In the News: August 2021 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. In the News: August 2021 Regulatory and Development Updates.

Advancing from Research to Development: What Can Go Wrong?

Camargo

The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval. This blog post offers advice for avoiding major pitfalls during the drug development process.

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In the News: September 2021 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. Continued development of the use of complex innovative trial designs.

In the News: July 2021 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. In the News: July 2021 Regulatory and Development Updates.

In the News: June 2021 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 required reporting process is often a source of confusion for IND sponsors new to drug development.

In the News: March 2021 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. Fotivda was initially developed for first-line RCC.

Researchers develop 3D-printed jelly

Scienmag

Biology Biomedical/Environmental/Chemical Engineering Materials Research/Development Technology/Engineering/Computer Science

In the News: May 2021 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. In the News: May 2021 Regulatory and Development Updates.

FDA seeking more consistency from cell, gene therapy developers, top official says

Bio Pharma Dive

A number of drugmakers have recently faced development delays after the FDA's asked for more information on how they measure the potency of their products

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.

Gene therapy developer gets chance at a comeback with Pfizer deal

Bio Pharma Dive

Voyager Therapeutics recently scrapped much of its pipeline and replaced top executives. Now, a Pfizer deal on new technology gives investors hope

Jennifer Doudna-founded CRISPR biotech raises new cash to broaden drug development work

Bio Pharma Dive

Formed as a diagnostics developer, Mammoth Biosciences, which Doudna started with two of her former students at the University of California, has accelerated plans to make gene editing medicines as well

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

UCLA bioengineers develop new class of human-powered bioelectronics

Scienmag

Technology and Engineering bioelectronics bioengineers class develop humanpowered UCLAA team of bioengineers at the UCLA Samueli School of Engineering has invented a novel soft and flexible self-powered bioelectronic device.

In the News: April 2021 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. In the News: April 2021 Regulatory and Development Updates.

COVID-19 drug developer Adagio plans IPO to cap fast rise

Bio Pharma Dive

The offering is the latest step in the rapid emergence of Adagio, which raised nearly $400 million and brought a drug to pivotal testing in less than a year

Infants exposed to domestic violence have poorer cognitive development

Scienmag

Biology cognitive development domestic exposed infants poorer violenceCOLUMBIA, Mo. While assessing a pregnant woman with premature labor in 1983, Linda Bullock noticed bruises on the woman.

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

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.

Inflammasome develops combo HIV/birth control implant

Outsourcing Pharma

Clinical DevelopmentThanks in part to grants from the Gates Foundation, the company has come up with a bioerodible implant that combines HIV prevention and birth control.

Multidisciplinary Team Advances Immuno-Oncology Development

Camargo

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

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.

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.

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

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.

KIMM develops a flexible, stretchable battery capable of moving smoothly like snake scales

Scienmag

The Korea Institute of Machinery and Materials (KIMM), an institute under the jurisdiction of the Ministry of Science and ICT, has developed a flexible, stretchable battery that bends and stretches like a snake.

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

In the News: February 2021 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. In the News: March 2021 Regulatory and Development Updates.

Is your ML training set biased? How to develop new drugs based on merged datasets

Scienmag

Social & Behavioral Science based biased datasets develop Drugs merged set trainingCAMBRIDGE October 01 2021—Polymorphs are molecules that have different molecular packing arrangements despite identical chemical compositions.

In the News: December 2020 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. Camargo has extensive experience in the development and approval of drugs with a single pivotal study.

Chemist develops synthetic materials for energy-saving applications

Scienmag

Technology and Engineering applications chemist develops energysaving Materials SyntheticA chemist at The University of Texas at Arlington is working to create new synthetic materials that can improve on inorganic metal oxides for use in a variety of energy-saving applications.

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.

NIST, collaborators develop sensitive new way of detecting transistor defects

Scienmag

Social & Behavioral Science collaborators defects Detecting develop NIST sensitive transistor

International experts develop Clinical Care Pathway in response to NASH epidemic

Scienmag

Biology care clinical develop epidemic Experts international NASH pathway response

Third Rock-backed startup launches to develop cell therapies for MS, diabetes

Bio Pharma Dive

Led by CEO Samantha Singer, Abata Therapeutics has $95 million to advance its plans to engineer regulatory T cells for treating autoimmune diseases

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

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?

Vaccine development in the spotlight as WHO sets out roadmap to tackle meningitis

BioPharma Reporter

While several vaccines protect against meningitis, there remains an urgent need for innovation, funding and research to develop more meningitis-preventive vaccines, according to a new report from the WHO. Bio Developments

Drug development advancements call for skilled workforce

Outsourcing Pharma

Clinical DevelopmentAccording to a leader from Saama Technologies, keeping competitive in the face of technology evolution requires staff that can keep up with the changes.

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

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

Why do muffins rise in the oven? Researcher wins NSF award to develop phenomenon-based science courses for elementary teachers

Scienmag

Social & Behavioral Science award courses develop elementary muffins NSF oven phenomenonbased Researcher rise Science teachers wins

Researchers develop chip that improves testing and tracing for COVID-19

Scienmag

and West Virginia University, have developed a chip that provides a simpler and more rapid method of genome sequencing for viruses like COVID-19. […].