Bio Pharma Dive
APRIL 21, 2021
Two Phase 3 trials have now shown that Lilly's autoimmune drug baricitinib may effectively treat alopecia areata. But the FDA's concerns with so-called JAK inhibitors could complicate a review.
Scienmag
APRIL 21, 2021
Credit: WVU Water researchers at West Virginia University hope to turn a pollutant – acid mine drainage – into a technological resource through the continuation of a $2.1 million contract from the National Energy Technology Laboratory. The West Virginia Water Research Institute, a program of the Energy Institute at WVU, earned the funding to explore […].
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Bio Pharma Dive
APRIL 21, 2021
Versant's announcement comes as biotechs continue to rake in record levels of cash, supporting a wave of new drug company startups.
XTalks
APRIL 21, 2021
Chef Avenue , a Silicon Valley-based cookware company, started a Kickstarter on April 6 for their product, Omnipan, which has made over $200,000 in just over two weeks. In fact, they were fully funded five hours after the launch of their Kickstarter. Omnipan allows consumers to prep, cook, bake and steam their meals in the same patent-pending technology pan.
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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
BioSpace
APRIL 21, 2021
Simply put, an antibody is a large, Y-shaped blood protein produced by plasma cells that the immune system uses to take down pathogens like bacteria – and of course, viruses like SARS-CoV-2.
Scienmag
APRIL 21, 2021
Scientists developed a model showing that a fragile, temporary state of immunity emerged during the early epidemic but got destroyed as people changed their social behaviors over time, leading to future waves of infection. Credit: BNL Scientists at the U.S. Department of Energy’s (DOE) Brookhaven National Laboratory and the University of Illinois Urbana-Champaign (UIUC) have […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
APRIL 21, 2021
A high-conductivity n-type polymeric ink for printed electronics Credit: Thor Balkhed Researchers at Linköping University, Sweden, have developed a stable high-conductivity polymer ink. The advance paves the way for innovative printed electronics with high energy efficiency. The results have been published in Nature Communications. Electrically conducting polymers have made possible the development of flexible and […].
BioSpace
APRIL 21, 2021
The approval was specifically for patients with recurrent or advanced endometrial cancer who had progressed on or after previous treatment with platinum-based chemotherapy and whose cancers have a dMMR genetic anomaly.
Scienmag
APRIL 21, 2021
Credit: Sarah Moor Using a novel molecular-data-storage technique, researchers at the University of Texas at Austin have encoded a quote from Jane Austen’s classic novel Mansfield Park in a series of oligomers, which a third party could read back without prior knowledge of the structures that encoded the passage. The findings, published April 21st in […].
BioSpace
APRIL 21, 2021
On the back of the two positive Phase III trials, Ortho said it will submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2022.
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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
Scienmag
APRIL 21, 2021
Modeling study suggests vigorous ventilation can cause spike in viral concentrations Credit: Illustration/Animation: Cortland Johnson/Sara Levine, Pacific Northwest National Laboratory Vigorous and rapid air exchanges might not always be a good thing when it comes to addressing levels of coronavirus particles in a multiroom building, according to a new modeling study.
BioSpace
APRIL 21, 2021
The long and strange journey of Biogen’s Alzheimer’s drug aducanumab is coming to an end. Whether it will be a complete ending—with the U.S. FDA rejecting it—or a new chapter, with an approval, remains to be seen.
XTalks
APRIL 21, 2021
Long-time partners Medrio and HMD Clinical have come together, with Medrio acquiring the randomization and trial supply management (RTSM) firm for an undisclosed amount. The deal closed this month and San Francisco-based Medrio has already redirected the UK company’s webpage to its domain. As a leader in the eClinical space, Medrio is betting on HMD Clinical’s RTSM expertise to expand its offerings to trial sponsors, sites and clinical research organizations (CROs) around the world.
BioSpace
APRIL 21, 2021
BioSpace recently spoke with Norman Sussman, chief medical officer at DURECT, a company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and lifesaving therapies based on its endogenous epigenetic regulator program.
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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
APRIL 21, 2021
Credit: © Beaulieu Making the speed of electronic technology as fast as possible is a central aim of contemporary materials research. The key components of fast computing technologies are transistors: switching devices that turn electrical currents on and off very quickly as basic steps of logic operations. In order to improve our knowledge about ideal […].
