Three days after Bristol-Myers Squibb filed for FDA approval of the NS5A drug daclatasvir combined with asunaprevir, an NS3 protease inhibitor, the biotech company has turned over some of the Phase III cards it will be playing for an approval in markets around the world.
As Roche, Bristol-Myers Squibb and Merck race to the market with promising immunotherapies for advanced melanoma, analysts' sky-high sales estimates for the new drug class may soon have to reckon with revenue-slashing competition and pricing pressures.
What does $190 million in R&D spending get you? In the case of Alder Biopharmaceuticals, it got a blockbuster $1.35 billion development deal with Bristol-Myers Squibb and an in-house migraine drug headed into a Phase IIb study. It also takes the biotech to the threshold of an IPO it detailed today, which is designed to raise $115 million to fund operations through 2015.
When Bristol-Myers Squibb and Pfizer launched their new anticoagulant, Eliquis, early last year, Wall Street analysts predicted it would be a $3-billion-a-year blockbuster. After more than a year of struggling to reach that goal, the companies got some good news late Friday, when the FDA approved the drug to reduce the risk of blood clots in the legs and lungs following hip or knee replacement surgery.
Bristol-Myers Squibb, a leader in the race to develop new immuno-oncology therapies, is pairing up with Five Prime Therapeutics to come up with a second set of cancer therapies that target two undisclosed immune checkpoint pathways in a deal worth up to $350 million.
Ireland's liberal tax code continues to attract drugmakers, but some of the long-term players are cutting back on their extensive manufacturing there. Bristol-Myers Squibb, with plans to lay off about 160 workers at two facilities, can now be added to that list.
Bristol-Myers Squibb turned in improved financial results last year, in part by cutting costs after refining its focus, like its decision to drop its diabetes drug development partnership with AstraZeneca. The drugmaker is continuing that trend by tightening its manufacturing operations in Ireland and cutting about 160 jobs.
According to new research published online Monday at the Journal of Clinical Oncology, 63% of the patients taking the immunotherapy were alive after one year and 43% were still alive after two years on the drug. And the researchers say that the durable response was also reflected in patients who had stopped taking the drug.
Is Pfizer and Bristol-Myers Squibb's Eliquis really safer than its competitors? A recent analysis of FDA adverse events reports suggested that it is.
Bristol-Myers Squibb has picked up its second "breakthrough" drug designation for a daclatasvir-based, all-oral combo for hepatitis C from the FDA, potentially shaving some regulatory time off its late-stage program as developers scramble to hijack market share from Gilead's pioneering approach.