Bristol-Myers scored FDA approval for its cancer immunotherapy Opdivo (nivolumab) three months ahead of schedule, setting it up for a head-to-head contest against Merck's recent debut in the same class, Keytruda.
Bristol-Myers Squibb has won a pioneering FDA approval for Opdivo (nivolumab), its top therapeutic asset in the pipeline, as a new therapy for melanoma.
Merck's new PD-1 cancer drug Keytruda (pembrolizumab) has posted another round of positive early-stage results that help demonstrate its potential in an important cancer R&D arena: hematology. But some of the biggest players and punters in the immuno-oncology field may be left wondering if Merck's top therapeutic hopeful is losing market ground to Bristol-Myers Squibb's rival treatment.
GlaxoSmithKline's bribery scandal in China has changed the way drugmakers do business there. For Bristol-Myers Squibb, it means a smaller structure, with much of the shrinkage coming in the sales ranks.
Western drugmakers were pretty head-over-heels about prospects in China until authorities launched a bribery probe against GlaxoSmithKline which dragged on for a year and ended with a half billion dollar fine and people going to jail. That has left drugmakers to rethink their strategies there and for Bristol-Myers Squibb it means cutting hundreds off its payroll.
The FDA has slapped down Bristol-Myers Squibb's closely watched hep C drug daclatasvir, handing out a complete response letter for the linchpin drug in its cocktail strategy.
Bristol-Myers Squibb announced a new project in Ireland earlier this month, followed by Amgen's completion of a continuous processing facility in Singapore. Now AstraZeneca says it needs more biologics capacity and will spend in excess of $200 million to build out a facility in Maryland.
Bristol-Myers Squibb has signed a deal with Five Prime Therapeutics to determine whether a combination of its star immuno-oncology contender and the biotech's antibody can make a difference in a range of cancers.
Bristol-Myers Squibb, having already expanded its U.S. production to make more biologics with its facility in Devens, MA, will now erect its twin in Ireland, a 320,000-square-foot facility adjacent to a bulk manufacturing facility in Dublin.
Bristol-Myers Squibb has pulled the covers off of impressive Phase III data on Opdivo (nivolumab), pointing to a 73% survival rate among advanced melanoma patients after one year of therapy compared to 42% for the long-used chemo drug dacarbazine.