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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The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel, advancing the company’s commitment to personalised healthcare through tests that determine which patients are most likely to benefit from specific and targeted therapies. today announced U.S. Source link: [link].

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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.

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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.

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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.

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The Pharma Data

AUGUST 27, 2020

Cancer is a disease of the genome, driven by genetic mutations within a tumour’s DNA. FoundationOne Liquid CDx analyses circulating cell-free DNA from a patient’s blood sample and uses massively parallel sequencing to detect the four main classes of genomic alterations.

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FDA Approval Genomics Genome Gene 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.

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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.

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Pharmaceutical Technology

OCTOBER 26, 2022

Gene therapy uses DNA to manipulate cells and correct defective genes, whereas cell therapy is the infusion or transplantation of cells into a patient. Early gene therapy methods were proposed in the 1970s, and the first approved gene therapy clinical research in the US began in 1990. The future of cell and gene therapies.

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pharmaphorum

MAY 25, 2022

After more than six years of development, Angle has scored an FDA approval for Parsortix as a diagnostic for metastatic breast cancer – the first ever in the US for a device used to detect cancer by harvesting cells from a patient blood sample. The post Angle claims FDA okay for Parsortix liquid biopsy system appeared first on.

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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.

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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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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.

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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.

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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.

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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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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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The Pharma Data

SEPTEMBER 15, 2020

New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs. HPV DNA screening identifies women at risk for cervical cancer by detecting the presence of high-risk HPV DNA in cervical samples.

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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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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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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.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Keytruda is the only FDA-approved immunotherapy available to treat cervical cancer. Apart from checkpoint inhibitors, other approaches like DNA vaccines to treat cervical cancer also made an appearance at the Congress. At the time, the companies had stated that discussions with ex-US agencies were ongoing.

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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.

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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.

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FDA Approval Clinical Trials Clinical Trials DNA 52

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).

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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.”.

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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.”

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XTalks

OCTOBER 4, 2024

The original Cologuard test allowed patients to test at home without special preparation, identifying DNA markers and blood in stool linked to CRC and precancer. Modeling data over the past decade indicated that it had detected more than 623,000 cancers and precancers, likely saving the US healthcare system an estimated $22 billion.

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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.

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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.

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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.

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XTalks

DECEMBER 20, 2023

This year, the very first CRISPR-based therapy received FDA approval for sickle cell disease. The approval was awarded to Vertex Pharmaceuticals and CRISPR Therapeutics’ jointly developed Casgevy (exa-cel).

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Pharmaceutical Technology

NOVEMBER 22, 2022

326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). An imbalance between supply and demand of plasmid DNA — a key raw material in mRNA production — has also become a bottleneck. .

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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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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.

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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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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.

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