Merck stops coronavirus vaccine development in surprise setback

Bio Pharma Dive

The drugmaker, one of the largest vaccine developers globally, won't move forward with either of two candidates it's been testing after disappointing data in early trials

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.

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Vaccine Developers of the Year: BioNTech and Moderna

Bio Pharma Dive

Defying expectations, BioNTech and Moderna each designed and developed highly effective coronavirus shots far faster than previously considered possible

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.

Gilead partners with a cancer biotech, seeking to develop an HIV immunotherapy

Bio Pharma Dive

Gritstone Oncology, known for its cancer research, is drawing attention in infectious disease, signing a deal with Gilead two weeks after announcing plans to develop a coronavirus vaccine

Multidisciplinary Team Advances Immuno-Oncology Development

Camargo

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

Analytical quality by design: Development of cell-based bioassays

Bio Pharma Dive

Care needs to be taken during analytical development to ensure methodologies firstly, reflect the MoA, and are also reproducible, accurate, and robust

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

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.

Novartis, Molecular Partners partner to develop a scalable COVID-19 drug

Bio Pharma Dive

The two Swiss firms will develop protein drugs that are meant to have similar effects as coronavirus antibodies, but would be easier to mass produce

New Corona test developed

Scienmag

Researchers develop a low-cost and fast method to detect a COVID-19 infection from a pool of gargle lavage samples Credit: MPI f.

UMass Amherst joins partnership to develop sustainable food products

Scienmag

Technology and Engineering Chemistry/Physics/Materials Sciences Diet/Body Weight Food/Food Science Grants/Funding Medicine/Health Nanotechnology/Micromachines Nutrition/Nutrients Public Health Research/Development Technology/Engineering/Computer Science

In the News: October 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: October Regulatory and Development Updates appeared first on Camargo.

COVID-19 vaccines: The latest developments

BioPharma Reporter

Get up to speed with the latest developments in COVID-19 vaccines here. Bio DevelopmentsTook a break over Christmas and New Year?

In the News: November Regulatory and Development Updates

Camargo

Camargo can help you to develop the right pricing and access strategy for your product; contact us for more information. The post In the News: November Regulatory and Development Updates appeared first on Camargo. Remote Document Review Leads to CRL: Be Careful What You Wish for?

Using mRNA technology to develop vaccines for HIV and beyond

BioPharma Reporter

ConserV Bioscience and eTheRNA immunotherapies are to collaborate on development of mRNA vaccines for infectious diseases. Bio Developments

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.

Navigating the challenges of proper fill and finish in clinical development

Bio Pharma Dive

Given all the uncertainties of fill and finish in clinical development, one thing is certain – there is little room for failure, and rarely a second chance

Bayer partners with CureVac on coronavirus vaccine development

Bio Pharma Dive

The German companies will work together to push a shot using similar technology as Moderna's and BioNTech's over the finish line

Researchers develop roadside barrier design to mitigate air pollution

Scienmag

Technology and Engineering Biology Biomedical/Environmental/Chemical Engineering Climate Change Climate Science Environmental Health Pollution/Remediation Research/Development

Balancing climate and development goals

Scienmag

Delaying less developed countries’ efforts to reduce carbon emissions would have a minimal impact on global temperature change That is the key finding in a new study published today in Environmental Research Letters by scientists from the Carnegie Institution for Science, USA and the University of Waterloo, Canada. Atmospheric Science Climate Change Climate Science Developing Countries Earth Science Poverty/Wealth

GSK returns to Vir with expanded deal to develop drugs for flu, other viruses

Bio Pharma Dive

The British drugmaker will pay the San Francisco-based biotech $225 million upfront, while also investing another $120 million in Vir shares

Gilead, Galapagos halt development of experimental drug, denting research alliance

Bio Pharma Dive

Independent reviewers found the benefits of the lung disease drug didn't outweigh its risks, marking a second major setback in six months for the companies' partnership

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

Moderna developing COVID-19 vaccine booster shot against South Africa variant

BioPharma Reporter

But it does suggest reduced protection against the South Africa strain, and so the company is also developing a new booster designed for maximum efficacy against this variant. Bio Developments

Sensing robot healthcare helpers being developed at SFU

Scienmag

The current pandemic highlights how remote healthcare robots currently being developed at SFU could be beneficial in the future Credit: Simon Fraser University Robots that could take on basic healthcare tasks to support the work of doctors and nurses may be the way of the future.

