pharmaphorum

MARCH 4, 2021

In a separate announcemen t, the UK’s Medicines and Healthcare products Regulatory Authority (MHRA), issued guidance outlining plans to fast-track modified vaccines for new coronavirus variants. The guidance comes from the ACCESS Consortium of regulators from the UK, Australia, Canada, Singapore and Switzerland.

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FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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XTalks

OCTOBER 8, 2024

The approval was awarded to Abbott’s Alinity m MPXV assay, the first mpox in vitro diagnostic (IVD) listed under the WHO’s Emergency Use Listing (EUL) procedure. It is intended for use by trained clinical laboratory professionals skilled in PCR techniques and IVD procedures. Mpox has led to at least 635 deaths in the DRC this year.

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pharmaphorum

OCTOBER 27, 2022

Why is guidance needed? Uses of social media is continually expanding and it has been difficult for companies to apply general advertising rules and guidance to the modern world. What is the scope of the Guidance? Information on social media and digital channels should be kept up to date and date stamped, with the date posted or last updated.

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Scienmag

OCTOBER 18, 2020

18, 2020) – Success rates for in vitro fertilization are higher at clinics that voluntarily share more information than required by government regulators, according to new research by faculty at the University of Colorado School of Medicine. AURORA, Colo.

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XTalks

MARCH 1, 2021

In addition, the companies are also engaged in discussions with regulatory agencies, including the US Food and Drug Administration (FDA) and the European Medicines Agency, with respect to a registration-enabling study for the evaluation of a variant-specific vaccine with a new mRNA code. The new mRNA sequence would be based on the B.1.351

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FDA Law Blog

MAY 25, 2022

Indeed, the communication identifies several medical societies (the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM), and the American College of Medical Genetics and Genomics (ACMG)) that recommend use of these types of tests as part of standard prenatal care.

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FDA Law Blog

AUGUST 18, 2024

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. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.

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The Pharma Data

APRIL 7, 2021

today announced the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies. Beyond breakthrough cancer medicines, Roche also offers a growing number of testing solutions to help physicians diagnose and treat people with cancer. said Thomas Schinecker, CEO Roche Diagnostics.

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pharmaphorum

DECEMBER 16, 2020

There were companies that allowed their staff to volunteer to deliver medicines to vulnerable people, and many HCPs that work in the industry have gone back to frontline care. We’ve also seen a very mixed picture in the market for pharmaceuticals,” he says. We had companies collaborating to develop laboratories.

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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. FDA Investigational New Drug (“IND”)-enabling pharmacology studies. About BetterLife Pharma: BetterLife Pharma Inc.

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Pfizer

JANUARY 27, 2023

and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. It is important to note that these studies are required by U.S. and around the world.

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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. Previously, he held roles as CMO at Trimeris Inc.

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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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Cloudbyz

AUGUST 19, 2024

Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare. This is where the importance of stringent safety processes, robust systems, and comprehensive regulations comes into play. What is the Medical Device Safety process?

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The Pharma Data

MARCH 23, 2022

While the results are promising, the researchers caution the public against rushing to buy sulforaphane supplements available online and in stores, noting that studies of sulforaphane in humans are necessary before the chemical is proven effective, and emphasizing the lack of regulation covering such supplements. alone each year.

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The Pharma Data

SEPTEMBER 9, 2020

The longer-term data for ENSPRYNG further reinforce the previously observed efficacy of this medicine for this debilitating disorder that is often mistaken for multiple sclerosis,” said Levi Garraway, M.D., ENSPRYNG lowered relapse severity in double-blind periods of SAkura Phase III studies. ENSPRYNG was recently approved by the U.S.

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The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. “Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of hospitalisation and death. About Ronapreve (casirivimab and imdevimab).

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The Pharma Data

AUGUST 18, 2020

We are excited about the potential for one medicine to serve both as a treatment for those infected as well as protection for people exposed to the virus. REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. and around the world. and around the world.

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Pfizer

AUGUST 15, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 I am grateful to have received four doses of the Pfizer-BioNTech vaccine and I am feeling well while experiencing very mild symptoms. FDA Emergency Use Authorization Statement.

