Pharmaceutical Technology

APRIL 25, 2023

sCFH is an engineered and improved version of complement factor H (CFH) that can fit into adeno-associated virus (AAV) vectors with solid expression and applications confirmed in cultured human cells in vitro, in addition to various preclinical animal models in vivo. The firm will also receive single-digit royalties on net sales.

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In-Vivo In-Vitro Sales Engineer 130

FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

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Regulation Compliance Engineer Manufacturing 40

The Pharma Data

MARCH 18, 2022

Columbia Engineering researchers report that they have developed a “cloaking” system that temporarily hides therapeutic bacteria from immune systems, enabling them to more effectively deliver drugs to tumors and kill cancer cells in mice. Sheng Professor of Biomedical Engineering. ” An Effective On/Off Switch.

Bacteria 52

Bacteria Engineer Drugs Research 52

FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

Regulation 40

Regulation Compliance Engineer Manufacturing 40

Advarra

AUGUST 10, 2023

Gene therapy has achieved notable successes, particularly in treating resistant or refractory B cell leukemias (achieving overall response rates around 90% or greater) and the speed with which COVID-19 vaccines were developed under the original Operation Warp Speed. Why Warp Speed for Rare Diseases? What is the FDA Proposing to do?

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Gene Therapy Development Gene Drugs 52

Scienmag

APRIL 19, 2021

Credit: Nina Brooks Like superheroes capable of seeing through obstacles, environmental regulators may soon wield the power of all-seeing eyes that can identify violators anywhere at any time, according to a new Stanford University-led study.

Regulation 54

Regulation Research Engineer Development 54

FDA Law Blog

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. During her FDA tenure, Ms. Gibbs , HP&M Director.

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In-Vitro Engineer Production Regulation 59

Pharmaceutical Technology

MAY 4, 2023

Led by Columbus Venture Partners, the financing round has seen the participation of existing investors the Centre for the Development of Industrial Technology (CDTI), AdBio Partners and Invivo Capital. New investors Sound Bioventures, Hadean Ventures and the European Innovation Council (EIC) fund have also participated.

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Clinical Trials Clinical Trials Trials Protein 130

Pharma Marketing Network

OCTOBER 31, 2023

These strategies include creating an engaging website, optimizing for search engines, developing digital marketing campaigns, and leveraging customer data to personalize the user experience. Additionally, businesses must ensure that their website is secure and compliant with industry regulations.

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Sales Engineer Regulation Marketing 52

Drug Discovery World

NOVEMBER 27, 2023

Across the biotherapeutics workflow The landscape of large molecule drug development has evolved significantly in recent decades. Technological innovations supporting discovery and development stages have concentrated on both upstream and downstream aspects of the workflow. This article is sponsored by Revvity.

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Production Engineer Gene Editing Gene 59

Pharmaceutical Technology

DECEMBER 8, 2022

Under the prior deal, Daiichi Sankyo acquired exclusive rights for the development, manufacturing and commercialisation of Yescarta in Japan. Regulators in Japan have granted approval for the manufacturing plant of Kite in El Segundo, California, US, to produce Yescarta for the Japanese market.

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Licensing Licensing Gene Therapy Gene 305

Drug Discovery World

JANUARY 26, 2023

DDW Editor Reece Armstrong takes a look at the pharmaceutical research and development market in 2023 and asks key opinion leaders what challenges and trends will emerge throughout the year. billion showed the pharma giant taking further steps into the oncology market and developing its speciality medicines vaccines portfolio.

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Development Drugs Clinical Trials Clinical Trials 98

Roots Analysis

AUGUST 31, 2023

Type of Gene Regulation Based on the type of transcription factor ( activators / repressors ), gene regulation has been categorized into positive and negative gene regulation. Negative Gene Regulation: Repressor is a protein molecule that initiates negative regulation.

Gene 40

Gene Gene Therapy Gene Expression Regulation 40

Drug Discovery World

DECEMBER 18, 2023

University College London (UCL) researchers have developed a new gene therapy to cure focal cortical dysplasia, which a new study shows can significantly reduce seizures in mice. Focal cortical dysplasia is caused by areas of the brain that have developed abnormally and is among the most common causes of drug-resistant epilepsy in children.

Gene Therapy 105

Gene Therapy Gene Regulation Engineer 105

Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. Cameron Ross, SVP, Generative AI, Elsevier “AI has the potential to dramatically shorten one of the most costly areas of early drug development – small molecule discovery.

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Genome Genomics Life Science Gene Therapy 139

Drug Discovery World

NOVEMBER 13, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Ali Madani, PhD, Founder and CEO, Profluent Bio, on: ‘Protein engineering with large language models’.

Protein 59

Protein Antibody Engineer Scientist 59

Drug Discovery World

JULY 11, 2023

Drug discovery and development timelines can span 10-15 years or more from initial discovery to market approval and typically require the analysis of massive amounts of data. How AI and ML are influencing drug development Biopharma has experienced significant growth in using these technologies for the past 10 years.

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Big Data Development Life Science Drugs 40

XTalks

SEPTEMBER 22, 2020

MIT engineers have designed a food sensor , made from an array of silk microneedles, that can pierce through the plastic packaging of foods to sample for bacterial contamination and spoilage. The Velco-like device pierces the packaging and the food via silk microneedles that suck in material through capillary action.

