Current Issue

Quality-by-Design in Spray Drying Processes – Transfer from Lab to Production

Dr. Sune Klint Andersen, Scientific Associate Director, Johnson & Johnson Innovative M...

Current and Future Applications of Near-Infrared Spectroscopy in Pharmaceutical and Biopha...

Erik Skibsted, Principal Scientist, Novo Nordisk

Reliable Cell Product Characterization by Flow Cytometry

Ruud Hulspas, Ph.D., Technical Director Process Development, Dana-Farber Cancer Institute,...


Featured Articles

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

Choice of Upstream Bioreactor Technologies for Industrial Scale Viral Manufacturing (White Paper USD3244)

Pall Corporation

Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins

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.

View All Featured Articles

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

View All Careers Articles

Headline News

Novo Nordisk secures EU regulatory approval to streamline Wegovy distribution, paving way for broader home delivery


AstraZeneca’s Alexion unit set to showcase broad rare disease data at AAN 2026


Spyre Therapeutics showcases positive phase 2 data for SPY001 in ulcerative colitis, opening enrolment for combination cohorts


Read All Headlines

Upcoming Webinars

View All Upcoming Webinars

Past Webinars

Advanced Raman Spectroscopy Beyond In-Process Glucose Control of Commercial Cell Culture Processes

Presented by Dan Hill, Manufacturing Scientist at Biogen and Maryann Cuellar, Life Science Product Manager at Kaiser Optical Systems, Inc.
03rd June 2020


Understanding the Propensity of Sequence Variants During Cell Line and Culture Process Development

Presented by Dr. Lisa Marzilli, Associate Research Fellow and group leader at Pfizer, USA
18th March 2019


Continuous Manufacturing: Business Case Drivers and Deployment Strategies

Presented by Lawrence De Belder, Senior Principal Engineer Continuous Manufacturing at Johnson and Johnson and Richard Steiner, Business Development Manager at GEA Group
26th February 2019


View All Past Webinars

Featured Companies

 

View All Companies

© 2026 biopharma-asia.com. All rights reserved. Privacy Policy

Biopharma Asia