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. A gene contains instructions within our DNA.

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Regulation Genetics Scientist RNA 52

FDA Law Blog

JULY 11, 2023

To set the stage for this case, we need to go back to March 2020 , when a new definition of “biological product” threw the world of protein products into a tizzy. As a result of the Biologics Price Competition and Innovation Act (BPCIA) passed in 2010, the definition of a “biological product” expanded to include “proteins.”

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The Pharma Data

MARCH 23, 2022

Polymerase is a viral protein that directs how Ebola virus replicates its genome as it infects new hosts. The researchers discovered that Ebola virus polymerase hijacks a cellular protein called GSPT1. To treat Ebola virus infections, researchers are taking a close look at a key piece of the virus: polymerase.

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XTalks

APRIL 22, 2021

While Clara Foods, a leader in animal-free proteins, worked for years to replicate the taste, function and proteins of eggs without the chickens, scaling the product has been difficult — until now. How these eggs will be regulated is another question. Making Animal-Free Eggs. The same can be said for lab-grown meat.

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Scienmag

DECEMBER 9, 2021

When the body attempts to fight off an infection, immune cells called neutrophils may shoot out spider web-like networks of toxic proteins to help contain the invaders.

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Immune Response Containment Protein Regulation 60

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

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Vaccine Vaccination Trials Protein 104

The Pharma Data

MARCH 30, 2021

Basel, March 30, 2021 — Novartis has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents including FAPI-46 and FAPI-74, through an assignment agreement with iTheranostics, Inc., an affiliate of SOFIE Biosciences, Inc. Disclaimer.

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Pharmaceutical Technology

FEBRUARY 1, 2023

However, specific antibody-resistant mutations have already been documented within the RSV- F protein after prophylactic administration of nirsevimab. Once fully approved, it is expected to completely replace Synagis from the market, given its higher efficacy and single-dose administration.

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Vaccine Vaccination Antibody Protein 162

FDA Law Blog

MARCH 5, 2024

Gaulkin & Riëtte van Laack — As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products. By Sophia R.

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XTalks

JANUARY 14, 2021

The EFSA’s decision is the first step in heralding in EU-wide approval of snacks and other foods containing the insect as an ingredient. A source of protein, fat and fiber, mealworms also show promise as a sustainable source of food for generations to come. But that could all change with EFSA’s recent ruling.

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Allergies Protein Containment Sales 97

pharmaphorum

JUNE 9, 2022

The new vaccine contains mRNA coding for the spike protein of both the original wild-type SARS-CoV-2 virus and the Omicron variant, and is being positioned as a second booster shot that could be used in forthcoming immunisation campaigns. It has predicted sales of COVID-19 vaccines will be around $21 billion this year.

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FDA Law Blog

OCTOBER 5, 2022

The proposed rule is intended to align with current nutrition science, the Dietary Guidelines for Americans 2020-2025 and the 2016 nutrition labeling regulation (which also was intended to align with the Dietary Guidelines for Americans). This information is not included in the proposed codified language for the regulation.

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Containment Production Protein Regulation 52

XTalks

OCTOBER 4, 2021

Nestlé Cereals, a UK division of the international food giant, recently announced the launch of Cheerios Vanilla O’s, a low-sugar cereal that contains no artificial colors or flavors. Classified as non-HFSS (high in fat, salt or sugar) under new UK government regulations , the new cereal’s main ingredient is whole grains.

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XTalks

OCTOBER 13, 2023

This diagnosis sparked a realization for the team, inspiring them to create beverages that were healthier and contained reduced sugar. While its line of Zero Sugar juice drinks don’t contain sugar, the products contain aspartame and other additives to provide and regulate tartness. Sugar is ubiquitous.

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Containment Production Marketing Branding 105

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.

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XTalks

JUNE 22, 2023

The Rethink Plastic alliance, in collaboration with a coalition of 81 organizations, is advocating for the integration of effective reuse systems into the European Union’s (EU’s) Packaging and Packaging Waste Regulation. This push aims to mitigate waste produced by single-use plastic takeaway packaging.

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Packaging Packaging Containment Contamination 52

XTalks

JULY 15, 2021

For a wine to be made quickly, some shortcuts can be taken to speed up the clarification process by adding specific agents such as gelatine, isinglass- derived from fish bladder, albumen- egg whites and casein-milk proteins. . Some winemakers believe this removes any odors, colors or haziness in the wine.

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XTalks

JUNE 13, 2024

In this episode of the Xtalks Food Podcast, Sydney talks about the hemp beverage market, which has seen a steady influx of new products, including hemp-infused teas, sparkling waters and protein shakes. The US Food and Drug Administration (FDA) plays a crucial role in regulating hemp products, particularly those intended for consumption.

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Marketing Protein Regulation Production 52

XTalks

MAY 31, 2023

Although studies have associated some diets with lower levels of the Alzheimer’s disease biomarker tau protein, such as the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets, this study suggests that high sodium intake contributes to the formation of tau tangles (clusters of tau proteins) in the brain.

