In the News: July Regulatory and Development Updates

Camargo

The post In the News: July Regulatory and Development Updates appeared first on Camargo. 505(b)(2) Development Blog DESI Drug Regulatory Strategy & SubmissionsEach month, Camargo’s “In the News” series will highlight important changes and advancements in the.

In the News: August Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explore how those changes could impact your program. Fitbit developing algorithm COVID-19 early detection.

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Multidisciplinary Team Advances Immuno-Oncology Development

Camargo

The post Multidisciplinary Team Advances Immuno-Oncology Development appeared first on Camargo. Case Studies

Multidisciplinary Team Advances Immuno-Oncology Development

Camargo

The post Multidisciplinary Team Advances Immuno-Oncology Development appeared first on Camargo. Blog Clinical Studies, Phases I-IV CMC Regulatory Strategy & Submissions Services

In the News: September Regulatory and Development Updates

Camargo

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. The post In the News: September Regulatory and Development Updates appeared first on Camargo.

Scientists develop detector for investigating the sun

Scienmag

Journal of Instrumentation Researchers from MIPT have developed a prototype detector of solar particles. Technology and Engineering Electromagnetics Research/Development Space/Planetary Science Stars/The SunCredit: Egor Stadnichuk et al./Journal

Groundbreaking research into solar energy technology develops through new EU-project

Scienmag

Now, an EU project led by Chalmers will develop prototypes of […].

Patient-Centered Drug Development for Oncology Products

Camargo

The post Patient-Centered Drug Development for Oncology Products appeared first on Camargo. Oncology patients face a difficult journey — a frightening diagnosis followed by intricate and oftentimes. Blog Commercialization Product Selection and Planning Regulatory Strategy & Submissions Therapeutic Areas

What to Expect from the FDA During COVID-19 Product Development

Camargo

The post What to Expect from the FDA During COVID-19 Product Development appeared first on Camargo. As the COVID-19 national emergency stretches on in the United States, the eyes of the. Blog Regulatory Strategy & Submissions

The future of vaccine development: 5 legacies from COVID-19

BioPharma Reporter

But what can the industry learn from these achievements to inform vaccine development in the future? Bio DevelopmentsThe progress in the race for a COVID-19 vaccine to date has been nothing short of phenomenal.

Single-Arm Trials Using Real-World Evidence for Rare Disease Product Development

Camargo

Similarly, in rare disease drug development, where a placebo control group may not be an option, a single-arm trial can be a successful approach. Natural history data becomes critical for product development when there is no concurrent control.

SUTD researchers develop simple method to 3D print milk products

Scienmag

Chemistry AND Physics Chemistry/Physics/Materials Sciences Health Care Materials Medicine/Health Nutrition/Nutrients Research/Development

Developing Drug Products with the Label’s Commercial Value in Mind

Camargo

The post Developing Drug Products with the Label’s Commercial Value in Mind appeared first on Camargo. Whether you plan to out-license or commercialize your product, getting the label right matters.

Scientists develop new precise therapeutic leukemia vaccine

Scienmag

Credit: WEI Wei Exploration of new leukemia antigens and construction of appropriate delivery systems using FDA-approved material are important strategies for developing leukemia vaccines for clinic use.

INRS researchers develop a new membraneless fuel cell

Scienmag

Chemistry AND Physics Algorithms/Models Biomechanics/Biophysics Chemistry/Physics/Materials Sciences Energy Sources Energy/Fuel (non-petroleum) Industrial Engineering/Chemistry Materials Nanotechnology/Micromachines Research/Development

Drug Development for an Aging Population

Camargo

The post Drug Development for an Aging Population appeared first on Camargo. Fueled by unprecedented medical, technological and social advancements of the past century, it should be. Blog Combination Products

Crowdfunding COVID-19 vaccine development

BioPharma Reporter

Axon Neuroscience is launching the world's first crowdfunding exercise for the development of a COVID-19 vaccine, following what it says are strong pre-clinical results.

Strategic interventions in dairy production in developing countries can help meet growing global demand for milk

Scienmag

Dairy production in developing countries highlighted in November issue of the Journal of Dairy Science® Credit: Adesogan, A.T. MILK Symposium Introduction: Dairy production in developing countries.

Cobra to supply plasmids to UK COVID-19 vaccine developer

BioPharma Reporter

Contract development and manufacturing organization (CDMO), Cobra Biologics, has been selected to manufacture plasmids for a Phase I clinical trial of a COVID-19 vaccine being developed by UK company, Scancell. Bio Developments

Collaborative VLP tech bolsters COVID-19 vaccine development

BioPharma Reporter

VLP platform using structural elements of coronavirus and modified surface spike molecules could be an âidealâ for COVID-19 vaccine development. Bio Developments

Roche Selects Veeva Development Cloud Applications

BioTech 365

–(BUSINESS WIRE)–#lifesciences—Veeva Systems (NYSE: VEEV) today announced that Roche (SWX: ROG) has selected Veeva Development Cloud applications globally to streamline clinical, regulatory, and quality processes.

