pharmaphorum

AUGUST 5, 2020

DBV Technologies’ long and tortuous path to an FDA verdict on its Viaskin Peanut allergy shot has led to another dead end. The rationale behind Viaskin Peanut is to expose people with peanut allergy to small, rising amounts of peanut protein – which acts as an allergen – to encourage the immune system to develop tolerance over time.

Allergies 52

Allergies Production Clinical Trials Clinical Trials 52

Pharmaceutical Technology

DECEMBER 7, 2022

GlobalData anticipates that this safety update will likely raise physician and regulator vigilance regarding long-term Dupixent use but is unlikely to impact overall prescribing patterns for the product. Sanofi and Regeneron’s Dupixent had previously been linked to conjunctivitis, an eye condition usually caused by allergies or an infection.

Production 162

Production Regulation Clinical Trials Clinical Trials 162

NPR Health - Shots

AUGUST 1, 2022

Many medications can impede the body's ability to regulate heat. They include high blood pressure treatments, some anti-depressants, beta-blockers and common antihistamines for treating allergies.

Allergies 75

Allergies Regulation 75

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). While this act is intended to make it easier for consumers with food allergies to identify potential allergens in the products they purchase, many believe it falls short. We go to the facility.

Allergies 98

Allergies Manufacturing Contamination Production 98

XTalks

APRIL 16, 2024

Attendees will also gain firsthand insights from speakers from the Canadian Food Inspection Agency (CFIA), the US Food and Drug Administration (FDA), Food Allergy Canada, IBM Food Trust and Celiac Canada, among others, who are at the forefront of food safety and quality assurance.

Regulation 105

Regulation Compliance Allergies Manufacturing 105

XTalks

SEPTEMBER 28, 2023

In most cases, commercials are regulated to ensure they provide accurate information, include the benefits and risks of the drugs and encourage viewers to talk to their healthcare providers about the medication. Astepro Maker: Bayer Treatment for: Cold, flu, allergies Number of ad impressions: 7.4

Drugs 105

Drugs Allergies Branding FDA Approval 105

XTalks

NOVEMBER 23, 2023

This persistent strain of Salmonella , also known as REPJFX01, not only led to significant illnesses but also prompted a massive recall and stricter regulations on poultry processing. The scandal led to stricter regulations on pesticide use and a push for organic farming methods.

Contamination 103

Contamination Regulation Bacterium Allergies 103

Pharmaceutical Technology

JANUARY 8, 2023

Research has found cytokines are central to the regulation of an allergic phenotype , immunoglobulin E (IgE) response and cell-mediated inflammation. With three votes for and 16 against, the US Pulmonary Allergy Drugs Advisory Committee refused its use as an add-on treatment to inhaled corticosteroid-based maintenance.

Antibody 298

Antibody Trials Clinical Trials Clinical Trials 298

XTalks

JULY 26, 2021

For example, the Allergen Bureau indicated a possible connection between pea protein and peanut allergies. Consumers with allergies should pay close attention to the labels and the source of the plant proteins in plant-based meats. FDA Regulation.

Protein 98

Protein Contamination Allergies Bacteria 98

pharmaphorum

MARCH 23, 2021

The company’s share price ticked down after the statement on Monday from the US National Institute for Allergy and Infectious Diseases (NIAID). Regulators including the European Medicines Agency and the UK’s Medicines and Healthcare products Regulatory Agency have already approved it.

Vaccine 98

Vaccine Vaccination Trials Allergies 98

Scienmag

JULY 14, 2021

Scientists report that the alternative-splicing regulator NSrp70 influences immune T cell development Credit: Gwangju Institute of Science & Technology T lymphocytes, or T cells, are immune cells with diverse roles in building the body’s immunity. How does one particular cell type fight against a host of different pathogens?

Scientist 98

Scientist Regulation Development Allergies 98

XTalks

JANUARY 14, 2021

And while the insects have been given the food safety go-ahead, the EFSA recommended that they should not be consumed by people with certain allergies, including shellfish and dust mites. But it will likely take time before even those without such allergies come to accept insects on their dinner plates.

