Bio Pharma Dive
JULY 7, 2021
Hoos, who led cancer R&D at GSK, will take over as head of Scorpion Therapeutics, a new biotech company that's raised $270 million in venture funding since launching last October.
Pharma Times
JULY 7, 2021
Eli Lilly and Boehringer Ingelheim have revealed positive results from a Phase III study of Jardiance in HFpEF patients
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Bio Pharma Dive
JULY 7, 2021
Having proved mRNA's might in COVID-19, the biotech company aims to develop similar vaccines for other respiratory illnesses caused by influenza, RSV and metapneumovirus.
BioSpace
JULY 7, 2021
Ivermectin has become a contentious issue as to whether it effectively prevents and treats COVID-19. Several studies suggest it is effective, while others have indicated it is not.
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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 7, 2021
Once long-shot experiments in the rush to repurpose drugs for COVID-19, both Actemra and Kevzara could become more widely used, renewing questions around cost and access.
BioPharma Reporter
JULY 7, 2021
WHO is recommending the use of interleukin-6 (IL)-6 receptor blockers in patients with severe and critical COVID-19, adding them to its list of treatments for the virus.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JULY 7, 2021
Agenus, an immuno-oncology company based out of Lexington, Mass., has purchased a 120-acre plot of land near Genentech’s manufacturing facility in Vacaville, Cali.
Drug Patent Watch
JULY 7, 2021
Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. There are thirteen patents protecting this drug. XHANCE drug…. The post New patent for Optinose Us drug XHANCE appeared first on DrugPatentWatch - Make Better Decisions.
XTalks
JULY 7, 2021
World Chocolate Day is a day dedicated to celebrating chocolate each year on July 7. This day was chosen because some believe that the same day in the year 1550 was the date that chocolate was first introduced in Europe. This day brings together all the chocolate lovers around to world to indulge and feel no guilt eating their favorite treats. There is a wide range of chocolate to choose from in the market —including milk chocolate, white chocolate and dark chocolate — but within these broad cat
Drug Patent Watch
JULY 7, 2021
Annual Drug Patent Expirations for MYCAMINE Mycamine is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. There is one patent protecting…. The post New patent expiration for Astellas drug MYCAMINE appeared first on DrugPatentWatch - Make Better Decisions.
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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
pharmaphorum
JULY 7, 2021
The FDA indicated something was not well with Provention Bio’s filing for type 1 diabetes therapy teplizumab in April when it delayed its review. Now, the agency has rejected the application entirely, sending the company’s shares into a steep slide. The complete response letter (CRL) for teplizumab as a treatment to delay clinical type 1 diabetes in at-risk individuals reiterates the FDA’s concerns around the pharmacokinetics (PK) data for the antibody.
Scienmag
JULY 7, 2021
In a first-of-its-kind study, the UMD team used electroencephalography (EEG) to better understand and work toward solutions for VR-induced discomfort Credit: Maryland Blended Reality Center If a virtual world has ever left you feeling nauseous or disorientated, you’re familiar with cybersickness, and you’re hardly alone. The intensity of virtual reality (VR)–whether that’s standing on the […].
pharmaphorum
JULY 7, 2021
The European Commission has given competition clearance to the $39 billion acquisition of Alexion by AstraZeneca, leaving the UK as the last remaining obstacle to getting the deal across the line. The EU approval comes after the merger has already been okayed by the US, Japan and a number of other countries around the world, and AZ says it is now hoping to completing the transaction by the end of this quarter.
Scienmag
JULY 7, 2021
Credit: (Image by Argonne Leadership Computing Facility, Visualization and Data Analytics Group [Janet Knowles, Joseph Insley, Victor Mateevitsi, Silvio Rizzi].) When gravitational waves were first detected in 2015 by the advanced Laser Interferometer Gravitational-Wave Observatory (LIGO), they sent a ripple through the scientific community, as they confirmed another of Einstein’s theories and marked the birth […].
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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.
BioSpace
JULY 7, 2021
A Phase II study shows the vaccine by Imugene Limited improved survival rates and overall response in patients with HER2-positive stomach or gastroesophageal junction cancer.
