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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FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).

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XTalks

APRIL 13, 2021

While it has been known for about five decades now that patients with Parkinson’s disease have a higher likelihood of developing melanoma than the general population, the exact reasons for this were unknown. Now, thanks to a study funded by the National Institutes of Health Intramural Research Program, scientists have discovered that ?-synuclein,

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The Pharma Data

JANUARY 27, 2021

Avacta has worked with Adeptrix Inc (Beverly, MA, USA) to develop a coronavirus antigen test that combines enrichment of the sample using Affimer® reagents with the analytical power of mass-spectrometry. Beverley, MA) (“Adeptrix”). I look forward to updating the market when we have definitive clinical performance data.”.

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The Pharma Data

AUGUST 15, 2021

Even as several safe and effective COVID-19 vaccines are being administered to people worldwide, scientists are still hard at work developing different vaccine strategies that could provide even stronger or longer-lasting immunity against SARS-CoV-2 and its variants.

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XTalks

AUGUST 9, 2023

a leader in developing therapeutic solutions for common diseases with limited treatment alternatives, has secured approval from the US Food and Drug Administration (FDA) for its drug, Xdemvy (lotilaner ophthalmic solution) 0.25%. California-based Tarsus Pharmaceuticals Inc., What Is Demodex Blepharitis? Collarettes were identified in 69.1

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The Pharma Data

DECEMBER 20, 2020

. PARTNERSHIP LEVERAGES COMPLEMENTARY STRENGTHS OF IN SILICO, IN VITRO AND IN VIVO ANTIBODY DISCOVERY IN A RANGE OF INDICATIONS. ” ABOUT ALLOY THERAPEUTICS Alloy Therapeutics is a biotechnology company dedicated to empowering scientists in the relentless pursuit of making better medicines for all.

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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. “Applying 3a’s proprietary enhanced RNA technology to PCR testing was a logical next step in our product development pipeline,” said Dr. . About XPhyto Therapeutics Corp.

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pharmaphorum

AUGUST 24, 2020

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.

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The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Dr. Graham earned an M.D.,

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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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The Pharma Data

DECEMBER 21, 2020

These results suggest that early antiviral treatment of SARS-CoV-2 infection may protect against developing severe COVID-19 lung disease. The trial was not designed or sized to demonstrate clinical efficacy and no clinical efficacy benefit with galidesivir treatment compared to placebo treatment was observed in the trial.

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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. It is worth noting that several companies have begun to develop mRNA-based cancer immunotherapies and vaccines for infectious diseases.

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The Pharma Data

NOVEMBER 11, 2020

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

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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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XTalks

JANUARY 27, 2021

The company used in vitro neutralization antibody studies to evaluate the activity of Moderna’s vaccine-generated antibodies in human sera against several variants of the novel coronavirus, including the B.1.1.7 The in vitro study evaluated the ability of mRNA-1273-generated antibodies to neutralize the new SARS-CoV-2 variants.

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The Pharma Data

JANUARY 31, 2021

As a first step, Sosei Heptares and Metrion will combine their respective capabilities in a drug discovery program to identify novel, highly specific drug leads for further development against a single ion channel associated with neurological diseases. No further financial details are disclosed. ” About Sosei Heptares.

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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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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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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. In fact, NIPT were one of 20 “bad tests” that Dr. Shuren identified in the Agency’s November 2015 “Public Health Evidence for FDA Oversight of Laboratory Developed Tests” ( here ).

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The Pharma Data

DECEMBER 14, 2020

”) platform to transform drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, announced today new scientific data that substantiates blood brain barrier permeability (BBB) for its drug candidate LP-184. . . DALLAS , Dec. Lantern’s A.I.

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The Pharma Data

OCTOBER 14, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Roche today announced European Medicines Agency (EMA) approval of a new, shorter 90-minute Gazyvaro® (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma (FL).

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The Pharma Data

DECEMBER 2, 2020

Progenity”) (NASDAQ: PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced the pricing of its previously announced underwritten public offering of 7,645,259 shares of its common stock at a public offering price of $3.27 SAN DIEGO, Dec.

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The Pharma Data

JANUARY 19, 2021

NNI-362 was discovered and is being developed to actually cure age-related neurodegenerative disorders, by replacing lost neurons and ensuring these adult-born neurons survive even in disease,” said founder and CEO, Judith Kelleher-Andersson, Ph.D. CLARKSVILLE, Md., 20, 2021 (GLOBE NEWSWIRE) — Neuronascent Inc. ,

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pharmaphorum

NOVEMBER 2, 2021

Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed. They are also designed to have a short in vitro half-life, meaning that they will be cleared from a patient’s system within several hours.

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The Pharma Data

JANUARY 12, 2021

INCHEON, South Korea–( BUSINESS WIRE )– Celltrion Group today announced top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. days quicker compared to placebo. Patients treated with CT-P59 (40mg/kg) recovered 3.4

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The Pharma Data

DECEMBER 2, 2020

SAN DIEGO, Dec. 02, 2020 (GLOBE NEWSWIRE) — Progenity, Inc. NASDAQ: PROG) today announced the pricing of its offering of $75.0 The issuance and sale of the notes are scheduled to settle on December 7, 2020, subject to customary closing conditions. million principal amount of notes. per share of common stock.

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The Pharma Data

OCTOBER 22, 2020

The Company intends to use the net proceeds from this offering to support its planned New Drug Application submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical development of sulopenem, and for working capital and general corporate purposes.

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The Pharma Data

NOVEMBER 4, 2020

CENTOGENE’s SARS-CoV-2 test is a molecular diagnostic test performed for the in vitro qualitative detection of RNA from the SARS-CoV-2 in oropharyngeal samples from presymptomatic patients and probands according to the recommended testing by public health authority guidelines. CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Nov.

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Camargo

NOVEMBER 29, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms.

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XTalks

NOVEMBER 7, 2022

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. These tumor-derived entities are used to derive genomic and proteomic data. The same webinar held a Q&A session with Dr. Bahassi and two other experts from Medpace, Dr. Lyon L.

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The Pharma Data

SEPTEMBER 17, 2020

This is the focus of vaccines in development and convalescent plasma therapy. 2 Measuring antibody levels could also be vital in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19. The test targets antibodies against the spike protein. Food and Drug Administration (FDA).

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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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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

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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The Pharma Data

DECEMBER 29, 2020

Program includes development of a heat-sensitive fluorescent SARS-CoV-2 detection assay through patient mucosal sampling. Due to the breadth of our antibody discovery capabilities, IPA is very well positioned to deliver anti-virus antibodies in various formats, opening doors for inclusion in different therapeutic and diagnostic approaches.

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Cloudbyz

AUGUST 19, 2024

Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market. European Medicines Agency (EMA): Regulates medical devices within the European Union through the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

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