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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Packaging Packaging Production In-Vitro 64

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

Drug Discovery World

OCTOBER 27, 2023

Accurate modeling of the human tumour microenvironment is essential to the development of new cancer therapies, but has always been a challenge for drug developers. Accurate modeling of the human tumour microenvironment is essential to the development of new cancer therapies, but has always been a challenge for drug developers.

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Research Gene Therapy In-Vivo In-Vitro 72

XTalks

JANUARY 8, 2021

The FDA instituted STeP to help developers of safer devices and diagnostics for conditions excluded from the Breakthrough Devices Program to benefit from prioritized review and enhanced communication with the agency throughout the development process. This includes non-life-threatening or reasonably reversible conditions.

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Camargo

MARCH 25, 2021

Its purpose is to stimulate the development of new drugs for rare pediatric diseases by offering additional incentives for obtaining FDA approval of such products beyond the incentives offered by the ODD program. Criteria for Rare Pediatric Disease Designation. Criteria to Obtain the Designation.

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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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Allergies Antibody In-Vitro Development 98

The Pharma Data

NOVEMBER 29, 2021

First Combination of Immunotherapy With Tyrosine Kinase Inhibitor Approved in Europe for Adult Patients With Advanced or Recurrent Endometrial Carcinoma With Disease Progression on or Following Prior Treatment With a Platinum-Containing Therapy in Any Setting and Who Are Not Candidates for Curative Surgery or Radiation.

In-Vitro 52

In-Vitro Containment Development Medicine 52

Drug Discovery World

OCTOBER 19, 2022

Ashley Rein , Global Market Manager for Topical Drug Delivery at Lubrizol Life Science Health (LLS Health), explains how by using mucoadhesive drug delivery, developers can bring novel drugs to market and maximise the efficacy of pre-existing APIs. . Drug discovery and development is a time-consuming and costly endeavour.

Drug Delivery 52

Drug Delivery Drugs Drug Delivery Systems Development 52

Camargo

FEBRUARY 16, 2021

Many diseases and conditions affect such small numbers of people that a drug or biological product developed to treat these patients generates relatively little return on investment for development costs. Subscribe to our mailing list at the bottom of this page to be notified when Parts 3 and 4 are published. Scientific Rationale.

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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.

RNA 52

RNA Drug Delivery Production In-Vitro 52

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.

Contamination 52

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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.,

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

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.

In-Vitro 40

In-Vitro Insulin Development Containment 40

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,

Research 98

Research Protein In-Vitro Gene Therapy 98

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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FDA Approval In-Vitro Trials Bacteria 98

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

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 ).

Regulation 40

Regulation Genetics In-Vitro Development 40

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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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

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.

Containment 40

Containment Clinical Trials Clinical Trials In-Vitro 40

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.

Sales 40

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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

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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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Marketing Production Drugs Licensing 75

The Pharma Data

MAY 18, 2021

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Roche’s Chief Medical Officer and Head of Global Product Development. Roche’s Chief Medical Officer and Head of Global Product Development.

Medicine 52

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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).

In-Vitro 52

In-Vitro Antibody Medicine Clinical Trials 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

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.

Drugs 52

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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

Clinical Trials 40

Clinical Trials Clinical Trials Trials In-Vivo 40

Drug Discovery World

AUGUST 3, 2022

To address these problems, it’s vital to develop delivery systems that enable oligonucleotides to reach their targets: cell-penetrating peptides (CPPs) present a potential solution to this issue. These peptides typically contain up to 30 amino acids and can be cationic, amphipathic or both. How are cell-penetrating peptides used?

Bioavailability 52

Bioavailability In-Vivo RNA In-Vitro 52

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.,

In-Vivo 40

In-Vivo In-Vitro Bioavailability Clinical Trials 40

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.

In-Vitro 63

In-Vitro Containment Radiology Life Science 63

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.

Sales 40

Sales In-Vitro Containment Development 40

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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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

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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.

In-Vitro 40

In-Vitro Clinical Trials Clinical Trials Sales 40

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),

Antibody 52

Antibody Clinical Trials Clinical Trials Vaccination 52

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.

Genetics 40

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