Worldwide Clinical Trials

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Currently, there are 12 approved ADC drugs, and several hundred more are in the development pipeline.

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XTalks

SEPTEMBER 30, 2020

While it remains unclear why some people become more gravely ill than others when infected with the SARS-CoV-2 virus that causes COVID-19, researchers have found that an immune deficiency may be part of it. Two recent studies have shown that individuals who lack an important immune factor may have reduced ability to fight the virus.

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Pharmaceutical Technology

FEBRUARY 20, 2023

Hans Bunschoten, chief strategy officer, Cerba Research: “Cerba Research and Viroclinics-DDL have a lot of synergies” The discrepancy is magnified in pivotal studies with a 76.1% This may sound obvious, but it is still a major hurdle in drug development. of the clinical trial population globally.

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Pfizer

JANUARY 27, 2023

Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. and around the world.

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Pharmaceutical Technology

MAY 31, 2023

The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Roche conducts research to identify novel methods to prevent, diagnose, and treat diseases. ZNA-1041 is under clinical development by F. Hoffmann-La Roche and currently in Phase I for Solid Tumor. Buy the report here.

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Scienmag

SEPTEMBER 28, 2020

Credit: Bat-science.com New research by BAT indicates that modern oral products (MOPs) showed lower toxicity responses in certain assays than traditional cigarettes. Velo was compared with a reference cigarette […].

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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 in melanocytes — the skin cells that produce melanin and give rise to melanoma — are correlated with reduced melanin production. Additionally, higher levels of ?-synuclein

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Medical Xpress

JANUARY 26, 2023

Bioengineered artificial skin has become an increasingly important and reliable platform for researchers to test the safety and efficacy of drugs and cosmetics. The most promising technologies for production of in vitro models include 3D bioprinting.

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pharmaphorum

JANUARY 22, 2021

So far, neither variant seems to be associated with more severe COVID-19 symptoms, although there has been some preliminary research suggesting the SA strain could allow reinfection with SARS-CoV-2, and also be less susceptible to vaccines. The UK strain – known as B.1.1.7

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FDA Law Blog

AUGUST 3, 2022

Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products. Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug.

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Roots Analysis

AUGUST 18, 2023

Animal testing is a vital part of drug development process, which is beneficial for researchers in understanding the cause, diagnosis, and treatment of various medical conditions. In order to fasten the discovery of innovative drugs and personalized medication, improved in vitro simulation of human biology and pathologies is required.

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Pharmaceutical Technology

SEPTEMBER 10, 2008

was established in 1999 in the process of privatisation of the State Research Institute for Pharmacy and Biochemistry in the Czech Republic. ” New projects we have been involved with have helped the company to accelerate its development in the field of pre-clinical research. Dr Ivana Surovà: Biotest s.r.o.

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pharmaphorum

OCTOBER 18, 2021

Also worth exploring is the regulatory oversight and approval process for medical devices and in-vitro diagnostics (IVDs). In contrast to the evaluation of medicines, the supervisory framework for medical devices and IVDs is fragmented and there is no single ‘go-to’ authority, which can be problematic for some products.

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Roots Analysis

DECEMBER 12, 2022

Animal testing is a vital part of drug development process, which is beneficial for researchers in understanding the cause, diagnosis, and treatment of various medical conditions. In order to fasten the discovery of innovative drugs and personalized medication, improved in vitro simulation of human biology and pathologies is required.

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Pharmaceutical Technology

JUNE 5, 2023

The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Roche conducts research to identify novel methods to prevent, diagnose, and treat diseases. Pralsetinib is under clinical development by F. Hoffmann-La Roche and currently in Phase II for Pancreatic Cancer.

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Advarra

JULY 18, 2023

Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) requirements ( 21 CFR 812 ). In IVD research , device risk determinations are primarily tied to sampling procedures and the consequences of invalid test results.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Devex’s global COVID-19 funding dashboard recorded $172 million invested in vaccine research between 1 January 2020 and 27 June 2020. Research into the therapeutic use of mRNA had been ongoing for decades prior to the COVID-19 pandemic. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed.

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Advarra

APRIL 19, 2023

In vitro diagnostic (IVD) devices are tests used on human biospecimens (e.g., IVDs are used in almost all clinical research. IVDs are used in almost all clinical research. However, the testing itself often occurs in laboratories or some other healthcare setting away from research participants.

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Pharmaceutical Technology

MAY 26, 2023

Enzymatic DNA production company Touchlight have augmented its DNA production capabilities with a newly announced expansion to its London facilities. Tripling its production capacity, Touchlight can now manufacture 8kg plasmid DNA, a key component for mRNA gene therapies and vaccines.