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XTalks

JUNE 28, 2023

DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells. Elevidys’ approval was based on data from a randomized trial that showed the therapy increased expression of the Elevidys micro-dystrophin protein, which was used as a surrogate endpoint, in DMD patients aged four to five years of age.

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Gene Therapy Gene Protein FDA Approval 98

XTalks

AUGUST 26, 2024

A recent study published in the journal Nutrients highlights significant concerns, revealing that many baby foods contain excessive amounts of sugar and salt, coupled with misleading marketing claims. Protein content is another significant issue. Yet, many products in the US baby food aisle fall short of nutritional standards.

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XTalks

JUNE 13, 2024

Eating a healthy, balanced diet is no longer just about getting the right mix of vitamins, minerals, carbohydrates, protein and fat. They are packed with protein, low in fat and rich in soluble fiber. It is rich in protein, omega-3 fatty acids, vitamin C, antioxidants and iodine.

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The Pharma Data

JULY 8, 2021

Today, access to the world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease was launched through a genetic exome sequence analysis collaboration between AbbVie (NYSE: ABBV), Biogen Inc. PFIZER DISCLOSURE NOTICE: The information contained in this release is as of July 8, 2021.

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XTalks

AUGUST 25, 2023

In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). Xtalks spoke to Betsy Craig, CEO and founder of MenuTrinfo, to find out how the company certifies products and where government regulations fall short. We go to the facility.

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XTalks

JANUARY 12, 2022

The innovative food packaging is made from a type of corn protein called zein , starch and other naturally-derived biopolymers, which have been found to be sustainable replacements for PFAS and other plastic-coated paper. Additionally, the recycling rate of generated packaging and containers was only 53.9 So, how does it work?

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Packaging Packaging Scientist Bacteria 98

Pharmaceutical Technology

OCTOBER 28, 2022

For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve. There are many variabilities with biosimilars and the brand name protein drug.” For biosimilars, however, this process is slightly more complex.

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The Pharma Data

SEPTEMBER 14, 2020

On September 6 the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators, after one trial volunteer experienced an unexplained illness. Source link.

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XTalks

JUNE 5, 2024

The FDA’s assessment comes over two years after Daily Harvest’s French Lentil + Leek Crumbles product containing tara flour sickened nearly 400 people. Tara flour is also high in protein — about 43 percent protein by weight — making it an ideal source of plant-based protein.

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Protein Manufacturing Regulation Production 52

XTalks

AUGUST 6, 2020

Epidiolex is the only FDA-approved formulation that contains CBD derived from the cannabis plant. CBD is the most abundant non-psychoactive cannabinoid compound found in the cannabis plant, making up about 40 percent of the plant’s extract, which contains over 100 different cannabinoid compounds.

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FDA Approval Protein Containment Genetic Disease 64

XTalks

JANUARY 28, 2022

Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators. Kimmtrak is a bispecific protein that contains a soluble T cell receptor fused to an anti-CD3 immune-effector function.

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XTalks

APRIL 14, 2021

Scientists used synthetic biology and computational protein design tools to develop an enzymatic process to transform red cabbage anthocyanins into their desired color. How Are Synthetic Food Dyes Regulated? Meanwhile, in Europe, the regulations of synthetic dyes differ from those in the US. These include FD&C Blue No.

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Regulation Production Branding Research 94

Roots Analysis

AUGUST 31, 2023

Further, the expression of any gene is dependent on the rate at which it is transcribed into mRNA and translated into proteins. There are various regulatory proteins or transcription factors that are responsible for affecting the transcription rate. These genetic switches assist transcription factors in binding to the promoter region.

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Pharmaceutical Technology

DECEMBER 9, 2022

Beyond our expertise in small molecules, we have built a solid reputation with biopharmaceutical companies for the characterisation and analysis of monoclonal antibodies, therapeutic proteins and biosimilars. Solvias is well equipped to provide stability testing for all stages of drug development. Quality control release testing.

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XTalks

JULY 1, 2021

Using it as an additive to dairy can also reduce calories, fat and protein compared to adding milk, cream or whey powders. Some fat-free ice creams, snack cakes, cookies, confections, jelly beans and mints also contain titanium dioxide. It is also used as white colorant in some dairy products to replace more expensive dairy solids.

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pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator.

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Immune Response Trials Drugs Containment 72

pharmaphorum

SEPTEMBER 14, 2020

While there may be just under 20,000 confirmed protein coding genes, it turns out that much of the genome outside of these genes is also important in regulating how the genome is controlled. Most current technology actually focuses on looking at the bits of the genome that produce proteins.

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The Pharma Data

MARCH 18, 2021

The UK regulator confirmed that the benefits of the vaccine in preventing COVID-19 far outweigh the risks, and people should continue to get vaccinated when asked to do so. We trust that, after the regulators’ careful decisions, vaccinations can once again resume across Europe.”.

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