Allergies 97

Allergies Protein Containment Sales 97

pharmaphorum

AUGUST 10, 2020

It also includes the phase 3 randomised, placebo-controlled study of Veklury conducted by the National Institute of Allergy and Infectious Diseases (NIAID). The filing with the FDA follows approval by several regulators across the world, including in the European Union and Japan.

Drugs 99

Drugs In-Vivo In-Vitro Contract Manufacturing 99

FDA Law Blog

DECEMBER 21, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won & Lisa M. medication reconciliations and test reconciliations); Reminders for preventive care or clinician’s orders; and.

Cosmetics 59

Cosmetics Allergies Regulation Drugs 59

pharmaphorum

SEPTEMBER 16, 2020

The ACTT-2 trial, funded by the US government and run by the National Institute for Allergy and Infectious Diseases (NIAID), involved COVID-19 patients who had been hospitalised because of severe symptoms.

Trials 111

Trials Trial Funding Allergies Drugs 111

pharmaphorum

OCTOBER 4, 2022

Criteria for regulation. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). peer-reviewed clinical studies or clinical practice guidelines) meet Criterion 2 and are not medical devices subject to FDA regulation and oversight.

Development 105

Development Regulation Cosmetics Life Science 105

The Pharma Data

APRIL 18, 2022

Food allergies and other types of food hypersensitivities affect millions of people in the U.S. The draft guidance focuses on immunoglobulin E antibody (IgE)-mediated food allergies, which are capable of triggering anaphylaxis and are considered the most severe and immediately life-threatening food allergies. effective Jan.

Allergies 52

Allergies Cosmetics Production Drugs 52

XTalks

NOVEMBER 5, 2024

Additionally, devices should not be used to deliver medications, on patients with known nickel allergies or inflammatory conditions or for more than 14 days under these restricted conditions.

Compliance 103

Compliance Manufacturing Allergies Drugs 103

BioPharma Reporter

MARCH 23, 2021

The US National Institute of Allergy and Infectious Diseases (NIAID) says it is concerned that AstraZeneca 'may have included outdated informationâ when releasing initial data from its COVID-19 vaccine clinical trial.

Vaccine 52

Vaccine Vaccination Allergies Trials 52

XTalks

JULY 15, 2021

Not all winemakers mention whether a wine is vegan because there is no regulation that says to include which fining agents were used. Million to Help Parents Fight the Food Allergy Epidemic. Still, others say that this process removes the rich flavor and changes the texture of the beverage. . Related: Ready, Set, Food! Receives $3.5

Protein 98

Protein Allergies Containment Production 98

Scienmag

MAY 21, 2021

UC San Diego School of Medicine researchers identify how the body regulates and prevents constant skin inflammation The human body is constantly exposed to various environmental actors, from viruses to bacteria to fungi, but most of these microbial organisms provoke little or no response from our skin, which is charged with monitoring and protecting (..)

Bacteria 75

Bacteria Regulation Medicine Research 75

XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. Also in this episode, Sydney talks about the recent approval of house crickets in food products in the European Union (EU).

Production 52

Production Containment Allergies Packaging 52

Scienmag

NOVEMBER 13, 2020

Whether the signaling molecule IL-33 wakes up or turns down the immune response depends on what cell type releases it, School of Veterinary Medicine researchers found. ” “The mantra of my […].

Immune Response 46

Immune Response Regulation Medicine Research 46

pharmaphorum

DECEMBER 29, 2021

IL-13 inhibitor tralokinumab has been cleared by the US regulator as Adbry as a treatment for moderate-to-severe atopic dermatitis in adults who can’t control symptoms using topical prescription therapies.

Sales 111

Sales Dermatology Marketing Allergies 111

Scienmag

FEBRUARY 1, 2021

A long noncoding RNA regulates the expression of inflammatory genes and has a surprising effect on vulnerability to septic shock in mice Credit: Apple Vollmers When the body’s immune response to an infection gets out of control, the result can be sepsis, a life-threatening condition in which an overwhelming inflammatory response can lead rapidly (..)

