Bio Pharma Dive
FEBRUARY 4, 2022
Gene therapy developers have struggled to secure reimbursement in Europe, making Orchard's deal with the National Health Service in England and Wales a notable accomplishment.
Pharma Mirror
FEBRUARY 4, 2022
Rockville, Emmes, a global, full-service Clinical Research Organization dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced its role as a Data Coordinating Center on a team whose work has accelerated pediatric COVID-19 research through the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02).
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Bio Pharma Dive
FEBRUARY 4, 2022
In a regulatory filing, Biogen said the FTC and the SEC are looking for information about Aduhelm's approval and marketing, meaning the drug is now the focus of four government probes.
Scienmag
FEBRUARY 4, 2022
Even the finest particles of pollution influence the process of cloud formation and the rainfall regime. A study conducted in Manaus, the capital of Amazonas state in Brazil’s North region, shows that oxidation leads small aerosols expelled by factories and car exhausts, for example, to grow very rapidly, reaching up to 400 times their original […].
NY Times
FEBRUARY 4, 2022
Tower Health Medical Group said in a statement that it learned of the allegations on Wednesday. After an investigation, the doctor’s employment was “terminated effective immediately.”.
pharmaphorum
FEBRUARY 4, 2022
The approval of Novavax’ COVID-19 vaccine in Great Britain could help the country save a “considerable amount of money” if it is used in future booster campaigns, according to the former chair of UK Vaccine Taskforce. Dr Clive Dix said that Nuvaxovid has excellent clinical data and – as a it has good stability at fridge temperatures – could be easily rolled out with the flu vaccine next winter, and should “replace the need to buy more Pfizer and Moderna vaccine.” Nu
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
FEBRUARY 4, 2022
Eli Lilly has backed away from plans to file Alzheimer’s drug donanemab in the first quarter of this year, saying the proposal to limit reimbursement of Biogen’s first-to-market Aduhelm has made going down the accelerated approval route all-but pointless. The company has planned to filed for speedy approval of donanemab based on the results of its TRAILBLZAR-ALZ study, in the hope of being allowed by the FDA to make the drug available to patients while its confirmatory TRAILBLAZER-AZ
Pharma Times
FEBRUARY 4, 2022
Pharma giant Sanofi continues to modernise with branding which reflects its commitment to social responsibility and sustainability
Scienmag
FEBRUARY 4, 2022
Wetland plants have a high tolerance against flooding due to the formation of “lysigenous aerenchyma,” air channels that help transfer gases to the submerged roots. These channels also help the plant withstand drought and nutrient deficiency. Now, scientists from Japan investigate the underlying mechanism of aerenchyma formation to understand the phenomenon better, opening doors to […].
Drug Channels
FEBRUARY 4, 2022
Today’s guest post comes from Jeff Berkowitz, CEO of advisory firm Real Endpoints. Jeff describes problems with Medicare copays that reduce adherence and persistence among seniors. He then describes RE Assist , Real Endpoints’ tech-enabled solution with key information on foundations for more than 30 diseases. To learn more about Medicare copayments and how the RE Assist solution helps patients, register to view Real Endpoints’ free webcast: Solving the Medicare Co-pay Dilemma.
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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
FEBRUARY 4, 2022
East Hanover, NJ. February 3, 2021. Seeking ways to improve outcomes of stroke rehabilitation, researchers from Kessler Foundation explored available evidence for the neural mechanisms of prism adaptation therapy, an intervention with efficacy for the treatment of spatial neglect. They analyzed published fMRI studies conducted in healthy individuals and stroke survivors with spatial neglect.
Pharma Times
FEBRUARY 4, 2022
Health and social care secretary will declare war on cancer with a decade-long plan to combat disease misery
Scienmag
FEBRUARY 4, 2022
Blacklists are one of the most common policy measures to limit biological invasions. They identify small groups of highly impactful invasive alien species: species introduced outside their native range that threaten biodiversity. By doing so, they inform key decision-makers, who then impose limitations or bans on their trade and introduction, or set requirements about specific […].
pharmaphorum
FEBRUARY 4, 2022
Last year, Bayer launched a project to explore the use of artificial intelligence in clinical trials, working with Finland’s Aalto University to find ways to use the technology to support decentralised trials and streamline the testing process. Now, an extension of the work is starting that will see if AI can be used to reduce or remove the need for a control group in some clinical trials , for example in rare diseases where there may be ethical issues in giving an inactive treatment.
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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
Scienmag
FEBRUARY 4, 2022
The deep-ocean floor is the least explored ecosystem on the planet, despite covering more than 60% of the Earth surface. Largely unknown life in abyssal sediments, from benthic animals to microbes, helps to recycle and/or sequester the sinking (in)organic matter originating from pelagic communities that are numerically dominated by microscopic plankton.
