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Expert consortium comment on FDA report on risk of T-cell malignancy  

Drug Discovery World

These therapies, which exhibit substantial long-term side effects, including genotoxicity and an increased predisposition to secondary cancers, have significantly higher rates of subsequent malignancies than the rate reported for patients following CAR-T cell immunotherapies.

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IN FOCUS: Solvias

Pharmaceutical Technology

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict. Quality control release testing.

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The Future for Biotesting

Pharmaceutical Technology

was established in 1999 in the process of privatisation of the State Research Institute for Pharmacy and Biochemistry in the Czech Republic. ” New projects we have been involved with have helped the company to accelerate its development in the field of pre-clinical research. .” Dr Ivana Surovà: Biotest s.r.o.

In-Vitro 130
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Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

Container closure systems are highly regulated by health agencies. USP and EP Organizations for Container Regulation. If they do, the FDA will assume the worst-case scenario and deem the compound or fragment to be genotoxic or eugenic. shaking, changes in pressure, etc.). Requirements for Primary Packaging Components.

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FIRST-LINE IBRANCE® (PALBOCICLIB) COMBINATION THERAPY IN HR+, HER2- METASTATIC BREAST CANCER

The Pharma Data

These findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research. lead researcher and Professor in Breast Cancer Excellence in the Perelman School of Medicine at the University of Pennsylvania.

HR 52
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PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. This extension does not include potential pediatric exclusivity. About IBRANCE® (palbociclib) 125 mg tablets and capsules.

HR 52
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Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

While the discovery phase – which includes target discovery, target validation, lead compound identification, and lead compound optimisation – averages several years and $200 million, the majority of the research, time, and financial spend takes place downstream in drug development.