XTalks

APRIL 18, 2024

There are currently no FDA-authorized blood tests for detecting Alzheimer’s disease. The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

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. Andrew Busey , Co-Founder, Form Bio discusses why vertical AI is set to reshape the cell and gene therapy sector. Here’s what this means for pharmaceutical leaders and patients.

Gene Therapy 64

Gene Therapy Gene In-Vitro Development 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. Join us as we explore the inspiring journey and significant contributions of these top 10 medical device companies.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

The Pharma Data

SEPTEMBER 9, 2020

ENSPRYNG was recently approved by the U.S. Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. Ongoing data continues to show a favourable safety profile for ENSPRYNG.

Antibody 52

Antibody Medicine HR In-Vitro 52

pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed.

Antibody 52

Antibody Immune Response Production Engineer 52

Pfizer

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., In addition, to meet U.S. and around the world.

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

MAY 18, 2021

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding.

Medicine 52

Medicine Containment In-Vitro Development 52

The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

Medicine 40

Medicine In-Vitro Antibody Development 40

The Pharma Data

AUGUST 31, 2020

Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S.

FDA Approval 52

FDA Approval In-Vitro Antibody Medicine 52

The Pharma Data

JANUARY 6, 2021

Studies Show Cyto-111 Enables Delivery of Antibodies to Previously Inaccessible Intraneuronal Targets without the need for a Viral Vector or Transfection. The complete text of the article titled, “Neuronal Delivery of Antibodies has Therapeutic Effects in Animal Models of Botulism,” can be found h e re. NEW YORK, Jan.

Medicine 52

Medicine Antibody Protein In-Vitro 52

The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Medicine 52

The Pharma Data

SEPTEMBER 10, 2020

OCREVUS is the first and only treatment approved for both relapsing MS (RMS) and primary progressive MS (PPMS) and now more than 170,000 people have been treated with OCREVUS globally in clinical trial and real-world settings; favourable benefit-risk profile remains consistent over 7 years. Separate data from a U.S. and more than 2.3

In-Vitro 52

In-Vitro FDA Approval Medicine Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Roche’s Chief Medical Officer and Head of Global Product Development. “We

Clinical Trials 52

Clinical Trials Clinical Trials Trials Medicine 52

The Pharma Data

MAY 4, 2021

Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Billion and Adjusted Diluted EPS (2) to a Range of $3.55 Now Anticipates Revenues of Approximately $26 Billion for BNT162b2, Reflecting 1.6 Billion Doses Expected to be Delivered in 2021 Under Signed Contracts as of Mid-April 2021. per share amounts). Reported Diluted EPS (1).

Vaccination 40

Vaccination Vaccine Production Sales 40