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Contamination Scientist Development Bacterium 98

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies have also entered the social media marketing domain in compliance with governmental regulations to communicate directly with patients using covert persuasion methods such as collaboration with social media influencers. Discover the leading direct-to-consumer pharmaceutical marketing companies.

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Marketing Compliance Doctors Doctor 130

XTalks

JULY 14, 2022

However, there is limited knowledge about the upstream regulators of most genes. The maps provide valuable insight into immune cell function and the development of autoimmune diseases. They found that many of the regulators controlled each other through numerous interconnected feedback loops. Impact for Patients.

Gene 98

Gene Regulation Protein Gene Editing 98

The Pharma Data

OCTOBER 26, 2020

This work complements the Company’s own development work currently being undertaken. This additional extension of the collaboration will allow us to choose the best CDX antibody for pre-clinical and clinical development.” ” Market Abuse Regulation (MAR) Disclosure. [link]. .

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Development Antibody Engineer Production 40

The Pharma Data

MAY 3, 2021

Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Continuous professional development. Many in the regulatory profession have transitioned from an established previous career such as engineering, law, or bench research.

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Development Contamination In-Vitro Production 52

FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. By Adrienne R. Design controls (21 C.F.R.

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Compliance Marketing Regulation Development 98

The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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Antibody Development Licensing Licensing 40

Drug Discovery World

NOVEMBER 16, 2022

They regulate tissue repair and regeneration, organ development, and immune response to disease but remain understudied by biopharma due to low abundance, higher structural complexity, and the massive search space to map secreted proteins to disease-reversing effects in specific target cells across human organs.

Protein 52

Protein Engineer Immune Response Insulin 52

Pharmaceutical Technology

APRIL 5, 2023

This includes the first potential approval of a CRISPR-based gene therapy called exa-cel , which is developed by CRISPR Therapeutics and Vertex Pharmaceuticals. It’s a multifaceted issue and we perhaps need to go beyond our comfort zone in science and clinical development to understand what barriers patients are really facing.

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Gene Therapy Gene Engineer Production 147

Drug Discovery World

AUGUST 1, 2023

Synthetic biology is increasingly important to drug discovery and development. Partnerships Earlier this year cell-engineering company MaxCyte signed a strategic platform license (SPL) with biotechnology company Catamaran Bio. In return MaxCyte will receive platform licensing fees and program-related revenue.

Drugs 52

Drugs Gene Expression Engineer Gene 52

Pharmaceutical Technology

FEBRUARY 16, 2023

Stringent government regulations and the growing need for uncompromised quality have further encouraged demand. It will need superior flexibility, functionality, higher speeds for precise measurement, and improved real-time testing, driving the market for the development of better testing and measurement equipment.

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Engineer Manufacturing Containment Production 130

Drug Discovery World

FEBRUARY 27, 2024

The epigenome is a system of reversible marks that regulate how the DNA is read, translated, and used. To address this issue, standardising practices across development and manufacturing pipelines can help reduce the variability and improve the overall efficiency of the process.

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Gene Expression DNA Genetics Gene 59

FDA Law Blog

DECEMBER 6, 2023

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

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Regulation Genetics Cosmetics Compliance 59

Pharmaceutical Technology

MARCH 10, 2023

Freeze-drying systems companies help in the verification and validation monitoring of the freeze-drying process to comply with the latest regulations and good automated manufacturing practice (GAMP) guidelines.

Manufacturing 147

Manufacturing Production Containment Antibody 147

Drug Discovery World

FEBRUARY 6, 2024

From finding potential active substances and identifying novel targets, to simulating how drugs will function in the human body and optimising laboratory workflows, digital technologies are having a significant impact on drug discovery and development.

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Marketing Medicine Genome Genomics 69

pharmaphorum

MAY 4, 2022

The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, and large-volume drug products. Assess developments in primary packaging and CMC considerations for injectable devices. Drug developers.

Drug Delivery 52

Drug Delivery Packaging Packaging Engineer 52

pharmaphorum

JANUARY 29, 2021

California-based Sangamo Therapeutics is one such company that believes in the powerful potential of in vivo genome editing and regulation, together known as genome engineering, and has built up a sizable preclinical pipeline of genome regulation treatments for diseases such as Huntington’s disease and Amyotrophic lateral sclerosis (ALS).

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Gene Editing Gene Gene Therapy In-Vivo 144

XTalks

SEPTEMBER 15, 2022

According to the order, it will improve and expand biomanufacturing production capacity and processes, train a biotech workforce, expand market opportunities for these products and streamline regulation. Related: Top Food Industry Regulations to Watch in 2022. Here’s everything you need to know.

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FDA Approval Genetic Engineering Genetics Production 95

Scienmag

JUNE 7, 2021

Research team led by the University of Göttingen develops new strategy for labelling peptides Credit: Nikolaos Kaplaneris, University of Göttingen Biomolecules regulate the biological functions inside every living cell.

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Regulation Scientist Development Research 88

pharmaphorum

JANUARY 18, 2022

With that in mind, the 9th annual Pre-Filled Syringes East Coast conference will bring together leading industry experts representing big pharma and device developers to discuss the key drivers accelerating the expansion of the industry. Tieming Ruan, Senior Director of Device Development, Alexion Pharmaceuticals. Drug developers.

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Drug Delivery Production Drug Delivery Systems Packaging 52