The Pharma Data

MARCH 7, 2022

Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). Solomon, D.V.M., Source link: [link].

Genome 52

Genome Genomics Production Marketing 52

Drug Discovery World

FEBRUARY 1, 2024

Microbial control within biopharmaceutical manufacturing is a critical quality control to help ensure drug products are free from viable microorganisms. Regulatory agencies consider genotypic identification to be more reliable than phenotypic methods.

Manufacturing 52

Manufacturing Genotype Gene Therapy Compliance 52

Drug Discovery World

FEBRUARY 8, 2024

Microbial control within biopharmaceutical manufacturing is a critical quality control to help ensure drug products are free from viable microorganisms. Regulatory agencies consider genotypic identification to be more reliable than phenotypic methods.

Manufacturing 52

Manufacturing Genotype Gene Therapy Compliance 52

Drug Discovery World

FEBRUARY 1, 2024

Microbial control within biopharmaceutical manufacturing is a critical quality control to help ensure drug products are free from viable microorganisms. Regulatory agencies consider genotypic identification to be more reliable than phenotypic methods.

Manufacturing 52

Manufacturing Genotype Gene Therapy Compliance 52

Pharmaceutical Technology

DECEMBER 15, 2022

Major factors driving this growth include the launch of improved human fibrinogen concentrate (HFC) products, the large market potential for HFC in treating acquired fibrinogen deficiency (AFD), and recent increased demand for blood plasma. HFC products must be administered intravenously in a healthcare setting and carry risks of thrombosis.

Marketing 130

Marketing Production Genotype Development 130

Scienmag

DECEMBER 15, 2020

Striving for a better understanding of pest resistance in experimental lines Credit: Gurjit Singh Tifton, Georgia: A study out of the University of Georgia sought to determine the level of host plant resistance that can be assured by several promising experimental bermudagrass genotypes against potential damages committed by the fall armyworm.

Genotype 66

Genotype Research Production 66

Pharmaceutical Technology

JUNE 6, 2023

Pharma Mar offers in vitro diagnostic products used for detection of virus and bacteria in respiratory infections and human papilloma virus genotypes, among others. The drug candidate is a marine-derived compound. Pharma Mar Overview Pharma Mar discovers, develops and markets marine-derived drugs to treat cancer.

Hormones 100

Hormones In-Vitro Genotype Bacteria 100

Drug Discovery World

DECEMBER 12, 2023

KRRO-110 is designed to co-opt an endogenous enzyme Adenosine Deaminase Acting on RNA (ADAR) to repair a pathogenic single nucleotide variant (SNV) on RNA and restore production of normal A1AT.

RNA 52

RNA In-Vivo Genotype Genetics 52

The Pharma Data

NOVEMBER 2, 2020

ONWARD is investigating Adial’s lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes related to the serotonin transporter and receptor genes. Key ONWARD highlights include: All 25 planned investigative sites are active.

Trials 52

Trials Genotype Marketing Production 52

Roots Analysis

SEPTEMBER 20, 2023

Cannabis-infused products primarily contain the cannabinoids cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC). THC is main psychoactive cannabinoid, which is used in recreational products. The market for cannabis-infused products is growing like weed. Which Countries have Legalized the Use of Medical Cannabis?

Laboratory Information Management System 40

Laboratory Information Management System Production Contamination Containment 40

pharmaphorum

JANUARY 29, 2023

The EU regulator’s Committee for Medicinal Products for Human Use (CHMP) said it will “assess the impact of these findings on the balance of benefits and risks of Adakveo” and the impact on its conditional approval, which was granted in 2020. That study showed that Adakveo lowered the median annual rate of VOCs to 1.63

Genotype 52

Genotype Trials Antibody Regulation 52

pharmaphorum

DECEMBER 9, 2020

In the US, Zinteglo has hit a speed-bump with the FDA, which is asking for more information about production facilities before a review of clinical data can begin. Results announced at the American Society of Hematology could help bluebird make the case for the long-term use of the therapy as the treatment approaches the market in Europe.

Gene Therapy 54

Gene Therapy Gene Genotype Marketing 54

XTalks

APRIL 3, 2024

genotype in wild birds from November 2023. Although it’s confirmed that HPAI is present, it’s still uncertain if it’s the sole cause of the symptoms observed, which include a significant reduction in milk production and unusual illness profiles, especially in mature cows. clade, with origins traced back to the B3.2

Genotype 45

Genotype Contamination Bacteria Development 45

pharmaphorum

AUGUST 11, 2022

The program is aiming to genotype roughly 150,000 participants over the next few years to demonstrate the impact personalised testing can have on a large scale. In the near future, more testing must be put into place and standardised throughout the industry. The post How Pharmacogenomics may finally realise its promise appeared first on.

Genome 98

Genome Genomics Genetics Drugs 98

XTalks

SEPTEMBER 15, 2020

In addition to the vaccine, the company is also developing an investigational drug called Remygen for the regeneration of endogenous insulin production and to improve hormonal response to hypoglycemia; trials to test the treatment are currently ongoing in patients that have been living with type 1 diabetes for more than five years.

Vaccination 103

Vaccination Vaccine Insulin Trials 103

XTalks

APRIL 24, 2023

Dr. Eagleton recently spoke on a webinar with his colleagues from Medpace about lessons learned from successful approaches from rare disease and gene therapy product approvals. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

Drug Discovery World

FEBRUARY 27, 2024

Where cancers were previously understood by their tissue of origin and cell morphology, we can now define them based on their genotypes and molecular drivers. First, from the beginning, we designed the data production strategy with machine learning in mind and considered many factors that we knew were going to be important.

