Cloudbyz

JUNE 21, 2023

In the world of clinical research, Electronic Data Capture (EDC) systems play a pivotal role in efficiently collecting, managing, and analyzing clinical trial data. The Study Data Tabulation Model (SDTM) is a widely accepted format that ensures consistency and interoperability of clinical trial data.

Clinical Trials 68

Clinical Trials Clinical Trials Compliance Trials 68

Camargo

JULY 30, 2021

They immediately stood up and said, “No, we’re doing six clinical trials in pediatrics now, specifically in the infant population, for something called pulmonary hypertension in these kids.” But now it’s a warning in their package insert. There were six Pfizer people in the audience.

Clinical Research 226

Clinical Research Research Gene Therapy Gene 226

BioSpace

NOVEMBER 23, 2022

BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its BLA for Roctavian an AAV gene therapy for adults with severe hemophilia A.

Gene Therapy 40

Gene Therapy Gene Packaging Packaging 40

pharmaphorum

MARCH 3, 2022

The investment package includes £200 million ($268 million) to enable researchers to better access NHS data through what the government calls Trusted Research Environments and digital clinical trial services.

Manufacturing 52

Manufacturing Life Science Clinical Trials Clinical Trials 52

Cloudbyz

AUGUST 9, 2023

Let’s delve into why this method is paramount for the transformation of clinical research management. Unified Data Management Clinical trials generate vast amounts of data, from patient records to lab results and monitoring findings. Flexibility and Customization Not all clinical trials are the same.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 10, 2023

According to a recent review published in Nature , as of April 2022 almost 1,800 active cell therapy clinical trials were listed in ClinicalTrials.gov, a 33 percent increase from 2021. In a recent webinar, Dr. Vassallo discussed the operational considerations for complex cell therapy clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Gene Therapy 52

Camargo

AUGUST 11, 2021

In addition, the sponsor seeks an agency’s agreement on its proposed plans, including clinical and nonclinical studies. Pre-submission meetings are usually associated with milestone submissions , such as applications to initiate clinical trials or marketing applications. Meeting Package Due. Meeting Type. Meeting Purpose.

Production 230

Production Packaging Packaging Marketing 230

The Pharma Data

JUNE 7, 2023

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch. at the BioProcess International Theater.

Manufacturing 40

Manufacturing Development Protein Gene Therapy 40

pharmaphorum

JUNE 11, 2021

The Philadelphia-based company said it had taken the decision to go down the biologics license application (BLA) route for Covaxin based on FDA feedback to the EUA data package it had submitted to the agency. — FDA Biologics (@FDACBER) May 25, 2021. million doses.”

Vaccination 60

Vaccination Vaccine Clinical Trials Clinical Trials 60

Drug Discovery World

MARCH 13, 2023

The cell and gene therapy (CGT) landscape has grown significantly in the past year. Between the 24 therapies already approved by the FDA 1 and a marked increase in clinical trials, widespread accessibility to precision medicine feels within reach.

Gene Therapy 52

Gene Therapy Gene Manufacturing Development 52

pharmaphorum

APRIL 11, 2022

Innovative ‘next-generation’ medicines are met with a series of hurdles such as increased cost of development, regulatory challenges and delays, and longer and more complex clinical trials. And it all fuels the debate: are medicines a cost or an investment? The answer to this question comes back to our definition of value.

Medicine 106

Medicine Clinical Trials Clinical Trials Development 106

Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). For rare disease drugs, a variable RDP period of five, nine, or ten years, depending on the novelty of the drug.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

Drug Discovery World

FEBRUARY 10, 2023

Magnus Persson is a physician and scientist with a background in both academia and industry, working for the likes of Sanofi on clinical trials activities and across venture capital firms in the US. He is now a founding partner of EIR Ventures, a venture capital firm investing in innovative companies across the Nordics.

Life Science 52

Life Science Drugs Gene Therapy Manufacturing 52

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. SVP, Chief Medical Officer, Novartis Gene Therapies. “We

Clinical Trials 52

Clinical Trials Clinical Trials Gene Therapy Trials 52

STAT News

NOVEMBER 4, 2022

Terry had long been too old to participate in clinical trials of experimental therapies for the disease, which are often geared towards young boys. The clinical trial was to be the first time anyone got a gene editing therapy for muscular dystrophy.

Gene Editing 105

Gene Editing Gene Gene Therapy Clinical Trials 105

Drug Discovery World

DECEMBER 15, 2022

Now, after nearly 35 years of research and more than a decade of preclinical progress, several different gene editing modalities are being tested in early phase clinical trials. Early phase clinical trials for gene editing therapies. Gene editing challenges and potential solutions.

Gene Editing 52

Gene Editing Gene In-Vivo Genome 52

Drug Discovery World

AUGUST 5, 2022

In drug development, the originator company or sponsor is the primary stakeholder in the development of their drug, be it a small or large molecule, a cell or gene therapy. Why sponsors use external consultants.

Development 52

Development Drugs Production Gene Therapy 52

Drug Discovery World

JULY 18, 2023

Rolf Turk , Senior Manager, Genomics Medicine at Integrated DNA Technologies, examines how CRISPR is being used to enhance cancer therapies. These methods offer safer CAR T-based therapies, laying the foundation for clinical trials and the rapid development of a new generation of CAR T cells for both autologous and allogeneic use.

DNA 98

DNA Genome Genomics RNA 98

XTalks

AUGUST 2, 2023

2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. Meanwhile, BioMarin’s gene therapy Roctavian is approved by the FDA for the treatment of hemophilia A. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13 Both are anti-CD20 agents.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

pharmaphorum

JANUARY 4, 2023

The cell and gene therapy (CGT) industry is poised to achieved a significant milestone at the end of 2022: the first approval of an allogeneic T-cell therapy in the world. . Over the last two years, the company has doubled its cryogenic storage capacity across its global network of clinical and commercial depots.

Gene Therapy 92

Gene Therapy Manufacturing Gene Production 92