BioSpace

DECEMBER 17, 2020

Food and Drug Administration (FDA) had several approvals this week. Read on to see what the regulatory agency gave the go-ahead to.

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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.

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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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Drug Discovery World

FEBRUARY 2, 2023

The approval of elacestrant is welcomed as it offers a novel option for patients with ER+, HER2- metastatic breast cancer.

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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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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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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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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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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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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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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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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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Drug Discovery World

APRIL 4, 2023

Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February. This made Jesduvroq is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to be approved in the US.

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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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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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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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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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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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Drug Discovery World

JULY 7, 2023

In other headline news, the FDA approved the first cellular therapy for type 1 diabetes which could allow some patients to become insulin-independent, and a new study linked severe Covid-19 outcomes with high levels of antibiotics use.

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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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Drug Discovery World

JULY 10, 2023

In other headline news, the FDA approved the first cellular therapy for type 1 diabetes which could allow some patients to become insulin-independent, and a new study linked severe Covid-19 outcomes with high levels of antibiotics use.

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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.

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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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pharmaphorum

SEPTEMBER 12, 2022

This reach allows us to support 82% of the novel drugs and therapeutic products approved by the US FDA, including 63% of those specific to oncology,” Reddy states. The test informs HCPs through a comprehensive genomic and immune profiling test clinically and analytically validated for all solid tumours. Tailored oncology.

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Drug Discovery World

SEPTEMBER 14, 2023

In May 2023, Pfizer announced the FDA approval Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older. Read about more recent corporate appointments here.

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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.

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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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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.” The most common adverse reactions (?25%)

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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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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. BRCA mutation (BRCAm) can be inherited or acquired. Ovarian cancer is the eighth most common cancer in women worldwide.

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Drug Discovery World

MARCH 16, 2023

With a maturing clinical pipeline, many FDA-approved treatments are on the horizon. genomics, transcriptomics, proteomics, metabolomics) to identify the critical determinants of success. The cell and gene therapy (CGT) market is rapidly expanding, and projections suggest it will reach over $90B by 2023.

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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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Pharmaceutical Technology

DECEMBER 22, 2022

Sanofi wins the Product Launches award this year following the further development of its Dupixent (dupilumab) product and a string of approvals. In May the drug became the first medicine available in the US for eosinophilic oesophagitis following approval.

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Drug Discovery World

SEPTEMBER 14, 2023

8 On August 29, Janssen submitted a supplemental New Drug Application (sNDA) to the FDA seeking full approval of erdafitinib in this indication based on Cohort 1 of the Phase III THOR study. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. N Engl J Med 2019; 381(4):338-348. Fernandez E, et al. J Clin Med.

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Advarra

JULY 5, 2022

The results of glucose monitoring with a continuous glucose monitor (GCM) already approved by the Food and Drug Administration (FDA) is an example of a validated result. Conversely, a CGM not yet FDA-approved assessed in the study for reliability, would yield an investigational result.

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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. The vectors can potentially cause cancer by inserting genetic material into a patient’s genome, particularly near cancer-related DNA sequences or suppressors​​​​.

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The Pharma Data

JANUARY 17, 2021

We are pleased to announce this partnership with VHIO which will bring liquid biopsy comprehensive genomic testing to more cancer patients in Spain and beyond,” said Helmy Eltoukhy, Guardant Health CEO. Guardant Health has achieved CE mark approval as well as U.S.

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