Genome 52

Genome Genomics Genotype Medicine 52

Roots Analysis

APRIL 28, 2024

Absence of Biomarkers for Diagnosis: Due to the absence of genotype-phenotype correlations and prognostic markers, there have been challenges in the diagnosis and treatment of rare kidney diseases. Insufficient Model Organisms: Limitations of these model organisms includelong generation time and strain effects.

Genetics 40

Genetics Genotype Development FDA Approval 40

Drug Discovery World

NOVEMBER 23, 2023

But despite significant investment into companies built on the foundation of AI tools, most have yet to see the products of their in silico experimentation prove successful in human clinical trials and the most advanced human trials of AI-developed drug candidates are still in phase II stage.

Biobanking 59

Biobanking Drugs Medicine Genome 59

pharmaphorum

NOVEMBER 10, 2021

This database should support automatic importation from hospitals, laboratories and surveillance networks and link to genotypic data when available.”. While this is a promising development, most of these products… do not appear to be meaningfully different from existing medicines,” said the report. Growing threat of AMR.

Medicine 104

Medicine Genome Genomics Genotype 104

Advarra

FEBRUARY 28, 2023

The policy is fundamentally intended to promote and expedite the “translation of research results into knowledge, products, and procedures to improve human health.” The NIH data sharing principles are not new. For example, the Genomic Data Sharing Policy applies to NIH-funded research generating large-scale human or non-human genomic data.

Research 52

Research Genome Genomics Genotype 52

XTalks

MARCH 3, 2021

It is characterized by a deficiency in molybdenum cofactor production. In the analysis involving 31 patients, 13 were treated with Nulibry and compared to 18 genotype-matched untreated patients from the history control group.

FDA Approval 64

FDA Approval Genotype Clinical Trials Clinical Trials 64

The Pharma Data

NOVEMBER 24, 2020

The excess production of oxalate results in the deposition of calcium oxalate crystals in the kidneys and urinary tract and can lead to the formation of painful and recurrent kidney stones, nephrocalcinosis, progression to kidney failure, and systemic organ dysfunction. President of R&D at Alnylam.

FDA Approval 52

FDA Approval Production RNA Medicine 52

XTalks

APRIL 15, 2021

It’s not just one disease,” says Dr. Irene Blat, PhD, senior director of data products and analytics, Genuity Science. Though the HERMES, and the related 2010 CHARGE study, performed large heart failure genomic association analysis, both consortia relied on genotyping and self-reported data. Genuity Science Drug Target Discovery Study.

Development 98

Development Drugs Genome Genomics 98

The Pharma Data

DECEMBER 9, 2020

Vigil’s pipeline strategy is to target these diseases by combining a high-level understanding of microglia physiology, disease genotyping, and patient phenotyping to identify specific genetic variations associated with microglial dysfunction. It’s like taking out the trash.

Marketing 52

Marketing In-Vivo Protein In-Vitro 52

The Pharma Data

MARCH 16, 2022

To support customers performing human genotyping, TIB Molbiol provides custom-made LightSNiP assays for SNP analysis. Roche is working closely with governments and health authorities around the world, and has significantly increased production to support availability of tests globally. TIB Molbiol is headquartered in Berlin (Germany).

In-Vitro 52

In-Vitro Genotype Reagent Protein 52

The Pharma Data

APRIL 7, 2021

The incidence of Grade 3-4 neutropenia in genotyped patients was 69% in patients homozygous for the UGT1A1*28, 48% in patients heterozygous for the UGT1A1*28 allele and 46% in patients homozygous for the wild-type allele. The European Medicines Agency has also validated a Marketing Authorization Application for Trodelvy in the European Union.

HR 52

HR Genotype FDA Approval Genotoxicity 52

Roots Analysis

AUGUST 31, 2023

Similarly, people suffering from lactose intolerance must avoid milk products. For example, people affected by phenylketonuria must avoid consuming food containing phenylalanine amino acid. Additionally, nutrigenomics helps in risk assessment of diet related disorders using the predictive power of single nucleotide polymorphism (SNP).

Genome 40

Genome Genomics Genetics Gene 40

The Pharma Data

DECEMBER 9, 2020

The aim of the research will be to create a TGS IVD platform by optimizing a multi-layer approach encompassing the initial sample and library preparation, state-of-the-art sequencing technologies and improved genotyping procedures. To meet the increased demand, HALIX expands with two additional viral vector production, the company said.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

XTalks

DECEMBER 12, 2023

It aids in optimizing individualized treatment plans by offering insights into brain volume to help inform the selection of the precise dose of the investigational product (IP). Importantly, FDA-approved products are now available for these PET imaging applications.

Trials 111

Trials Clinical Trials Clinical Trials Genetics 111

The Pharma Data

MARCH 25, 2021

The MAA is now under accelerated review by the EMA, in recognition of the product being considered of major interest for public health and therapeutic innovation. The appropriate dose for patients who are homozygous for UGT1A1*28 is not known and should be considered based on individual patient tolerance to treatment.

Genotoxicity 52

Genotoxicity Genotype Containment Protein 52

Delveinsight

AUGUST 25, 2021

The company offers a variety of products under the three major business divisions i.e. Pharmaceutical, Medical Devices, and Consumer Health. Through its animal health division, it deals in Veterinary Pharmaceuticals and Vaccines (Livestock and Companion Animal Products). The annual sale of Merck and Company in the year 2020 was USD 47.9

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Vaccination Vaccine Sales Drugs 98