Pharmaceutical Technology

FEBRUARY 13, 2023

With the latest advances in whole genome sequencing , it is increasingly clear that rare epilepsies are largely caused by a single genomic mutation, says Ferraro. New developments in the anti-seizure pipeline Genomic screenings can also be used to sharpen the efficacy of already available treatments.

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Research Gene Gene Therapy Genomics 264

Pharmaceutical Technology

JUNE 29, 2022

For example, while orphan drug designations have more than doubled in the last decade compared to the previous one, only 16% of therapies with orphan tags have managed to gain FDA approval in some indications. An orphan drug designation does not automatically translate into approval.

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Drugs FDA Approval Development Marketing 246

BioSpace

JULY 7, 2022

Last year, the FDA's Center for Drug Evaluation and Research approved 50 drugs. A new study found that 33, or 66% of them, were supported with genomic data.

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FDA Approval Genetics Genome Genomics 72

XTalks

AUGUST 18, 2020

Instead of RNA extraction, the Yale test involves use of a reagent that when mixed with a saliva sample and heated for a short period of time, releases the viral genome for subsequent detection with PCR. Last month, the FDA approved a pooled test for COVID-19 developed by Quest Diagnostics. And now it’s getting approval.

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FDA Approval Reagent RNA Genomics 90

Scienmag

OCTOBER 13, 2020

Oncotarget Volume 11, Issue 29 reported that acute myeloid leukemia is a heterogeneous malignancy with the most common genomic alterations in NPM1, DNMT3A, and FLT3. Midostaurin was the first FLT3 inhibitor FDA approved for AML and is standard of care for Credit: Correspondence to – Mara W.

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Genomics Genome FDA Approval Drugs 52

The Pharma Data

DECEMBER 17, 2020

There will be a brand-new treatment for actinic keratosis on the market next year, with Tuesday’s FDA approval of Athenix’s Klisyri® (tirbanibulin). The FDA approval of Klisyri is a significant milestone for Athenex. The new two-hour infusion time was previously approved by the European Medicines Agency (EMA) in May 2020.

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FDA Approval Genomics Genome Production 52

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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FDA Approval Genomics Genome DNA 97

Medical Xpress

DECEMBER 6, 2024

Cleveland Clinic Genome Center researchers have unraveled how immune cells called microglia can transform and drive harmful processes like neuroinflammation in Alzheimer's disease.

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FDA Approval Genome Genomics Drugs 77

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. FoundationOne Liquid CDx adds to Foundation Medicine’s genomic testing portfolio supporting Roche’s mission to deliver truly personalised healthcare.

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FDA Approval Genome Genomics Gene 52

Scienmag

MAY 19, 2021

Proprietary bioinformatics, paired with comprehensive clinical curation results in reporting that defines clinically actionable, FDA-approved, and clinical trial drug options for the management of the patient’s cancer.

Genomics 41

Genomics Genome Bioinformatics FDA Approval 41

The Pharma Data

SEPTEMBER 7, 2020

We remain committed to finding personalised treatment options for people with cancer based on specific genomic or molecular alterations, and we look forward to partnering with Blueprint Medicines to further explore the potential of Gavreto across multiple RET-altered tumour types.”.

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FDA Approval Genomics Genome Clinical Trials 52

The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. SILVER SPRING, Md. , 14, 2020 /PRNewswire/ — Today, the U.S.

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FDA Approval Genomics Genome Production 52

pharmaphorum

SEPTEMBER 16, 2022

With approximately one third of all current FDA-approved drugs targeting GPCRs, Verily/Sosei Heptares are looking to expedite GPCR research within not only immunology, but also gastroenterology and immuno-oncology as well, and the latest data bodes well for future development of therapeutic options in these areas. AI relies on data.

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Development Research Drugs Clinical Trials 135

Pharmaceutical Technology

JULY 29, 2022

In 2013, the US Food and Drug Administration (FDA) approved Ravicti (glycerol phenylbutyrate), manufactured by Hyperion Therapeutics, which has since then been acquired by Horizon Pharma. According to Bumcrot, regRNAs are “RNAs that arise out of the non-coding genome”.

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RNA Gene Expression Gene Gene Therapy 245

XTalks

FEBRUARY 21, 2025

More recently, MSN reported on a Cell Genomics study where CRISPR reactivated dormant genes in patient-derived cells, restoring normal gene expression and improving metabolic function an innovation that could address PWS at its genetic roots.

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Genetics Hormones Gene Expression Gene 59

pharmaphorum

DECEMBER 21, 2021

However, despite the work still left to be done, there are now a growing number of treatments in the pipeline and 2020 proved to be a remarkable year for orphan drug approvals, with the US FDA approving more orphan designated treatments than non-orphan drugs. The potential to leverage genomic data.

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Development Genomics Genome Drugs 98

The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. ” The findings published today (Feb.

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FDA Approval Drugs Protein In-Vitro 52

The Pharma Data

JULY 8, 2021

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. 1) as determined by an FDA-approved test. Head and Neck Squamous Cell Cancer.

FDA Approval 52

FDA Approval Containment Trials Genomics 52

Camargo

NOVEMBER 11, 2020

Approval of the Month: Companion Diagnostic for Bayer’s Vitrakvi Should Lead to Improved Patient Outcomes. In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics.

