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Genotox Laboratories Announces Availability of 1,500 COVID-19 Tests per Day

BioTech 365

Number of Tests Accepted per Day is Limited to Ensure Rapid Turnaround Time AUSTIN, Texas–(BUSINESS WIRE)–#coronavirus–Genotox Laboratories, an Austin, Texas based company, has announced the capacity to complete 1,500 COVID-19 tests per day.

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#news #biotech PCR-test reveals risk of genotoxity of genome editing

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: PCR-test reveals risk of genotoxity of genome editing. from European Biotechnology – first and foremost in European biotech [link].

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ICH announces sign-off of residual solvent guideline

The Pharma Data

According to a Step 4 training presentation on the guideline, the Q3C (R8) Expert Working Group (EWG) review of available toxicity data with 2-MTHF, also known as tert -butylmethyl ether, found no evidence for genotoxicity or reproductive toxicity and no observed effect level in repeat dose toxicity studies involving rats. For CPME, EWG’s review found no evidence of genotoxicity and no data available demonstrating carcinogenic effects. Posted 03 May 2021 | By Joanne S. Eglovitch .

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The Composition and Value of a Portfolio Analysis

Camargo

A nonclinical safety evaluation program typically includes pharmacology, general toxicity, toxicokinetics, nonclinical PK, reproductive toxicity, genotoxicity, and carcinogenesis.

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IN FOCUS: Solvias

Pharmaceutical Technology

Dedicated experts in extractables and leachables and genotoxic impurities (GTIs) deploy organic trace analysis by liquid chromatography-mass spectrometry (LC-MS), as well as gas chromatography-mass spectrometry (GC-MS) equipment. Rankings 2022.

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

Camargo

Sponsors can select the patient population and leverage companion diagnostics, and nonclinical study requirements such as genotoxicity and carcinogenicity studies can often be waived or delayed to later stages of development, especially for end-stage cancer therapies.

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Moving off the critical path: Streamlining strategies for drug substance synthesis and manufacturing

Pharmaceutical Technology

Drug substance plays a key part in ensuring a drug program achieves its major milestones, keeps to budget and delivers on its corporate goals.

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Current and Emerging Therapies for Patients With Multiple Myeloma

CATO Research

Based on preliminary data and published reports, exposure to high doses of the genotoxic agent melphalan might render the residual malignant myeloma cells into more aggressive clones, accelerating relapse (8, 9) by potentially altering the stroma (10, 11). Multiple myeloma (MM) is a malignant disease of the bone marrow characterized by clonal expansion of plasma cells (1, 2).

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Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

FDA prefers the use of DEREK, a knowledge-based expert system for the qualitative prediction of toxicity, and SARAH, a statistical software to identify potentially toxic chemicals for assessment of genotoxic and sensitization potential.

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FIRST-LINE IBRANCE® (PALBOCICLIB) COMBINATION THERAPY IN HR+, HER2- METASTATIC BREAST CANCER

The Pharma Data

IBRANCE may impair fertility in males and has the potential to cause genotoxicity.

HR 52
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Treatment of Metastatic Triple-Negative Breast Cancer

The Pharma Data

SG contains a genotoxic component and can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Gilead Sciences, Inc.

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PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Pfizer Inc. NYSE: PFE) today announced that the U.S. Patent and Trademark Office (USPTO) recently issued a U.S. Patent Term Extension (PTE) certificate for IBRANCE® (palbociclib).

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Trodelvy® for the Treatment of Metastatic Urothelial Cancer

The Pharma Data

TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells.

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Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

The Pharma Data

TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Trodelvy Significantly Reduced the Risk of Death by 49% Compared with Single-Agent Chemotherapy in the Phase 3 ASCENT Study –.

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Let's Quit Sugar With Audiobook – Let's Quit Sugar

The Pharma Data

Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. Product Name: Let's Quit Sugar With Audiobook – Let's Quit Sugar.

Insulin 52