Drug Discovery World

SEPTEMBER 29, 2023

In vitro transcription (IVT) can be a complicated reaction. The impact of reaction time, volume, temperature, mixing, reagent concentration, IVT buffer composition and single vs. pulsed addition of reagents on the overall mRNA yield, purity, dsRNA content and capping efficiency will be discussed in detail.

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XTalks

APRIL 22, 2022

Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. All drug development processes evaluate a drug’s pharmacokinetics (PK) to gather data about its absorption, distribution, metabolism, and excretion in the body.

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pharmaphorum

SEPTEMBER 29, 2022

Food and Drug Administration (FDA) regulation as a medical device. In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products.

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FDA Law Blog

APRIL 19, 2021

FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device. Circuit rejected FDA’s claim that it could regulate, at its discretion, any medical device as a drug. Add one more to that tally.

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Drug Discovery World

APRIL 3, 2023

As the industry moves to reduce the use of animals in research and testing, aptamers also support here, as they are discovered, developed, and manufactured entirely in vitro , removing the need for animals in antibody discovery processes. DDW’s Diana Spencer caught up with co-founder and CEO Dr Arron Tolley.

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Drug Discovery World

OCTOBER 23, 2023

Join DDW for this exclusive free event, Scaling up in vitro transcription: Key results and considerations , which is supported by Thermo Fisher Scientific. In vitro transcription (IVT) can be a complicated reaction. The post Webinar: Scaling up IVT in mRNA production appeared first on Drug Discovery World (DDW).

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Drug Discovery World

MAY 16, 2023

What are the global innovations in cell and gene therapy? What opportunities and challenges are emerging and can therapies get to market faster? DDW’s Megan Thomas finds out. He says: “In recent years, the field has seen exponential growth, which has outpaced the rate at which new professionals enter.

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FDA Law Blog

AUGUST 3, 2022

Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug.

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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.

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FDA Law Blog

NOVEMBER 1, 2023

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 ).

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FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. There is much to unpack, and we intend to do so in a series of blog posts.

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Drug Discovery World

FEBRUARY 15, 2023

Evolution of such defence mechanisms can lead to multi-drug resistance, further disease progression, and cancer metastasis. Cancer is a complex heterogenous multistep disease characterised by uncontrolled cell proliferation combined with a dysregulated immune response. This continues to be the standard of care.

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Drug Discovery World

FEBRUARY 27, 2023

The company launched its EnVision Nexus system at the show, which is designed for demanding HTS applications and to help accelerate drug discovery efforts. As the company’s first HT system, it has been designed to overcome adoption barriers currently limiting the use of predictive human liver models within drug discovery workflows.

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Drug Discovery World

OCTOBER 14, 2022

HTS as a tool for drug discovery has evolved rapidly since the origin of the technique in the 1990s. HTS is widely used by pharmaceutical companies to identify compounds (or ‘hits’) that show pharmacological activity, which are used as starting points to optimise medicines during the drug discovery process.

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The Pharma Data

AUGUST 4, 2020

Food and Drug Administration (FDA) has authorised the cobas® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. Test meets World Health Organization standards for consistent result reporting among laboratories across the U.S.,

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The Pharma Data

SEPTEMBER 7, 2020

Food and Drug Administration (FDA) 510k clearance for the cobas® BKV Test on the cobas® 6800 and 8800 Systems. The test offers an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories.

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