The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, announced today that the U.S. BOSTON, Nov.

FDA Approval 52

FDA Approval Genetic Disease Genetics Clinical Trials 52

XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

FDA Approval 111

FDA Approval Gene Therapy Clinical Trials Gene 111

XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

FDA Approval 101

FDA Approval Drugs Sales Development 101

pharmaphorum

OCTOBER 3, 2022

DMD is a severe, progressive muscle-wasting genetic condition caused by the lack of a protein called dystrophin. A gene therapy, it permits the body to read over the DNA mutation and still continue to produce dystrophin. The post Translarna not approved by NICE for DMD on NHS appeared first on.

Gene Therapy 98

Gene Therapy Gene FDA Approval DNA 98

The Pharma Data

NOVEMBER 23, 2021

The study compared the two groups’ plasma CMV DNA concentration levels at the end of the study’s eighth week, with efficacy defined as having a level below what is measurable. Livtencity works by preventing the activity of human cytomegalovirus enzyme pUL97, thus blocking virus replication.

FDA Approval 52

FDA Approval Drugs DNA Cosmetics 52

pharmaphorum

AUGUST 21, 2020

Both previously worked at Cambridge-based DNA sequencing specialist Base4 Innovation, where the technology was developed. The company says its assays can detect as little as a single molecule of mutated DNA amongst the billions of normal molecules found in a patient sample, generating “fast, affordable, easy to interpret results.”.

DNA 59

DNA Gene Sequencing Genetics FDA Approval 59

XTalks

DECEMBER 20, 2023

Given its ability to precisely edit genes, there is tremendous promise for the revolutionary technology to offer cures for genetic disorders and to treat various diseases. This year, the very first CRISPR-based therapy received FDA approval for sickle cell disease.

Life Science 119

Life Science Gene Editing Development Clinical Trials 119

XTalks

JANUARY 26, 2024

This technology, which allows for precise editing of DNA at specific locations, has been a major focus in the field due to its potential to directly target and modify cancer-causing genes. By tailoring treatments based on an individual’s genetic makeup, it may allow for more effective and targeted therapies.

Research 118

Research Gene Editing Gene Genetics 118

XTalks

DECEMBER 28, 2023

Utilizing BillionToOne’s unique molecular counting technology, Quantitative Counting Templates (QCTs), the test employs next-generation sequencing (NGS) to detect genetic variants linked to the relevant fetal antigens. Such precise detection is crucial for accurately pinpointing patients most susceptible to developing severe HDFN.

Trials 97

Trials Clinical Trials Clinical Trials Antibody 97

XTalks

NOVEMBER 7, 2022

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. Regulatory Approvals for CTC-Based Assays in Oncology. The cfDNA that originates from tumors is called circulating tumor DNA (ctDNA).

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

SEPTEMBER 13, 2022

Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001. This was an entirely new approach to DNA research. Previously, DNA would be segmented into short sections, which would then be read and sequenced separately.

Genome Project 98

Genome Project Genome Genomics DNA 98

XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

FDA Approval 52

FDA Approval Drugs Sales Development 52

The Pharma Data

JANUARY 21, 2021

INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.

FDA Approval 52

FDA Approval RNA Drugs Containment 52

XTalks

OCTOBER 26, 2023

The US Food and Drug Administration (FDA) approved new updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna that target the Omicron XBB.1.5 In May, the FDA approved GSK’s Arexvy as the first RSV vaccine, which was shortly followed by the approval of Pfizer’s RSV vaccine Abrysvo.

Vaccine 105

Vaccine Vaccination RNA Manufacturing 105

The Pharma Data

JUNE 24, 2021

The study will evaluate the efficacy and safety of talazoparib, an oral poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with enzalutamide, an androgen receptor inhibitor, compared with placebo plus enzalutamide in men with DNA damage response (DDR)-deficient metastatic castration-sensitive prostate cancer (mCSPC).

DNA 52

DNA Clinical Trials Clinical Trials Trials 52

XTalks

DECEMBER 4, 2023

In a statement outlining its investigation, the FDA said it received reports of the T-cell malignancies from clinical trials and post-marketing safety monitoring. Depending on the findings of the FDA’s probe, the agency could require the risk to be included in a black-box warning, which is the highest safety alert level on a drug label.

Gene Therapy 69

Gene Therapy Gene Clinical Trials Clinical Trials 69

XTalks

DECEMBER 22, 2021

RNA therapeutics hold promise as powerful treatments for diseases, including those that are genetic-based. The gene-editing tool CRISPR edits DNA using specialized strands of guide RNA and endogenous cellular mechanisms of RNA interference. RNA Therapeutics. The deal is worth $1.5 Prior to this, Lilly struck an agreement worth $1.25

Life Science 98

Life Science RNA Vaccine Vaccination 98

WCG Clinical

MAY 28, 2024

CAR-T Cells Target Harmful B Cells in Lupus CAR-T cell technology, which uses genetic engineering to direct white blood cells to attack specific molecular targets, was originally proposed for treatment of HIV infection and hematological malignancies. The currently approved CD-19 CAR products are autologous, ex vivo cellular therapies.

In-Vivo 40

In-Vivo Clinical Trials Clinical Trials FDA Approval 40

The Pharma Data

OCTOBER 21, 2020

INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Such factors include, but are not limited to, those described under Item 3.D

Clinical Development 52

Clinical Development Development Medicine Clinical Trials 52

Roots Analysis

JANUARY 14, 2024

Given the ongoing scientific advancements and the rise of FDA-approved biologics, the pharmaceutical industry seems to be approaching the era of biologics. Since its genetic and physiological profiles are well characterized, genetic manipulation in E. The most widely used bacterial host system is Escherichia coli (E.

Contract Manufacturing 40

Contract Manufacturing Protein Manufacturing Production 40

The Pharma Data

DECEMBER 21, 2020

AstraZeneca in lung cancer AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action. Cancer Discov. 2014;4(9):1046-1061. Source link.

Trials 52

Trials Medicine HR Development 52

XTalks

DECEMBER 24, 2020

However, for virologists like Lori Frappier, PhD, professor in the department of molecular genetics at the University of Toronto, the outbreak of SARS-CoV-2 was less of a surprise and more of an inevitability. She told Xtalks that, “Experts have always known that this kind of pandemic was a possibility, especially with coronaviruses.

Life Science 111

Life Science Vaccine Vaccination Gene 111

Pharmaceutical Technology

APRIL 24, 2023

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

Drug Delivery 147

Drug Delivery Vaccine Vaccination Research 147