Bio Pharma Dive
JUNE 7, 2021
With the decision, the agency cleared the way for what many predict will become a lucrative and highly sought-after option — though fierce debate continues over whether the medicine, Biogen's aducanumab, actually benefits patients' daily lives.
pharmaphorum
JUNE 7, 2021
Researchers in the US have developed a wearable fabric that can sense, store and analyse data that could be used to measure physiological functions or detect illness. The team from Massachusetts Institute of Technology (MIT) claim this is the first example of a fabric which can record data in a digital rather than in an analogue format, allowing it to be programmed like any other digital device.
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Bio Pharma Dive
JUNE 7, 2021
The identification of these novel clinical biomarkers allows researchers to better understand complex mechanisms of immune response to diseases, facilitating the development of more effective therapeutics.
BioSpace
JUNE 7, 2021
The first human case of a new strain of avian flu was diagnosed in China in late May. Chinese health authorities say there is a low risk of contagion. After China notoriously underreported COVID-19 mortality, can this new assurance be trusted?
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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
JUNE 7, 2021
Wegovy, a weekly drug, joins daily Saxenda in the pharma's portfolio, which could soon be under pressure from an experimental Lilly medicine.
BioPharma Reporter
JUNE 7, 2021
The virtual clinical development firmâs analysis of patient profiles reflects obesity is the most significant indicator for severity in those under 40.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JUNE 7, 2021
Novartis’ Kymriah has had the CAR-T therapy market for acute lymphoblastic leukaemia (ALL) to itself so far, but Gilead Sciences’ Kite subsidiary is now looming in the rear view mirror – armed with new data for its already-filed rival Tecartus. Results of the phase 1/2 ZUMA-3 trial of Tecartus (brexucabtagene autoleucel) reported at the ongoing ASCO conference revealed a 71% complete response rate with the CAR-T in heavily pre-treated adult patients with B-cell precursor ALL.
Bio Pharma Dive
JUNE 7, 2021
IQVIA experts weigh in on the importance of an omnichannel approach.
BioSpace
JUNE 7, 2021
BioSpace recently interviewed Elizabeth Elting, founder and CEO of the Elizabeth Elting Foundation, to discuss her thoughts on how the pandemic has affected women in the workforce.
Bio Pharma Dive
JUNE 7, 2021
An investigation by the company determined the treatment was "very unlikely" to be the cause of a case of leukemia reported in one of the trials.
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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
Drug Patent Watch
JUNE 7, 2021
Annual Drug Patent Expirations for TOVIAZ Toviaz is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are four patents protecting…. The post New patent for Pfizer drug TOVIAZ appeared first on DrugPatentWatch - Make Better Decisions.
BioPharma Reporter
JUNE 7, 2021
The US Food and Drug Administration (FDA) has approved Biogenâs Aduhelm (aducanumab) for the treatment of Alzheimerâs: making it the first new treatment approved for the disease since 2003.
Drug Patent Watch
JUNE 7, 2021
Annual Drug Patent Expirations for BRUKINSA Brukinsa is a drug marketed by Beigene and is included in one NDA. There is one patent protecting this drug. This drug has twenty-three…. The post New patent for Beigene drug BRUKINSA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 7, 2021
Credit: Photo by Fred Zwicky CHAMPAIGN, Ill. — A new book written and illustrated by two recent alumnae of the University of Illinois Urbana-Champaign introduces third graders to the nuts and bolts of automotive mechanics and engineering. “Jenny Saves a Convertible” is the first book written and illustrated by U. of I. students to be […].
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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
JUNE 7, 2021
Despite controversy over the drug’s effectiveness, it appears to have spiked interest in investing in Alzheimer’s drug companies, something that had been on the decline for several years.
BioPharma Reporter
JUNE 7, 2021
Moderna has applied to expand use of its COVID-19 vaccine to adolescents in the EU: and also plans to submit an application for emergency use authorization (EUA) for this age group in the US.
BioSpace
JUNE 7, 2021
Not everyone is so confident that Aduhelm will transform the Alzheimer’s drug development landscape.
pharmaphorum
JUNE 7, 2021
The ways in which HCPs prefer to engage with pharma has been changing for quite some time, and the digital transformation brought by COVID has dramatically accelerated that. In a recent pharmaphorum webinar, in partnership with Axtria , commercialisation experts from across the industry discussed how the right field force training and execution in combination with the appropriate technology can help to transform this engagement model.
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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
JUNE 7, 2021
The tool developed by On Target boosts the ability of surgeons to find and remove cancerous lesions during surgical procedures, increasing progression free and overall survival.
Scienmag
JUNE 7, 2021
Credit: Toshiba Corporation Cambridge, UK, 7th June 2021: The Cambridge Research Laboratory of Toshiba Europe today announced the first demonstration of quantum communications over optical fibres exceeding 600 km in length. The breakthrough will enable long distance quantum-secured information transfer between metropolitan areas and is a major advance towards building the future Quantum Internet.
BioSpace
JUNE 7, 2021
The findings also highlight additional mechanistic, drug product stability, pharmacokinetics and toxicology studies that support the candidate as a potential HIV prevention and treatment.
NY Times
JUNE 7, 2021
Aducanumab is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some prominent experts say there’s not enough evidence it can address cognitive symptoms.
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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.
BioSpace
JUNE 7, 2021
It's important to understand that as someone in the meeting, there are things you can do personally to become a more effective contributor. Here are four tips for being more productive in meetings.
Drug Patent Watch
JUNE 7, 2021
Annual Drug Patent Expirations for CYCLOSET Cycloset is a drug marketed by Veroscience and is included in one NDA. It is available from one supplier. There are fifteen patents protecting…. The post New patent for Veroscience drug CYCLOSET appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 7, 2021
Credit: ETH Zurich Many modern fitness trackers and smartwatches feature integrated LEDs. The green light emitted, whether continuous or pulsed, penetrates the skin and can be used to measure the wearer’s heart rate during physical activity or while at rest. These watches have become extremely popular. A team of ETH researchers now wants to capitalise […].
Pharma Times
JUNE 7, 2021
Iksuda will use the funds to support the progression of IKS03 into first-in-human Phase I clinical trials
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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
JUNE 7, 2021
To feed the growing population, researchers urge attention to essential vitamins and minerals Credit: Nick Smith, Riddet Institute Rockville, Maryland (June 7, 2021) — Reducing food waste is crucial to our ability to feed the growing human population but will not fully solve the problem alone, according to a new study based on a computational […].
Outsourcing Pharma
JUNE 7, 2021
The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.
Scienmag
JUNE 7, 2021
Credit: Oak Ridge National Laboratory/U.S. Dept. of Energy Six science and technology innovators from across the United States will join the fifth cohort of Oak Ridge National Laboratory’s Innovation Crossroads program in June. As the Southeast’s only research and development program for entrepreneurs based at a U.S. Department of Energy national laboratory, Innovation Crossroads provides […].
NY Times
JUNE 7, 2021
Aducanumab, or Aduhelm, is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some experts say there’s not enough evidence it can address cognitive symptoms.
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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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