XTalks

NOVEMBER 1, 2022

Rinvoq received its sixth FDA approval, this time it is for treating adults with non-radiographic axial spondyloarthritis, a form of inflammatory arthritis that affects the spine. Photo courtesy of AbbVie. . They are chronic and progressive, meaning they will worsen over time without proper intervention.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy has also become the first targeted therapy for the dMMR positive subset of endometrial cancers.

FDA Approval 105

FDA Approval Trials Antibody DNA 105

XTalks

DECEMBER 27, 2022

Ferring Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved Adstiladrin (nadofaragene firadenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Gene Therapy 52

Gene Therapy FDA Approval Gene Clinical Trials 52

Pharmaceutical Technology

NOVEMBER 3, 2022

Trial 1092 met the primary endpoint of the percentage of subjects with HBV deoxyribonucleic acid (DNA) levels less than 20 IU/ml following 24 weeks of treatment. At 24 weeks, 21% of the participants who received 25mg Vemlidy attained HBV DNA less than 20IU/ml versus 0% in the placebo arm.

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DNA FDA Approval Clinical Trials Clinical Trials 130

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

JAMA Internal Medicine

AUGUST 27, 2023

In recent years, blood tests that look for circulating tumor DNA and biomarkers (termed liquid biopsies) have been developed. Most importantly, these blood tests are also being explored as multicancer early detection (MCED) tests for cancer screening in asymptomatic persons.

FDA Approval 76

FDA Approval DNA Clinical Trials Clinical Trials 76

The Pharma Data

MAY 18, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. MMR is a molecular mechanism that functions to correct certain errors that can spontaneously occur during DNA replication. MMR deficiency is most common in endometrial cancer. J Natl Cancer Inst.

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FDA Approval DNA Protein In-Vitro 40

XTalks

DECEMBER 21, 2023

Other Treatments for Metastatic Colorectal Cancer In August 2023, Taiho Oncology received FDA approval for Lonsurf (trifluridine and tipiracil) to be used in combination with bevacizumab in treating mCRC. This combination hinders cancer cell growth by integrating trifluridine into the DNA of cancer cells.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials DNA 52

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 may reduce the antiviral activity of ganciclovir and valganciclovir, so coadministration with these drugs is not recommended.

FDA Approval 52

FDA Approval Drugs DNA Cosmetics 52

Pharmaceutical Technology

AUGUST 5, 2022

A PARP inhibitor, Lynparza (olaparib) is said to be the first targeted therapy to hinder DNA damage response in cells/tumours with a deficiency in homologous recombination repair. The US Food and Drug Administration (FDA) approved Lynparza in March for this indication.

FDA Approval 147

FDA Approval DNA Clinical Trials Clinical Trials 147

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.

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FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

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. Related Articles: Imcivree (setmelanotide) FDA Approval History.

FDA Approval 52

FDA Approval Genetic Disease Genetics Clinical Trials 52

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 Antibody Genome 130

Drug Discovery World

JUNE 5, 2023

million. Auger emitters such as I-123 combined with a PARP inhibitor enable delivery of radionuclides to the DNA to selectively kill cancer cells whilst sparing healthy tissue, thereby offering a potentially powerful treatment option in several cancer indications. million in cash and milestone payments totalling up to $41.5

FDA Approval 52

FDA Approval DNA Production Licensing 52

The Pharma Data

DECEMBER 16, 2020

Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation. For more information, please visit www.CNSPharma.com.

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab overview Amivantamab-vmjw (Rybrevant) is a low-fucose human immunoglobulin G1-based bispecific antibody developed using recombinant DNA technology. It is formulated as solution and concentrate for solution for intravenous infusion.

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Recombinant DNA Technology Production Antibody FDA Approval 100

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?

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Recombinant DNA Technology Packaging Packaging Pharma Packaging 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.

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Gene Therapy Gene FDA Approval DNA 98

XTalks

DECEMBER 14, 2023

The US Food and Drug Administration (FDA) has approved Iwilfin (eflornithine) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have had at least a partial response to previous multiagent, multimodality therapy including anti-GD2 immunotherapy.