Pharma Tutor
FEBRUARY 4, 2022
Pharmacy Bill: a Kaleidoscope. Dr. R. S. Thakur. Chief Editor, Journal of Pharmaceutical Research. Krupanidhi College of Pharmacy, Bengaluru-560035. Email: drramsthakur@gmail.com. . admin. Fri, 02/04/2022 - 14:11. Tags. Articles.
Scienmag
FEBRUARY 4, 2022
“Sunset clauses” should be introduced into relevant legislation to limit the use of coronavirus certificates to just the current pandemic and not beyond, a study warns. Legislation should set a clear expiry date for the passes to prevent the normalisation of the current level of interference with individuals’ privacy, and to stop the technical infrastructure […].
Drug Patent Watch
FEBRUARY 4, 2022
Annual Drug Patent Expirations for VASCEPA Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. It is available from two suppliers. There are sixty-six patents…. The post New patent for Amarin Pharms drug VASCEPA 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
FEBRUARY 4, 2022
More than two billion people face severe water shortages and a similar number have been affected by flooding over the past 20 years, with these challenges expected to rise in coming years due to climate change, growing populations and increased economic activity. Therefore, a global initiative led by the World Meteorological Organization (WMO) and coordinated […].
pharmaphorum
FEBRUARY 4, 2022
Belgian drugmaker UCB says it will be able to file not one but two new drug therapies for autoimmune disease generalised myasthenia gravis (gMG) this year, after its C5 inhibitor zilucoplan hit the mark in a phase 3 trial. Zilucoplan achieved a significant improvement in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score compared to placebo at week 12 in the RAISE trial, which UCB said was a “clinically meaningful” result.
Scienmag
FEBRUARY 4, 2022
TAMPA, Fla. (Feb. 4, 2022) — The University of South Florida recently received a highly competitive National Institutes of Health (NIH) Institutional Training Grant (Award Number T32HL160529), boosting the USF Health Morsani College of Medicine’s (MCOM) capacity to prepare the next generation of scientists in an emerging area of research applicable to many major diseases. […].
Drug Discovery Today
FEBRUARY 4, 2022
• Face-to-face event, taking place in London, UK, 26-27th April, will feature two dedicated tracks: ‘Scientific’, focused on seven core therapy areas and ‘Life Sciences Business’ Programme features keynote from George Freeman MP, with an update on the UK Government Life Sciences VisionRegistration for BioTrinity 2022 now available online
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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
FEBRUARY 4, 2022
Despite broad support in the United States for reshaping policing, movements to “defund” or “abolish” police departments generate strong public opposition. The resistance is largely due to discomfort with the movements’ policy goals, not their slogans or negative beliefs about the activists associated with them, according to a new study co-authored by Yale political scientist […].
BioTech 365
FEBRUARY 4, 2022
Vigil Health Announces Interim Order for Acquisition by ASSA ABLOY Vigil Health Announces Interim Order for Acquisition by ASSA ABLOY VICTORIA, British Columbia, Feb. 04, 2022 (GLOBE NEWSWIRE) — Vigil Health Solutions Inc.
Scienmag
FEBRUARY 4, 2022
Brianna Rick, a doctoral student in the Department of Geosciences at Colorado State University, has been conducting research in Alaska for several years. She’s developed an interest in studying glacial lakes, bodies of water that form near glaciers, which can impact glacier behavior and drain catastrophically. Credit: Brianna Rick, Colorado State University Brianna Rick, a […].
BioTech 365
FEBRUARY 4, 2022
Calidi Biotherapeutics Announces Appointment of Alfonso “Chito” Zulueta, Former President of International for Eli Lilly, to Its Board of Directors Calidi Biotherapeutics Announces Appointment of Alfonso “Chito” Zulueta, Former President of International for Eli Lilly, to Its Board of Directors … Continue reading →
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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
FEBRUARY 4, 2022
PHILADELPHIA — (Feb. 4, 2022) — Nearly four decades after its discovery, HIV has killed 36.3 million people, with no vaccine in sight. However, a new study by researchers at The Wistar Institute, an international biomedical research leader in cancer, immunology, infectious disease, and vaccine development, takes a promising step in the direction of developing […].
BioTech 365
FEBRUARY 4, 2022
Nyxoah to Present at BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference Nyxoah to Present at BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference Nyxoah to Present at BTIG MedTech, Digital Health, Life Science & Diagnostic … Continue reading →
Scienmag
FEBRUARY 4, 2022
“The long divided, must unite; long united, must divide. Thus it has ever been.” Credit: UNSW “The long divided, must unite; long united, must divide. Thus it has ever been.” The opening lines of the great Chinese historical novel Romance of the Three Kingdoms condense its complex and spectacular stories into a coherent pattern, that is, power […].
BioTech 365
FEBRUARY 4, 2022
FDA approves Enjaymo™ (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease FDA approves Enjaymo™ (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease FDA approves Enjaymo™ (sutimlimab-jome), first treatment for use in patients with cold … Continue reading →
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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.
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