Pharma Marketing Network
APRIL 21, 2021
[link]. The Pharma Marketing Podcast is pleased to present this special guest episode from our friend and Editorial Advisory Board member Darshan Kulkarni, Sales and Marketing Oversight – April 21, 2021. Darshan Kulkarni and Marc Banjak, General Counsel at Dova Pharmaceuticals, discuss sales compliance in the life sciences. Sales and marketing representatives in the life science industry must comply with state and federal regulations.
Scienmag
APRIL 21, 2021
A revolutionary technique gives scientists an unparalleled close-up view inside fleeting particles called excitons Credit: OIST In a world-first, researchers from the Okinawa Institute of Science and Technology Graduate University (OIST) have captured an image showing the internal orbits, or spatial distribution, of particles in an exciton – a goal that had eluded scientists for […].
BioSpace
APRIL 21, 2021
Shareholders have been pleased with the company’s mRNA vaccine, but some, including the company’s cofounder, are cashing in on their stock gains.
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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
APRIL 21, 2021
Lessons learned can be applied in future health crises Credit: Regenstrief Institute INDIANAPOLIS — A team from Regenstrief Institute leveraged OpenMRS, a global open-source electronic medical record (EMR), to create an emergency EMR for Indianapolis first responders preparing for a possible influx of COVID-19 patients. This process was completed in a week to allow Indianapolis […].
BioSpace
APRIL 21, 2021
Do you know what your “dream job” is? Would you be able to identify it if you had multiple job offers? Many people are in search of a dream job, but don’t really know how to find one and what makes it different than other average job opportunities.
Scienmag
APRIL 21, 2021
Credit: Ma Lab MADISON, Wis. — Tens of millions of people worldwide are affected by diseases like macular degeneration or have had accidents that permanently damage the light-sensitive photoreceptors within their retinas that enable vision. The human body is not capable of regenerating those photoreceptors, but new advances by medical researchers and engineers at the […].
BioSpace
APRIL 21, 2021
Biopharma and life sciences companies from around the globe provide updates on their businesses and pipelines.
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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
APRIL 21, 2021
Credit: IBEC Robotics field aims at mimicking what natural biological entities have achieved throughout millennia of evolution – actions like moving, adapting to the environment, or sensing. Beyond traditional rigid robots, the field of soft robotics has recently emerged using compliant, flexible materials capable to adapt to their environment more efficiently than rigid ones.
JAMA Internal Medicine
APRIL 21, 2021
This cohort study examines viral dynamics and transmission of infection for National Basketball Association players, staff, and vendors who had clinically recovered from SARS-CoV-2 infection but continued to have positive test results following discontinuation of isolation precautions.
Scienmag
APRIL 21, 2021
Credit: NIAID A Phase 2/3 trial to evaluate a new fully-human polyclonal antibody therapeutic targeted to SARS-CoV-2, called SAB-185, has begun enrolling non-hospitalized people with mild or moderate cases of COVID-19. The trial, ACTIV-2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
JAMA Internal Medicine
APRIL 21, 2021
A fundamental question of the COVID-19 pandemic has been when it is safe to discontinue isolation precautions in patients who have recovered. The US Centers for Disease Control and Prevention (CDC) originally recommended a test-based strategy for discontinuing isolation, requiring 2 consecutive negative reverse-transcription–polymerase chain reaction (RT-PCR) tests at least 24 hours apart.
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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
APRIL 21, 2021
Credit: Jonathan Borba A new study has found up to half of all children with language difficulties and mental and physical health problems have been exposed to intimate partner violence, prompting calls for health and social care services to provide more effective identification and early intervention. The research, led by the Murdoch Children’s Research Institute […].
BioTech 365
APRIL 21, 2021
22nd Century Group Issues Annual Letter to Shareholders 22nd Century Group Issues Annual Letter to Shareholders Company’s Confidence in MRTP Authorization is High; Launch of VLN® is Only the Beginning for Tobacco Franchise Key Partnerships to Drive Differentiation and Value; … Continue reading →
Scienmag
APRIL 21, 2021
Credit: Anna Wallis Like humans, certain plants are treated with antibiotics to ward off pathogens and protect the host. Saving millions, antibiotics are one of the 20th century’s greatest scientific discoveries, but repeated use and misuse of these life-saving microbial products can disrupt the human microbiome and can have severe effects on an individual’s health. […].
BioSpace
APRIL 21, 2021
Novavax is plugging along to get their COVID-19 vaccine candidate, NVX-CoV2373, through late-stage clinical trials and authorized in the U.S. and elsewhere.
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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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