pharmaphorum

SEPTEMBER 29, 2022

Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. If an mHealth device is life sustaining, then the FDA is certainly going to regulate the device.

Development 105

Development Regulation Production Life Science 105

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.

Clinical Trials 65

Clinical Trials Clinical Trials Regulation Bacteria 65

Drug Discovery World

JANUARY 23, 2023

Researchers have discovered a clinical drug that sensitises glioblastoma (GBM) cells to radiotherapy and could replace the current standard of care. They showed that diacylglycerol kinase B (DGKB), a regulator of the intracellular level of diacylglycerol (DAG), was significantly suppressed in radioresistant GBM cells.

FDA Approval 52

FDA Approval Drugs In-Vivo In-Vitro 52

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. Clinical evidence generation. Intended use.

Research 52

Research Regulation Clinical Trials Clinical Trials 52

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials In-Vitro 98

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.

Vaccination 106

Vaccination Vaccine Development Life Science 106

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.

DNA 105

DNA In-Vitro Doctors Doctor 105

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.

Gene Therapy 65

Gene Therapy Gene In-Vitro Development 65

XTalks

MARCH 1, 2021

Pfizer/BioNTech are executing the three-dose study to also determine the effectiveness of a third dose against evolving variants as part of their clinical development strategy. Sera from individuals will also be taken to evaluate neutralization of different SARS-CoV-2 strains in in vitro studies.

Vaccination 111

Vaccination Vaccine Development In-Vitro 111

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.

In-Vitro 64

In-Vitro Regulation Marketing Clinical Trials 64

Drug Discovery World

MAY 16, 2023

Many developers encounter multi-year delays in programme development because they fail to invest in the development of later stage processes critical to scale-up while collecting early clinical data. What are the global innovations in cell and gene therapy? What opportunities and challenges are emerging and can therapies get to market faster?

Gene Therapy 52

Gene Therapy Gene Manufacturing Marketing 52

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.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

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. Schleifer, M.D.,

Antibody 52

Antibody Clinical Trials Clinical Trials Manufacturing 52

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 I am encouraged by this clinical data for fenebrutinib, which is important news for people living with MS,” said Levi Garraway, M.D.,

FDA Approval 40

FDA Approval In-Vitro Trials Clinical Trials 40

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.

Antibody 52

Antibody Medicine Production In-Vitro 52

The Pharma Data

AUGUST 16, 2020

Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. We thank the NMOSD community, including patients and investigators who participated in ENSPRYNG clinical trials.”. “We Chief Medical Officer and Head of Global Product Development. “We

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

The Pharma Data

APRIL 28, 2021

Fosmanogepix is currently in Phase 2 clinical trials evaluating the safety and efficacy of both intravenous (IV) and oral formulations for the treatment of patients with life-threatening invasive fungal infections caused by molds, yeasts and rare molds (e.g., NEW YORK–(BUSINESS WIRE)– Pfizer Inc. and Scedosporium spp).

Clinical Trials 40

Clinical Trials Clinical Trials Containment In-Vitro 40

Pharmaceutical Technology

SEPTEMBER 10, 2008

Before the inception of this institute, the facility was oriented towards pre-clinical toxicology and breeding of the laboratory animals. Before the inception of this institute, the facility was oriented towards pre-clinical toxicology and breeding of the laboratory animals. Dr Ivana Surovà: Biotest s.r.o.

In-Vitro 130

In-Vitro Genotoxicity In-Vivo Clinical Research 130

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. The IVD may be the primary focus of the clinical trial, or it may be evaluated in a minor, exploratory objective.

Research 52

Research Regulation Clinical Trials Clinical Trials 52

pharmaphorum

OCTOBER 18, 2021

Also worth exploring is the regulatory oversight and approval process for medical devices and in-vitro diagnostics (IVDs). In addition to data obtained in a clinical setting, information from outside of the clinic can contribute to understanding how a medicine works in daily life.”. billion people have been fully vaccinated.

Vaccination 143

Vaccination Vaccine Regulation Medicine 143

Pfizer

JANUARY 27, 2023

The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks.

Marketing 75

Marketing Production Drugs Licensing 75

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.”. In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 52

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.

Trials 52

Trials In-Vitro Insulin Protein 52

pharmaphorum

OCTOBER 4, 2022

Part 2 of this series is devoted to clinical decision support (CDS) software. 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). Criterion 1. Criterion 2.

Development 105

Development Regulation Cosmetics Life Science 105

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.

Protein 52

Protein Immune Response In-Vitro Regulation 52

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.

Research 52

Research In-Vitro In-Vivo Development 52

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.

Production 52

Production In-Vitro Marketing Clinical Trials 52

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.

Drugs 110

Drugs Licensing Licensing Production 110

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.

Marketing 52

Marketing Gene Drugs Protein 52

The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase IIIb OCREVUS higher dose clinical trial programme and Phase IV study evaluating OCREVUS in minority populations. New data further reinforce OCREVUS (ocrelizumab) as a highly effective treatment option offering a favourable and consistent benefit:risk profile, with high treatment persistence and adherence.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Medicine 52

Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. Pfizer oral treatment remains available to eligible U.S. NEW YORK, December 20, 2022 -- Pfizer Inc. In the U.S., approximately 7.6

Drugs 69

Drugs Licensing Licensing Containment 69

XTalks

DECEMBER 19, 2023

In the fast-evolving pharmaceutical landscape, tracking the top-selling drugs offers valuable insights into trends, healthcare priorities and the dynamics of the global market. As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. 2) Humira (adalimumab) Sales in 2022: $21.24

Sales 64

Sales FDA Approval Drugs Vaccination 64

XTalks

JUNE 12, 2023

Medtronic’s proactive stance towards R&D is evident from the over 230 clinical trials it conducted and the more than 200 regulatory approvals it received in the US, Europe, Japan and China in the 2022 fiscal year. Note: When it comes to companies that report in foreign currencies, the conversion to U.S.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

Pfizer

NOVEMBER 23, 2022

Clinical data and real-world evidence for PAXLOVID have shown that it can be an important tool in helping to reduce hospitalizations and deaths in those at increased risk of serious illness from COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “As This agreement will supply participating countries up to 3.4

Licensing 40

Licensing Licensing Drugs Manufacturing 40

FDA Law Blog

OCTOBER 11, 2022

The Act defines substantial evidence as that consisting of “adequate and well-controlled [clinical] investigations” upon which qualified scientific experts could conclude that a drug will have its purported effect. More importantly, replication is but one means to substantiate the results of a clinical investigation or scientific study.

Clinical Trials 61

Clinical Trials Clinical Trials Drugs Trials 61

The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] The primary efficacy analysis showed median rPFS was extended by six months in patients treated in the combination arm compared with patients in the control arm (22.6

HR 52

HR In-Vitro Development Clinical Trials 52

XTalks

OCTOBER 1, 2020

Dr. Lin received a medical degree from Shanghai Medical University and specialized in hematology after which she began working in the clinical research unit at the university, treating patients with acute leukemia. However, this has since changed, and now, transitioning between academia and industry has become more commonplace. Key Moments.

Scientist 52

Scientist In-Vitro Research Life Science 52