FDA Approval 52

FDA Approval Dermatology Drugs DNA 52

XTalks

DECEMBER 28, 2023

BillionToOne developed the UNITY Fetal Antigen CTA to assist in J&J’s AZALEA trial, and the US Food and Drug Administration (FDA) approved an investigational device exemption for it in April, enabling its use in the trial. The UNITY Fetal Antigen CTA is just one of the many applications of our QCT technology’s capabilities.”

Trials 97

Trials Clinical Trials Clinical Trials Antibody 97

Drug Discovery World

OCTOBER 10, 2023

Read more: Another milestone achieved in major depressive disorder trial More accessible treatment The US Food and Drug Administration (FDA) approved Sage Therapeutics’ Zurzuvae (zuranolone) in August, making it the first oral medication indicated to treat postpartum depression (PPD) in adults.

Drugs 57

Drugs Gene Expression Gene Immune Response 57

Pharmaceutical Technology

FEBRUARY 14, 2023

Among maturing innovation areas are controlled drug release devices, and DNA nanoprobes, which are now well established in the industry. In 2005, the FDA approved Bristol-Myers Squibb's Abraxane, a PX albumin-bound nanoparticle formulation with 130nm particles, for treating metastatic breast cancer.

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Drug Delivery Drugs Drug Delivery Systems FDA Approval 147

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

Drug Discovery World

DECEMBER 21, 2023

A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years. DDW Multimedia Editor Megan Thomas explored three trends in the market.

Gene Therapy 57

Gene Therapy Gene Antibody FDA Approval 57

Drug Discovery World

AUGUST 14, 2023

For instance, in a trial where patients are selected based on a specific human leukocyte antigen (HLA) type, the FDA requires the use of a fully certified, FDA approved Companion Diagnostic. The EMA, however, doesn’t require the use of an agency-approved diagnostic.

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Gene Therapy Marketing Gene DNA 52

XTalks

MARCH 16, 2022

Cologuard is a non-invasive stool-based DNA screening test approved by the US Food and Drug Administration (FDA) for adults 45 and older who are at average risk for colon cancer. It detects altered DNA and/or blood in stool and finds 92 percent of colon cancers.

DNA 98

DNA FDA Approval Doctors Doctor 98

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

Drug Discovery World

OCTOBER 18, 2023

Food & Drug Administration (2017) FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss. Food & Drug Administration (2019) FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality.

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Gene Therapy Gene Clinical Trials Clinical Trials 62

Drug Discovery World

FEBRUARY 7, 2024

Referencing the unmet potential for both genomic medicine, as well as the interest in cell-free DNA markers, particularly for early detection of cancers, he goes on to share the hopefulness that proteomics will do better. He elaborates in the podcast.

Medicine 57

Medicine Protein FDA Approval DNA 57

Roots Analysis

DECEMBER 10, 2023

Diagnosis Methodology The blood test operates on a revolutionary mechanism, detecting the presence of cell-free DNA (cfDNA) released by neurons in the brain during cell death. The implications of such accuracy are monumental, potentially paving the way for earlier interventions and improved patient outcomes.

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DNA FDA Approval Research Doctors 40

Drug Discovery World

SEPTEMBER 7, 2023

5 The Research to Accelerate Cures and Equity (RACE) for Children Act of 2017 authorised the Food and Drug Administration (FDA) to require paediatric clinical trials for new oncology drugs with relevant molecular targets and has a had a positive impact on the number of drugs approved in paediatric indications.

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Drugs Clinical Trials Clinical Trials Trials 57

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

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer.

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

pharmaphorum

OCTOBER 27, 2022

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. It can be caused by different types of mutation, including within the BRCA gene and other forms of altered gene expression.

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Trials DNA Genome Genomics 94

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

Drug Discovery World

MARCH 7, 2023

Dr Emily Leproust, Founder and CEO, Twist Biopharma In 2015, Dr LeProust was named one of Foreign Policy’s 100 Leading Global Thinkers for fast-tracking the building blocks of life, and Fast Company named her one of the most creative people in business for synthesising DNA faster than ever. She has published over 30 peer-reviewed papers.

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Life Science DNA Clinical Development Development 98

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