FDA Law Blog

AUGUST 3, 2022

If anything, the announcement was remarkably inconspicuous: a seemingly throwaway sentence in a draft compliance policy guide for research use only and investigational use only products. These products are subject to the same regulatory requirements as any unapproved medical device”).

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Camargo

NOVEMBER 29, 2021

Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available. Biologic products are used for the prevention or treatment of numerous diseases and conditions, including: Cancer. Nonclinical Testing.

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XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. Although recruitment has not started, AZALEA plans to enroll and assess the therapy in 120 participants.

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The Pharma Data

SEPTEMBER 17, 2020

Industry body says in vitro diagnostics are vital to clearing the backlog of undiagnosed conditions. Ahead of the upcoming comprehensive spending review, The British In Vitro Diagnostics Association (BIVDA) has called for more support for the UK in vitro diagnostics (IVD) industry. Source link.

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pharmaphorum

DECEMBER 16, 2020

Soon the ABPI and the entire industry were facing the ripple effects of COVID-19, including a significant slowdown in non-COVID clinical research, which Torbett says was challenging for the industry to deal with. “We’ve We’ve also seen a very mixed picture in the market for pharmaceuticals,” he says. Strength in the second wave.

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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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XTalks

JULY 28, 2020

Now, results from a new study conducted by researchers at the UC San Francisco (UCSF) School of Pharmacy and the Novartis Institutes for BioMedical Research (NIBR), have challenged drugmakers’ understanding of the effects of excipients. But just how inert are these excipients?

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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. For instance, in pharmaceutical manufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches.

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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

This is the first time that research scientists can conduct oncology research with Foundation Medicine’s comprehensive genomic profiling in their own laboratories to gain meaningful genomic insights and deepen their understanding of cancer biology. Roche today announced that it has launched the AVENIO Tumor Tissue CGP Kit.

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Advarra

AUGUST 31, 2022

In response to a growing demand for faster, approved, and cost-effective medical devices for chronic diseases, medical device manufacturers and emerging biotech companies are facing increasingly complex pathways to successfully bring their innovative ideas to the market. Quality assurance and risk management. Clinical evidence generation.

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The Pharma Data

DECEMBER 22, 2020

Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. Series B in October.

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XTalks

JUNE 27, 2022

CerTest Biotec specializes in the development and manufacturing of in vitro diagnostic medical devices and has expertise in the detection of human diseases. In a joint press release , the companies said the aim of the partnership is to design a diagnostic test that can help advance understanding of the global spread of the disease.

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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. “By working with customers from the initial research stage through to the development stage and finally the production stage, Sartorius can address and remove any issues. .

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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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FDA Law Blog

SEPTEMBER 21, 2022

The monkeypox test policy describes how FDA will prioritize review of EUA requests for monkeypox tests, stating that FDA intends to focus on requests for high-throughput tests, tests with home specimen collection, or rapid diagnostic tests, all from experienced developers with high manufacturing capacity.

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XTalks

SEPTEMBER 20, 2024

Vittoria’s investigational CAR-T therapy leverages gene editing to modulate the CD5 signaling pathway and a shorter manufacturing time to enhance efficacy and improve manufacturing efficiencies and vein-to-vein time. Such challenges highlight a significant unmet need and call for further advancements in the field.

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pharmaphorum

JANUARY 17, 2023

Research into mRNA dates back to the 1970s, but with the approval of both Moderna and BioNTech/Pfizer’s vaccines, this approach has finally been validated. In addition, the construction of a specialised manufacturing facility for mRNA vaccines was agreed.

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FDA Law Blog

MARCH 31, 2024

A fundamental divide is over whether LDTs and in vitro diagnostic products (IVDs) should continue to be regulated differently or if legislation can be crafted and enacted that will cover both types of products. This seems to have been the outcome that many lawmakers desired. These are areas where “revenue is modest,” she said.

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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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FDA Law Blog

DECEMBER 11, 2023

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 ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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The Pharma Data

DECEMBER 20, 2020

Athenex and Almirall have a license deal with Almirall having the license to research, develop and commercialize the drug in the U.S. The FDA also said there were deficiencies at the third-party facility where scPharmaceuticals’ off-the-shelf alcohol swabs are manufactured. The drug is a once-daily, beta-3 adrenergic agonist.

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The Pharma Data

DECEMBER 14, 2020

Preclinical research suggests that this antibody against the target can potentially address the existing pandemic, as well as escape mutants. . AbbVie will conduct the clinical development of the product, and if it is successful, it will manufacture and commercialize the product around the globe. before expanding it into Europe.

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Advarra

SEPTEMBER 23, 2022

Whether the methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity.” . The Food and Drug Administration (FDA) is the federal entity in the U.S. When Does an IND go into Effect? . The IND goes into effect; and .

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pharmaphorum

JUNE 9, 2022

Antimicrobial resistance (AMR) is an issue of global concern, killing roughly 1.2 million 1 people per year and projected to rise to 10 million people by 2050 2. It occurs when bacterial pathogens adapt over time to develop resistance to traditional antibiotics, resulting in “superbugs” that are near impossible to treat.

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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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pharmaphorum

OCTOBER 27, 2022

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? Companies should ensure key words are appropriate and do not constitute unauthorised promotion to the public.

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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. These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products.

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The Pharma Data

AUGUST 18, 2020

The companies will collaborate on developing and manufacturing REGN-COV2. We’re committing our manufacturing expertise and capacity, and our global distribution network to bring Regeneron’s potential antibody combination to as many people around the world as we possibly can.”. Regeneron will distribute REGN-COV2 in the U.S.

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The Pharma Data

MARCH 16, 2022

Roche and its subsidiary, Tib Molbiol, confirm that it has tests for research use that identify the SARS-CoV-2 subvariants of concern, Omicron: BA.1, It’s critical to quickly and accurately identify variants to inform ongoing research – including the ongoing development of therapeutics and vaccines. 3 and Delta. “In

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The Pharma Data

MARCH 23, 2021

The oral antiviral clinical candidate PF-07321332, a SARS-CoV2-3CL protease inhibitor , has demonstrated potent in vitro anti-viral activity against SARS-CoV-2, as well as activity against other coronaviruses, suggesting potential for use in the treatment of COVID-19 as well as potential use to address future coronavirus threats.

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The Pharma Data

MAY 3, 2021

Included were articles on the mid-career transition from research scientist to regulatory professional, continuous professional development and the value of graduate-level qualifications, and findings from two surveys on different aspects of the profession. Continuous professional development. Who is the average regulatory professional?

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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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Roots Analysis

AUGUST 7, 2023

On the other hand, cell free system / cell free expression system are ­in-vitro platforms that harness the transcription and translation machinery of living cells, in the form of cell lysates, to synthesize various types of biologics, particularly proteins. Interestingly, most of these kits are used for cell-free protein expression.

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Cloudbyz

AUGUST 19, 2024

Medical device safety is a multifaceted discipline encompassing the design, manufacturing, testing, and monitoring of devices throughout their lifecycle. Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market. What is the Medical Device Safety process?

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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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The Pharma Data

DECEMBER 9, 2020

With the launch of Overland, we are creating a robust research and development engine in parallel with the significant growth and opportunity presented by Asia’s evolving biotech industry. A solution could be at hand with Overland Pharmaceuticals. Below is a roundup of some of this week’s interesting news.

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