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

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Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

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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. Interest in the pulmonary route has also grown in recent years because delivering the drugs through the lungs allows direct systemic delivery and bypasses the first pass metabolism.

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Drug Delivery Drugs Allergies Medicine 130

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

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.

Allergies 98

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FDA Law Blog

DECEMBER 21, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won & Lisa M. Two days after the blog post, FDA updated the Digital Health Policy Navigator to improve access to the tool through the webpage and add examples to the clinical decision support software policy considerations in Step 6.

Cosmetics 59

Cosmetics Allergies Regulation Drugs 59

FDA Law Blog

APRIL 26, 2021

On Friday April 23, President Biden signed into law the Food Allergy Safety, Treatment, Education and Research (FASTER) Act that designates sesame as the ninth major food allergen. By Karin F.R. Moore & Riëtte van Laack —. Then in 2019 Illinois enacted a law that required sesame allergen labeling.

Allergies 98

Allergies Cosmetics Containment Regulation 98

pharmaphorum

AUGUST 10, 2020

Gilead has filed its COVID-19 drug remdesivir with the FDA, to treat patients with severe disease, under the brand name Veklury. The drug is currently available to US patients under an Emergency Use Authorisation for treatment of hospitalised patients with severe COVID-19.

Drugs 86

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pharmaphorum

NOVEMBER 3, 2022

The hope that nerve growth factor (NGF) inhibitors could be an alternative to opioid for pain relief has finally been extinguished with the news that Regeneron had abandoned the last drug in the class. The post And then there were none: Regeneron cans last late-stage NGF drug appeared first on.

Drugs 52

Drugs Antibody Allergies Development 52

VirTrial

FEBRUARY 28, 2024

If you missed Signant’s February 2024 webinar about optimizing patient-reported outcomes measurement strategy throughout oncology drug development, we’ve summarized the key takeaways and provided a link for you to watch the recording. Watch the recording You can watch the recorded webinar here.

Development 52

Development Drugs Trials Clinical Development 52

The Pharma Data

APRIL 18, 2022

Food and Drug Administration issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major nine food allergens identified by law in the U.S (non-listed Today, the U.S. non-listed food allergens). effective Jan. effective Jan.

Allergies 52

Allergies Cosmetics Production Drugs 52

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

XTalks

JULY 26, 2021

Soybean and wheat, ingredients predominantly found in plant-based meats, are two of the “ big eight ” allergenic foods identified by the US Food and Drug Administration (FDA). For example, the Allergen Bureau indicated a possible connection between pea protein and peanut allergies. FDA Regulation.

Protein 98

Protein Contamination Allergies Bacteria 98

Drug Discovery World

AUGUST 1, 2023

The NIH states: “This natural mechanism for sequence-specific gene silencing promises to revolutionise experimental biology and may have important practical applications in functional genomics, therapeutic intervention, agriculture and other areas.” There are many examples of ways in which RNAi is impacting drug discovery.

RNA 52

RNA Drugs Gene Silencing Vaccination 52

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

Development 103

Development Regulation Cosmetics Life Science 103

Drug Discovery World

FEBRUARY 20, 2023

At the start of the year, a study sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID) proved that an additional dose of a Covid-19 vaccine is safe in adults who had previously received a full regimen of an approved vaccine.

Drug Trials 52

Drug Trials Trials Clinical Trials Clinical Trials 52

FDA Law Blog

APRIL 26, 2021

Moore & Riëtte van Laack — On Friday April 23, President Biden signed into law the Food Allergy Safety, Treatment, Education and Research (FASTER) Act that designates sesame as the ninth major food allergen. By Karin F.R. Then in 2019 Illinois enacted a law that required sesame allergen labeling.

Allergies 40

Allergies Cosmetics Containment Regulation 40

pharmaphorum

SEPTEMBER 16, 2020

Adding Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) and Gilead Sciences’ remdesivir reduces recovery time in COVID-19 patients compared to remdesivir alone, says a new trial. ACTT-2 used a 4mg dose of the drug, which wasn’t approved by the FDA on safety grounds.

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Trials Trial Funding Allergies Drugs 109

pharmaphorum

DECEMBER 22, 2021

Japanese drugmaker Takeda has suffered a blow to its late-stage pipeline, after the FDA rejected its marketing application for TAK-721, a drug candidate that is trying to be the first approved therapy in the US for eosinophilic oesophagitis (EoE). Takeda acquired the drug as part of its $62 billion merger with Shire in 2019.

