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.

FDA Approval 111

FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

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​​​​.

Gene Therapy 69

Gene Therapy Gene Clinical Trials Clinical Trials 69

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

Drugs 246

Drugs FDA Approval Marketing Development 246

Pharmaceutical Technology

OCTOBER 26, 2022

The biotherapeutics market is rapidly growing, with 2021 seeing the highest-ever cell and gene therapy approval number. Gene therapy uses DNA to manipulate cells and correct defective genes, whereas cell therapy is the infusion or transplantation of cells into a patient.

Gene Therapy 130

Gene Therapy Gene Marketing Manufacturing 130

pharmaphorum

FEBRUARY 11, 2022

Data from the first patients enrolled into Regenxbio’s trial of its gene therapy for rare inherited disease mucopolysaccharidosis type I (MPS I) – also known as Hurler syndrome – has shown the first signs of clinical activity. The post Regenxbio expands MPS I gene therapy trial after first look at data appeared first on.

Gene Therapy 111

Gene Therapy Gene Trials FDA Approval 111

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.

Drugs 59

Drugs Vaccination Vaccine Medicine 59

Delveinsight

DECEMBER 15, 2020

The initial data from the trial demonstrated no statistically significant reduction in the number of hospitalized COVID-19 patients receiving ruxolitinib plus SoC therapy who experienced severe complications including death, mechanical ventilation or ICU care by Day 29, compared to SoC treatment alone.

Vaccination 54

Vaccination Vaccine Gene Therapy Gene 54

Pharmaceutical Technology

FEBRUARY 13, 2023

Although recently approved drugs can treat seizures more safely, they do not treat the comorbidities that patients experience. Several biotech companies and researchers are now exploring medical devices and gene therapies to address not just common forms of epilepsy, but also rare conditions such as Dravet Syndrome.

Research 264

Research Gene Gene Therapy Genome 264

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. Cancer cells and tumours behave differently than normal cells and have changes in their genes that make them different from an individual’s normal cells.

Genome 105

Genome Genomics Clinical Trials Clinical Trials 105

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. The US Food and Drug Administration (FDA) has approved a number of new rare disease drugs in recent years, including gene therapies.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Gene-based therapeutics and vaccines hold immense potential for more efficient and personalised treatment and prevention of complex diseases.

Production 52

Production Gene Protein Vaccination 52

Drug Discovery World

AUGUST 10, 2022

Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. CAR T cells are T cells that have been trained to attack tumours.

Manufacturing 98

Manufacturing Gene Genome Genomics 98

XTalks

DECEMBER 20, 2023

CRISPR Gene Editing Therapeutics CRISPR/Cas-9 technology makes lists like this almost every year, and for good reason. 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.

Life Science 119

Life Science Gene Editing Development Clinical Trials 119

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.

Life Science 105

Life Science Branding Clinical Trials Clinical Trials 105

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.

Development 176

Development Genetics Production Clinical Trials 176

XTalks

MARCH 25, 2021

Biomedical Research and Technologies : Presenting the latest biomedical research from both industry and academia, including preclinical studies as well as technological innovations in genomics, single cell analysis, proteomics, metabolomics and much more.

Life Science 105

Life Science HR Clinical Trials Clinical Trials 105

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. CRISPR Gene Editing Inventors Win Nobel Prize. The illness was later named coronavirus disease 2019 (COVID-19).

Life Science 111

Life Science Vaccination Vaccine Gene 111

The Pharma Data

AUGUST 11, 2020

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

MAY 5, 2021

FDA approves 100th monoclonal antibody product ( Nature Reviews Drug Discovery ). Affinia Therapeutics raises $110 million for gene therapy treatments ( STAT ). New variant-hardy AbCellera-Lilly mAb shows utility of viral genomics surveillance ( BioCentury ). Medtech.

Vaccination 52

Vaccination Vaccine Gene Therapy Contract Packaging 52