Bio Pharma Dive
MAY 26, 2022
Fresh study results showed similar rates of response and progression-free survival with Mirati's experimental adragasib as with Amgen's approved Lumakras. The new data might raise safety questions, however.
XTalks
MAY 26, 2022
The US FDA approved Dupixent (dupilumab) developed by Regeneron as the first treatment for eosinophilic esophagitis, a chronic immune disorder that damages the esophagus. Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease caused by type 2 (allergic) inflammation. An overreaction of the immune system recruits eosinophils, a type of white blood cell, to the esophagus, resulting in inflammation as they respond to the “threat”.
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Bio Pharma Dive
MAY 26, 2022
Detailed results from important studies of AstraZeneca’s breast cancer drug Enhertu, Gilead’s Trodelvy and Roche’s TIGIT blocker are among the most anticipated late-breaking data set to be presented next month.
pharmaphorum
MAY 26, 2022
The co-founder of Los Angeles biotech Enochian Biosciences has been arrested in connection with a federal investigation into the murder of a Vermont man in 2018. Serhat Gümrükcü (39) has been charged with conspiring to use interstate commerce facilities in the commission of murder-for-hire, along with alleged co-conspirator Berk Eratay (35) of Las Vegas.
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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
MAY 26, 2022
Bosley, who once led the CRISPR gene editing biotech, will become a venture partner at Advent Life Sciences, which backs a range of early-stage drug companies.
Scienmag
MAY 26, 2022
The National Science Foundation (NSF) recently announced a new investment of more than $37 million aimed to develop intelligent, resilient and reliable next generation – of NextG – Networks. NextG promises faster cellular, Wi-Fi and satellite networks, all of which can be used to enhance data streaming, wireless communications, analytics and automation.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
MAY 26, 2022
Every second, an older person in the United States falls and injures themselves, and every 20 minutes one of them dies from the fall. More than 30 percent of adults 65 and older fall every year and 25 percent of them have moderate to severe injuries. These falls result in 3 million visits to the […].
Bio Pharma Dive
MAY 26, 2022
The drugmaker is spending $2 billion on the new facilities, which will be staffed with up to 500 new corporate positions and support production of its pipeline of new products.
Scienmag
MAY 26, 2022
The incoming director of a major new research and teaching Centre has described the urgent need to place empathy at the heart of healthcare. Credit: University of Leicester The incoming director of a major new research and teaching Centre has described the urgent need to place empathy at the heart of healthcare. Professor Jeremy Howick […].
Pharma Times
MAY 26, 2022
Approval provides another step forward in transforming multiple myeloma outcomes and eliminating the disease
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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
MAY 26, 2022
A team of researchers from SWOG Cancer Research Network, a cancer clinical trials group funded by the National Cancer Institute (NCI), have shown that they can use methylation patterns in cell-free DNA (cfDNA) extracted from blood samples to predict which patients with muscle-invasive bladder cancer are likely to benefit from chemotherapy before their surgery.
Pharma Times
MAY 26, 2022
Libtayo has been approved for adults when curative surgery or radiation is not appropriate
Scienmag
MAY 26, 2022
Boston – Several phase 3 studies conducted by researchers from Dana-Farber Cancer Institute show promising results for patients with multiple myeloma and breast cancer. The results of these studies, along with dozens of others led by Dana-Farber researchers, will be presented at the 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO).
pharmaphorum
MAY 26, 2022
Cumulus Neuroscience has started a pair of clinical trials to gauge the value of a panel of physiological and digital biomarkers in tracking the course of neurodegenerative diseases, including Alzheimer’s. The hope is that the toolkit will improve on current measurement tools for dementia and other neurological conditions that have serious limitations, according to the Northern Ireland company’s chief scientific officer Brian Murphy.
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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
MAY 26, 2022
The 25th SpaceX cargo resupply services mission (SpaceX CRS-25) carrying scientific research and technology demonstrations to the International Space Station is scheduled for launch June 9 from NASA’s Kennedy Space Center in Florida. Experiments aboard the Dragon capsule include studies of the immune system, wound healing, soil communities, and cell-free biomarkers, along with mapping the composition of Earth’s dust and testing an […].
ProRelix Research
MAY 26, 2022
The United States has always been and remains to be the leading place for the conduct of clinical trials. According to Clinicaltrials.gov, the largest clinical trials registry, 32% of registered […]. The post Planning Clinical Trial in USA? Here is what you should know appeared first on ProRelix Research.
Scienmag
MAY 26, 2022
A University of Texas at Arlington hydrology researcher will collect historical data about the Brazos River Basin to help the Texas Water Development Board (TWDB) make far-reaching decisions about securing water supplies for Texas’ growing population. Credit: UT Arlington A University of Texas at Arlington hydrology researcher will collect historical data about the Brazos River […].
