FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software.

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XTalks

APRIL 13, 2021

Now, thanks to a study funded by the National Institutes of Health Intramural Research Program, scientists have discovered that ?-synuclein, synuclein, a protein involved in the formation of amyloid deposits in the brain characteristic of Parkinson’s disease and other neurodegenerative disorders, is also implicated in melanoma. Excessive levels of

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XTalks

JANUARY 8, 2021

Addressing this, the final guidance now contains additional information on eligibility criteria. In vitro diagnostics that monitor and evaluate serious adverse events associated with newly approved drugs may also qualify. Concerns Raised by AdvaMed. The initial STeP guidance document was drafted in 2019. More Specifics.

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XTalks

JULY 28, 2020

For example, Advil tablets contain 18 inactive ingredients alongside ibuprofen, the drug’s active pharmaceutical ingredient (API). But just how inert are these excipients? The results of their interaction study identified 19 excipients which interacted with 12 human proteins in a total of 25 different configurations.

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Druggist

FEBRUARY 17, 2021

Insect venoms (wasps) contain several allergens, which cause unpleasant symptoms, and in some cases, may cause an anaphylactic reaction (Moffitt, 2003). For many customers, ointment or cream for insect bites is the first line of rescue in stings management. What causes bite itchiness and redness? Hydrocortisone cream for insect bites.

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FDA Law Blog

FEBRUARY 14, 2023

Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease. This product contains at least 4% of naturally conserved cocoa flavanols.

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Camargo

FEBRUARY 16, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Criteria for Orphan Drug Designation. Scientific Rationale.

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XTalks

NOVEMBER 4, 2020

In the fetus, the antibody binds to fetal mast cells, a type of allergen-responsive immune cell that contains granules rich in histamine and heparin; these are released (in a process called degranulation) when the cells are stimulated by an allergen, triggering an allergic reaction. Related: Red Meat Allergy Test Gets FDA Clearance.

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The Pharma Data

AUGUST 15, 2021

After characterizing the nanoparticles in vitro, they injected them into mice, along with separate polymersomes containing an adjuvant, in two doses that were three weeks apart. For comparison, they immunized another group of mice with polymersomes that encapsulated the RBD, along with the nanoparticles containing the adjuvant.

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XTalks

AUGUST 9, 2023

Xdemvy, specifically formulated as an ectoparasiticide (anti-parasitic) for Demodex blepharitis treatment, contains the active ingredient lotilaner, a member of the isoxazoline compound family. California-based Tarsus Pharmaceuticals Inc., Xdemvy is now authorized to treat Demodex blepharitis, offering a new option for affected patients.

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Druggist

DECEMBER 2, 2020

In today’s post, I will review over the counter antibiotic creams in the UK. Some over the counter creams, gels and ointments available in the UK, have an ‘antibiotic’ properties however most of them are not genuinely classified as antibiotics, due to their limitations in terms of elimination of infections.

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pharmaphorum

AUGUST 24, 2020

Container Closure Integrity Evaluation: USP Perspective. • Container Closure Integrity and Controls Strategies Ensuring Product Sterility. Monocyte Activation Test: The In-vitro Pyrogen Test Based on Human Immune Cells for Batch Release Testing of Medical Products. Container Closure Integrity Evaluation: USP Perspective. •

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Pfizer

DECEMBER 13, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

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pharmaphorum

MARCH 11, 2021

The UK’s perceived failure to contain the initial spread of the virus was, we were told, in part due to a lesser focus on test and trace procedures than in some other countries, and that was down to us not having a tradition of diagnostics in this country. Over a year ago PCR testing was not a familiar term but is now known by general public.

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Pfizer

JANUARY 27, 2023

and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., 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 around the world.

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FDA Law Blog

OCTOBER 18, 2022

FDA’s retrospective review of the 2003 guidance documents will include user labeling for devices that contain natural rubber and premarket approval application modular review. The 2013 guidance documents include, but are not limited to, in vitro diagnostic and clinical trial considerations.

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The Pharma Data

OCTOBER 27, 2020

The test is planned for commercial launch as a CE-IVD ( in vitro diagnostic) certified product in the European Union in Q1 2021. The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 pandemic. About XPhyto Therapeutics Corp. XPhyto Therapeutics Corp.

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XTalks

JANUARY 29, 2024

Coloplast is leading by example and has launched new packaging that contains no aluminum for their soft catheter SpeediCath Flex. Coloplast is leading by example and has launched new packaging that contains no aluminum for their soft catheter SpeediCath Flex. They have created a Strive25 strategy with sustainability in mind for 2025.

