Featured Articles

Trends in Single-Use Mixing Technologies and Insight into Pall and Lonza Ibex® Solutions

Scheduling and Optimization of Biomanufacturing Activities in Multi-product Facilities with Disposable Technologies

Gloria Gadea-Lopez, Ph.D. is Director of Production and Business Systems at the Shire Lexington, John Maguireis the Associate Director of Manufacturing Systems at Shire’s Lexington and Megan Rabideau is a Manufacturing Systems Engineer at Shire’s Lexington

Bristol Myers Squibb adopts positive CHMP opinion for Opdivo plus Yervoy for patients with Microsatellite instability high or mismatch repair deficient metastatic colorectal cancer

Bristol Myers Squibb has announced that the CHMP of the EMA has recommended approval of Opdivo  plus Yervoy for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient unresectable or metastatic colorectal cancer. Of significance, the CheckMate -8HW trial results showed reduction in the risk of disease progression or death by 79%  compared to chemotherapy in this patient population.

“Approximately 5-7% of metastatic colorectal cancer patients have dMMR or MSI-H tumors, and current treatment options often do not provide sufficient benefit,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. “This is the first dual checkpoint inhibitor treatment for first-line metastatic colorectal cancer, delivering a transformative benefit for MSI-H/dMMR patients in this population. We are focused on bringing Opdivo plus Yervoy to these patients in the European Union and look forward to EC’s upcoming decision.”

Note that, the positive opinion is based on results from the CheckMate -8HW trial, which were presented at medical congresses earlier this year. These data formed the basis for the Company’s Type II variation application, which was validated by the EMA In the study, Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoint of progression-free survival compared to the investigator’s choice of chemotherapy as assessed by Blinded Independent Central Review.

Volume Reduction and Process Optimization with Cadence Inline Concentrator

Careers

Delivering Better Outcomes for Patients Starts with Creating a Workplace Where all Colleagues Can Thrive

Ahmed Elhusseiny, Roche Pharmaceuticals, Area Head, Asia Pacific

Amgen is a Company that Cares about People, I Feel Genuinely Listened to Here

Jason Rudd, Amgen, Statistical Programming Manager

Inspiring the Next Generation at Bristol Myers Squibb

Elizabeth Jurica, Bristol Myers Squibb, Principal Scientist

A Great Working Atmosphere, Strong Collegial Relationships, and Opportunities to Grow at Lonza

Vijetha Bhat, Lonza, Houston,Texas, Scientist, Research and Development

At Bayer We Foster an Environment of Openness and Understanding Not Pity

Jürgen Schrapp, Bayer, Head of R&D Procurement

The Best Thing About Evotec, Without Question, Is The People

Stuart Flanagan, Evotec, Group Leader