Bio Pharma Dive
JULY 8, 2021
Treatments from Bluebird bio and CRISPR Therapeutics have shown considerable promise and could soon be nearing regulatory review. A full pipeline is growing behind them.
World of DTC Marketing
JULY 8, 2021
SUMMARY: TV continues to be the dominant channel for DTC advertising. Some of the TV spots for drugs are horrible, and some products should even be on TV because of terrible fair balance. TV ads only drive awareness as the first step for online health seekers. More conversations are happening on social media, and pharma seems to be immune to the conversations.
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Bio Pharma Dive
JULY 8, 2021
The approval of Aduhelm last month, already highly controversial, was made more so by the agency's decision to clear the drug for an exceptionally broad group of patients. New prescribing information more closely matches clinical testing.
Camargo
JULY 8, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Old Antidepressants Being Repurposed to Treat Cancer . At Camargo, we have worked with hundreds of investigators who have found new targets for established drugs. It is exciting to find new uses of drugs with known safety because these drugs can reach new groups of patients in a relatively short timeframe.
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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
JULY 8, 2021
Second quarter sales of Nurtec ODT, which recently became the first migraine drug cleared for acute and preventive treatment, were nearly twice what analysts on Wall Street had predicted.
Scienmag
JULY 8, 2021
New simulations suggest that waiting until a student tests positive is too late for prevention Credit: Paul Tupper (CC BY 4.0, [link] A new study examines factors that underlie COVID-19 outbreaks in schools and suggests that large outbreaks can only be prevented with regular monitoring of everyone in the school setting. Paul Tupper and Caroline […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JULY 8, 2021
Acting commissioner of the U.S. FDA asked the independent Office of the Inspector General to investigate how the FDA and representatives of Biogen interacted prior to the FDA’s approval of the company’s Aduhelm (aducanumab) for Alzheimer’s disease.
Outsourcing Pharma
JULY 8, 2021
The immunotherapy firm is conducting a Phase III trial centered on an innovative approach to treating recurrent glioblastoma, an aggressive brain cancer.
Pharma Times
JULY 8, 2021
Company is aiming to transform the discovery of therapeutics focused on enzyme inhibition
pharmaphorum
JULY 8, 2021
GlaxoSmithKline’s head of oncology Axel Hoos has resigned from the company, and will take up a new role as chief executive of US biotech Scorpion Therapeutics. . Hoos is leaving GSK after nine years, a period that saw a complete revamp of the unit including the wholesale divestment of cancer drugs to Novartis in a $16 billion deal announced in 2014 – which completed as he took over the division.
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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
Pharma Times
JULY 8, 2021
Collaboration will focus on the development of smart neurostimulators for the treatment of severe chronic diseases
BioSpace
JULY 8, 2021
The two companies said a booster dose given six months after the second dose had a consistent tolerability profile while still creating high immune responses against the Alpha and Beta variant.
Pharma Times
JULY 8, 2021
COVID-19 infection rates were three times lower in fully vaccinated people compared to unvaccinated people
XTalks
JULY 8, 2021
The World Health Organization (WHO) has backed the use of interleukin (IL)-6 receptor blockers as a COVID-19 treatment for severely or critically ill patients with the infection, alongside corticosteroids. The IL-6 receptor antagonists are used to treat rheumatoid arthritis and include drugs such as Roche’s Actemra (tocilizumab) and Regeneron’s Kevzara (sarilumab).
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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
JULY 8, 2021
Seismic activity could give scientists a read on the thickness of the ice encasing the moon and the oceans believed to lie beneath Credit: AGU/ JGR: Planets WASHINGTON–Tidal stresses may be causing constant icequakes on Saturn’s sixth largest moon Enceladus, a world of interest in the search for life beyond Earth, according to a new […].
Drug Patent Watch
JULY 8, 2021
Annual Drug Patent Expirations for RESCULA Rescula is a drug marketed by Sucampo Pharma Llc and is included in one NDA. There is one patent protecting this drug and one…. The post New patent expiration for Sucampo Pharma drug RESCULA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JULY 8, 2021
Credit: Manuel Will The average body size of humans has fluctuated significantly over the last million years and is strongly linked to temperature. Colder, harsher climates drove the evolution of larger body sizes, while warmer climates led to smaller bodies. Brain size also changed dramatically but did not evolve in tandem with body size. An […].
BioSpace
JULY 8, 2021
?Sparx Therapeutics is expanding its operations into Yangzhou, China, with the imminent construction of a 1.2 million square foot facility for its commercial production.
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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
JULY 8, 2021
A new vaccine technology combining capture of bacterial pathogens with effective immune-reprogramming biomaterials could be applied to a broad spectrum of infectious diseases Credit: Wyss Institute at Harvard University. (BOSTON) — Current clinical interventions for infectious diseases are facing increasing challenges due to the ever-rising number of drug-resistant microbial infections, epidemic outbreaks of pathogenic bacteria, […].
Pharma Times
JULY 8, 2021
Priority review comes following positive results from the Phase III NAVIGATOR trial
Scienmag
JULY 8, 2021
Credit: Matthew Silk Players of the popular game Red Dead Redemption 2 learn how to identify real American wildlife, new research shows. The game, set in the American West in 1899, features simulations of about 200 real species of animals. The new study, by the University of Exeter and Truro and Penwith College, challenged gamers […].
NY Times
JULY 8, 2021
Scientists were critical of the announcement, pointing to evidence that the current two-dose regimen is powerfully effective against the coronavirus.
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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
JULY 8, 2021
Credit: Image created by Y. Abdelhafez and B.A. Spencer, EXPLORER Molecular Imaging Center, UC Davis, Sacramento, CA Reston, VA–A performance evaluation of the uEXPLORER total-body PET/CT scanner showed that it exhibits ultra-high sensitivity that supports excellent spatial resolution and image quality. Given the long axial field of view (AFOV) of the uEXPLORER, study authors have […].
BioSpace
JULY 8, 2021
Philip Morris will acquire Vectura to gain access to its inhaled drug formulas to bolster its Beyond Nicotine strategy.
Scienmag
JULY 8, 2021
Study finds HIE event notification promising tool to solve major healthcare challenge Credit: Regenstrief Institute INDIANAPOLIS – A new study from U.S. Department of Veterans Affairs, Regenstrief Institute, IUPUI and Icahn School of Medicine at Mount Sinai researchers reports that primary care physicians recognize the need for better coordination and welcome health information exchange (HIE) […].
BioSpace
JULY 8, 2021
The company launches with the new funding to advance its focus on first-in-class small molecule therapies for neurodegenerative diseases.
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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
JULY 8, 2021
A new study monitored satellite images to obtain sea discoloration data as a novel indicator in detecting if an underwater volcano’s eruption is imminent. Credit: JAXA/Yuji Sakuno A new study suggests sea discoloration data obtained from satellite images as a novel criterion in predicting if eruption looms for an underwater volcano. There have been frequent […].
BioSpace
JULY 8, 2021
This week's announcement includes a step to the side for CMO Amit Rakhit, who will transition to the biotech's advisory board.
Scienmag
JULY 8, 2021
Credit: Philip Kiberd Evidence from an ancient eggshell has revealed important new information about the extreme climate change faced by human early ancestors. The research shows parts of the interior of South Africa that today are dry and sparsely populated, were once wetland and grassland 250,000 to 350,000 years ago, at a key time in […].
BioSpace
JULY 8, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
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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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