PLOS: DNA Science

SEPTEMBER 5, 2024

A Brief History of Targeted Cancer Drugs In 1978, FDA approved the first targeted cancer drug, tamoxifen. The FDA approved Herceptin , targeting a different receptor (HER2) in breast cancer cells, in 1998. Keytruda illustrates more recently approved cancer drugs. More information enables more treatment choices.

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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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Drug Target Review

JANUARY 8, 2024

Modifications to the epigenome, such as DNA hypermethylation, modify the expression of genes by increasing or decreasing their expression without altering the genes themselves. One way we are doing this at Life Biosciences is through partial epigenetic reprogramming. The epigenome drifts with age, leading to dysregulated gene expression.

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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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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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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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PLOS: DNA Science

JANUARY 4, 2024

The end-of-year FDA approval of the first CRISPR-based therapy , for sickle cell disease, came a mere dozen years after Jennifer Doudna and Emmanuelle Charpentier introduced the technology. One of the first FDA-approved gene therapies was to treat LCA2, another form of retinal blindness. It restores vision in just days.

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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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Agency IQ

JULY 21, 2023

The next chapter in the ctDNA story: Still promising, not ready for prime time A recent workshop summed up the state of play for circulating tumor DNA.

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Codon

AUGUST 26, 2024

DNA delivered to the nose or lungs can express an encoded protein for months to over a year in mice if the vector—the “backbone” of DNA-based medicines controlling the level and timing of expression of the encoded protein—is specifically engineered to be long-lasting. PCANS can be freely purchased online.

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Codon

NOVEMBER 3, 2024

Some fluoroquinolones — a class of antibiotics that inhibits DNA replication — may even cause psychosis. Food and Drug Administration (FDA)-approved drug library, some of which inhibit E. Their algorithm works by discerning which chemical structures are likely to inhibit E. coli bacteria from growing.

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Drug Target Review

MAY 14, 2024

Which natural agonists impede the activation of intracellular DNA sensors in APCs, and what challenges do they pose? Since cancer cells are under chronic stimulation of ER stress, the polypeptides cannot activate innate immune sensors in cancer cells even upon the polypeptide treatment.

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Broad Institute

OCTOBER 11, 2023

As a first step, Manguso set his sights on treatments called PD-1 checkpoint inhibitors, which at the time had shown tremendous promise in clinical trials and would receive their first FDA approval in 2014. They are used to treat cancers including melanoma and non-small cell lung cancer, but work only for a small fraction of patients.

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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.

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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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Codon

MAY 22, 2023

And experiments at Tune Therapeutics showed that CRISPR epigenome editing — which doesn’t cut DNA at all, but merely silences genes by adding chemical groups to them — can curb “bad cholesterol” by more than 50% in monkeys. These tools do not cut or nick DNA, and so they may be safer than other options.

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Molecule Blog

AUGUST 13, 2021

If successful, this work could result in the repurposing of several FDA-approved therapeutics for the purpose of extending the human lifespan, at a lower cost and over faster timelines than conceivably possible with de novo drug discovery. The Scheibye-Knudsen lab has analyzed 1.5 billion prescriptions from 4.8

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FDA Approval DNA Small Molecule FDA 52

Broad Institute

JULY 26, 2022

Learn more Drug Repurposing Hub A curated and annotated collection of FDA-approved drugs, clinical trial drugs, and pre-clinical tool compounds. Learn more Genome Analysis Toolkit (GATK) Industry standard for identifying SNPs and indels in germline DNA- and RNA-seq data.

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Compound Screening FDA Approval Engineering RNA 52

PLOS: DNA Science

OCTOBER 17, 2024

FDA approved a treatment for type 3 of the ultra-rare genetic disease September 20. The new drug is taken with miglustat , which FDA approved for use in NPD3 in 2009. The original approved was in 2003 to treat a type of Gaucher disease. Until today, there were no approved therapies in the US.

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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).

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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. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. Merck’s Focus on Cancer.

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DNA Clinical Trials Trials Therapies 52

Codon

MAY 18, 2023

shelves, it’s easy to find DNA in the air , and some weird insect cybernetics. 2/ Your DNA is Everywhere. A study published Monday in Nature Ecology & Evolution shows that tiny amounts of human DNA, shed into the soil or air, can be easily detected using little more than a $1,000 Nanopore MinION. Read more in WIRED.

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Codon

MAY 18, 2023

shelves, it’s easy to find DNA in the air , and some weird insect cybernetics. 2/ Your DNA is Everywhere. A study published Monday in Nature Ecology & Evolution shows that tiny amounts of human DNA, shed into the soil or air, can be easily detected using little more than a $1,000 Nanopore MinION. Read more in WIRED.

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DNA Therapies Engineering Virus 52

Codon

APRIL 2, 2023

But now, by studying DNA extracted from microbes in the blood of almost 10,000 healthy people, this paper shows that there is no such thing. Read Transcription factors bind to DNA and control gene expression. Read Switchable hydrophobic pockets in DNA protocells enhance chemical conversion. Nature Microbiology. Meeussen J.V.W.

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DNA RNA Engineering Licensing 52

Codon

MAY 22, 2023

And experiments at Tune Therapeutics showed that CRISPR epigenome editing — which doesn’t cut DNA at all, but merely silences genes by adding chemical groups to them — can curb “bad cholesterol” by more than 50% in monkeys. These tools do not cut or nick DNA, and so they may be safer than other options.

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DNA Engineering Science Trials 52

Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. 2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases.

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PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Historically, the available drugs and U.S.

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Alta Sciences

APRIL 17, 2024

Several viral vectors are being used currently, in addition to non-viral vectors, such as oligonucleotides, naked DNA, and lipoplexes and polyplexes. Technologies for somatic gene modification (replacing or inactivating defective genes) are advancing in sophistication and applicability, with CRISPR being the most recent. Asia, and Europe.

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The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin.

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Vial

DECEMBER 5, 2023

In 2017, the Food & Drug Administration (FDA) approved the first gene therapy for cancer and for inherited diseases, the first multiplex NGS panel for companion diagnostics (CDx), and the first drug targeting a genetic signature though not a disease.

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sptlabtech

JUNE 27, 2022

Farruk Kabir | NGS Lab Manager | Aperture NextGen Laboratories Aperture NextGen Laboratories is an FDA approved CLIA lab for interdisciplinary clinical testing and research. "For the last couple of years, we've been Covid testing and have been very successful with the SPT Labtech liquid handlers."

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Laboratories FDA Approval RNA FDA 52

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).

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The Pharma Data

MAY 7, 2021

Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). WHO approves emergency use of China’s Sinopharm Covid vaccine ( FT ). AZ’ Tagrisso first to win MHRA approval under Project Orbis ( PharmaTimes ) ( Pink Sheet ) ( MHRA ).

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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 Source: GSK .

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Codon

MARCH 24, 2024

Water accounts for 70 percent of a bacterium by mass; the other 30 percent includes everything else: proteins, RNA, DNA, lipids, and so on. Experiments around using genetically modified organisms to produce proteins have been taking place since the earliest days of the recombinant DNA revolution.

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The Pharma Data

JUNE 30, 2021

Mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

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Treatment Trials FDA Approval Disease 52

The Pharma Data

JULY 15, 2021

In 2019, the US Food and Drug Administration (FDA) approved ruxolitinib (marketed by Incyte Corporation in the US as Jakafi ® ) for the treatment of steroid-refractory acute GvHD in adult and pediatric patients 12 years and older, based on results of the single-arm Phase II REACH1 trial 6. Jakavi vs. 16.5%

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