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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. All our equipment is in line with the latest European Medicines Agency (EMA) and FDA methods.

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Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We Animals were administered molnupiravir for longer and at higher doses (mg/Kg) than those employed in human studies. About Molnupiravir.

Trials 69
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PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

IBRANCE may impair fertility in males and has the potential to cause genotoxicity. At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Advise male patients to consider sperm preservation before taking IBRANCE.

HR 52
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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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Moving off the critical path: Streamlining strategies for drug substance synthesis and manufacturing

Pharmaceutical Technology

From a customer perspective, this means that we are able to pursue more innovative solutions, reducing overall costs and getting new medicines to market faster.". In summary, there are many challenges and considerations that drug developers must be aware of before kicking off their drug substance program.

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Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

The Pharma Data

“Women with triple-negative breast cancer have historically had very few effective treatment options and faced a poor prognosis,” said Aditya Bardia, MD, MPH, Director of Breast Cancer Research Program, Mass General Cancer Center and Assistant Professor of Medicine at Harvard Medical School, and global principal investigator of the ASCENT study.

HR 52