Camargo

APRIL 20, 2021

Sponsors can select the patient population and leverage companion diagnostics, and nonclinical study requirements such as genotoxicity and carcinogenicity studies can often be waived or delayed to later stages of development, especially for end-stage cancer therapies. A strong IP position. Secure the Right Development and Regulatory Partners.

Development 137

Development Genotoxicity Production Drugs 137

The Pharma Data

FEBRUARY 8, 2021

Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% IBRANCE may impair fertility in males and has the potential to cause genotoxicity. DISCLOSURE NOTICE : The information contained in this release is as of February 5, 2021. of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1%

HR 52

HR Clinical Trials Clinical Trials Containment 52

The Pharma Data

APRIL 14, 2021

Accelerated Approval Granted for Locally Advanced or Metastatic Urothelial Cancer Following a Platinum-Containing Chemotherapy and a PD-1/PD-L1 Inhibitor –. – New Indication Marks Second FDA Approval for Trodelvy in 2021 –. Continued approval is contingent upon verification and description of clinical benefit in a confirmatory trial.

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52

The Pharma Data

MARCH 25, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. SG contains a genotoxic component and can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. About the ASCENT Study. Embryo-Fetal Toxicity.

Genotoxicity 52

Genotoxicity Genotype Containment Protein 52

The Pharma Data

MAY 13, 2021

Fructose Containing Sugars at Normal Levels of Consumption Do Not Effect Adversely Components of the Metabolic Syndrome and Risk Factors for Cardiovascular Disease. Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. Arq Gastroenterol. 2014 AprJun;51(2):118-22. PMID: 25003263.

Insulin 52

Insulin Production Hormones Medicine 52

The Pharma Data

APRIL 7, 2021

The Phase 3 ASCENT study, an open-label, active-controlled, randomized confirmatory trial, enrolled more than 500 patients with relapsed/refractory metastatic triple-negative breast cancer (TNBC) who had received two or more prior systemic therapies (including a taxane), at least one of them for metastatic disease. About the ASCENT Study.

HR 52

HR Genotype FDA Approval Genotoxicity 52