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Roots Analysis

AUGUST 15, 2023

Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. Additionally, these types of cell free systems do not contain proteases and nucleases as crude cell lysates, which further helps in improving the production of many proteins.

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FDA Law Blog

MARCH 16, 2023

We are not aware of any other microbiological in vitro diagnostic test that contains the word “simple” in the regulation. symptomatic) when testing is started within 6 days of symptom onset. We note the unique use of the word “simple” to define a point-of-care device.

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The Pharma Data

NOVEMBER 11, 2020

ADDS IN VITRO PHARMACOLOGY AND EXPANDS PROTEIN SCIENCES. CREATES UNIQUE CO-LOCATED, FULLY-INTEGRATED, HIGH-CAPACITY R&D CENTRE. CREATES CENTRE OF EXCELLENCE FOR STRUCTURE-BASED DRUG DESIGN. INCREASES GLOBAL CAPACITY FOR HIGH-VALUE INTEGRATED DRUG DISCOVERY AND COMMERCIAL DEVELOPMENT OFFERING.

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Roots Analysis

MARCH 16, 2023

In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent. Prevention of infectious diseases: Development of a prophylactic or therapeutic vaccine is one of the most effective ways to contain and fight an epidemic / pandemic.

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Pfizer

AUGUST 15, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

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Roots Analysis

OCTOBER 16, 2023

These clones can be manipulated and mutated in vitro to alter the expression and function of a protein. These clones can be manipulated and mutated in vitro to alter the expression and function of a protein. There are some motifs, such as hairpin loops which hinder the usability of a gene.

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The Pharma Data

SEPTEMBER 1, 2020

Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions. Antigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection status. Food and Drug Administration (FDA).

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Pfizer

JANUARY 27, 2023

The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks.

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The Pharma Data

JANUARY 11, 2021

Our antibody clones in their original IgG format have shown potent neutralization activity in in vitro assays and, in the case of our lead clone, in an in vivo animal model. Upon binding, the antibodies block the spike protein from interacting with ACE2 and thereby prevent virus-induced cell-killing, also known as cytopathic effect.

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FDA Law Blog

MAY 25, 2022

It is not uncommon for some in vitro diagnostic tests to suffer from poor positive predictive value, in part due to the rarity of the disease. The VALID Act would give FDA authority to regulate laboratory developed tests and fundamentally change the regulatory paradigm for all in vitro diagnostic tests. (As

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Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. Pfizer oral treatment remains available to eligible U.S. patients under Emergency Use Authorization as a critical tool in the fight against COVID-19. NEW YORK, December 20, 2022 -- Pfizer Inc. NYSE: PFE) announced today that the U.S. In the U.S.,

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The Pharma Data

SEPTEMBER 17, 2020

3 Knowing a given population’s seroprevalence is important in understanding how to contain the spread of the virus, as well as how to safely ease lockdown restrictions. 3 Knowing a given population’s seroprevalence is important in understanding how to contain the spread of the virus, as well as how to safely ease lockdown restrictions.

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The Pharma Data

JANUARY 19, 2021

CLARKSVILLE, Md., 20, 2021 (GLOBE NEWSWIRE) — Neuronascent Inc. , a privately-held neuron regeneration therapeutics company, today announced the publication of results of their novel pharmacotherapy: NNI-362 to allosterically stimulate neural regeneration in human cultures and in vivo models of aging and disease. About NNI-362.

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The Pharma Data

DECEMBER 2, 2020

Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. SAN DIEGO, Dec. 02, 2020 (GLOBE NEWSWIRE) — Progenity, Inc. About Progenity. Progenity, Inc. Progenity, Inc. Forward Looking Statements.

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The Pharma Data

JANUARY 31, 2021

They are well established drug targets, particularly in neurological and cardiovascular diseases, but many remain undrugged or poorly drugged, and may be tractable to structure-based approaches. Metrion will contribute intellectual property, know-how and use of screening models for the nominated ion channel target. ” About Sosei Heptares.

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Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that safe and effective drugs are available to improve the health of the people in the United States.” .

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The Pharma Data

APRIL 28, 2021

Fosmanogepix has demonstrated broad-spectrum activity in-vitro and has shown wide distribution to various tissues including the brain, lung, kidney and eye. Deal expands anti-infectives pipeline with addition of novel antifungal Phase 2 candidate, Fosmanogepix (APX001). NEW YORK–(BUSINESS WIRE)– Pfizer Inc. and Scedosporium spp).

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The Pharma Data

JANUARY 24, 2021

Brilacidin has shown in vitro to be have antiviral properties against different SARS-CoV-2 strains and other human coronaviruses. With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. Read on to see. COVID-19-Related. Non-COVID-19-Related.

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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.

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