BioSpace
MAY 31, 2021
Newly entrenched in a leadership role within one of the most complex therapeutic spaces, Tole discussed the complexities of being both a woman and a woman of color in the biotech industry.
BioPharma Reporter
MAY 31, 2021
Samsung Biologics will add mRNA vaccine drug substance production capability to its facility in South Korea, aiming to provide end-to-end mRNA vaccine manufacturing services.
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BioSpace
MAY 31, 2021
The FDA gave the green light to Amgen's Lumakras under accelerated approval as a treatment for patients with KRAS mutation whose disease has worsened over time.
Scienmag
MAY 31, 2021
There’s Simon and Garfunkel, Tina and Ike, and Armstrong and Fitzgerald. But now, nature’s famed duet singers, the plain-tail wren, shows neurobiologists the magic between collaborative performers sparks when music-making parts of the brain go silent. Credit: Melissa Coleman Art Garfunkel once described his legendary musical chemistry with Paul Simon, “We meet somewhere in the […].
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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
MAY 31, 2021
The latest news in COVID-19 includes support for an investigation into the origins of the virus, a new naming system, and legal discussions of whether employers can mandate vaccination.
Scienmag
MAY 31, 2021
First used to soak up oil in water, new sponge sequesters excess phosphate from water Credit: Northwestern University Phosphate pollution in rivers, lakes and other waterways has reached dangerous levels, causing algae blooms that starve fish and aquatic plants of oxygen. Meanwhile, farmers worldwide are coming to terms with a dwindling reserve of phosphate fertilizers […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
MAY 31, 2021
OncoSTART sees 12 expert partners join forces to combine networks to promote entrepreneurial innovation to tackle cancer head on.
BioSpace
MAY 31, 2021
Sanofi said that the phase II/III trial studying venglustat in autosomal dominant polycystic kidney disease was scrapped because it “did not meet futility criteria.
Scienmag
MAY 31, 2021
ICIQ scientists from the Lloret-Fillol group have, for the first time, isolated and fully characterised an elusive intermediate in the Water Oxidation Reaction. Credit: ICIQ The Water Oxidation Reaction (WOR) is one of the most important reactions on the planet since it is the source of nearly all the atmosphere’s oxygen. Understanding its intricacies can […].
BioSpace
MAY 31, 2021
The early termination of the trials places a damper on Novartis' hopes of competing even further with Regeneron Pharmaceuticals' retinal disease drug Eylea.
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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
XTalks
MAY 31, 2021
Tillamook County Creamery Association (TCCA), known for its cheddar cheese, ice cream and other dairy products, created a partnership to make ice cream creamier. Baddie Winkle, a style icon and ice cream super fan, wants to promote creamier ice cream and remind consumers of what it used to taste like. TCCA announced the Partnership for Creamier Ice Cream as a public service campaign dedicated to ensuring that each scoop of ice cream has more cream and better ingredients. .
BioSpace
MAY 31, 2021
Heading into the U.S. Memorial Day holiday weekend and the official start of summer, it was a moderately busy week for clinical trial news. Take a look.
Scienmag
MAY 31, 2021
By including multi-ethnic participants, a largescale genetic study has identified more regions of the genome linked to type 2 diabetes-related traits than if the research had been conducted in Europeans alone. By including multi-ethnic participants, a largescale genetic study has identified more regions of the genome linked to type 2 diabetes-related traits than if the […].
BioSpace
MAY 31, 2021
MyMD Pharmaceuticals’ TNF-? regulator may be able to be commercialized without the black-box warnings that accompany so many TNF-? therapies.
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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.
XTalks
MAY 31, 2021
You’ve seen his vibrant personality shine on screen in his various cooking shows. You’ve indulged in traditional Italian recipes that leap off the pages of his many cookbooks. Now, coming soon, you’ll get to experience more of David Rocco’s authentic Italian flair at his new wine bar opening in Yorkville, a posh neighborhood in the heart of Toronto, Ontario in Canada. .
BioSpace
MAY 31, 2021
There were seven initial public offerings (IPOs) for biotech companies in the month of May. Here’s a look.
