XTalks

NOVEMBER 4, 2020

It has long been known that mothers greatly influence the development of the growing fetus by not only providing nutrients through the placenta, but also a growing list of biological elements including beneficial antibodies, gut bacteria and now, allergies. They reported their findings last week in the journal Science.

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The Pharma Data

JANUARY 27, 2021

BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments in mental disorders and viral infections, announces it has entered into an agreement with Eurofins Discovery for TD-0148A’s U.S. VANCOUVER, Jan.

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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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Protein Drugs In-Vitro Scientist 103

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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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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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

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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Protein Vaccination Vaccine Antibody 52

Pfizer

DECEMBER 13, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1,

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Drugs Licensing Licensing Production 110

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

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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Contamination In-Vitro Production Containment 52

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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Protein In-Vitro Production Reagent 52

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.

Vaccination 52

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Pfizer

JANUARY 27, 2023

In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., It is important to note that these studies are required by U.S. and around the world.

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Research Vaccination Vaccine Drugs 112

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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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.

Production 52

Production In-Vitro Marketing Clinical Trials 52

Pfizer

AUGUST 15, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

Pfizer

JANUARY 27, 2023

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision.

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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).

Antibody 52

Antibody Vaccination Vaccine In-Vitro 52

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.

Drugs 52

Drugs Protein In-Vitro Development 52

Pfizer

DECEMBER 20, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. NEW YORK, December 20, 2022 -- Pfizer Inc.

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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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 52

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

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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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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DNA Gene Protein In-Vitro 40

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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The Pharma Data

APRIL 28, 2021

a privately-held company dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems. a privately-held company dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems.

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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

OCTOBER 21, 2020

We look forward to advancing clinical development of KB-0742 to establish the dose, safety and efficacy of this investigational therapy as a potential treatment for MYC-amplified tumors.”. However, most patients will develop resistance to treatment and progress to CPRC,” said Dr. Koehler. SAN MATEO, Calif., and CAMBRIDGE, Mass.,

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The Pharma Data

MARCH 16, 2021

The cobas SARS-CoV-2 Variant Set 1 Test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission. Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas ® SARS-CoV-2 Variant Set 1 Test to detect and differentiate mutations found in variants that originated in the UK (B.1.1.7),

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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

JANUARY 24, 2021

Gritstone Oncology , based in Emeryville, California, announced that it is advancing development of its own second-generation vaccine against COVID-19. Brilacidin has shown in vitro to be have antiviral properties against different SARS-CoV-2 strains and other human coronaviruses. Read on to see. COVID-19-Related.

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