Drug Patent Watch
MAY 26, 2022
Annual Drug Patent Expirations for REZUROCK Rezurock is a drug marketed by Kadmon Pharms Llc and is included in one NDA. There are four patents protecting this drug. This drug…. The post New patent for Kadmon Pharms drug REZUROCK appeared first on DrugPatentWatch - Make Better Decisions.
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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
MAY 26, 2022
Artificial Intelligence (AI) can track the health of coral reefs by learning the “song of the reef”, new research shows. Credit: Tim Lamont Artificial Intelligence (AI) can track the health of coral reefs by learning the “song of the reef”, new research shows. Coral reefs have a complex soundscape – and even experts have to […].
Drug Patent Watch
MAY 26, 2022
Annual Drug Patent Expirations for KISQALI Kisqali is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are eight patents protecting…. The post New patent for Novartis drug KISQALI appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
MAY 26, 2022
Researchers from City University of Hong Kong, University of Minnesota, and University of Illinois Urbana-Champaign published a new paper in the Journal of Marketing that finds that requesting customers to rate service professionals first can lead to smaller tips, whereas asking customers to tip first does not influence subsequent rating scores. The study, forthcoming in the Journal of Marketing, is […].
Drug Patent Watch
MAY 26, 2022
Annual Drug Patent Expirations for KISQALI+FEMARA+CO-PACK+%28COPACKAGED%29 Kisqali Femara Co-pack (copackaged) is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are…. The post New patent for Novartis drug KISQALI FEMARA CO-PACK (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.
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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 26, 2022
ANN ARBOR, Michigan — Scientists at the University of Michigan Rogel Cancer Center were optimistic when they identified a small molecule that blocked a key pathway in brain tumors. But there was a problem: How to get the inhibitor through the bloodstream and into the brain to reach the tumor. Credit: University of Michigan Rogel […].
FDA Law Blog
MAY 26, 2022
By Kurt R. Karst — Thanks to years of watching @eavoss of New Rockstars, we have a pretty good handle on the Marvel Cinematic Universe (“MCU”). We know that Earth-199999, known in-universe as Earth-616, is the designated universe number for the main MCU; that there are a multitude of other universes (such as Earth-838 where the Illuminati reside. or resided at least); and that so-called “incursions” occur when two MCU universes collide with one another, resulting in the complete destruction of
Scienmag
MAY 26, 2022
Tie-dyeing is a fun activity that can spice up clothes with colorful patterns. Although kits are available in stores, nature provides dyes that can be extracted from items found in one’s yard — for example, acorns and rust. In ACS’ Journal of Chemical Education, researchers present a “green” process for tie-dyeing cotton with renewable resources […].
XTalks
MAY 26, 2022
Mars Wrigley announced a voluntary recall of various candy products after consumers reported thin metal strands in the candy itself or loose in the bag. In this episode of the Xtalks Food Podcast, Sydney talks about the latest Mars recall, which included Starburst, Skittles and Life Savers gummies that were manufactured by a third party and distributed across North America.
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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 26, 2022
Boyce Thompson Institute (BTI) is pleased to welcome Sheila Ochugboju as the new Executive Director of the Alliance for Science (AfS), a global communications initiative dedicated to promoting access to scientific innovation as a means of enhancing food security, improving environmental sustainability, and raising the quality of life globally. Her start date is June 1. […].
pharmaphorum
MAY 26, 2022
For years, key opinion leaders (KOLs) have held a position of authority and respect amongst those working across the life science industry, be it a result of their expertise in a specific therapeutic area, notable experience working in a particular field, or their connections with researchers, decision-makers, and patients. In a traditional setting, where face-to-face interactions are prioritised, identifying KOLs is relatively straightforward.
Scienmag
MAY 26, 2022
Initial study results show that an experimental drug, called nemvaleukin alfa, when used alone or in combination with another anticancer drug (pembrolizumab) may be effective in treating several types of late-stage cancers in some patients. Both drugs are immunotherapies, medications designed to help the body’s immune defense system detect and kill cancer cells, much like […].
XTalks
MAY 26, 2022
In this episode, Ayesha discussed the FDA approval of Eli Lilly’s diabetes injection Mounjaro (tirzepatide) for the treatment of adults with type 2 diabetes This is a great advancement in the diabetes space as Mounjaro is a first-in-class medicine that targets the activity of two hormones involved in hunger and blood sugar control (GLP-1 and GIP). With the approval, Eli Lilly will be giving Novo Nordisk’s blockbuster diabetes injection Ozempic some tough competition.
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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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