Allergies 52

Allergies Drugs Clinical Trials Clinical Trials 52

XTalks

SEPTEMBER 23, 2022

The US Food and Drug Administration (FDA) issued a stern warning to address a disturbing trend among teens: cooking chicken in NyQuil. Even if you don’t eat the chicken, inhaling the medication’s vapors while cooking could cause high levels of the drugs to enter your body. It could also hurt your lungs.”.

Allergies 96

Allergies Drugs Medicine Production 96

pharmaphorum

OCTOBER 23, 2020

Gilead’s Veklury (remdesivir) has become the first COVID-19 drug approved in the US following a nod from the FDA. As an antiviral drug, remdesivir works to stop replication of SARS-CoV-2, the virus that causes COVID-19. In the meantime, it has been subject to a ‘rolling submission’ with the FDA that began in April.

Allergies 57

Allergies Trials Drugs Branding 57

pharmaphorum

DECEMBER 29, 2021

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. That was enough to secure approval although it remains to be seen how well it will fare commercially against Sanofi and Regeneron’s drug.

Sales 109

Sales Dermatology Marketing Allergies 109

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

FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021). Gaulkin & Riëtte van Laack — On May 16, the U.S.

Containment 45

Containment Contamination Compliance Manufacturing 45

XTalks

DECEMBER 7, 2020

This level of protection far exceeds expectations set by the Food and Drug Administration (FDA) in the US that indicated they would approve a vaccine if it were only 50 percent effective against the virus. In their trial, some 30,000 patients received either two doses of Moderna’s mRNA-1273 vaccine 28 days apart or placebo.

Vaccination 52

Vaccination Vaccine Development Drugs 52

pharmaphorum

APRIL 6, 2021

Whatever the cause, AZ is now pulling out of the facility and will shift production elsewhere, while J&J says it is “assuming full responsibility” for manufacturing of the drug substance for its vaccine at the plant. The post AZ exits US vaccine plant after mix-up spoils J&J’s COVID jab appeared first on.

Vaccination 55

Vaccination Vaccine Contamination Contract Manufacturing 55

XTalks

JULY 6, 2022

The four-year results from the VivAer clinical trial were published in the International Forum of Allergy & Rhinology. The VivAer Stylus received CE Mark in 2016 and US Food and Drug Administration (FDA) 510(k) clearance in December 2017. The tissue temperature is continuously monitored by a sensor on the stylus tip.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Allergies 52

The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. Food and Drug Administration. SILVER SPRING, Md. , 14, 2020 /PRNewswire/ — Today, the U.S. In the U.S.,

FDA Approval 52

FDA Approval Genome Genomics Production 52

The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. today announced that the U.S. indications. In the U.S., About Xolair. About Roche in Immunology.

FDA Approval 52

FDA Approval Clinical Development Allergies Medicine 52

Pfizer

JANUARY 27, 2023

and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). and around the world.

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

NOVEMBER 25, 2020

November 25, 2020 — Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). Background Randomized, controlled trials are the gold standard for evaluating the safety and effectiveness of drugs. Source: FDA. Posted: November 2020.

Trials 52

Trials Clinical Trials Clinical Trials Drugs 52

XTalks

NOVEMBER 16, 2020

This would have barely met the US Food and Drug Administration (FDA)’s 50 per cent efficacy requirement for a COVID-19 vaccine to prevent the infection, and even include possible prevention of severe disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2.

Vaccination 105

Vaccination Vaccine Trials Allergies 105

The Pharma Data

MAY 27, 2022

Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula on U.S. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Production 52

Production Manufacturing Cosmetics Allergies 52

The Pharma Data

MAY 15, 2021

Page 84 – Discover what one doctor did to get 70 percent of his patients opening of their clogged arteries and off of drugs or surgery, in mere weeks. Page 152 – The one vitamin which has been shown to naturally normalize cholesterols levels within 3 weeks, without drugs or pills.

Doctors 52

Doctors Doctor Containment Allergies 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. Together with Matt Wallach, Gassner began with the life sciences, and they never looked back.

Life Science 98

Life Science Pharma Companies Sales Marketing 98

The Pharma Data

MAY 27, 2022

Food and Drug Administration is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions. Today, the U.S. Source link: [link].

Production 52

Production Manufacturing Pharmacy Cosmetics 52

The Pharma Data

JANUARY 12, 2021

Virology, Respiratory, Dermatology, Allergy, & Rheumatology) in early & late stage Clinical Development and in Medical Affairs, with a strong track record for Developing and Accelerating Phase I–IV programs. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52