pharmaphorum

NOVEMBER 4, 2020

It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease.

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. These tumor-derived entities are used to derive genomic and proteomic data. Concentration of CTCs in Cancer Patients.

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Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

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Advarra

SEPTEMBER 23, 2022

In other words, the FDA also regulates whether investigational products may be manufactured, shipped, and administered to human subjects who participate in clinical investigations. . 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 . 21 CFR 312.40(a)

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Clinical Trials Clinical Trials Trials Regulation 52

Drug Discovery World

SEPTEMBER 28, 2023

Earlier this year, we explored the microbiome and its role in drug development across various therapeutic areas. This article will focus on one such area of great unmet need and promise: women’s health. This is likely in part because their byproduct, lactic acid, is known to inhibit pathogenic bacteria 25.

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Clinical Trials Clinical Trials Regulation Bacteria 64

XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

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Vaccination Vaccine Trials Clinical Trials 59

Drug Discovery World

MARCH 26, 2024

We were excited to unveil data showing that two distinct chemical series exhibit METTL1 inhibition in vitro at low nanomolar concentrations with minimal interference with other RNA and protein methyltransferases. Results of that Phase I trial are expected to be presented later this year. MT: What’s next for STORM’s research?

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Advarra

APRIL 19, 2023

In vitro diagnostic (IVD) devices are tests used on human biospecimens (e.g., Additionally, while the Food and Drug Administration (FDA) regulates all IVDs as medical devices, the agency has generally not enforced device regulations for certain IVDs designed, manufactured, and used within a single CLIA-certified laboratory.

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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. Meeting with the Regulators. Intended use.

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Research Regulation Clinical Trials Clinical Trials 52

Drug Discovery World

JANUARY 23, 2023

They showed that diacylglycerol kinase B (DGKB), a regulator of the intracellular level of diacylglycerol (DAG), was significantly suppressed in radioresistant GBM cells. Additionally, the clinical trial period will be considerably shorter than that required for new drug development.

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XTalks

MARCH 1, 2021

NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. The study will be a part of current Phase I, II and III trials. Pfizer Inc.

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pharmaphorum

AUGUST 10, 2020

The filing with the FDA follows approval by several regulators across the world, including in the European Union and Japan. Originally intended as a treatment for Ebola virus, Veklury is a nucleotide analogue with broad-spectrum antiviral activity both in vitro and in vivo in animal models against several emerging viruses.

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pharmaphorum

SEPTEMBER 22, 2021

The software – called Paige Prostate – is the first artificial intelligence-based to be approved by the FDA for this purpose, according to the US regulator. With Paige, three new prostate cancer cases were discovered that were initially missed, according to the results of the trial, which were reported at last year’s ASCO congress.

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pharmaphorum

MARCH 4, 2021

Sunak pledged £28 million towards the UK’s capacity for vaccine testing, support for clinical trials and to improve the ability to acquire samples of new COVID-19 variants. The guidance comes from the ACCESS Consortium of regulators from the UK, Australia, Canada, Singapore and Switzerland.

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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). Janssen’s Saskia De Haes, VP EMEA Regulatory Affairs, looks at how the pandemic response has shaped tomorrow’s regulatory landscape. When the COVID-19 pandemic hit, it lit a fire under the regulatory system.

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pharmaphorum

OCTOBER 4, 2022

Criteria for regulation. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). peer-reviewed clinical studies or clinical practice guidelines) meet Criterion 2 and are not medical devices subject to FDA regulation and oversight.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.

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The Pharma Data

JANUARY 27, 2021

We look forward to working with Eurofins Discovery to bring this treatment to patients as quickly as possible as we prepare for our IND and trials,” said BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian. FDA Investigational New Drug (“IND”)-enabling pharmacology studies. About BetterLife Pharma: BetterLife Pharma Inc.

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Drug Discovery World

FEBRUARY 15, 2023

However, over the last few decades, it has been widely accepted that interaction between the tumour and host immune response plays a critical role in regulating tumour biology and hence its progression. Over 250 clinical trials are currently in progress, and novel immuno-oncological treatments are already proving to be successful.

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XTalks

APRIL 6, 2022

Register for this webinar to get an overview of the role of long non-protein coding RNAs (lncRNAs) in gene regulations. Therefore, these patients could have a clinical benefit from further treatment or participation in a clinical trial. Photo source: Inivata. Around 85 percent of cases are non-small cell lung cancer (NSCLC).

