Bio Pharma Dive
APRIL 1, 2021
Updated Phase 3 study results could position Pfizer to file for full approval of its vaccine and might have implications for its plans to develop a booster shot.
World of DTC Marketing
APRIL 1, 2021
IN BRIEF: At some point, we need to realize that good health is our personal responsibility. All prescription drugs don’t make us healthy; they just mask a potentially unhealthy lifestyle that eventually will cost patients and our healthcare system a lot of money, time, and pain. Responsibility for health should be a collaborative effort among individuals and the societies in which they live.
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Bio Pharma Dive
APRIL 1, 2021
One vaccine batch being manufactured for J&J by Emergent Biosolutions failed quality checks, reportedly ruining material sufficient for up to 15 million doses.
XTalks
APRIL 1, 2021
There is no shortage of post-workout drinks on the market, including innovative new additions to the category, like high-protein chocolate milk to sports drinks made with upcycled dairy byproducts. But could an electrolyte beer be just the thing to quench consumers’ thirst after a session at the gym? A few breweries in the US are trying to make that a reality with low alcohol by volume (ABV) beers infused with electrolytes and other nutrients.
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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
APRIL 1, 2021
Natalie Holles, who was appointed CEO of Audentes soon after Astellas acquired the gene therapy developer in 2019, has departed amid the company's integration.
pharmaphorum
APRIL 1, 2021
AI simulated cell company Turbine is just one of many digital drug discovery firms on the rise in Hungary. We speak to the company’s CEO and co-founder, Szabolcs Nagy, to find out why moving beyond traditional biotech drug development is a good fit for the country’s ecosystem. Hungarian company, Turbine, is taking an alternative approach to the standard biotech drug development model with its AI-based simulated cell technology, which helps the bulk of preclinical drug discovery take place digita
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
APRIL 1, 2021
In a large-scale research study published today in The New England Journal of Medicine (NEJM), Dr. David Ilson reported on the potential of Opdivo (adjuvant nivolumab) as a treatment for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.
Druggist
APRIL 1, 2021
Amlodipine is one of the most commonly prescribed drugs in the UK and the most prescribed high blood pressure ( BP ) medication. When patients are diagnosed with high blood pressure and a drug is recommended, amlodipine may be the first choice, but not always. Taking any drugs comes with a risk of side effects, with amlodipine associated with few common side effects.
BioSpace
APRIL 1, 2021
For more than a decade, team members of Watertown, Mass.-based Arranta Bio have been studying the physical and functional characteristics of Live Biotherapeutic Products.
XTalks
APRIL 1, 2021
Is there arsenic in your baby food? In this week’s episode of the Xtalks Food Podcast, Sydney discusses the Baby Food Safety Act of 2021 which aims to help the FDA regulate heavy metal contamination in baby food. Also in this episode, Mira talks about Pepsi’s unique social media campaign surrounding the launch of its new flavor Pepsi Mango. The team discusses why mango Pepsi may have been chosen as the brand’s first new permanent flavor in five years, and whether Pepsi’s social media-based
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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
APRIL 1, 2021
The year 2020 and the COVID-19 pandemic created a number of challenges for individuals and companies. Despite these hurdles, Maryland-based Precigen still managed to achieve its clinical milestones in oncology.
Scienmag
APRIL 1, 2021
Credit: Scott Ableman/Flickr How plants will fare as carbon dioxide levels continue to rise is a tricky problem and, researchers say, especially vexing in the tropics. Some aspects of plants’ survival may get easier, some parts will get harder, and there will be species winners and losers. The resulting shifts in vegetation will help determine […].
BioSpace
APRIL 1, 2021
Pfizer announced plans to create a professional services office in Tampa, Florida. It will be located in more than 100,000 square feet of office space and believe they will be generating hundreds of new jobs.
Scienmag
APRIL 1, 2021
Among typical anesthetics, only isoflurane results in undisrupted memory formation in mice Credit: Simon Wiegert, CC-BY Memory loss is common after general anesthesia, particularly for events occurring immediately before surgery–a phenomenon called retrograde amnesia. But a new study publishing on April 1st 2021 in the open access journal PLOS Biology, led by Simon Wiegert at […].
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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.
Outsourcing Pharma
APRIL 1, 2021
The advanced biotech analysis company is harnessing the power of a formidable supercomputer to discover potential treatments for the virus and mutations.
