XTalks

APRIL 22, 2021

Then, it uses yeast engineering and fermentation technologies to design the perfect strain of yeast capable of producing proteins that are identical to those found in eggs. . While its eggs don’t harm animals, there is some debate whether they can still be considered vegan since they contain the same proteins as chicken eggs.

Protein 98

Protein Production Manufacturing Regulation 98

Advarra

OCTOBER 26, 2023

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. The containment must then prevent spills or leaks if the IP is dropped. Size matters.

Production 52

Production Containment Biohazard Biohazard 52

FDA Law Blog

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

Compliance 105

Compliance Manufacturing Containment Regulation 105

Roots Analysis

AUGUST 31, 2023

Further, the transcription factors contain two molecular domains, the DNA binding domain and the activation domain. Moreover, some transcription factors contain additional domains, such as ligand binding domain in order to interact with chemical signals.

Gene 40

Gene Gene Therapy Gene Expression Regulation 40

XTalks

MAY 4, 2021

These modifications regulate gene expression without changing the sequence or structure of DNA. The tool targets the epigenome, the collection of DNA modifications in a cell such as methylation and post-translational histone modifications. It’s a great tool for controlling gene expression.”. pyogenes dCas9.

DNA 98

DNA Gene Gene Silencing Genomics 98

XTalks

JANUARY 21, 2025

From non-invasive cancer diagnostics to life-saving cardiovascular implants, the latest medical devices cleared or approved by the FDA in 2024 reflect the remarkable strides in science and engineering. TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR).

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

XTalks

MAY 12, 2022

Engineers at the University of California, San Diego (UCSD) developed a prototype of a wearable sensor for continuous monitoring of glucose, alcohol and lactate. The UCSD researchers published an article on May 9 in Nature Biomedical Engineering that describes their new device. Engineering a Continuous Monitoring Device.

Engineer 59

Engineer Development Containment Regulation 59

pharmaphorum

NOVEMBER 17, 2021

This year’s conference will explore the exciting advances in the combination product delivery space including insights into how the industry is adapting to the delayed EU MDR, takeaways from the global pandemic and a future outlook exploring how pharma, device developers and regulators can work together to encourage innovation.

Drugs 52

Drugs Drug Delivery Engineer Production 52

XTalks

MARCH 10, 2023

XTALKS WEBINAR: Tissue-Engineered Human Models of Cardiac Disease: A Case Study of Friedreich’s Ataxia (FRDA) Register for this free webinar to learn the use of human pluripotent stem cells (hPSCs) and tissue-engineered models to study Friedreich’s ataxia cardiomyopathy.

FDA Approval 52

FDA Approval Engineer Clinical Trials Clinical Trials 52

pharmaphorum

AUGUST 31, 2021

For the innovators and early adopters of the life sciences industry, engineering a regulatory-grade ECA can be daunting. The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond. It is true that RWD contains more potential bias as a result.

Clinical Trials 89

Clinical Trials Clinical Trials Life Science Trials 89

The Pharma Data

AUGUST 24, 2020

TGF-beta is a key cytokine that regulates various cell processes, including regulation of the immune system. In contrast, TGF-beta 2 is a positive regulator of hematopoiesis and normal cardiac function, and blockade of TGF-beta 2 is therefore undesirable. AVID200 neutralizes TGF-beta 1 and -beta 3 with picomolar potency.

Regulation 52

Regulation Engineer Development Protein 52

The Pharma Data

MAY 6, 2021

We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline.

Containment 52

Containment Production Development Engineer 52

pharmaphorum

MAY 25, 2021

One of the main reasons to use RWE is to counter a common criticism of the large phase 3 trials that for so long have been the ‘gold standard’ when developing drugs and gaining authorisations from regulators. Savana is built following the highest privacy-by-design standards and with medical reliability engineered by doctors for doctors.

Big Data 104

Big Data Clinical Research Research Trials 104

The Pharma Data

DECEMBER 8, 2020

Takeda has built a world-class, state-of-the-art R&D engine and has generated a diverse and dynamic pipeline of approximately 40 clinical-stage new molecular entities that is beginning to deliver. Bringing a Highly Innovative Pipeline to Patients for Sustained Growth. For more information, visit [link]. Takeda Forward-Looking Statements.

Containment 52

Containment Engineer FDA Approval Vaccination 52

Pfizer

APRIL 26, 2023

Our engineers created specially designed, temperature-controlled shipping containers (that we call “shippers”), which contain GPS temperature enabled trackers for continuous, real-time location and temperature monitoring and can maintain required temperature conditions for up to 10 days unopened.

Vaccination 52

Vaccination Vaccine Manufacturing Containment 52

The Pharma Data

OCTOBER 26, 2020

” Market Abuse Regulation (MAR) Disclosure. Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 until the release of this announcement. Enquiries: Hemogenyx Pharmaceuticals plc. .

Development 40

Development Antibody Engineer Production 40

Cloudbyz

AUGUST 19, 2024

Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare. This is where the importance of stringent safety processes, robust systems, and comprehensive regulations comes into play. What is the Medical Device Safety process?

