XTalks

JUNE 16, 2023

Foundation Medicine recently announced that the US Food and Drug Administration (FDA) approved FoundationOne Liquid CDx to serve as a companion diagnostic for identifying metastatic colorectal cancer patients with BRAF V600E alterations, suitable for treatment with Pfizer’s Braftovi (encorafenib) with cetuximab.

FDA Approval 97

FDA Approval Genome Genomics DNA 97

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

The Pharma Data

AUGUST 27, 2020

FoundationOne Liquid CDx analyses more than 300 cancer-related genes and multiple genomic signatures to help inform treatment decisions for all solid tumour cancers. Cancer is a disease of the genome, driven by genetic mutations within a tumour’s DNA. Many cancer patients are unable to have a tissue biopsy.

FDA Approval 52

FDA Approval Genome Genomics Gene 52

pharmaphorum

OCTOBER 3, 2022

A gene therapy, it permits the body to read over the DNA mutation and still continue to produce dystrophin. Translarna has had European approval for usage since 2014 and has also been available under terms similar to the MAA to DMD patients in Scotland since 2021. Eventually, they will need assistance with breathing.

Gene Therapy 98

Gene Therapy Gene FDA Approval DNA 98

Pharmaceutical Technology

FEBRUARY 15, 2023

Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely.

Genetics 130

Genetics DNA Genome Genomics 130

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

XTalks

JANUARY 26, 2024

Innovations in Cancer Therapy CRISPR/Cas9, a groundbreaking gene-editing technology, has demonstrated significant potential in oncology, offering new avenues for cancer treatment. By editing these genes, researchers can effectively neutralize their cancer-promoting effects.

Research 118

Research Gene Editing Gene Genetics 118

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. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. BOSTON, Nov. in the first quarter of 2021.

FDA Approval 52

FDA Approval Genetic Disease Genetics Clinical Trials 52

XTalks

JULY 19, 2021

Phosphorus may be a familiar name as it was one of the first to develop an FDA-authorized at-home test for COVID-19 ; it was also the first test to have received an asymptomatic, direct-to-consumer FDA approval.

Genetics 98

Genetics Genome Genomics Gene 98

XTalks

DECEMBER 20, 2023

CRISPR Gene Editing Therapeutics CRISPR/Cas-9 technology makes lists like this almost every year, and for good reason. 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.

Life Science 119

Life Science Gene Editing Development Clinical Trials 119

pharmaphorum

AUGUST 21, 2020

Cambridge, UK-based Biofidelity has raised $12 million in first-round funding for its cancer diagnosis platform, which can detect mutations quicker than current approaches like gene sequencing. Both previously worked at Cambridge-based DNA sequencing specialist Base4 Innovation, where the technology was developed.

DNA 59

DNA Gene Sequencing Genetics FDA Approval 59

pharmaphorum

OCTOBER 27, 2022

It can be caused by different types of mutation, including within the BRCA gene and other forms of altered gene expression. HRD impairs cells’ ability to repair structural DNA breaks, leading to additional changes in the DNA of the tumour (known as genomic instability), and how that tumour will respond to certain treatments.

Trials 94

Trials DNA Genome Genomics 94

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. Such information can reveal details about tumor staging, tumor progression, heterogeneity, gene mutations and clonal evolution. Concentration of cfDNA and ctDNA in Cancer Patients.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

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. Despite the concerns, the FDA maintains that the overall benefits of the therapies outweigh the potential risks for their approved uses​​​​.

Gene Therapy 69

Gene Therapy Gene Clinical Trials Clinical Trials 69

Pharma Packaging Solutions

SEPTEMBER 22, 2023

There are a few common types of biologics, including extracted (taken directly from a living system), semi-synthesized (produced with recombinant DNA technology), vaccines, and gene therapies. What are Biosimilars?

Recombinant DNA Technology 52

Recombinant DNA Technology Packaging Packaging Pharma Packaging 52

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. With the launch of the 100,000 Genomes Project in 2012, an international team of researchers studied the role that genes play in health and disease. 2002 – Emergence of CAR-T therapy.

Genome Project 98

Genome Project Genome Genomics DNA 98

Find Me Cure

OCTOBER 13, 2019

There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials. PI3 kinase is an enzyme controlled by the PIK3CA gene, a gene that is often mutated in breast cancer, which in turn causes the cancerous tumour to grow. .

Development 52

Development DNA Clinical Trials Clinical Trials 52

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

MARCH 15, 2022

LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. HRR Gene-mutated Metastatic Castration Resistant Prostate Cancer. Merck’s Focus on Cancer.

DNA 52

DNA Trials Clinical Trials Clinical Trials 52

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

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

DECEMBER 22, 2021

The gene-editing tool CRISPR edits DNA using specialized strands of guide RNA and endogenous cellular mechanisms of RNA interference. In 2021, we saw a number of innovations in fields like neuromodulation, with several neurostimulation devices having received FDA approvals.

Life Science 98

Life Science RNA Vaccination Vaccine 98

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. It is worth mentioning that in vitro gene expression requires a suitable host for the production of a specific gene product.

Contract Manufacturing 40

Contract Manufacturing Protein Manufacturing Production 40

The Pharma Data

APRIL 28, 2023

Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).

HR 40

HR FDA Approval Trials DNA 40

WCG Clinical

MAY 28, 2024

Today there are six CAR-T products with FDA approval for the treatment of multiple myeloma and B cell malignancies, with many related and next-generation products under development. CAR-T products with FDA approval for treatment of B cell lymphomas express receptors engineered to recognize CD19.

In-Vivo 40

In-Vivo Clinical Trials Clinical Trials FDA Approval 40

XTalks

AUGUST 12, 2020

Related: FDA Approves Rukobia for HIV Patients with Limited Treatment Options. Work from different fields, including evolutionary biology, suggest that there are four fundamental building blocks of life: DNA and RNA (nucleic acids), protein, lipids and sugars.

RNA 52

RNA Protein DNA In-Vivo 52

Roots Analysis

NOVEMBER 3, 2023

NAD + is involved in a wide range of cellular processes, including energy metabolism, DNA repair, and gene expression. Further, we identified the key parameters / strategies that, we believe, are likely to have a significant impact on the FDA approval of NAMPT inhibitors.

Development 40

Development Drugs Trials FDA Approval 40

The Pharma Data

DECEMBER 27, 2020

Notably, we never modify the DNA of these cells, which avoids some of the safety concerns that have been reported with certain gene-editing technologies. From these cells we apply proprietary methods to manufacture pure populations of only the cell types which we wish to use in patients.

Manufacturing 40

Manufacturing Production Development Clinical Trials 40

XTalks

DECEMBER 24, 2020

From rare disease drug approvals to treatments involving immunotherapies and gene therapies and awarding of a Nobel Prize to the inventors of the gene-editing tool CRISPR, 2020 was a year of great activity and productivity despite the backdrop of the pandemic. CRISPR Gene Editing Inventors Win Nobel Prize.

Life Science 111

Life Science Vaccination Vaccine 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 Vaccination Vaccine Research 147