Scienmag
APRIL 1, 2021
2D materials combine, becoming polarized and giving rise to photovoltaic effect Credit: ©2021 Ideue et al. For the first time, researchers have discovered a way to obtain polarity and photovoltaic behavior from certain nonphotovoltaic, atomically flat (2D) materials. The key lies in the special way in which the materials are arranged. The resulting effect is […].
pharmaphorum
APRIL 1, 2021
The head of the EMA has reiterated that there is no evidence to limit the use of AstraZeneca’s COVID-19 vaccine in any age group, after Germany and Canada imposed restrictions in younger patients. . “Our position has not changed” from a safety update two weeks ago, said Emer Cooke at an EMA press conference today. “According to the current scientific knowledge, there is no evidence that would support restricting the use of this vaccine in any population.” She added
Scienmag
APRIL 1, 2021
Credit: Christina Gandolfo Kidney development is a balancing act between the self-renewal of stem and progenitor cells to maintain and expand their numbers, and the differentiation of these cells into more specialized cell types. In a new study in the journal eLife from Andy McMahon’s laboratory in the Department of Stem Cell Biology and Regenerative […].
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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.
BioPharma Reporter
APRIL 1, 2021
The FDAâs recent endorsement of Abecma marks the first approved treatment in oncology for gene therapy developer, bluebird bio.
Scienmag
APRIL 1, 2021
Credit: Dan Addison | UVA Communications Children and young adults who receive CAR T-cell therapy for the most common childhood cancer – acute lymphoblastic leukemia – suffer remarkably fewer relapses and are far more likely to survive when the treatment is paired with a subsequent stem cell transplant, a new study finds. The research, with […].
NY Times
APRIL 1, 2021
I’ve reported on behavior and mental health for 20 years. As I exit, I can’t help but wonder why researchers have placed so little emphasis on helping people in distress today.
Scienmag
APRIL 1, 2021
Model provides new insights into how whisker bending translates to sensory touch signals Credit: Yifu Luo and Nadina Zweifel Researchers have developed a new mechanical model that simulates how whiskers bend within a follicle in response to an external force, paving the way toward better understanding of how whiskers contribute to mammals’ sense of touch. […].
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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
APRIL 1, 2021
Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee published their objections to the drug in a JAMA article.
Scienmag
APRIL 1, 2021
New model captures glycan molecules whose motions shield much of the spike from immune defenses Credit: Mateusz Sikora, Sören von Bülow, Florian E. C. Blanc, Michael Gecht, Roberto Covino and Gerhard Hummer A new, detailed model of the surface of the SARS-CoV-2 spike protein reveals previously unknown vulnerabilities that could inform development of vaccines.
pharmaphorum
APRIL 1, 2021
Incentivising people with KPI-linked bonuses is nothing new. Especially in commercial roles it has long been standard. The issue with KPIs is they can be very ineffective. If clearly defined they will get you results, but if not, they can just reinforce the wrong behaviours. The difficulty is to define the right ones. Bottomline is that KPI-based incentives will hardly ever create the behaviour that you want and in some of the worst examples have caused a disaster like the financial crisis in 20
Scienmag
APRIL 1, 2021
Salk scientists reveal new insights into neurodegenerative disorders and potential for genetic therapies Credit: Salk Institute/Waitt Advanced Biophotonics Center LA JOLLA–(April 1, 2021) Neurons lack the ability to replicate their DNA, so they’re constantly working to repair damage to their genome. Now, a new study by Salk scientists finds that these repairs are not random, […].
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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.
BioSpace
APRIL 1, 2021
Days after announcing the U.S. Food and Drug Administration (FDA) has cleared the next clinical trials to launch for its lead natural killer (NK) cell therapies, NKMax America announced it has renamed itself NKGen Biotech.
Scienmag
APRIL 1, 2021
Researchers have confirmed for the first time that Pine Island Glacier in West Antarctica could cross tipping points, leading to a rapid and irreversible retreat which would have significant consequences for global sea level Credit: Dr Sebastian Rosier Researchers have confirmed for the first time that Pine Island Glacier in West Antarctica could cross tipping […].
BioSpace
APRIL 1, 2021
One of the common research approaches to treating brain diseases such as Parkinson’s disease (PD) and Alzheimer’s disease (AD) is using antibodies designed to clear the accumulated misfolded proteins implicated in the diseases. To date, these drug trials have not been particularly successful at i.
Scienmag
APRIL 1, 2021
This content published in Annals is free to the public Below please find a summary of a new article that is published in Annals of Internal Medicine today. The summary is not intended to substitute for the full article as a source of information. Physicians must advocate for common sense gun laws for good of […].
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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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