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The Pharma Data

JANUARY 31, 2021

Ion channels are a class of integral membrane proteins that regulate the flow of ions across the cell membrane as a means of conducting signals between cells and their environment. . TOKYO and CAMBRIDGE, England , Feb. ” About Sosei Heptares.

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XTalks

NOVEMBER 7, 2022

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. These tumor-derived entities are used to derive genomic and proteomic data. The same webinar held a Q&A session with Dr. Bahassi and two other experts from Medpace, Dr. Lyon L.

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The Pharma Data

DECEMBER 29, 2020

Innovative, novel approach to treat and protect against SARS-CoV-2 using thermoresponsive virus-targeting nanoparticles as an inhalation medicine. Program includes development of a heat-sensitive fluorescent SARS-CoV-2 detection assay through patient mucosal sampling. About Radboudumc.

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Pfizer

JANUARY 27, 2023

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. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries to treat COVID-19.

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XTalks

APRIL 2, 2021

Pfizer and German partner BioNTech are preparing to promptly submit the updated COVID-19 vaccine trial results to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to request expansion of the Emergency Use Authorization (EUA) and EU Conditional Marketing Authorization for BNT162b2. “We

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The Pharma Data

AUGUST 16, 2020

“Today’s FDA approval of ENSPRYNG, the first subcutaneous NMOSD treatment using novel recycling antibody technology, builds upon the work we’ve done in multiple sclerosis with OCREVUS to develop first-in-class medicines and further the scientific understanding of neuroimmunological diseases,” said Levi Garraway, M.D., with placebo.

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The Pharma Data

DECEMBER 9, 2020

The new company, created by Hillhouse Capital Venture Partners, launched this week with a mission to pursue the most promising advances in medicine for underserved patients in Asia and around the world. A solution could be at hand with Overland Pharmaceuticals.

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XTalks

SEPTEMBER 20, 2024

I’m a firm believer that cell therapy, and the modality in general, is going to be the future of medicine and has the potential to be curative for chronic diseases that in the past, we could at best, hope to manage,” he stated. Such challenges highlight a significant unmet need and call for further advancements in the field.

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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. They can be used in patient selection, stratification, risk mitigation and assessment of safety and efficacy endpoints.

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The Pharma Data

MAY 18, 2021

If approved, ENSPRYNG will be the first and only treatment available to both adults and adolescents from 12 years of age with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD in the EU. ENSPRYNG is the only subcutaneous treatment option for NMOSD that can be administered at home every four weeks.

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Roots Analysis

JANUARY 14, 2024

In fact, biologics are anticipated to play a significant role in shaping the pharmaceutical industry and will eventually serve as an integral part of traditional medicines. Overview of Biologics Biologics refer to medicinal / therapeutic products that are either manufactured using living organisms or semi-synthesized from biological sources.

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The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase III clinical trial programme for fenebrutinib, an investigational medicine designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, which may offer novel approach to suppress disease activity and slow disease progression in MS.

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Pfizer

DECEMBER 20, 2022

The extension of the NDA review period will not impact the Emergency Use Authorization (EUA) or the current availability of the medicine for eligible patients. 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. In the U.S.,

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XTalks

DECEMBER 19, 2023

One of the key factors in its success is its versatility as it is getting approvals for different types of cancers, especially at the advanced stages where other medicines are no longer working. As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales.

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The Pharma Data

MAY 17, 2023

BTK, also known as tyrosine-protein kinase BTK, is an enzyme that regulates B-cell development and activation and is also involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia. Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

APRIL 27, 2021

They are among the first products certified under the new European In Vitro Diagnostics Regulation (IVDR) and available as of today in countries accepting CE mark. These gold standard biomarkers³ have proven to be successful in supporting cardiovascular disease management and can help clinicians diagnose heart attacks? NT-proBNP).

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XTalks

AUGUST 12, 2020

Despite the effectiveness of anti-retroviral therapy (ART) in significantly improving health, quality of life and reducing mortality among HIV-positive individuals, new research shows that persistent infections may be due to the ability of the virus to take refuge in distinct subsets of immune T cells.

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