Pharmaceutical Technology

FEBRUARY 13, 2023

Gene therapies are an attractive way of targeting the underlying genetic mutations, but traditional approaches cannot be used while targeting mutations for Dravet Syndrome, forcing researchers to develop new ways. Meanwhile, others are researching the link between gene variation and different responses to treatments.

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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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Pharmaceutical Technology

JULY 29, 2022

However, in patients with urea cycle disorders, genetic defects result in inadequate amounts of the enzymes needed to convert nitrogen into urea. 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.

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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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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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FDA Law Blog

MARCH 3, 2024

Biotechnology equipment includes genetic sequencers, mass spectrometers, polymerase chain reaction machines or any other equipment, components or accessories designed for the research, development, product, or analysis of biological materials as well as any software, firmware, or other digital components. China, Russia, Iran or North Korea).

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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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XTalks

DECEMBER 20, 2023

Given its ability to precisely edit genes, there is tremendous promise for the revolutionary technology to offer cures for genetic disorders and to treat various diseases. This year, the very first CRISPR-based therapy received FDA approval for sickle cell disease.

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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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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

DECEMBER 22, 2022

The company is a clinical-stage biopharmaceutical startup that uses its artificial intelligence (AI)-enabled platform to measure brain biomarkers, including electroencephalogram (EEG) activity and behavioural patterns, wearable data, genetics and other factors, to drive targeted drug development in mental health.

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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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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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XTalks

MARCH 28, 2024

For CRC, treatment options that are targeting genetic mutations such as BRAF , KRAS and HER2 have been developed. Gene Editing and CAR T-Cell Therapy Genetic engineering technologies, such as CRISPR-Cas9, are providing newer potential avenues for cancer treatment. Yang Liu and CFO Abid Ansari – Xtalks Life Science Podcast Ep.

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Camargo

DECEMBER 10, 2021

Biomarin’s stock shot up after the drug was first approved in the EU this past August, and on the day the news broke of the FDA approval, the stock improved 10.3%. Subsequent revisions of the document reflect the experience gained as gene therapy products of this type have been approved.

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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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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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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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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. Depending on the findings of the FDA’s probe, the agency could require the risk to be included in a black-box warning, which is the highest safety alert level on a drug label.

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XTalks

DECEMBER 24, 2020

From isolating SARS-CoV-2 in early January to sequencing its genome shortly thereafter and having a prototype vaccine against it within days, scientific process and progress have held steadfast throughout the pandemic. Infectious disease expert, epidemiologist and director of the Yale Institute for Global Health at Yale University, Saad B.

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XTalks

SEPTEMBER 12, 2023

Biomedical Research and Technologies: Get access to the most recent biomedical research news from both industry and academia, including preclinical studies and technological breakthroughs in genomics, single cell analysis, proteomics, metabolomics and much more.

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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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XTalks

MARCH 25, 2021

Ayesha obtained an MSc in Cancer & Genetics from McMaster University and a PhD in Medical Biophysics from the University of Toronto. Topics will include technologies for vaccine development, genetic tools such as CRISPR, gene therapies and more.

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Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. CAR T cells are T cells that have been trained to attack tumours.

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Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

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XTalks

OCTOBER 26, 2023

The US Food and Drug Administration (FDA) approved new updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna that target the Omicron XBB.1.5 In May, the FDA approved GSK’s Arexvy as the first RSV vaccine, which was shortly followed by the approval of Pfizer’s RSV vaccine Abrysvo.

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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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Drug Discovery World

AUGUST 1, 2023

The NIH states: “This natural mechanism for sequence-specific gene silencing promises to revolutionise experimental biology and may have important practical applications in functional genomics, therapeutic intervention, agriculture and other areas.” There are many examples of ways in which RNAi is impacting drug discovery.

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XTalks

FEBRUARY 27, 2024

There have been significant advancements in new rare disease drugs, particularly for genetic disorders that can be treated by correcting, replacing or silencing defective genes. In 2020, 31 out of 53 novel drug approvals were for rare or orphan diseases​​.

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pharmaphorum

DECEMBER 7, 2021

The researchers from the Cleveland Clinic discovered the association between Viagra and a lower risk of Alzheimer’s as part of a wide-ranging study that looked at more than 1,600 FDA-approved medicines to try to find drugs that could be re-purposed as dementia therapies.

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Drug Discovery World

APRIL 17, 2023

There are a lot of tools that we know have reduced cancer death rates substantially for specific cancers, and if those are used more broadly, with greater access, we feel that this ambitious goal might be achievable,” said Dr Meredith Shiels of NCI’s Division of Cancer Epidemiology and Genetics, who led the study.

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XTalks

APRIL 24, 2023

Approximately 72 percent of rare diseases are genetic, and around 70 percent of rare genetic diseases emerge in childhood. Out of over 7,000 rare diseases, only 5 percent (or less) of rare diseases are thought to have approved treatment options, known as “orphan” therapies.

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Drug Discovery World

MAY 11, 2023

May 2021 marked a milestone in that regard, as the US FDA approved an investigational new drug (IND) application for a pharmaceutical company that ran HCP analysis for their virus-like particle-based vaccine booster using only mass spectrometry data from Alphalyse.

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