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: 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.

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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: 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 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.

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

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

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.

Multidisciplinary Team Advances Immuno-Oncology Development

Camargo

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

Researchers develop 3D-printed jelly

Scienmag

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

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.

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.

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: 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.

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.

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.

Gilead, Foresite back biotech developer of COVID-19 pill in latest SPAC deal

Bio Pharma Dive

A merger with Foresite Capital's blank-check company makes Pardes Biosciences the latest well-funded drugmaker pursuing development of an oral coronavirus antiviral

BioNTech to develop mRNA malaria vaccine; unveils ambitions for Africa vaccine supply

BioPharma Reporter

BioNTech aims to develop the first mRNA-based malaria vaccine, hoping to reach clinical trials by 2022. Bio Developments

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: 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: January 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.

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

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

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: 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.

How the Elsevier Foundation partnerships support sustainable development

Pharma R&D Today

OWSD-Elsevier Foundation Awards for Early-Career Women Scientists in the Developing World award winners. We know how important recognition and professional visibility are for developing high-profile international scientific careers,” said Ylann Schemm, Director of the Elsevier Foundation.

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?

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

Development of Oncology Therapies – Tips from the FDA to Drive Success

Camargo

This trend progressively reduces the attractiveness of engaging in the early stages of oncology therapy development in the eyes of Big Pharma and opens the space for small pharma and biotech players. Become Fluent in the Drug Development “Languages.”.

Regeneron, AZ partner on development of novel obesity drugs

Pharma Times

Collaboration will focus on developing small molecule medicines targeting GPR75

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

Mogrify looks to transform cell therapy development

BioPharma Reporter

Bio DevelopmentsBiotech, Mogrify, recently closed a Series A financing of US$17m, bringing the total raised to US$33m in the round, with the investment set to support the advancement of the companyâs immuno-oncology and ophthalmology programs.

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

CRISPR, with new partner, to develop gene editing therapies for ALS, nerve disorder

Bio Pharma Dive

A deal with biotech startup Capsida, which recently raised $140 million, gives CRISPR access to a Caltech technology that aims to improve the delivery of genetic medicines

Developing new techniques to build biomaterials

Scienmag

Credit: Lorna Dougan/Phospho Animations Scientists at the University of Leeds have developed an approach that could help in the design of a new generation of synthetic biomaterials made from proteins.

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

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.

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.

Drug developer uses RWE to research psychedelic therapies

Outsourcing Pharma

The UK-based development and research firm hopes to accelerate patient access to psychedelic therapies for treatment of various mental health conditions. Clinical Development

Exosome formulation developed to deliver antibodies for choroidal neovascularization therapy

Scienmag

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

BioMarin partners with Allen Institute to develop gene therapies for the brain

Bio Pharma Dive

Far along in testing for a hemophilia treatment, BioMarin is expanding its gene therapy research into diseases of the central nervous system and aims to use some of the institute's technology