Clinical Development, In-Vitro, Regulation and Trials

Conversations from ESMO Targeted Anticancer Therapies Congress 2024

Drug Discovery World

MARCH 26, 2024

DDW’s Megan Thomas caught up with Oliver Rausch, Chief Scientific Officer at Storm Therapeutics, following the ESMO Targeted Anticancer Therapies Congress 2024, a global meeting focusing on promising new anticancer targets and agents, focusing on those in early phase clinical development. MT: What’s next for STORM’s research?

RNA

RNA In-Vivo In-Vitro DNA

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

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.

Vaccination

Vaccination Vaccine Development In-Vitro

Expert view: What’s next for cell and gene therapy?

Drug Discovery World

MAY 16, 2023

Skills gap Bruce Levine, International Society for Cell & Gene Therapy (ISCT) Immediate Past President and Chair, Strategic Advisory Council, says a critical challenge that has become apparent for the CGT sector is the need for workforce development and training resources. What are the global innovations in cell and gene therapy?

Gene Therapy

Gene Therapy Gene Manufacturing Marketing

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

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

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

Trials In-Vitro Insulin Protein

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

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

FDA Approval

FDA Approval Antibody Clinical Trials Clinical Trials

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

The Achilles’ heel of cancer

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

Protein Immune Response In-Vitro Regulation

The evolution of assays for immuno-oncology research

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

Research In-Vitro In-Vivo Development

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

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.

Antibody

Antibody Trials Vaccination Vaccine

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

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

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.

Vaccination

Vaccination Vaccine Antibody Life Science

Clinical Research Informer

Conversations from ESMO Targeted Anticancer Therapies Congress 2024

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

Trending Sources

Expert view: What’s next for cell and gene therapy?

Cardiac Biomarkers in Cardiovascular Clinical Trials: Caveats and Considerations

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

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

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

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 Achilles’ heel of cancer

The evolution of assays for immuno-oncology research

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

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

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

COVID-19 Pandemic Coverage

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