Remove Antibody Remove Hormones Remove In-Vitro Remove Protein
article thumbnail

Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

Recombinant therapeutic proteins. Fusion proteins. Monoclonal antibodies (mAbs). In vitro binding assays and functional tests might be required to identify the test material which is pharmacologically active , and a potency assay is required due to the complexity and heterogeneity of biologics. Growth factors.

article thumbnail

Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer

The Pharma Data

Safety for the Tecentriq combination appeared to be consistent with the known safety profile of the individual medicines, and no new safety signals were identified. Roche’s Chief Medical Officer and Head of Global Product Development. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

Insiders

Sign Up for our Newsletter

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

article thumbnail

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer

The Pharma Data

The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts, though the recommendations are not binding. The FDA has not announced when it will make its final decision for Tecentriq in this indication. Roche’s Chief Medical Officer and Head of Global Product Development.

article thumbnail

News from AACR 2024: Wednesday’s highlights

Drug Discovery World

The company reported that these data further support the combination of nab-sirolimus with endocrine therapy for hormone-driven cancers, as is currently being investigated in patients with advanced or recurrent endometrioid endometrial cancer in a Phase II study. And thanks to the city of San Diego for its hospitality.”

HR 52
article thumbnail

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020

The Pharma Data

New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers. New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. Join this event on Roche’s LinkedIn page here. Roche highlights featured at ESMO Virtual Congress 2020.

HR 52
article thumbnail

Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020

The Pharma Data

Data from the Phase III IMpassion031 study demonstrated that Tecentriq in combination with chemotherapy improved pathological complete response for patients with early triple-negative breast cancer (TNBC), when compared to placebo plus chemotherapy. Roche’s Chief Medical Officer and Head of Global Product Development. from 41.1% (95% CI: 33.6–48.9)

HR 52
article thumbnail

Pfizer Responds to Research Claims

Pfizer

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. 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.

Research 112