BioPharma Reporter

FEBRUARY 25, 2021

A program at the University Hospital of TÃbingen is the first in Germany to use whole genome sequencing (WGS) to improve the diagnosis of rare diseases and hereditary cancers.

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Pharmaceutical Technology

JUNE 5, 2023

Regulators need to work together with industry to certify hot patches to quickly fix vulnerabilities while maintaining pharmaceutical quality,” adds Fracchia. Pharmacies have also received EU General Data Protection Regulation (GDPR) fines for not being in compliance,” he adds. “Right now, it’s compliance by checkbox, in a static way.

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Pharmaceutical Technology

SEPTEMBER 9, 2022

It is expected to expedite the development of a wide range of new therapeutics using the small non-coding area of the genome that is not explored. The mutations were expected to regulate biological pathways that are related to a clinical syndrome. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

MAY 25, 2023

The Yellow Card biobank will launch as a joint venture with the UK-government funded entity Genomics England on June 1. According to the press release, the MHRA will be the first drug safety regulator in the world to pilot such a biobank. Genomics England will assist the MHRA with sequencing and genetic material storage.

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Medical Xpress

FEBRUARY 13, 2023

The findings of the genome exploration study, published in The Journal of Clinical Investigation, provide insight into how heartbeats are regulated and could impact diagnosis and risk prediction for a variety of common arrhythmias.

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pharmaphorum

OCTOBER 19, 2022

million ($40 million) first-round financing that will be used to explore so-called ‘dark’ regions of the human genome. Nucleome’s platform adds 3D genomic information to a wealth of available genomic data, uncovering a new dimension of information that is disease as well as cell type-specific.

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Scienmag

APRIL 15, 2021

Epigenetic regulator HPI1a drives de novo genome reorganization in early Drosophila embryos Credit: MPI of Immunobiology and Epigenetics, F. Zenk The DNA molecule is not naked in the nucleus. This […].

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Scienmag

DECEMBER 7, 2021

A new paper in Genome Biology and Evolution, published by Oxford University Press, maps out for the first time how Hydra, which are a group of small aquatic animals, can regenerate their own heads by changing the way that their genes are regulated, known as epigenetics.

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BioTech 365

JUNE 2, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Regulation of the genome affects its 3D structure.All the cells of an organism share the same DNA sequence, but their functions, shapes or even lifespans vary greatly. … Continue reading →

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BioPharma Reporter

FEBRUARY 21, 2022

PerkinElmerâs Sirion Biotech business is teaming up with the Centre for Genomic Regulation (CGR) to jointly develop new generation adeno-associated virus (AAV) vectors for type 1 and type 2 diabetes gene therapy in the pancreas.

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BioPharma Reporter

OCTOBER 9, 2023

Congenica, a digital health company providing software and solutions for the analysis and interpretation of genomic data at scale, has announced a two-year extension to its contract for the Hong Kong Genome Project (HKGP), the first large-scale genome sequencing initiative in Hong Kong.

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BioPharma Reporter

OCTOBER 4, 2022

Alexion, AstraZeneca Rare Disease will acquire LogicBio Therapeutics, an American genomic medicine company.

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Scienmag

MAY 7, 2021

The two meters of -stretched- DNA contained in human cells are continuously twisting and untwisting to give access to genetic information: when a gene is expressed to generate a protein, the two strands of DNA are separated to give access to all the machinery necessary for this expression, resulting in an excessive accumulation of coiling […]. (..)

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Scienmag

MARCH 12, 2021

Credit: The Wistar Institute PHILADELPHIA — (March 12, 2021) — Scientists at The Wistar Institute identified a new function of ADAR1, a protein responsible for RNA editing, discovering that the ADAR1p110 isoform regulates genome […].

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Scienmag

OCTOBER 29, 2021

A decade ago, genome sequencing revealed a big surprise: about 50 percent of human cancers are linked to mutations in what are known as epigenetic regulators, which control the activity of genes.

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BioPharma Reporter

MAY 20, 2024

CRISPR licensing company ERS Genomics and drug discovery firm IRBM have entered into a non-exclusive CRISPR/Cas9 license agreement.

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BioTech 365

OCTOBER 26, 2020

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: A ‘genomic rosetta stone’ for discovering the rules of gene regulation.As

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XTalks

JULY 3, 2024

Genome Editing in Plants The FDA has also released guidance for foods derived from plants produced using genome editing. This guidance aims to address the regulatory framework and safety assessments for genome-edited plant foods, providing clarity for industry participants involved in developing these innovative products.

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Outsourcing Pharma

SEPTEMBER 14, 2023

company Rome Therapeutics plans to use the proceeds of its $72 million Series B round to take an experimental autoimmune disease treatment through early clinical testing.

