Care Excellence (NICE), is often heatedly debated, and this time it’s for holding back a clinical guideline. Leela Barham looks into the controversy. Updating a previous clinical guideline. NICE began their work to update a 2007 clinical guideline on Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in January 2018.
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Bio Pharma Dive
OCTOBER 19, 2021
Following discussions with the FDA, the companies plan to submit zuranolone for approval in major depressive disorder and postpartum depression over the next roughly year and a half.
pharmaphorum
OCTOBER 19, 2021
A new poll of clinical trial sponsors has found that around nine out of 10 of them are running decentralised trials with the help of digital technologies, a big increase on pre-COVID-19 levels. The survey by Veeva Systems found a big increase in the adoption of technologies that enabled remote trials during COVID-19, with increased use of tools such as remote monitoring, electronic data collection and consent forms, and web portals for studies.
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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
OCTOBER 19, 2021
Drugs from Vertex can effectively treat the lung disease in as much as 90% of patients. Gene therapy could be a solution for the remaining 10%, but the path forward is challenging.
Outsourcing Pharma
OCTOBER 19, 2021
To fully reap the benefits of tech advances, a company leader advises, a life-sciences firm must embrace change and connection throughout the operation.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
OCTOBER 19, 2021
The idea of using mRNA has been around for some time, but only in recent years has it become practical. The COVID-19 pandemic provided the opportunity for the technology to push ahead.
BioPharma Reporter
OCTOBER 19, 2021
Announcing a new partnership, Autolomous and Vineti say they are integrating their technology to ensure scalability when cell and gene therapies become standard of care.
BioSpace
OCTOBER 19, 2021
?The National Academy of Medicine tapped 100 new members to its prestigious organization that represents some of the brightest minds in health and medicines. Here are some of them.
XTalks
OCTOBER 19, 2021
SimplyProtein has been in the plant-based snacking space for over 17 years, but today, Michael Lines, the president and CEO of SimplyProtein, has found new ways to bring it back to life. The company has reinvented itself and its positioning in the market as a product to provide consumers with “plant-powered fuel.”. Xtalks spoke with Lines about his involvement with SimplyProtein and how he has changed and adapted this company to the current times and trends.
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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
OCTOBER 19, 2021
Investors can take their pick of life sciences companies, with more innovative ideas and treatments being added to pipelines daily. Here's who brought in the sheaves this week.
Drug Patent Watch
OCTOBER 19, 2021
Annual Drug Patent Expirations for CALCIUM+GLUCONATE+IN+SODIUM+CHLORIDE Calcium Gluconate In Sodium Chloride is a drug marketed by Fresenius Kabi Usa and Hq Spclt Pharma and is included in two NDAs. It…. The post New patent for Hq Spclt drug CALCIUM GLUCONATE IN SODIUM CHLORIDE appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
OCTOBER 19, 2021
?Surgeons from NYU Langone Health recently hit a major milestone in transplantation science after successfully attaching a pig's kidney to a human patient and watching it work for several hours.
XTalks
OCTOBER 19, 2021
With October being Breast Cancer Awareness Month, celebrities are joining campaigns to help raise awareness of the disease. Singer Mary J. Blige is doing her part by sharing her personal story about how breast cancer has affected women in her family, and how she was unaware of the importance of early breast cancer screening because cancer was not a topic that was discussed in Black families like hers.
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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
OCTOBER 19, 2021
COVID-19 proved the value of locally led, place-based public health – but teams need long-term funding and support if they are to take their place as an essential cog in the ICS machine. Local public health teams have been acting as “linchpins” during the pandemic, building cross-sector relationships to respond to the immediate crisis, as well as addressing the associated social determinants of health.
Scienmag
OCTOBER 19, 2021
SAN FRANCISCO, CA—October 19, 2021—With the school year well on its way, we all recognize the importance of getting students energized. However, we also know that overstimulated children can wreak havoc on a classroom, leaving a teacher trying to regain control of their group. The situation is very similar in the brain, where cells must […].
BioSpace
OCTOBER 19, 2021
Parse Biosciences' multiplexed approach enables 96 samples and a total of 1 million single cells to be analyzed in parallel without the need for specialized lab instruments.
Scienmag
OCTOBER 19, 2021
CHAPEL HILL, NC – Food insecurity among older adults takes a toll on the nutrition and health of those affected. According to data from 2019, 5.2 million people age 60 and above in the U.S. were food insecure – equaling 7.1% of that population – and that number has likely grown during the COVID-19 pandemic. […].
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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.
BioSpace
OCTOBER 19, 2021
David Morse Livingston, a giant in oncology research known for his significant contributions to translational cancer research, unexpectedly died. He was 80.
Scienmag
OCTOBER 19, 2021
Fractures of the clavicle, or collarbone, are common. Unfortunately, current fixation plates that are used to surgically stabilize these fractures are suboptimal, leading to reoperation rates of up to 53%. A new study published in the Journal of Orthopaedic Research indicates that custom plates developed through computer modeling may be a better option.
BioSpace
OCTOBER 19, 2021
Choosing to exercise its options with a group of research and development partners, the pharma giant will accelerate a promising new C.F. gene therapy.
Scienmag
OCTOBER 19, 2021
Diagnosing and treating cancer can be a race against time. By the time the disease is diagnosed in a patient, all too often it is advanced and able to spread throughout the body, decreasing chances of survival. Early diagnosis is key to stopping it. Credit: Concordia University Diagnosing and treating cancer can be a race […].
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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
OCTOBER 19, 2021
Crinetics Pharmaceuticals, along with 5AM Ventures and Frazier Healthcare Partners, announced that it was spinning out a new company, Radionetics Oncology.
Scienmag
OCTOBER 19, 2021
From birds in the sky to fish in the sea, nature’s creatures possess characteristics naturally perfected over millennia. Studying them leads engineers to create new technologies that are essential to our way of life today. Mechanical engineers from Michigan Technological University share how they built a tiny, self-powered robot inspired by water-skimming insects.
NY Times
OCTOBER 19, 2021
The F.D.A. may authorize booster shots of vaccines different from the ones that Americans originally received. The science behind the move is promising.
BioSpace
OCTOBER 19, 2021
Peter Adams and Dave Harris at Rockies Venture Club (the oldest angel investment group in the U.S.) explored those myths and offered strategies to counter them.
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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
OCTOBER 19, 2021
Vipin Kumar, a composites researcher at Oak Ridge National Laboratory, has been recognized by SAMPE, the Society for the Advancement of Material and Process Engineering, with the 2021 Young Professional Emerging Leadership Award. Credit: ORNL/U.S. Dept. of Energy Vipin Kumar, a composites researcher at Oak Ridge National Laboratory, has been recognized by SAMPE, the Society […].
Drug Channels
OCTOBER 19, 2021
Hospitals and health systems are rapidly expanding their internal specialty pharmacies—and they’re using questionable tactics to boost revenues and profits. A new American Society of Hospital Pharmacists (ASHP) survey of health system pharmacies offers fresh insights into how these systems steer prescriptions to their internal specialty pharmacies: For most health systems' in-house specialty pharmacies, more than 90% of specialty prescriptions are written by system-employed physicians.
Scienmag
OCTOBER 19, 2021
Researchers report the development of frequency translating add/drop filters based on electro-optically modulated photonic molecules. The new class of filters could open important new avenues for on-chip light manipulation. Credit: Hayk Gevorgyan, Boston University Researchers report the development of frequency translating add/drop filters based on electro-optically modulated photonic molecules.
BioSpace
OCTOBER 19, 2021
Redosing is a large and growing concern for gene therapy developers and regulators.
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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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