pharmaphorum

JANUARY 24, 2023

Drug development has long been an issue for the pharma industry, due to the expense and the high failure rate of potential treatments. Ben Hargreaves finds that the vast amount of genetic data that exists today could help provide a faster, more targeted way of developing new drug candidates.

Genetics 98

Genetics Drugs Genome Project Biobanking 98

Pharmaceutical Technology

DECEMBER 15, 2022

High interest has sparked across the CFD drug space as more experts are becoming aware of the clinical efficacy and large market opportunity of using HFC products to treat various AFD indications, including surgeries involving massive blood loss and unexpected trauma. While they treat the symptoms of CFD, they are not curative.

Marketing 130

Marketing Production Genotype Development 130

Scienmag

MAY 16, 2021

The investigational drug evinacumab reduced triglycerides in patients with severe hypertriglyceridemia (sHTG) and a history of hospitalizations for acute pancreatitis in a phase 2 global study led by Mount Sinai.

Antibody 45

Antibody Genotype Drugs Clinical Trials 45

Pharmaceutical Technology

JUNE 6, 2023

The drug’s revenue forecasts along with estimated costs are used to measure the value of an investment opportunity in that drug, otherwise known as net present value (NPV). The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress.

Hormones 100

Hormones In-Vitro Genotype Bacteria 100

XTalks

JULY 10, 2024

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). Persing, Cepheid’s chief medical and scientific officer in Cepheid’s press release.

RNA 97

RNA In-Vitro Genotype Marketing 97

pharmaphorum

AUGUST 11, 2022

More than 60 percent of all American adults take prescription drugs , amounting to approximately 131 million individuals. These drugs have been rigorously tested by regulatory bodies around the world before they’re made available to ensure they work as labelled, but despite that, adverse events crop up.

Genomics 98

Genomics Genome Drugs Genetics 98

Bioengineer

JANUARY 16, 2024

Importantly, a triple mutant scenario with EGFR L858R/T790M/C797S or EGFRexon19del/T790M/C797S genotype may occur in patients with T790-positive NSCLC receiving osimertinib in second or later lines. Real-world cohorts report a prevalence of C797 mutations between 11% and 29%. Reported changes include L718Q and L718V.

Genomics 119

Genomics Genome Protein In-Vitro 119

Delveinsight

DECEMBER 13, 2020

alcohol, certain drugs) and autoimmune diseases can also cause hepatitis. Interferons are naturally occurring proteins in the body; recombinant IFNa is the protein-based drug that works to mobilize the body’s natural immune system to fight disease. Both drugs resulted in inhibition of HCV replication.

Genotype 52

Genotype FDA Approval DNA Drugs 52

XTalks

JANUARY 21, 2025

Agent drug-coated balloon. The balloons outer surface is coated with the drug paclitaxel, a safe and effective measure to prevent the arteries from narrowing again. The scaffold is placed inside the lower leg artery to help keep it open while gradually releasing a drug to reduce the risk of re-narrowing.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

The Pharma Data

OCTOBER 9, 2021

Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.

Drugs 52

Drugs Genotype Bioavailability Medicine 52

pharmaphorum

DECEMBER 9, 2020

The European Medicines Agency (EMA) has granted a conditional marketing authorisation for the drug that will be marketed as Zinteglo (betibeglogene autotemcel), meaning its licence must be renewed each year until confirmatory data is available. In Europe bluebird has set a price of up to $1.58 million euros for a single shot.

Gene Therapy 59

Gene Therapy Gene Genotype Marketing 59

pharmaphorum

JANUARY 29, 2019

How the shift towards cancer as a phenotype/genotype is being applied in clinical trials and how they are run •What are co-clinical trials and why could they hold the key to answering unmet need in cancer treatment and beyond into broader drug development? •What are the implications from these changes for clinical trials?

Genomics 52

Genomics Genome Medicine Clinical Trials 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

The Pharma Data

NOVEMBER 18, 2020

HIV drug resistance is caused by changes in the genetic structure of HIV that affects the ability of drugs to block the replication of the virus. Minimizing the emergence and transmission of HIV drug resistance is a vital part of global. WHO has developed survey methods to monitor pretreatment HIV drug resistance.

Drugs 52

Drugs Genotype Medicine Development 52

pharmaphorum

NOVEMBER 10, 2021

This database should support automatic importation from hospitals, laboratories and surveillance networks and link to genotypic data when available.”. When new antimicrobials are brought to market, good stewardship requires that older drugs be used first, even if there were no difference in price.”. One health.

Medicine 105

Medicine Genomics Genome Genotype 105

XTalks

MARCH 3, 2021

The US Food and Drug Administration (FDA) has granted approval to Nulibry (fosdenopterin) for reducing the risk of death associated with molybdenum cofactor deficiency type A (MoCD Type A), making it the first treatment for the ultra-rare, genetic metabolic disorder. The approval was granted to BridgeBio Pharma, Inc.

FDA Approval 64

FDA Approval Genotype Clinical Trials Clinical Trials 64

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.

Vaccine 103

Vaccine Vaccination Insulin Trials 103

The Pharma Data

NOVEMBER 10, 2020

“They will help researchers mechanistically assess target engagement in clinical trials,” and also will be used in clinical practice to identify the right drugs for the right patients, Howard Fillet, M.D., Importantly, “It demonstrated a lack of drug interference for each drug studied,” Dage said. ADNI trial.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

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). The FDA, an agency within the U.S.

Genomics 52

Genomics Genome Production Marketing 52

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. Tranquis Therapeutics.

