Clinical Development, In-Vitro and Regulation

Clinical Development

In-Vitro

Regulation

Pfizer/BioNTech Begin Studies for Third Booster Dose and Development of COVID-19 Vaccine Variants

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.

Vaccine

Vaccine Vaccination Development In-Vitro

Tiziana announces appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer

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. Dr. Graham earned an M.D.,

Life Science

Life Science Antibody In-Vivo In-Vitro

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Bridging Innovation & Patient Care: The Growing Role of AI

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Sosei Heptares to Explore Structure-based Drug Discovery (SBDD) Approaches to Ion Channels through Strategic Technology Collaboration with Metrion Biosciences

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.

Drugs

Drugs Protein In-Vitro Development

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Bridging Innovation & Patient Care: The Growing Role of AI

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Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.

Clinical Trials

Clinical Trials Clinical Trials Trials In-Vitro

Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

FDA Law Blog

OCTOBER 2, 2023

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.

Drugs

Drugs Development Trials In-Vitro

Poxel Announces Additional Positive Phase 2a Results, and Phase 2b Plan for PXL770, an Oral First-in-Class AMPK Activator, in NASH

The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. Selected Clinical Parameters in Patients with Type 2 Diabetes at 12 Weeks.

Trials

Trials In-Vitro Insulin Protein

Roche to present new data in multiple sclerosis and neuromyelitis optica spectrum disorder at MSVirtual2020

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. Roche’s Chief Medical Officer and Head of Global Product Development. Roche’s Chief Medical Officer and Head of Global Product Development.

Clinical Trials

Clinical Trials Clinical Trials Antibody Medicine

Cardiac Biomarkers in Cardiovascular Clinical Trials: Caveats and Considerations

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

Clinical Trials Clinical Trials Trials In-Vitro

New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)

The Pharma Data

SEPTEMBER 9, 2020

Roche’s Chief Medical Officer and Head of Global Product Development. ENSPRYNG lowered relapse severity in double-blind periods of SAkura Phase III studies. Pooled data from SAkura open-label extension (OLE) studies support continued effect of ENSPRYNG reducing risk of relapse in the longer term. ENSPRYNG was recently approved by the U.S.

Antibody

Antibody Medicine In-Vitro HR

Global Roundup: Overland Pharma Launches in China to Provide Access to Breakthrough Therapies

The Pharma Data

DECEMBER 9, 2020

Uniquely positioned in the rapidly evolving local biotech ecosystem in China in addition to an expansive global presence, Overland will strategically partner to jointly develop innovative, novel therapeutics. We look forward to developing and advancing our differentiated pipeline of novel therapeutics in carefully selected disease areas.”.

In-Vivo

In-Vivo In-Vitro Antibody Development

FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

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.

FDA Approval

FDA Approval Antibody Clinical Trials Clinical Trials

CHMP recommends EU approval of Roche’s ENSPRYNG (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD)

The Pharma Data

MAY 18, 2021

Chief Medical Officer and Head of Global Product Development. 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. Preventing these relapses is the primary goal for disease management.

Antibody

Antibody Medicine In-Vitro Development

Emergency Use Authorization request to FDA for VIR-7831 for the early treatment of COVID-19

The Pharma Data

MARCH 26, 2021

Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. GSK and Vir will continue discussions with the European Medicines Agency (EMA) and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible.

Antibody

Antibody Trials Vaccine Vaccination

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development. Section #1: FDA Interactions Given the wide range of sponsors (i.e.,

Gene Therapy

Gene Therapy Gene Production In-Vivo

COVID-19 Pandemic Coverage

XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. And in truth, the companies the White House picked were pretty savvy as several are current front-runners in the race to develop a vaccine. The price of that prize is incalculable.

Vaccine

Vaccine Vaccination Antibody Life Science

Clinical Research Informer

Pfizer/BioNTech Begin Studies for Third Booster Dose and Development of COVID-19 Vaccine Variants

Tiziana announces appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer

Webinars

Trending Sources

Sosei Heptares to Explore Structure-based Drug Discovery (SBDD) Approaches to Ion Channels through Strategic Technology Collaboration with Metrion Biosciences

Webinars

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

Poxel Announces Additional Positive Phase 2a Results, and Phase 2b Plan for PXL770, an Oral First-in-Class AMPK Activator, in NASH

Roche to present new data in multiple sclerosis and neuromyelitis optica spectrum disorder at MSVirtual2020

Cardiac Biomarkers in Cardiovascular Clinical Trials: Caveats and Considerations

New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)

Global Roundup: Overland Pharma Launches in China to Provide Access to Breakthrough Therapies

FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

CHMP recommends EU approval of Roche’s ENSPRYNG (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD)

Emergency Use Authorization request to FDA for VIR-7831 for the early treatment of COVID-19

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

COVID-19 Pandemic Coverage

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