Immune Response 70

Immune Response RNA Gene Regulation 70

Camargo

NOVEMBER 24, 2020

Most are familiar with, know someone who uses, or take “pumps” themselves to prevent or relieve shortness of breath after an effort or during allergy season. The following formula from Alexander et al. These considerations should be factored in when planning the manufacture of the test compound required for an inhalation program.

Drug Delivery 130

Drug Delivery Drugs Allergies Medicine 130

XTalks

NOVEMBER 16, 2020

The study is being conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH).

Vaccine 105

Vaccine Vaccination Trials Allergies 105

The Pharma Data

SEPTEMBER 15, 2020

The study, launching on 8 May and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the United States National Institutes of Health (NIH), included over 1,000 participants in total receiving 4mg baricitinib in combination in combination with remdesivir.

Allergies 52

Allergies Regulation Medicine Research 52

XTalks

SEPTEMBER 23, 2022

Aside from cooking chicken in NyQuil, the FDA notice included warnings about other dangerous social media trends, like one TikTok challenge that urged viewers to consume large doses of the allergy medication diphenhydramine, which is found in Benadryl and other OTC products, in order to hallucinate.

Allergies 96

Allergies Drugs Medicine Production 96

pharmaphorum

OCTOBER 23, 2020

It also includes the phase 3 randomised, placebo-controlled study of Veklury conducted by the National Institute of Allergy and Infectious Diseases (NIAID). The drug has already been approved by several other regulators across the world, including in the European Union and Japan.

Trials 59

Trials Allergies Drugs Branding 59

Scienmag

MARCH 5, 2021

Credit: Patrick Bolger DUBLIN, Friday, 5 March 2021: RCSI researchers have discovered a new way to ‘put the brakes’ on excessive inflammation by regulating a type of white blood cell that is critical for our immune system. The discovery has the potential to protect the body from unchecked damage caused by inflammatory diseases.

Research 53

Research Regulation Allergies Medicine 53

Scienmag

OCTOBER 13, 2020

Guangyu Wu is dissecting the molecular homing that enables a nascent protein to ultimately find its way to the surface of a cell as a mature receptor type that helps us taste, smell and even regulate our mood and immunity. “These receptors are essential for normal body […].

Protein 52

Protein Regulation Production Allergies 52

Scienmag

DECEMBER 17, 2020

Credit: WEHI, Australia WEHI researchers have identified a key molecular regulator involved in the progression and spread of stomach cancer, suggesting a potential new approach to treat this devastating disease.

Protein 52

Protein Regulation Research Allergies 52

Scienmag

JULY 5, 2021

This discovery suggests new opportunities to regulate the anti-tumour response of the immune […]. Researchers at Uppsala University have discovered lymph node-like structures close to the tumour in brain cancer patients, where immune cells can be activated to attack the tumour.

Regulation 50

Regulation Research Allergies Medicine 50

pharmaphorum

NOVEMBER 3, 2022

Regeneron’s main rival was Pfizer with tanezumab , which got as far as marketing applications in the US and EU for osteoarthritis-related pain before being shot down by regulators on safety grounds. The post And then there were none: Regeneron cans last late-stage NGF drug appeared first on.

Drugs 52

Drugs Antibody Allergies Development 52

pharmaphorum

DECEMBER 22, 2021

Takeda said it had received a complete response letter from the US regulator that is asking for another clinical trial of the drug, which could set back the timeline for the programme considerably. EoE is a chronic condition in which the oesophagus becomes inflamed as a result of an inflammatory reaction, generally caused by an allergy.

Allergies 52

Allergies Drugs Clinical Trials Clinical Trials 52

pharmaphorum

NOVEMBER 30, 2022

As an industry, pharma has specific needs; it is driven by targeted regulations and rules and has not been well served by technology. COUR currently has 12 sites for its peanut allergy trials. Founded in 2007 by Peter Gassner, a luminary of Silicon Valley with a net worth of circa $5.25

Life Science 98

Life Science Pharma Companies Sales Marketing 98