Tandon Researchers develop method to create colloidal diamonds

Scienmag

The long-awaited photonic technique could change the way optical technologies are developed and used over the next decade BROOKLYN, New York, Wednesday, September 23, 2020 – The colloidal diamond has been a dream of researchers since the 1990s. Technology and Engineering Atomic/Molecular/Particle Physics Chemistry/Physics/Materials Sciences Computer Science Hardware Materials Molecular Physics Optics Research/Development Superconductors/Semiconductors Weaponry

Premier Research: holistic approach benefits drug development

Outsourcing Pharma

A leader from the CRO shares insights as to what strategies and philosophies work best when working to craft a successful drug development program.

Researchers Develop Potential Breakthrough in Type 1 Diabetes Treatment

BioSpace

Researchers from the Salk Institute took a major step forward in developing a new insulin-producing pancreatic cell cluster as a potential treatment for type 1 diabetes patients

NanoViricides Outlines Two-Pronged Approach to Developing COVID-19 Therapies

BioSpace

NanoViricides, based in Shelton, Connecticut, outlined its approach to developing therapies against COVID-19 at the LD 500 investor conference yesterday

Internet connectivity is oxygen for research and development work

Scienmag

– Fast and reliable internet access is fundamental for research and development activity around the world. But in developing nations, technological limitations can become stumbling blocks to efficient communication and cause significant disadvantages.

Scientists develop genetic ‘monitors’ that detect when genes are active

Scienmag

New genetic sensors, developed by scientists at University of Warwick and Keele University, could function as a lab test device and even as a live monitoring system inside living cells The innovative system can detect when a specific gene in a cell is active – instead of only detecting its presence The technology is based […].

Boost to develop microalgae into health foods

Scienmag

However, its widespread development has been hampered by the current limits of bioimaging tools needed to allow easy, rapid and non-invasive evaluation […]. Dietary supplementation of fatty acids produced from microalgae have wide-reaching health benefits for humans, including the ability to reduce obesity, diabetes and fatty liver disease, preventing hair loss, and assisting wounds to heal.

Development of cost-efficient electrocatalyst for hydrogen production

Scienmag

Development of a highly efficient and durable electrocatalyst for water electrolysis that will lead to cost-efficient hydrogen production.

Researchers develop new detection method to protect Army networks

Scienmag

Army researchers developed a novel algorithm to protect networks by allowing for the detection of adversarial actions that can be missed by current analytical methods. Technology and Engineering Computer Science Multimedia/Networking/Interface Design Research/Development Technology/Engineering/Computer ScienceThe main idea of this research is to build a higher-order network to look for subtle changes in a stream of data that could point to suspicious activity.

Avacta Appoints Therapeutics Chief Development Officer

BioTech 365

Dresden physicists develop printable organic transistors

Scienmag

Credit: Copyright: IAPP High-definition roll-up televisions or foldable smartphones may soon no longer be unaffordable luxury goods that can be admired at international electronics trade fairs.

A method has been developed to study extreme space weather events

Scienmag

Chemistry AND Physics Astrophysics Research/Development Space/Planetary Science Stars/The Sun

New public-private projects to speed fusion energy development come to PPPL

Scienmag

Chemistry AND Physics Chemistry/Physics/Materials Sciences Nuclear Physics Research/Development

#news #biotech Santhera ends development of idebenone

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Santhera ends development of idebenone. from European Biotechnology – first and foremost in European biotech [link].

Omeros’ OMS906 Data Presented at Complement-based Drug Development Summit

BioTech 365

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (Nasdaq: OMER) presented data from its OMS906 program yesterday at the 4th Complement-based Drug Development Summit.

Study identifies key enzyme for development of autoimmune diseases

Scienmag

An enzyme associated with energy production in cells also participates in the differentiation of immune cells involved in exacerbated inflammation. The discovery could lead to more effective treatment.

Scientist develops new way to test for COVID-19 antibodies

Scienmag

Credit: Seattle Children’s When Dr. Stephen Smith of Seattle Children’s Research Institute came down with muscle aches, gastrointestinal distress and a sudden loss of smell in late February, he suspected he had COVID-19.

Frankfurt Edition on COVID-19 Vaccine Development News – Daily Report – ResearchAndMarkets.com

BioTech 365

DUBLIN–(BUSINESS WIRE)–The “Daily Report: COVID-19 Vaccine Development News – Frankfurt Edition” report has been added to ResearchAndMarkets.com’s offering. This report offers, at Frankfurt 9am, daily updates for 20+ global news related to COVID-19 Vaccine Development, comprehensively tracked, compiled and curated … Continue reading → Business Wire

Merck KGaA, IAVI and Serum Institute link up to develop COVID-19 mAbs

Pharma Times

Agreement will see partners develop SARS-CoV-2 neutralising monoclonal antibodies