Pharmaceutical Technology

APRIL 26, 2023

INB-400, an autologous, genetically engineered gamma-delta T cell therapy, is the company’s DeltEx chemotherapy-resistant autologous and allogeneic drug-resistant immunotherapy (DRI) technology. We eagerly anticipate enrolling our first Phase II patients for INB-400 later this year.”

Genetic Engineering 130

Genetic Engineering Drugs Genetics Engineer 130

Roots Analysis

AUGUST 30, 2023

The Art and Science of Tissue Engineering Do you know that scientists are now able to grow body parts in the lab? This incredible medical breakthrough is called tissue engineering. So, what is tissue engineering? Having said that regenerative grafts created using tissue engineering have numerous applications.

Engineer 52

Engineer Production Scientist Research 52

Scienmag

JANUARY 22, 2021

Cryo-electron microscopy study allows researchers to visualize structural changes in an E.

RNA 85

RNA Production Regulation Bacteria 85

Pharmaceutical Technology

JUNE 12, 2023

Quell Therapeutics and AstraZeneca have entered a collaboration, exclusive option and licence deal for the development, manufacturing and commercialisation of engineered T-regulator (Treg) cell therapies for autoimmune diseases.

Engineer 130

Engineer Gene Therapy Clinical Trials Clinical Trials 130

pharmaphorum

MARCH 3, 2021

Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks. The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation.

Vaccination 130

Vaccination Vaccine Regulation Immune Response 130

Pharma Marketing Network

MARCH 26, 2025

However, in a tightly regulated industry like pharmaceuticals, every message, medium, and model must adhere to strict legal and ethical standards. Misinformation and Hallucinations : Generative AI platforms may create content that is inaccurate, outdated, or off-labelviolating FDA regulations. This content is not medical advice.

Compliance 52

Compliance Marketing Regulation Pharma Companies 52

Advarra

JUNE 12, 2023

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. What do the Regulations Say about IBC Review? What Does an IBC Review?

Genetic Engineering 98

Genetic Engineering Gene Therapy Genetics Engineer 98

XTalks

OCTOBER 8, 2024

The 2024 Nobel Prize in Physiology or Medicine has been awarded to American scientists Victor Ambros and Gary Ruvkun for their groundbreaking discovery of microRNA (or miRNA) and its role in post-transcriptional gene regulation. This control plays a critical role in development and cellular function.

Regulation 52

Regulation Genetics Scientist RNA 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

Scienmag

MARCH 2, 2021

Xujie Lü report three orders of magnitude increase in the photoconductivity of Cs2PbI2Cl2 from its initial value, at the industrially achievable level of 2 GPa, using pressure regulation.

Regulation 53

Regulation Scientist Engineer 53

pharmaphorum

MARCH 19, 2024

Achieve Safe & Targeted In Vivo Delivery of Payloads with Clarity in Regulations & Appropriate Models to Advance the Next Frontier of In Vivo Editing from Research to Clinic

In-Vivo 52

In-Vivo Gene Editing Engineer Gene 52

Scienmag

MARCH 19, 2021

Credit: Thomas Gorochowski In a recent study led by the University of Bristol, scientists have shown how to simultaneously harness multiple forms of regulation in living cells to strictly control gene expression and open new avenues for improved biotechnologies.

Gene 75

Gene Gene Expression Engineer Scientist 75

Scienmag

JANUARY 6, 2022

Protein assembly is essential for the formation of ordered biological structures, but imagine engineering one! By regulating the tip-to-tip interactions of these needles, they allowed for their self-assembly into lattice structures, ordered monomeric states, and fiber assemblies, paving the way for […].

Protein 79

Protein Engineer Regulation Research 79

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

BioTech 365

JANUARY 11, 2022

BRAIN Biotech AG / Key word(s): Patent BRAIN Biotech AG: BRAIN-Engineered-Cas (BEC) Considered a Patentable Technology 11-Jan-2022 / 18:47 CET/CEST Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by DGAP – … Continue reading →

Engineer 40

Engineer Regulation 40

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.

In-Vivo 130

In-Vivo In-Vitro Sales Engineer 130

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).

Gene Editing 145

Gene Editing Gene Gene Therapy In-Vivo 145

pharmaphorum

SEPTEMBER 28, 2022

The nine-company pilot launched in 2017 and is designed to explore a new approach to regulating digital health, based on certifying companies and their internal processes rather than individual devices and apps. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot. O’Leary said.

