Remove Antibody Remove Containment Remove Drugs Remove Trials
article thumbnail

Regeneron’s Antibody Drug Becomes First Approved Treatment for Ebola

XTalks

The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the world’s first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including newborns of mothers who have tested positive for the virus. Targeted Antiviral Treatment.

article thumbnail

AI-designed monoclonal antibody ‘redirects’ the immune system

Drug Discovery World

Immuno-oncology company Aulos Bioscience has revealed interim results from an ongoing Phase I/II trial of monoclonal antibody AU-007 in solid tumours. AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumours. “In

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Trial of Jazz’ cannabis drug in glioblastoma will start next year

pharmaphorum

An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. Jazz acquired rights to Sativex when it completed its $7.2 billion takeover of Sativex’ developer GW Pharma earlier this year.

Trials 136
article thumbnail

Elrexfio Becomes Pfizer’s First Approved Multiple Myeloma Drug

XTalks

After Johnson & Johnson’s US Food and Drug Administration (FDA) approval last week for its second multiple myeloma bispecific, Talvey (talquetamab), Pfizer received an FDA nod for its B-cell maturation antigen (BCMA)-directed therapy Elrexfio (elranatamab) in the same indication. Elrexfio is Pfizer’s first approved multiple myeloma drug.

article thumbnail

The threat to the integrity of the drug approval process

World of DTC Marketing

IN SUMMARY: Under no circumstances can or should the US drug approval process come under questioning by the press or patients. When people start to doubt the effeciveness of new drugs we all, as a nation, suffer. We need randomized trials to determine if there is any benefit and, if so, what is the magnitude of benefit.

Drugs 278
article thumbnail

Merck wins regulatory approval for combination therapy to treat la/mUC

Pharmaceutical Technology

Merck has secured approval from the US Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for first-line treatment of some adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). The trial was jointly conducted by Seagen and Astellas.

Antibody 130
article thumbnail

The ABCs of Transitioning PK Assays from Preclinical to Clinical

Worldwide Clinical Trials

Ensuring a seamless transition from preclinical to clinical stages in large molecule bioanalysis will help you reach crucial trial milestones on time and within budget. Preclinical assays designed to assess drug toxicity and safety must detect total drug. anti-human IgG).

Reagent 130