Marketing 52

Marketing In-Vivo Protein In-Vitro 52

XTalks

DECEMBER 12, 2023

“In some areas, say Alzheimer’s disease, we have growing collections of imaging, gene, cerebrospinal fluid (CSF) and blood markers to follow and look at target engagement of our drugs,” says James Vornov, MD, PhD, Vice President of the Medical Department at Medpace. Furthermore, blood NfL has shown its versatility as a biomarker.

Trials 111

Trials Clinical Trials Clinical Trials Genetics 111

The Pharma Data

JANUARY 26, 2021

Food and Drug Administration to treat mild-to-moderate COVID-19 patients. VIR-3434 is an HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and reduce the level of virions and subviral particles in the blood.

Antibody 52

Antibody Genotype Trials Nurses 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. Such obstacles lead to the limited use of such mouse models for development of rare kidney disease drug.

Genetics 40

Genetics Genotype Development Research 40

Roots Analysis

AUGUST 12, 2024

Such test can be used for gene expression profiling, genotyping and detecting chromosomal abnormalities. These verticals include, medical devices / technologies, digital healthcare services and various drugs / disease indications. Examples includes microarrays and fluorescence in situ hybridization. Gaurav holds a B.

Genetics 40

Genetics Gene Expression RNA DNA 40

The Pharma Data

NOVEMBER 24, 2020

Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. Injection site reactions (ISRs) were the most common drug-related adverse reaction.

FDA Approval 52

FDA Approval Production RNA Medicine 52

XTalks

MARCH 1, 2024

Recently, the US Food and Drug Administration (FDA) has also approved new and more comprehensive HPV vaccines that offer enhanced protection against cervical cancer and other HPV-related conditions. Vaccination also continues to be the most powerful tool for preventing HPV infections and their associated health risks.

Vaccination 52

Vaccination Vaccine Life Science FDA Approval 52

pharmaphorum

JULY 13, 2021

That could present a window of opportunity to try to introduce changes to lifestyle such as physical exercise or non-drug therapies like memory or cognitive training that – in theory at least – could help slow down progression to symptomatic Alzheimer’s. It could potentially also help to select patients for drug therapies.

Genotype 111

Genotype Scientist Drugs Research 111

Delveinsight

AUGUST 25, 2021

The pharmaceutical industry finds, develops, manufactures, and promotes medicines or pharmaceutical drugs for usage as medications that are administered (or self-administered) to patients in order to cure, vaccinate, or relieve symptoms. Pharmaceutical companies may deal in both generic and brand-name drugs as well as medical devices.

Vaccine 98

Vaccine Vaccination Drugs Sales 98

XTalks

FEBRUARY 4, 2021

The power of leveraging clinical data to decipher disease mechanisms and fuel drug discovery has rapidly grown in the era of genomics and personalized medicine. Biobanking will continue to play an integral role in accelerating drug discovery and development, which will necessitate access to a larger array of biological samples.

Research 98

Research Biobanking Drugs Genomics 98

The Pharma Data

DECEMBER 9, 2020

Our focus on partnering to accelerate patient access to innovative medicines underscores our commitment to advancing breakthroughs in biomedicine such as antibody drug conjugates, cell therapy, RNAi and more, Ed Zhang, company co-founder, chief operating and business officer, said in a statement. “We million in a second financing round.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

pharmaphorum

JANUARY 29, 2023

On Friday, Novartis said that the phase 3 STAND trial of Adakveo (crizanlizumab) found no statistically significant difference between the drug and placebo on annualised rates of vaso-occlusive crises (VOCs) – the excruciatingly painful attacks that intermittently affect patients with SCD. compared to 2.98

Genotype 52

Genotype Trials Antibody Regulation 52

XTalks

APRIL 24, 2023

According to Dr. Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

The Pharma Data

SEPTEMBER 2, 2021

Transforming treatment of advanced cancers with antibody drug conjugates (ADCs). Durvalumab ± Tremelimumab + Platinum-Etoposide in 1L ES-SCLC: Exploratory Analysis of HLA Genotype and Survival in CASPIAN. Antibody drug conjugates. Antibody drug conjugates. Lead author. Abstract title. Presentation details. Garassino, MC.

Trials 52

Trials Medicine Antibody Clinical Trials 52

Delveinsight

DECEMBER 16, 2020

Further, diagnostics and screening, poverty, the stigma associated with the STDs, younger patient pool, illicit drug & alcohol use and negligence are some of the other key factors attributing to the increasing burden of STDs. A number of antiretroviral drugs are available in the market today, that can be combined in different ways.

Bacteria 52

Bacteria Development Genotype Vaccine 52

The Pharma Data

APRIL 14, 2021

The FDA’s accelerated approval mechanism enables drugs that treat serious diseases with unmet medical need to be approved based on a surrogate or intermediate clinical endpoint. Premedicate with a two or three drug combination regimen (e.g., DRUG INTERACTIONS. FOSTER CITY, Calif.–(BUSINESS

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52

The Pharma Data

APRIL 7, 2021

Food and Drug Administration (FDA) has granted full approval to Trodelvy ® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. DRUG INTERACTIONS.

HR 52

HR Genotype FDA Approval Genotoxicity 52

pharmaphorum

FEBRUARY 17, 2022

Monitoring allows researchers to understand previous evolutionary events and predict how viruses may change in the future, allowing for a better understanding of virulence evolution, drug resistance, and vaccine efficacy. ” Researchers used whole-genome data, providing the 17 whole genomes available for the variant.

Genomics 98

Genomics Genome Genetics Genotype 98