Bio Pharma Dive
MAY 2, 2022
The partners increased the size and length of a large, ongoing study in transthyretin amyloidosis cardiomyopathy, a decision that has implications Alnylam Pharmaceuticals, which is testing two of its drugs against the disease.
Drug Patent Watch
MAY 2, 2022
DrugPatentWatch has been named to Genetic Engineering News‘ Best of the Web list. The review by Genetic Engineering News profile highlighted the “new training modules designed to help you find…. The post DrugPatentWatch named “Best of the Web” by Genetic Engineering News appeared first on DrugPatentWatch - Make Better Decisions.
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Bio Pharma Dive
MAY 2, 2022
The regulator determined Vertex had "insufficient information" to test higher doses of the therapy, which showed promise in the first two patients treated.
Intouch Solutions
MAY 2, 2022
We’ve been thrilled to unveil a newly focused and funded project to Intouchers during Global Volunteer Month, and we’d love to tell you about it too. The Give Back is Intouch’s approach to – well – giving back. It’s a bigger, better philanthropy program than we’ve ever had before, supporting our efforts to make the world a better place, including the fight to overcome healthcare inequities and support social-justice initiatives.
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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 2, 2022
Real-world data (RWD) and real-world evidence (RWE) are valuable across the entire pharmaceutical product lifecycle, from examining patient outcomes to supporting disease education and awareness and beyond.
XTalks
MAY 2, 2022
Lecanemab, the product of Phase IIb clinical research completed by BioArctic and collaborator Eisai, is one therapy making strides this year for Alzheimer’s disease. Alzheimer’s disease (AD) is a progressive neurodegenerative disease, with the most recognizable and common symptom of AD being amnesia-like cognitive impairment, such as short-term memory loss.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
MAY 2, 2022
Mycovia Pharmaceuticals received approval from the US Food and Drug Administration (FDA) for Vivjoa (oteseconazole) for the treatment of recurrent vulvovaginal candidiasis (RVVC) or chronic yeast infection for permanently infertile or postmenopausal women. This is the very first approval for a medication for the chronic version of VVC. The approval is a significant breakthrough for RVVC as it is a condition with significant unmet need.
Bio Pharma Dive
MAY 2, 2022
As scientific discussions increase online, Medical Affairs teams need ways to listen to conversations.
Scienmag
MAY 2, 2022
EMBARGOED: THIS ARTICLE IS EMBARGOED UNTIL MONDAY, MAY 2, 3:00 PM, US EST Credit: Greg Asner, Center for Global Discovery and Conservation Science EMBARGOED: THIS ARTICLE IS EMBARGOED UNTIL MONDAY, MAY 2, 3:00 PM, US EST As the world sees rising ocean temperatures, it will also see more cases of coral bleaching. When corals bleach, […].
BioPharma Reporter
MAY 2, 2022
AstraZeneca is building a new HQ for Alexion in Kendall Square, Cambridge, Massachusetts, a life sciences hub.
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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 2, 2022
A University of Minnesota Twin Cities research team has developed a new microfluidic chip for diagnosing diseases that uses a minimal number of components and can be powered wirelessly by a smartphone. The innovation opens the door for faster and more affordable at-home medical testing. Credit: Laboratory of Nanostructures and Biosensing, University of Minnesota A […].
Intouch Solutions
MAY 2, 2022
We’ve been thrilled to unveil a newly focused and funded project to Intouchers during Global Volunteer Month, and we’d love to tell you about it too. The Give Back is Intouch’s approach to – well – giving back. It’s a bigger, better philanthropy program than we’ve ever had before, supporting our efforts to make the world a better place, including the fight to overcome healthcare inequities and support social-justice initiatives.
Scienmag
MAY 2, 2022
In the time since the first exoplanet was discovered in 1992, astronomers have detected more than 5,000 planets orbiting other stars. But when astronomers detect a new exoplanet, we don’t learn a lot about it: we know that it exists and a few features about it but the rest is a mystery. Credit: Alexander Madurowicz […].
The Pharma Data
MAY 2, 2022
The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD).
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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 2, 2022
Dartmouth has announced that the inaugural McGuire Family Prize for Societal Impact will be presented to Jason McLellan, a structural biologist whose groundbreaking coronavirus research conducted at the Geisel School of Medicine laid the foundation for COVID-19 vaccines that have saved countless lives. Credit: Vivian Abagiu / The University of Texas at Austin.
