The Pharma Data

OCTOBER 19, 2020

DB ( Becton, Dickinson and Company ) received a CE mark for its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes for assessing immune function in COVID-19 patients. A new clinical trial by the World Health Organization (WHO), however, reports that the drug does not have any particular effect on a patient’s survival.

Vaccination 52

Vaccination Vaccine Trials Clinical Trials 52

Pharmaceutical Technology

FEBRUARY 3, 2023

As opposed to other therapies or drugs that basically help you manage a condition, gene therapy has the potential to cure a disease,” says Nicole Faust, PhD, General Manager, Cell Line Development, Cytiva. After years of safety-related setbacks and development challenges, recent progress in gene therapy is especially exciting.

Genome 244

Genome Genomics Medicine Gene Therapy 244

FDA Law Blog

AUGUST 3, 2022

Thirty years ago today, FDA announced that it had the authority to regulate you. Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. By Jeffrey N. Gibbs & Allyson B. Mullen — Happy Birthday Laboratory Developed Tests (LDTs).

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In-Vitro Regulation Compliance Production 98

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

Drug Discovery World

MAY 16, 2023

Lending to the time-to-clinic discrepancy, we also see increasing demands on manufacturing capacity for CGT reagents.” appeared first on Drug Discovery World (DDW). There is a challenge to balance the time required to provide an appropriate focus on safety with the opportunity to treat patients in critical need.

Gene Therapy 52

Gene Therapy Gene Manufacturing Marketing 52

Drug Discovery World

MARCH 13, 2023

Before 2019, CGT drug developers still had a young, academic mindset, ordering reagents, materials, and equipment haphazardly and assuming they would show up when needed. But now, the increased efficiency is likely making drug development cheaper. Additionally, the complexity of these drugs remains vastly under appreciated.

Gene Therapy 52

Gene Therapy Gene Manufacturing Development 52

FDA Law Blog

OCTOBER 6, 2023

The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

In-Vitro 64

In-Vitro Regulation Production Compliance 64

The Pharma Data

DECEMBER 23, 2020

In July, ViiV Healthcare, which is based in London, resubmitted the New Drug Application (NDA) for once-monthly dosing of cabotegravir and rilpivirine to the U.S. Food and Drug Administration (FDA), and further regulatory applications have been submitted and are being reviewed by other regulatory bodies worldwide, the company said.

Drugs 52

Drugs Licensing Licensing Vaccination 52

Drug Discovery World

FEBRUARY 15, 2023

However, over the last few decades, it has been widely accepted that interaction between the tumour and host immune response plays a critical role in regulating tumour biology and hence its progression. Evolution of such defence mechanisms can lead to multi-drug resistance, further disease progression, and cancer metastasis.

Research 52

Research In-Vitro In-Vivo Development 52

Drug Discovery World

JULY 18, 2023

Current research is focused on designing CRISPR-enhanced CAR T cells that are resistant to immunosuppressive cytokines such as transforming growth factor-β (TGF-β) 2 , programmed cell death protein (PD-1) 3 , or other negative T cell regulators 4 (CTLA-4, LAG-3, and TIM-3), thus improving anti-tumour functions.

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DNA Genome Genomics RNA 98

XTalks

OCTOBER 1, 2020

Xtalks spoke with WeiQi Lin, MD, PhD, executive vice president, research & development, and principal scientist at DURECT Corporation — a company focused on developing drugs and drug delivery methods in therapeutic areas with significant unmet need — about her transition from academia to industry. Key Moments.

Scientist 52

Scientist In-Vitro Research Life Science 52

Drug Discovery World

DECEMBER 15, 2022

While LV can create sustained expression of the genome editing tool, the randomness of integration could lead to activation of oncogenes and poor regulation of the genome editing tool expression. The post Delivering on the promise of gene editing appeared first on Drug Discovery World (DDW).

Gene Editing 52

Gene Editing Gene In-Vivo Genome 52

Drug Discovery World

OCTOBER 20, 2022

It has been used to investigate rare cell populations, screen potential drug therapeutics, and examine sample phenotypes for diagnostic applications 2. CAFs are critical regulators of desmoplasia characteristic of this cancer, yet they are poorly characterised. Conventional flow cytometry. Elyada et al.

Antibody 52

Antibody In-Vivo Life Science Development 52

Drug Discovery World

AUGUST 23, 2023

There’s even a name for the downsides of such under-supported products, poor integrations, and bad user experience: frustrated ELN users call this the “tax on science” That tax has a real cost in terms of drug discovery. This transition improved intellectual property management for early drug discovery.

Laboratory Information Management System 52

Laboratory Information Management System Scientist Compliance Development 52