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BioPharma Reporter

NOVEMBER 10, 2021

The company recently opened a manufacturing and commercial hub in Singapore, making the facility its first outside of the US.

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BioPharma Reporter

JUNE 23, 2022

BIO, the worldâs largest trade association for the biotech industry, has responded to the US Food and Drug Administration's draft guidance on developing human gene therapy products that incorporate genome editing (GE) of human somatic cells.

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BioPharma Reporter

SEPTEMBER 19, 2023

The UK startup Broken String Biosciences has raised a $15 million Series A round to fund the development of a DNA sequencing platform that maps off-target DNA breaks resulting from genome editing technology.

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Scienmag

JANUARY 11, 2022

LA JOLLA—(January 11, 2022) What determines how a cell’s genome is regulated to ensure proper growth and development? Turns out, the parts of the genome that are turned on or off in each cell-type or tissue play a major role in this process. Now, a team at Salk has shown that the CLASSY gene family […].

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Outsourcing Pharma

SEPTEMBER 12, 2023

The AstraZeneca-owned company Alexion has teamed up with Verge Genomics to deploy the U.S. startupâs drug discovery platform in the search for novel drug targets for rare neurodegenerative and neuromuscular diseases.

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BioTech 365

AUGUST 6, 2020

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Comprehensive catalogue of the molecular elements that regulate genes.A 17-year research project has generated a detailed atlas of the genome that reveals the location of hundreds of … Continue reading →

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Camargo

NOVEMBER 11, 2020

Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks. The generic drug must also have the same labeling as the RLD (except for differences permitted under the Agency regulations). for patients with NTRK fusion cancer across all solid tumors.

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pharmaphorum

DECEMBER 21, 2021

In a recent webinar held by pharmaphorum, in partnership with IQVIA, a discussion was held looking at how to make academic and commercial medical research more efficient, while also looking at the opportunity of genomic data to bring benefits to patients and healthcare systems. The potential to leverage genomic data.

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Scienmag

OCTOBER 27, 2021

The rapid scientific advancements that followed the mapping of the human genome have revealed just how staggeringly complex the world of genetics is. We now know that proteins are not just the products of genes, but that they also interact with genes, influencing and regulating the rhythm of their expression.

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BioPharma Reporter

APRIL 6, 2022

The FDA has released two draft guidance documents: for human gene therapy products incorporating human genome editing, and for CAR T cell products.

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BioTech 365

DECEMBER 8, 2021

BRAIN Biotech AG / Key word(s): Miscellaneous/Patent BRAIN Biotech AG: Additional Differentiated Genome-Editing Nuclease: BRAIN-Metagenome-Cas 01 (BMC01) 08-Dec-2021 / 14:53 CET/CEST Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by DGAP … Continue reading →

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BioTech 365

MAY 6, 2021

BRAIN Biotech AG / Key word(s): Miscellaneous BRAIN Biotech AG: First Development Phase for a novel Genome Editing Tool Completed (CRISPR Cas) 06-May-2021 / 17:54 CET/CEST Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) … Continue reading →

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XTalks

SEPTEMBER 9, 2021

The federal regulator suspended BioMarin’s currently ongoing Phase I/II studies of the gene therapy based on interim safety findings from a preclinical study which revealed that mice treated with the therapy at high doses developed tumors on their liver. The preclinical study was being conducted to assess the durability of the treatment.

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Outsourcing Pharma

NOVEMBER 1, 2023

Element Biosciences, Inc., will share news of its sequencing methodology and host a workshop on higher accuracy sequencing for improved variant detection in Washington DC from today.

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BioPharma Reporter

JULY 20, 2023

London-based precision medicine software provider Lifebit has partnered with two population genomic initiatives in Mexico and Brazil to help diversify genomic research and reduce health inequality in Latin America.

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XTalks

JULY 14, 2022

However, there is limited knowledge about the upstream regulators of most genes. Although it was expected that numerous connections exist between the genes regulating the three immune genes, the extent of the connectivity was more elaborate than initially thought. All 24 of the regulators affected the levels of IL2RA.

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pharmaphorum

APRIL 14, 2021

A coalition of European academy networks has called upon European Union (EU) leaders to rethink how General Data Protection Regulation (GDPR) rules are applied to health data. The authors said there was a “statutory conflict between EU fundamental rights and other countries’ regulation”. Multiple and complex mechanisms.

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XTalks

FEBRUARY 21, 2025

Related: Obesity-Focused Metsera Launches IPO Amid Much Anticipation Aardvarks approach centers on developing novel, small-molecule drugs that harness the bodys natural hunger-regulating mechanisms.

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