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pharmaphorum

JANUARY 25, 2022

For example, there is no need for in vivo animal or in vitro pre-clinical or non-clinical studies. The area of digital therapeutics is growing rapidly, and in this piece Ben Hargreaves examines why this is the case, how broadly these therapies can be applied and why investment in the area is mounting. This equated to $21.3

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Pharmaceutical Technology

FEBRUARY 28, 2023

The bispecific antibody was found to conditionally activate the immune pathway in the tumour microenvironment in vitro and in vivo trials. The US Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) have accepted the investigational new drug (IND) application for a Phase I trial of YH008.

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pharmaphorum

OCTOBER 5, 2022

The US Government’s Biomedical Advanced Research and Development Authority (BARDA) has made an initial investment of approximately $55 million for rapid development of VIR-2482, the Vir Biotechnology’s investigational prophylactic monoclonal antibody (mAb) for seasonal and pandemic influenza viruses.

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XTalks

DECEMBER 11, 2023

Through the utilization of their state-of-the-art technology and substantial investments in research and development (R&D), these med tech/medical device companies persist in driving industry innovation beyond the pandemic, thereby laying the foundation for a more streamlined approach against diseases in the future.

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XTalks

JANUARY 21, 2025

From non-invasive cancer diagnostics to life-saving cardiovascular implants, the latest medical devices cleared or approved by the FDA in 2024 reflect the remarkable strides in science and engineering. In this blog, we discuss some of these new medical devices of 2024 that have improved patient outcomes and enhanced quality of life worldwide.

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Advarra

AUGUST 31, 2022

If a new medical device, software as a medical device (SaMD), or in vitro diagnostic (IVD) is poised to successfully make it through the development process to commercialization, sponsors must consider a trifecta of interconnected systems involving: Regulatory strategy and submissions. Quality assurance and risk management. Intended use.

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Roots Analysis

SEPTEMBER 4, 2024

The main purpose of in vitro diagnostic solutions is to perform non-invasive / minimally invasive test procedures in order to detect a variety of health conditions using samples, such as blood, tissue or urine. Such tests help to diagnose health conditions, monitor treatments, perform disease screening and aid in early diagnosis of diseases.

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The Pharma Data

OCTOBER 26, 2021

The AVENIO Tumor Tissue Comprehensive Genomic Profiling (CGP) Kit is the first jointly-developed product that brings together the expertise and reach of Roche with Foundation Medicine’s pioneering leadership in genomic science. We are bringing powerful insights from CGP to enable smarter, more efficient research and development.

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FDA Law Blog

AUGUST 18, 2024

De Novos now play an important role in product advancement. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process. Each of these De Novos can represent a clinical advance.

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The Pharma Data

JANUARY 27, 2021

Eurofins Discovery will be conducting the IND-enabling in-vitro preclinical primary pharmacology and safety pharmacology studies on TD-0148A at its state-of-the-art facilities at Eurofins Cerep, DiscoverX and Panlabs. This approach makes Eurofins Discovery uniquely qualified to fulfill the needed studies for this innovative product.

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pharmaphorum

OCTOBER 27, 2022

The Guidance applies to both product-related and therapeutic-area-related activities. These risks have resulted in many companies being found in breach of self-regulatory codes, and a view that an increasingly narrow interpretation was being taken by authorities. What is the scope of the Guidance?

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Druggist

DECEMBER 2, 2020

Patients are usually required to complete an online assessment , which is reviewed by a doctor who issues the prescription with the product delivered to the patient. Some antiseptic/bacteriostatic products can kill bacteria, however not in sufficient amounts as compared to antibiotics, which eliminate an infection.

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pharmaphorum

OCTOBER 12, 2020

Over the past few years, 3D Cell Culture has gained momentum within the pharmaceutical industry due to the benefits that this model offers for in vitro applications patient-derived tissues, drug discovery, predictivity and validation, and safety and toxicity. Fey, Founder and Chief Research Officer, CelVivo. 3D-cellculture.com/PR1. .

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The Pharma Data

DECEMBER 22, 2020

In vitro studies have provided compelling evidence supporting the view that Tmod-based cell therapy can distinguish tumor cells from normal cells, across multiple tumor targets,” said Dr. Perlmutter, President, Merck Research Laboratories. “We A2 will also receive from Merck an equity investment and reimbursement of certain expenses.

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XTalks

JUNE 30, 2023

Sartorius is a globally recognized player in the diagnostics industry, providing a variety of solutions for in vitro diagnostics kit (IVD) manufacturers. She has been involved in various medical and IVD product developments, certifications and registrations, both internally and externally. Xu joined Sartorius in 2002.

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FDA Law Blog

DECEMBER 11, 2023

However, this prediction is unfounded, because it assumes that there is an existing classification regulation and/or product code for 90% of currently available LDTs. Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ).

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pharmaphorum

AUGUST 4, 2022

If not internally, such specialist training programmes can be outsourced to third-party organisations, whether that involves pharmaceuticals, in vitro diagnostics (IVDs) or QP training. This has resulted in staff and talent shortages, meaning that industries have been forced to respond quickly to stay afloat. Harness technology.

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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, The additional 3.7 million treatment courses are planned for delivery by early 2023. . In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S.

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