FDA Law Blog

OCTOBER 24, 2024

Rather, developers of diagnostic tests and, indeed of any product that relies on free access to gene sequence and other biomarker information, should pay also close attention, as PERA would overturn longstanding judicial precedent. animal, viral, bacterial) DNA and RNA sequences. Supporters of AMP v.

Gene 62

Gene DNA Genetics Gene Sequencing 62

pharmaphorum

FEBRUARY 23, 2022

Interest in non-viral methods of delivering gene therapies has been growing in the face of current scrutiny of the safety of viral vectors like adeno-associated viruses (AAV), with a number of clinical programmes based on AAV under clinical holds imposed by the FDA.

Gene Therapy 105

Gene Therapy Gene Gene Sequencing Immune Response 105

pharmaphorum

AUGUST 21, 2020

Cambridge, UK-based Biofidelity has raised $12 million in first-round funding for its cancer diagnosis platform, which can detect mutations quicker than current approaches like gene sequencing. Both previously worked at Cambridge-based DNA sequencing specialist Base4 Innovation, where the technology was developed.

DNA 59

DNA Gene Sequencing Genetics FDA Approval 59

Roots Analysis

FEBRUARY 23, 2022

Further, NGS library preparation kits offer several benefits, such as low requirement of starting material, generation of longer RNA / DNA sequences and production of superior quality nucleotide libraries, thereby, catering to existing unmet needs of the research domain. Next Generation Sequencing (NGS) Library Preparation Kits.

Genetics 52

Genetics DNA RNA Reagent 52

pharmaphorum

AUGUST 10, 2021

The decision was taken by the UUS regulator after a case of a rare blood cancer (myelodysplastic syndrome) was seen in a patient treated with Skysona that probably arose as a result of the lentiviral vector used to deliver the gene therapy.

Gene Therapy 135

Gene Therapy Gene Marketing Genetic Disease 135

pharmaphorum

FEBRUARY 22, 2021

That therapy uses an adeno-associated virus (AAV) as a vector rather than a lentivirus, a vector type that features in approved gene therapies such as Roche’s Luxturna and Novartis’ Zolgensma. million in Europe.

Gene Therapy 52

Gene Therapy Gene Gene Sequencing Gene Expression 52

pharmaphorum

OCTOBER 1, 2021

Shares in DNA sequencing specialist Oxford Nanopore rocketed after the company made its debut on the London Stock Exchange yesterday, rising nearly 50% to propel its valuation up towards the £5 billion ($6.7 billion) mark.

Marketing 52

Marketing Genome Genomics Business Development 52

Pharmaceutical Technology

MAY 26, 2023

Enzymatic DNA production company Touchlight have augmented its DNA production capabilities with a newly announced expansion to its London facilities. Tripling its production capacity, Touchlight can now manufacture 8kg plasmid DNA, a key component for mRNA gene therapies and vaccines.

DNA 130

DNA Manufacturing Gene Gene Therapy 130