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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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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Pharmaceutical Technology

MARCH 10, 2023

Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity.

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Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Regulators are well-disposed to these boosters. 1 sub-lineage on 19 July. Moderna ready to compete with Pfizer for new variant business.

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Drug Discovery World

MARCH 26, 2024

METTL1 inhibition leads to reduced tRNA methylation and stability of a subgroup of tRNAs and in several cancer cell lines impairs cell proliferation and cell cycle progression, accompanied by reduced expression of cell cycle regulators.

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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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Drug Discovery World

JANUARY 26, 2023

In contrast, the larger NRAS-mutant cancer cells contained damage to their DNA instead of repairing it, accumulating mutations and enlarging. The major difference was cell size. BRAF-mutant cancer cells were very small whereas NRAS-mutant cancer cells were much bigger. Drug resistant NRAS cells were even bigger.

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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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Drug Discovery World

JANUARY 11, 2024

Argininosuccinic aciduria is an inherited metabolic disorder that affects how the body breaks down protein – potentially leading to high levels of ammonia in the blood. Patients affected by the disease are found to also experience an imbalance of glutathione regulation, which is important for liver detoxification.

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XTalks

DECEMBER 7, 2023

In the US, the regulation of food products, including the ban on certain items, falls primarily under the jurisdiction of two key agencies: the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). In this episode of the Xtalks Food Podcast, Sydney talks about the top 10 foods banned in the US and why.

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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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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

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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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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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

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

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

SEPTEMBER 28, 2023

This is because the US has more lenient food ingredient regulations, potentially exposing consumers to carcinogens and harmful chemicals. The Environmental Working Group (EWG) identified several food products containing this chemical, such as Entenmann’s Coconut Crunch Donuts and Sara Lee Honey Glazed Buns.

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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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Pfizer

AUGUST 11, 2022

The information contained in this statement is as of August 11, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. . Disclosure Notice . COVID-19, Vaccines. 07.19.2022. 1 Adapted Bivalent Vaccine Candidate. 07.13.2022.

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Pharmaceutical Technology

JUNE 24, 2022

The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 As per Rohde, the spike protein in the Omicron variant has “wicked alterations” in its antigenicity, shows a very high transmission ability and immune escape from those early vaccine induced immune individuals. 1 variant of concern.

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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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Pharma in Brief

DECEMBER 17, 2023

According to the Minister, JAMP’s new drug submission for SIMLANDI did not engage the Patented Medicines (Notice of Compliance) Regulations ( Regulations ). As a consequence, the Court’s recent decision of December 4, 2023 does not concern the Regulations , but rather parallel actions brought under the Patent Act. A-203-22).

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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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The Pharma Data

NOVEMBER 23, 2020

Under the partnership, Evotec will support Rappta’s programme of developing small molecule activators of the enzyme Protein Phosphatase 2A (“PP2A”), which downregulates multiple oncogenic signalling pathways responsible for driving cancer progression.

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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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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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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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The Pharma Data

OCTOBER 20, 2020

Patent and Trademark Office covering the use of Fatty Acid Binding Protein 5 (FABP5) inhibitors for the treatment of psychological disorders such as anxiety and post-traumatic stress disorder (PTSD). Chronic stress and anxiety disorders, including PTSD, represent significant healthcare and economic burdens worldwide.

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Roots Analysis

OCTOBER 24, 2023

The ADCs bind to specific proteins or peptides in cancer cells with very high specificity and efficacy influencing the biological functions. A molecule having 2-50 amino acids is considered as peptide whereas, group of peptides are responsible for forming a protein.

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FDA Law Blog

MARCH 16, 2023

Baumhardt, Senior Medical Device Regulation Expert — On March 8th FDA granted Quidel’s Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set. The new regulation is listed as 21 CFR 866.3982: “Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.”

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The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. It contains the genetic materials of the spike protein.

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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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The Pharma Data

NOVEMBER 29, 2021

Ovarian cancer often causes the body to overproduce a specific protein in cell membranes called a folate receptor. Following administration via injection, Cytalux binds to these proteins and illuminates under fluorescent light, boosting surgeons’ ability to identify the cancerous tissue. Source link: [link].

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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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The Pharma Data

JANUARY 10, 2021

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / January 11, 2021 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that Jean-Paul Kress, M.D., Source link.

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Drug Discovery World

NOVEMBER 14, 2022

A collaboration between PerkinElmer’s SIRION Biotech business and the Centre for Genomic Regulation (CRG) agreed to jointly develop new generation adeno-associated virus (AAV) vectors for type 1 and type 2 diabetes gene therapy in the pancreas. . Find out more: Collaboration to develop AAV vectors for diabetes gene therapy .

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