In the News: November 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. 505(b)(2) Development Blog In the News Pediatrics Regulatory Strategy & Submissions

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.

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Supporting multi-audience communication in all stages of drug development

Bio Pharma Dive

Biopharmaceutical companies have ongoing and extensive needs for print and digital communications throughout the drug development life cycle that can benefit from a single-source vendor

UCLA researchers develop novel microscopic picoshell particles

Scienmag

Biology develop microscopic particles picoshell researchers UCLAProduction of high-energy fats by microalgae may provide a sustainable, renewable energy source that can help tackle climate change.

Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

Modular super-enhancer controls retinal development

Scienmag

Jude Children’s Research Hospital studied the Vsx2 super-enhancer and its role in the development of the retina. Chemistry AND Physics controls development Modular retinal superenhancerEnhancers are regions of DNA that do not code for proteins, but control how genes are expressed.

DNA 83

Amgen partners with Arrakis to develop drugs aimed at RNA

Bio Pharma Dive

Arrakis, a specialist in designing oral drugs that target RNA, will receive $75 million under the deal, which could be worth "several billion dollars" more

RNA 219

PDUFA VII: Implications for Developers of Cell and Gene Therapies

Camargo

One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA).

Book examines the future of executive development

Scienmag

Toronto – Executive development programs have entered a period of rapid transformation, driven by digital disruption and a widening gap between the skills that participants and their organizations demand and those provided by their executive programs.

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: 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.

Developing bioactive coatings for better orthopaedic implants

Scienmag

Biology bioactive coatings developing implants orthopaedicMontréal and Varennes, December 22, 2021 – Bioactive coatings play a vital role in the success of implants such as those for knees or hips, because their properties induce a biological response that is good for the health.

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

Researchers develop 3D-printed jelly

Scienmag

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

Bias in artificial intelligence impacts drug development: AiCure

Outsourcing Pharma

According to an expert from the clinical insights company, prejudice in AI can impact patient outcomes as well as the ability to develop effective treatments. Clinical Development

Mutant stem cells defy rules of development

Scienmag

Biology cells defy development mutant rules StemSAN FRANCISCO, CA—January 26, 2022—Imagine you’re baking a cake, but you run out of salt.

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: 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.

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.

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.

Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available.

Researchers deliver road map of lung development

Scienmag

Researchers have compiled the most comprehensive road map of the protein composition of human lungs, providing a clearer picture of the healthy development of this essential organ that made terrestrial life possible. Medicine & Health deliver development lung map researchers road

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available.

Lightweight space robot with precise control developed

Scienmag

Latest News control developed Lightweight Precise robot spaceCredit: Space?Science Science & Technology Robots are already in space.

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.

Racialized women frequently excluded from developing medical guidance: Study

Scienmag

Social & Behavioral Science developing excluded frequently Guidance medical Racialized study women

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

Men who worry more may develop heart disease and diabetes risk factors at younger ages

Scienmag

Latest News ages develop Diabetes Disease factors heart men risk worry youngerEmbargoed until 4 a.m. CT/5 a.m. ET Monday, Jan. 24, 2022 […].

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

Newly developed injectable, adhesive surgical gel to prevent scar tissue

Scienmag

Up to 90% of patients who undergo open abdominal or pelvic surgery develop postoperative adhesions, or scar tissue. Biology adhesive developed Gel injectable Newly prevent scar Surgical tissue

Researchers develop first fully 3D-printed, flexible OLED display

Scienmag

Social & Behavioral Science 3Dprinted develop display flexible fully OLED researchersMINNEAPOLIS / ST.

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.

Modern humans developed a more effective protection against oxidative stress

Scienmag

Latest News developed effective humans modern oxidative protection stressVery few proteins in the body have a change that makes them unique compared to the corresponding proteins in Neanderthals and apes.

Wageningen University, VectorY team up to develop next gen AAV expression systems

BioPharma Reporter

Netherlands-based gene therapy company, VectorY Therapeutics, and Wageningen University have signed a strategic collaboration agreement for the development of novel baculovirus-based AAV production technologies. Bio Developments

UCF develops the world’s first optical oscilloscope

Scienmag

2021 – A team from UCF has developed the world’s first optical oscilloscope, an instrument that is able to measure the electric field of light. 2021 – A team from UCF has developed the world’s first optical oscilloscope, an instrument that is able to measure the electric field of light.

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

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

Study reveals link between brain cell development and risk of schizophrenia

Scienmag

Scientists from Cardiff University have discovered new links between the breakdown in brain cell development and the risk of schizophrenia and other psychiatric disorders. Latest News brain cell development Link reveals risk schizophrenia study

Cell wall remodeling enables fungal network development in grasses

Scienmag

Scientists now have a deeper understanding of how a fungus develops a symbiotic lifestyle inside grass leaf and why the grass leaf fails to defend itself against the intruder, thanks to research coming from Massey University in New Zealand and the University of Münster in Germany.

Atul Butte highlights regulatory, economic, and technical challenges in developing digital therapeutics

Scienmag

Article URL: [link] Article Title: Open challenges in developing digital therapeutics Author Countries: U.S.A. Space & Planetary Science Atul Butte challenges developing digital economic highlights regulatory technical therapeutics

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

NASA selects 4 CubeSats for space weather tech development

Scienmag

Space & Planetary Science CubeSats development NASA selects space Tech weather

Are researchers one step closer to developing the theory of impulse circuits?

Scienmag

Mathematics circuits closer developing impulse researchers step theoryComputers play an important role in many aspects of life today. Digital computers are the most widely used, while quantum computers are well known.