Radiology 135

Radiology Regulation Engineer Production 135

BioPharma Reporter

NOVEMBER 23, 2023

Cradle, the biotech startup using generative AI to help scientists design and engineer proteins, has raised $24 million in Series A funding.

Engineer 101

Engineer Protein Scientist Regulation 101

BioPharma Reporter

APRIL 11, 2023

Ginkgo acquires StrideBio's adeno-associated virus (AAV) capsid discovery and engineering platform assets and as well as gaining ownership of a preclinical asset.

Gene Therapy 98

Gene Therapy Gene Engineer Regulation 98

Pharmaceutical Technology

MAY 4, 2023

Originated by the company’s in-house discovery engine, ATX-01 is designed to target microRNA 23b (miR-23b), a pathogenic gene associated with regulating the muscleblind-like protein (MBNL) expression involved in DM1. It has a dual mechanism of action that targets toxic dystrophia myotonica protein kinase and MBNL protein.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Protein 130

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.

Gene 98

Gene Regulation Protein Gene Editing 98

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

XTalks

MARCH 19, 2025

Eneboparatide is engineered to bind with high affinity to a specific conformation of the PTH1R, essentially mimicking the hormones natural action. In doing so, it helps regulate calcium and phosphate more naturally, potentially limiting urinary calcium excretion and supporting kidney and bone health.

Trials 59

Trials Hormones Engineer Licensing 59

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

Pharma Times

DECEMBER 20, 2023

The pathological alpha-synuclein is genetically manipulated to over-express, causing cells to increase protein synthesis by activating the mammalian target of rapamycin (mTOR), which regulates protein production and breaks down proteins.

Protein 121

Protein Medicine Engineer Genetics 121

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.

Marketing 130

Marketing Compliance Production Doctor 130

Pharmaceutical Technology

JULY 25, 2022

You need good production, good science and engineering, and you need good lawyers. The only way forward for generics producers. Margins in the generics market are overall being driven down, Harvard Medical School Health Economics professor Richard Frank, PhD, tells Pharmaceutical Technology.

Drugs 298

Drugs Manufacturing Production Marketing 298

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

Pharmaceutical Technology

APRIL 5, 2023

First, by going back to the lab and looking at how we can engineer the process to make these therapies much less expensive. But I think we’ve never had more tools than we have now in synthetic biology, genetic engineering, enhanced potency design switches and CRISPR. We must approach this on several fronts. One challenge is in potency.

Gene Therapy 147

Gene Therapy Gene Engineer Production 147

Advarra

MARCH 6, 2025

The Value of Clinical Research Clinical research is the engine that drives medical innovation, leading to the discovery of new drugs, treatments and medical devices that enhance patients access to treatment options, improve patient care and outcomes, and transform the healthcare landscape.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Scienmag

MARCH 21, 2022

A new gene that controls self-fertilization has been identified in an engineered version of the model plant Arabidopsis thaliana bred by scientists at the University of Birmingham.

Gene 56

Gene Engineer Scientist Regulation 56

Pharmaceutical Technology

JULY 29, 2022

This is borne out of the fact that while nearly three-quarters are confident in the education and training for those in the pharma sector, just 64% are confident with the industry’s ability to source engineers against competition from other sectors. Government policy and regulation: Index score 6.96/10.

Manufacturing 147

Manufacturing Production Engineer Contract Manufacturing 147

Scienmag

SEPTEMBER 14, 2021

Scientists from the Max Planck Institute for Medical Research in Heidelberg and colleagues at the DWI Leibniz Institute for Interactive Materials in Aachen have engineered synthetic exosomes that regulate cellular signaling during wound closure.

Engineer 52

Engineer Scientist Regulation Research 52

BioPharma Reporter

SEPTEMBER 28, 2021

A new deal sees Bone Therapeutics gain access to iPSC derived, genetically engineered MSCs.

Genetic Engineering 72

Genetic Engineering Engineer Genetics Research 72

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.

In-Vitro 59

In-Vitro Engineer Production Regulation 59

Scienmag

SEPTEMBER 23, 2020

Researchers have found a surprising effect of the stem cell-regulating growth factor R-spondin in intestinal cancer. Credit: Marianne Lähde Colorectal cancer constitute the third most common cancer in the Western world.

Regulation 94

Regulation Research Gene Engineer 94