Scienmag
MAY 31, 2021
Very high atmospheric CO2 levels can explain the high temperatures on the still young Earth three to four billion years ago. At the time, our Sun shone with only 70 to 80 per cent of its present intensity. Nevertheless, the climate on the young Earth was apparently quite warm because there was hardly any glacial […].
BioSpace
MAY 31, 2021
The FDA approves Truseltiq for patients with previously-treated locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement.
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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.
Clinical Trial Podcast
MAY 31, 2021
The pandemic has helped accelerate the adoption of technology in clinical research. The greater use of technology has been a much needed change for the clinical trial industry as a whole. . This change in turn has led to an increased focus on decentralized clinical trials (DCTs). . But what exactly is a DCT? To learn more, I invited Derk Arts, Founder & CEO of Castor.
pharmaphorum
MAY 31, 2021
Digital health player Babylon Health is exploring a merger with a so-called ‘blank cheque’ company as a route to a public listing, according to a Swedish investment group. Kinnevik AB – which holds a 16% stake in Babylon – said that a transaction with a special-purpose acquisition company (SPAC) is being explored and may or may not take place, adding that it would not comment further on the matter for the time being.
Scienmag
MAY 31, 2021
Three groups (Dr. James Birchler’s group from University of Missouri, Dr. Jan Barto’s group from Institute of Experimental Botany of the Czech Academy of Sciences and Dr. HAN Fangpu’s group from the Institute of Genetics and Developmental Biology of the Chinese Academy of Sciences) recently reported a reference sequence for the supernumerary B chromosome in […].
BioSpace
MAY 31, 2021
The U.S. FDA is starting off the summer months with a busy week after the Memorial Day holiday in the U.S. Here’s a look.
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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 31, 2021
NIH- and USU- led study links ALS to a fat manufacturing gene and maps out a genetic therapy Credit: Courtesy of the NIH/NINDS. In a study of 11 medical-mystery patients, an international team of researchers led by scientists at the National Institutes of Health and the Uniformed Services University (USU) discovered a new and unique […].
Drug Patent Watch
MAY 31, 2021
VIBATIV (telavancin hydrochloride) Cumberland pharms Patent: 6,872,701 Expiration: Jun 5, 2021 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com…. The post Drug Patent Expirations for the Week of May 30, 2021 appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
MAY 31, 2021
Credit: Junxiang Zhao Electrical engineers at the University of California San Diego developed a technology that improves the resolution of an ordinary light microscope so that it can be used to directly observe finer structures and details in living cells. The technology turns a conventional light microscope into what’s called a super-resolution microscope.
BioSpace
MAY 31, 2021
Loncastuximab tesirine just got accelerated approval from the U.S. Food and Drug Administration (FDA). This is a systemic therapy for people with diffuse large B-cell lymphoma (DLBCL).
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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 31, 2021
Researchers analyze whether it is possible to simultaneously grow the economy while not producing more pollution Pollution from manufacturing is now widespread, affecting all regions in the world, with serious ecological, economic, and political consequences. Heightened public concern and scrutiny have led to numerous governments considering policies that aim to lower pollution and improve environmental […].
FDA Law Blog
MAY 31, 2021
By Faraz Siddiqui & Alan M. Kirschenbaum — The past two weeks have seen two noteworthy developments relating to CMS’s Medicaid Drug Rebate Program (MDRP) regulations. 1. PhRMA Sues CMS Challenging MDRP Rule Curbing Patient Assistance. In December 2020, CMS published a final rule making several changes to the MDRP regulations. See our post here and our summary of the final rule here.
Scienmag
MAY 31, 2021
Virginia Tech, Penn researchers show early learning shapes adult brain structure Credit: Virginia Tech An enhanced learning environment during the first five years of life shapes the brain in ways that are apparent four decades later, say Virginia Tech and University of Pennsylvania scientists writing in the June edition of the Journal of Cognitive Neuroscience. […].
pharmaphorum
MAY 31, 2021
After decades of mostly unsuccessful R&D, Amgen has claimed the first ever regulatory approval for a drug that inhibits KRAS – a cancer target that for a long time was all-but written off as “undruggable” The FDA’s conditional approval for Lumakras (sotorasib; formerly AMG-510) as a second-line treatment for KRAS G12c-mutated non-small cell lung cancer (NSCLC) has come more than two months ahead of schedule, which reflects the importance of the new drug.
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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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