Scienmag
JULY 7, 2021
Researchers from Germany and Canada work on new AI methods for picking robots Credit: Amadeus Bramsiepe, KIT Production, warehouse, shipping – where goods are produced, stored, sorted or packed, picking also takes place. This means that several individual goods are removed from storage units such as boxes or cartons and reassembled. Researchers at the Karlsruhe […].
BioSpace
JULY 7, 2021
The saga continues for Biogen’s Alzheimer’s drug Aduhelm as the U.S. Food and Drug Administration approved an updated label that emphasizes the disease stages for which the drug was approved.
Scienmag
JULY 7, 2021
Credit: Michael Gomez, Penn State Diversification in the sourcing of food into cities can go a long way to tempering “food shock” — a sudden drop in food supply due to unforeseen events, according to a team of researchers from Penn State and Northern Arizona University, who developed a statistical risk model linking supply chain […].
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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.
BioSpace
JULY 7, 2021
“The Great Resignation” is a term that’s been coined to describe the wave of people leaving their jobs for other opportunities or exiting the workforce altogether.
Scienmag
JULY 7, 2021
Credit: Matthew Jones LAWRENCE — A new paper appearing in Biology Letters describes the oldest-known fragmentary bat fossils from Asia, pushing back the evolutionary record for bats on that continent to the dawn of the Eocene and boosting the possibility that the bat family’s “mysterious” origins someday might be traced to Asia.
BioSpace
JULY 7, 2021
The two were charged with conspiracy to commit trade secret theft and wire fraud, international money laundering and obstruction of justice.
Scienmag
JULY 7, 2021
Johns Hopkins Medicine study uncovers enzyme inhibitor that boosts immune system to fight MRSA and other dangerous skin infections Credit: National Institute of Allergy and Infectious Diseases, National Institutes of Health FOR IMMEDIATE RELEASE In what turned out to be one of the most important accidents of all time, Scottish bacteriologist Alexander Fleming returned to […].
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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.
Pharma Times
JULY 7, 2021
New 'Life Sciences Vision' outlines seven critical healthcare missions
Scienmag
JULY 7, 2021
Seamounts offer clue to solving a tectonic puzzle Credit: Christine Chesley, using GeoMapApp and data from William Ryan et al., Geochemistry, Geophysics, Geosystems (2009) The Hikurangi Margin, located off the east coast of the North Island of New Zealand, is where the Pacific tectonic plate dives underneath the Australian tectonic plate, in what scientists call […].
BioSpace
JULY 7, 2021
Scorpion Therapeutics announced its new CEO Dr. Axel Hoos while Tenax Therapeutics named Christopher Giordano as its new chief executive.
Scienmag
JULY 7, 2021
Credit: Regenstrief Institute INDIANAPOLIS — The vast majority of electronic health record (EHR) alerts attempting to reduce the prescribing of high-risk medications linked to dementia in older adults went unread in a study led by research scientists from Regenstrief Institute, Purdue University and Indiana University School of Medicine. The goal of the intervention was to […].
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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
JULY 7, 2021
The vaccine demonstrated efficacy in mild, moderate, and severe COVID-19 of 77.8% with efficacy against severe disease of 93.4%.
Scienmag
JULY 7, 2021
Credit: Saint Louis University ST. LOUIS — In the United States, low-income and minority students are completing college at low rates compared to higher-income and majority peers — a detriment to reducing economic inequality. Double-dose algebra could be a solution, according to a new study published in roceedings of the National Academy of Sciences of […].
BioSpace
JULY 7, 2021
For the first time in an organ-on-a-chip model, the live SARS-CoV-2 virus has successfully infected and replicated in human tissue.
Scienmag
JULY 7, 2021
More than five million deaths a year can be attributed to abnormal hot and cold temperatures Credit: Monash University More than five million extra deaths a year can be attributed to abnormal hot and cold temperatures, according to a world first international study led by Monash University. The study found deaths related to hot temperatures […].
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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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