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FDA Law Blog

OCTOBER 18, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. The 2013 guidance documents include, but are not limited to, in vitro diagnostic and clinical trial considerations.

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Drug Discovery World

DECEMBER 8, 2023

With human clinical trials with AI-designed drugs now ongoing, it’s only a matter of time until the FDA approves its first AI-designed drug. With human clinical trials with AI-designed drugs now ongoing, it’s only a matter of time until the FDA approves its first AI-designed drug.

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FDA Law Blog

OCTOBER 18, 2023

Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. By Adrienne R. The Draft Guidance provides specific examples illustrating the application of each scenario.

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FDA Law Blog

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

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Drug Discovery World

AUGUST 2, 2023

Palmitoyl transferases are a zinc finger Asp-His-His-Cystype (ZDHHC) family containing 23 distinct mammalian genes (excluding ZDHHC10) that catalyse this reaction 1. Conformational changes in the Ras membrane proximal domain facilitate the phosphorylation of GDP to GTP and the kinase domain activation.

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Protein Immune Response In-Vitro Regulation 52

Delveinsight

JANUARY 18, 2021

The company was running Phase III trials of the therapy for AS; however, the therapy flunked in the trial failing to meet its primary endpoint. For instance, GTX-102 , an antisense therapy silencing the gene expression by binding to the RNA molecule behind the regulation of its expression, has also secured USFDA Fast Track Designation.

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Drug Discovery World

FEBRUARY 22, 2024

According to Medicine Discovery Catapult, these include: “Navigating the complexity of the CNS; understanding the disease pathology, and accessing predictable in vitro and in vivo cell models 2 ”. For example, it can take up to it three years to recruit enough participants for a dementia clinical trial. million deaths worldwide” 1.

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Drugs Gene Clinical Trials Clinical Trials 59

FDA Law Blog

OCTOBER 11, 2022

In prevalent conditions, FDA nearly universally requires that substantial evidence be demonstrated via two adequate and well-controlled clinical investigations, for example, two Phase 2 or 3 trials (as long as they have the characteristics delineated at 21 CFR § 314.126).

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Clinical Trials Clinical Trials Drugs Trials 61

The Pharma Data

MAY 17, 2023

Additionally, pre-clinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible inhibitor currently in Phase III trials for MS. “I Fenebrutinib significantly reduced the total number of new gadolinium-enhancing T1 brain lesions compared to placebo, the primary endpoint of the trial (p=0.0022).

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The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. About COMET-ICE.

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FDA Law Blog

OCTOBER 2, 2023

Just as the original 1962 efficacy standard makes scientific judgment central to a determination of substantial evidence, the 1997 amendment makes scientific judgment central to a determination of what constitutes sufficient confirmatory evidence to substantiate a single adequate and well-controlled trial.

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Drug Discovery World

DECEMBER 29, 2023

Given their role in regulating cellular functions, it comes as no surprise that membrane proteins are the primary targets for the majority of currently marketed therapeutics. Consequently, the selection and optimisation of membrane mimetics is one of the main bottlenecks in structural and functional studies of membrane proteins.

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Drug Discovery World

MAY 16, 2023

Investment landscape In 2023, Matthieu de Kalbermatten, CEO of CellProthera, looks forward to presenting the final safety and efficacy results of the company’s Phase II clinical trial, and for moving into Phase III. What are the global innovations in cell and gene therapy? DDW’s Megan Thomas finds out.

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Gene Therapy Gene Manufacturing Marketing 52

The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and around the world.

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The Pharma Data

JULY 23, 2021

In addition to the REGN-COV 2067 trial in non-hospitalised patients, Ronapreve is currently being assessed in a phase II/III clinical trial for the treatment of COVID-19 in hospitalised patients (REGN-COV 2066). Roche’s Chief Medical Officer and Head of Global Product Development. About Ronapreve (casirivimab and imdevimab).

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The Pharma Data

DECEMBER 13, 2020

The STAMP-NAFLD trial was a 12-week, randomized, parallel group study in 120 presumed NASH patients with or without type 2 diabetes (T2DM). The Company additionally announced new preclinical results and plans for a Phase 2b trial focused on patients with noncirrhotic biopsy-proven NASH and coexisting prediabetes or T2DM.

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