Compliance 52

Compliance Manufacturing Regulation Marketing 52

The Pharma Data

DECEMBER 29, 2020

The COVABELP program combines IPA’s technologies and expertise in antibody selection, development and engineering of single-domain antibodies (such as VHHs) with Radboudumc’s specialized skills in targeted nanomedicine and TU/e’s thermo-responsive diblock elastin-like peptide (dbELP) technology. Securities and Exchange Commission.

Antibody 52

Antibody In-Vitro Engineer Development 52

The Pharma Data

MARCH 23, 2022

The researchers found that Ebola virus polymerase leverages host protein GSPT1 to positively regulate viral transcription – a process the virus uses to convert its genetic material into instructions for making viral proteins. who could carry out experiments with live Ebola virus in a high containment research facility.

Protein 52

Protein Genomics Genome Research 52

The Pharma Data

JANUARY 5, 2021

The Company is an emerging personalized/precision medicine leader in the field of cellular therapies and tissue engineering, with a focus on bone, skin, and cartilage regeneration. Lattice Biologics maintains all necessary licensures to process and sell its tissue engineered products within the U.S. and internationally.

Engineer 40

Engineer Manufacturing Production Marketing 40

The Pharma Data

OCTOBER 19, 2020

Subsequently, he held executive and consultant positions in numerous start-up companies specializing in medical devices, healthcare, telemedicine, software engineering, biotech services, and other fields. He is also a co-founder of several software engineering and telemedicine firms, all of which continue in business to date.

Marketing 40

Marketing Engineer Production Containment 40

XTalks

MAY 4, 2021

These modifications regulate gene expression without altering the sequence or structure of DNA. Researchers at the University of California San Francisco (UCSF) and the Whitehead Institute have developed a novel CRISPR-based tool called “CRISPRoff” that can switch off genes in human cells without editing the genetic sequence itself.

DNA 52

DNA Gene Gene Silencing Genomics 52

The Pharma Data

JANUARY 12, 2021

Market Abuse Regulation (MAR) Disclosure. Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation No 596/2014 until the release of this announcement. Enquiries: Hemogenyx Pharmaceuticals plc. . .

Antibody 40

Antibody Development Licensing Licensing 40

Pharmacy Checkers

FEBRUARY 28, 2020

The report is an audit of companies in the drug supply chain to test compliance with regulations called for by the Drug Supply Chain Security Act of 2013 (DSCSA). Food and Drug Administration (FDA) is the gold standard when it comes to regulating the safety of our medicine supply. That narrative holds that any non-U.S.

Pharmacy 55

Pharmacy Drugs Medicine Sales 55

The Pharma Data

SEPTEMBER 8, 2020

Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs. Sanofi, Empowering Life. For further information, please visit www.sanofi.com.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

MARCH 4, 2021

We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. For more information, visit [link].

Development 52

Development Containment Medicine Clinical Trials 52

Pfizer

JANUARY 27, 2023

In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells. and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S.

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

SEPTEMBER 8, 2020

is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs. This press release contains “forward-looking statements” of. www.novavax.com.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

OCTOBER 27, 2020

To purchase DermSafe: Just search for “DermSafe” in Amazon.ca’s search engine or click on www.amazon.ca/shops/dermsafe. Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. The product listing offered on Amazon.ca

Sales 52

Sales Production Drug Delivery Development 52

The Pharma Data

JULY 27, 2021

“Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. chief executive officer of Teneobio.

Production 52

Production Antibody Sales Development 52

The Pharma Data

NOVEMBER 27, 2020

Obesity due to POMC, PCSK1 or LEPR deficiency are ultra-rare diseases caused by variants in POMC, PCSK1 or LEPR genes that impair the MC4 receptor pathway, which is a pathway in the hypothalamus that is responsible for regulating hunger, energy expenditure and consequently body weight. The company is based in Boston, MA.

FDA Approval 52

FDA Approval Genetic Disease Genetics Clinical Trials 52

The Pharma Data

MAY 7, 2021

GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19. Sotrovimab is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs. Review will support a formal Marketing Authorisation Application.

Antibody 40

Antibody Trials Vaccination Vaccine 40

The Pharma Data

MAY 15, 2023

He holds a Master of Science in Food Engineering and a Bachelor of Science in Chemical Engineering from the University of Leeds, UK. He held other supply chain roles of increasing responsibility over his 35 years successful international career with Procter & Gamble and served under three different CEOs.

Sales 40

Sales Production Doctor Doctors 40

The Pharma Data

APRIL 27, 2021

We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Forward-Looking Statements.

Drugs 52

Drugs FDA Approval Production Trials 52

The Pharma Data

FEBRUARY 25, 2021

Poultry Sense combines a wealth of expertise and evidence with the knowledge of specialist vets, engineers and data analysts to bring together real-time data across both environmental and health parameters to help facilitate improvements in bird performance, economics and welfare. Poultry Sense Limited.

Production 52

Production Vaccination Vaccine Marketing 52

The Pharma Data

OCTOBER 28, 2020

We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline.

Vaccination 40

Vaccination Vaccine Manufacturing Development 40

The Pharma Data

DECEMBER 3, 2020

We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Forward-Looking Statements.

Drugs 52

Drugs Medicine Trials Development 52