The Pharma Data
MAY 2, 2022
Teva Branded Pharmaceutical Products R&D, Inc. and Auspex Pharmaceuticals, Inc., U.S. affiliates of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), have reached an agreement with Lupin to resolve the dispute over Lupin’s Abbreviated New Drug Application (“ANDA”) for a generic deutetrabenazine product. Teva and Lupin have been involved in a patent infringement litigation in which Teva asserted a number of patents against Lupin that cover Teva’s AUSTEDO (deutetrabenazine) prod
Scienmag
MAY 2, 2022
Lips are famously sensual but, together with the gums and tongue, they are also surprisingly sensitive, second only to the fingertips in nerve density. Researchers at Carnegie Mellon University have exploited this latter characteristic to devise a practical new way for people to receive tactile feedback in virtual worlds. Credit: Carnegie Mellon University Lips are […].
The Pharma Data
MAY 2, 2022
– Gilead to License Exclusive Worldwide Rights to the Investigational Candidate DF7001, a 5T4-Targeting NK Cell Engager for Solid Tumors –. – Gilead to Have Options to License Several Additional NK Cell Engager Programs –. Gilead Sciences, Inc. (Nasdaq: GILD) and Dragonfly Therapeutics today announced a collaboration designed to advance a number of Dragonfly’s novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation indications.
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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 2, 2022
A cross-disciplinary UIUC team has demonstrated a major breakthrough in using automated synthesis to discover new molecules for organic electronics applications. Credit: University of Illinois Urbana-Champaign A cross-disciplinary UIUC team has demonstrated a major breakthrough in using automated synthesis to discover new molecules for organic electronics applications.
FDA Law Blog
MAY 2, 2022
By Larry K. Houck — Last week, Attorney General Merrick Garland reiterated the position expressed during his confirmation hearing that enforcement of marijuana cases in states where activities are legal is an inefficient use of Department of Justice (“DOJ”) resources. Responding to Senator Brian Schatz (D-Hawaii) during a Senate Appropriations subcommittee hearing on whether Garland intended to reinstate guidance to U.S.
Scienmag
MAY 2, 2022
Carbon dots (CDs) are a kind of zero-dimensional carbonaceous nanomaterial. Due to their ultra-small size (usually less than 10 nm), simple synthesis, low toxicity, well-documented biocompatibility, and outstanding luminescent properties, CDs have attracted wild applications, particularly in bioimaging and biomedical fields. Until now, efficient blue and green emissions with photoluminescence quantum yield (PLQY) higher than […].
Roots Analysis
MAY 2, 2022
In the past few years, plants have been gaining a rapid traction, involving genetic modification and expression of new genes in plant host cells. Owing to significant advantages over conventional expression systems, such as low production costs, product safety, and ease of scaling up, plants are being widely recognized as a potential platform for the development and manufacturing of wide range of biopharmaceuticals.
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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 2, 2022
Credit: Dr. Omri Bronstein. According to the researchers, the findings show that sea urchins appeared on Earth long (about 50 million years) before the date generally accepted by scientists The study points to a variety of species that survived the mass extinction event that occurred about 250 million years ago (long before the […].
Pharma Marketing Network
MAY 2, 2022
Tune in and watch the Pharma Marketing network and industry experts from Otsuka, Biogen, Janssen Pharmaceuticals, and more during part 2 of a 2-part series on engagement. This PMN DTC Engagement Summit focused on DTC engagement throughout the following panels: Marketing at the Speed of Digital: Patient Engagement. Effective Use of Data in DTC Marketing.
Scienmag
MAY 2, 2022
SAN ANTONIO — May 2, 2022 — Southwest Research Institute has developed technology to help government and industry detect cyber threats to industrial networks used in critical infrastructure and manufacturing systems. SwRI funded the research to address emerging cyber threats in the rapidly evolving ecosystem for industrial automation. The team used algorithms to scan for cyber […].
NY Times
MAY 2, 2022
Five men scheduled for execution this year were granted temporary reprieves while the state investigates why the drugs had not been tested for toxins.
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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 2, 2022
Is it possible to predict which consumers are in the risk zone for being misled by individuals who promote “financial b t”? Yes, according to researchers at Linköping University (LiU). And the answer is: young men with relatively high incomes who overestimate their financial expertise. Credit: Thor Balkhed Is it possible to predict which consumers are […].
Outsourcing Pharma
MAY 2, 2022
A leader from the life-science organization discusses how collaboration could lead to a broad range of benefits for everyone along the drug discovery pipeline.
Scienmag
MAY 2, 2022
Milan, 2 May 2022 – Online misinformation has negatively impacted the US COVID-19 vaccination campaign. This emerges from a study by Francesco Pierri, researcher at the Politecnico di Milano, in collaboration with Indiana University as part of the H2020 Periscope project, published in Nature Scientific Reports. Credit: Politecnico di Milano Milan, 2 May 2022 – […].
NY Times
MAY 2, 2022
His company, Emergent BioSolutions, won a lucrative contract to produce Covid vaccines but then had to throw out millions of contaminated doses.
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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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