French bank and angel investors back ‘smart chemotherapy’ drug developer

BioPharma Reporter

Seekyo, a startup biotechnology company specializing in the development of âsmart chemotherapyâ drugs that limit harmful side effects, has raised in excess of â650,000 (US$775K) in bridge funding. Bio Developments

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.

Danish computer scientist has developed a superb algorithm for findin

Scienmag

Technology and Engineering Algorithms/Models Calculations/Problem-Solving Computer Science Mathematics/Statistics Research/Development Robotry/Artificial Intelligence Software Engineering Technology/Engineering/Computer Science Theory/Design

Scientists developed a safe and cheap technology of disinfection of the packed eggs

Scienmag

Russian researchers have developed an inexpensive, safe, and reliable packed eggs surface disinfection technology. It allows to kill bacteria and to raise healthy chickens with less dose of antibiotics Credit: UrFU / Ilya Safarov.

Petroleum engineers of Samara Polytech developed a unique test facility

Scienmag

It is designed to simulate reservoir conditions Credit: @SamaraPolytech The original facility developed at Samara Polytech will help to explore the earth’s interior.

Merck exits COVID-19 vaccine development, cites disappointing data

BioPharma Reporter

Bio DevelopmentsMerck is shutting down the programs linked to its two COVID-19 vaccine candidates following early trial data indicating that they failed to generate immune responses comparable to a natural infection or existing vaccines.

Novel thermometer can accelerate quantum computer development

Scienmag

Researchers at Chalmers University of Technology, Gothenburg, Sweden, have developed a novel type of thermometer that can simply and quickly measure temperatures during quantum calculations with extremely high accuracy.

Half of global wastewater treated, rates in developing countries still lagging

Scienmag

Despite this promising finding, the authors warn that treatment rates in developing countries are still very low. Chemistry AND Physics Developing Countries Disease in the Developing World Earth Science Energy Sources Geography Hydrology/Water Resources

A Timeline of COVID-19 Vaccine Development

BioSpace

Vaccine development is an arduous process, taking about 10-15 years on average to accomplish. But with the imminent worries surrounding the COVID-19 pandemic putting unprecedented pressure on our healthcare systems and economies, unprecedented measures needed to be put in place

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

Novavax expands campus to support vaccine development

BioPharma Reporter

Novavax is expanding its Maryland campus to support the companyâs growth and the development of a COVID-19 vaccine. Bio Developments

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.

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 for its candidate.

Ajinomoto and Bright Peak partner to develop immunocytokines

BioPharma Reporter

have entered into a research collaboration and license agreement to develop immunocytokines. Bio DevelopmentsAjinomoto Co., Inc, and Bright Peak Therapeutics Inc.

Mitochondria-Targeted Drug Development Digital Summit

Pharma Phorum

The Mitochondria-Targeted Drug Development Digital Summit (April 27-29) is the only industry-led meeting focused on end-to-end mitochondria-targeting. Larimar Therapeutics examining CTI-1601 as a potential protein replacement therapy under development for Friedreich’s Ataxia.

Navigating the Global NHP Shortage: How to Keep Your Development Program on Track

Camargo

Safety studies in animals are an integral piece of the development and eventual approval of news drugs, as they are required by all regulatory agencies around the world. The post Navigating the Global NHP Shortage: How to Keep Your Development Program on Track appeared first on Camargo.

A big week for mRNA COVID-19 vaccines: Five key developments

BioPharma Reporter

Here's five key takeaways from this week's developments. Bio DevelopmentsItâs been a big week for mRNA-based COVID-19 vaccines: with both Pfizer/BioNTech and Moderna reporting impressive efficacy for their COVID-19 vaccine candidates.