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Development Bioequivalency Generic Drugs Production 242

Pharmaceutical Technology

FEBRUARY 26, 2023

In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. But the approval came through after an FDA Advisory Committee meeting. Although research here is about 20 years old, it remains new compared to other areas like genomics, says Gilbert.

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Bacteria Trials Research Medicine 278

Pharmaceutical Technology

FEBRUARY 15, 2023

These animals have been used as a key tool in functional genomics to generate models for human diseases and to validate new drugs. The Regeneron Genetics Center (RGC) is an integrated research initiative that improves patient care by using genomic approaches to expedite drug discovery and development.

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Genetics DNA Genomics Genome 130

XTalks

JULY 19, 2021

Phosphorus, a leading preventative genomics company, has developed the first comprehensive preventative genetic test for consumers. 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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Genetics Genomics Genome Gene 98

Pharmaceutical Technology

AUGUST 16, 2022

The accelerated US Food and Drug Administration (FDA) approval of Enhertu for HER2-mutant NSCLC was based on the findings of the Phase II DESTINY-Lung02 trial, which demonstrated an impressive 57.7% overall response rate (ORR), with a median duration of response (DOR) of 8.7

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Sales Trials FDA Approval Development 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 Gene Clinical Trials 111

Pharmaceutical Technology

OCTOBER 26, 2022

Early gene therapy methods were proposed in the 1970s, and the first approved gene therapy clinical research in the US began in 1990. New doors were opened in the 2000s with the development of genome editing, such as CRISPR-Cas9, which introduces molecular tools to change existing DNA. The future of cell and gene therapies.

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Gene Therapy Gene Marketing Manufacturing 130

The Pharma Data

SEPTEMBER 6, 2020

Basel, 7 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

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FDA Approval Medicine In-Vitro Genetics 52

BioTech 365

OCTOBER 23, 2020

Detection of genomic alterations that drive the growth and spread of the tumor can guide treatment decisions for cancer therapies, including available biomarker driven treatments FoundationOne®CDx analyzes substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 … Continue reading →

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FDA Approval Genome Genomics 40

pharmaphorum

FEBRUARY 11, 2022

The subject from the initial study of RGX-111 that led to FDA approval of the phase 1/2 trial also showed better-tan-expected improvements on those skills over a follow-up period of around 20 months.

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Gene Therapy Gene Trials FDA Approval 111

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. 2012 – The 100,000 Genomics Project begins. Unlocking the secrets of the human genome has intrigued investigators for centuries. 2002 – Emergence of CAR-T therapy.

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Genome Project Genomics Genome DNA 98

Pharmaceutical Technology

MARCH 2, 2023

Keytruda is also indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma (HNSCC) (as second and first line therapy), in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent Head And Neck Cancer Squamous Cell Carcinoma (HNSCC), as a single agent (..)

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FDA Approval Containment Development Genomics 100

FDA Law Blog

MARCH 3, 2024

Biotechnology companies of concern include BGI (formerly Beijing Genomics Institute), MGI, Complete Genomics, WuXi Apptec, and any subsidiary, parent, affiliate, or successor of such entities. Office of Management and Budget (OMB) can also specify other equipment or services to be subject to the Act’s prohibitions.

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Genomics Genome Manufacturing Production 102

XTalks

AUGUST 21, 2024

IDH1 and IDH2 genes were first implicated in lower-grade gliomas in a genome-wide study by the World Health Organization (WHO). Post-surgery, many patients with lower-grade glioma show deteriorations in physical health, general health and social function, with younger patients reporting higher physical deterioration.

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Drugs Genomics Genome Clinical Trials 111

pharmaphorum

MARCH 15, 2022

. “The most pressing challenge we face in profiling biomarkers from tumour samples is the ability to keep up with the pace of new biomarkers linked to new therapies and clinical trials,” commented Rhian White, of the All Wales Medical Genomics Services in Cardiff, UK.

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Gene Genomics Genome Gene Sequencing 52

The Pharma Data

MARCH 30, 2021

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. 1] as determined by an FDA-approved test. Head and Neck Squamous Cell Cancer.

FDA Approval 52

FDA Approval Containment Trials Genomics 52

XTalks

NOVEMBER 7, 2022

These tumor-derived entities are used to derive genomic and proteomic data. Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology.

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Clinical Trials Clinical Trials Trials FDA Approval 98

The Pharma Data

JULY 6, 2021

accelerated approval indication for KEYTRUDA for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [combined positive score (CPS ?1)] 1) as determined by an FDA-approved test. 1)] as determined by a U.S.

FDA Approval 52

FDA Approval Containment Trials Genomics 52

Delveinsight

JULY 20, 2021

CytoSorbents Receives FDA Approval of Investigational Device Exemption (IDE) for US STAR-T Trial on Ticagrelor Removal During Cardiothoracic Surgery. Abbott’s XIENCE Stent Receives FDA Approval for Shortest Blood Thinner Course for High Bleeding Risk Patients. Laboratory Director for Wren.

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FDA Approval Marketing Trials Gene 96