The U.S. FDA hit a Phoenix-based Abraxis Biosciences LLC facility with a warning letter citing out-of-control aseptic manufacturing processes for Abraxane (paclitaxel), a key chemotherapy drug. The letter, posted Nov. 8, noted that multiple media fill failures occurred last year during simulated aseptic processing operations on the Abraxane filling line.
Beigene Ltd., which in 2019 parlayed exclusive rights to distribute and promote Abraxane (paclitaxel) in China into more than $111 million in revenue, is contesting Celgene parent Bristol Myers Squibb Co.’s cancellation of the deal in arbitration proceedings at the International Chamber of Commerce.
Beigene Ltd., which in 2019 parlayed exclusive rights to distribute and promote Abraxane (paclitaxel) in China into more than $111 million in revenue, is contesting Celgene parent Bristol Myers Squibb Co.’s cancellation of the deal in arbitration proceedings at the International Chamber of Commerce.
Attributing recent reductions in certain U.S. prescription drug prices to intense congressional scrutiny rather than a biopharma industry commitment to affordability, Rep. John Sarbanes (D-Md.) said Congress must put more guardrails in place and restructure how the industry does business.
Rather than the in-your-face, blame-and-shame show that was expected, the Sept. 30 drug pricing hearing before the U.S. House Oversight Committee was more a reminder of the policy differences between Democrats and Republicans on how best to make prescription drugs more affordable.
Barely a day after its PDUFA date, despite the unfolding COVID-19 pandemic, the FDA has approved Bristol Myers Squibb Co.'s immunomodulator, ozanimod, an oral treatment for adults with relapsing-remitting multiple sclerosis (MS) and active secondary progressive disease branded as Zeposia.
Three candidates for FDA approval remain on BioWorld’s Drugs on Deck list for March, all of which have PDUFA dates scheduled for this month, even though most of the agency’s attention as of late is on the COVID-19 pandemic.
SAN DIEGO – At Biocom's 10th Annual Global Life Sciences Partnering Conference, a panel of players intimately familiar with last year's approval of myelofibrosis treatment Inrebic (fedratinib) explained the backstory of how they got the JAK2 kinase inhibitor off an FDA clinical hold, wrangled the rights to the drug back from the big pharma owner that had acquired the drug from Targegen Inc. and eventually helped the drug gain FDA approval after selling the rights to another large company.
SAN FRANCISCO – Atop the stage where, just a year ago, he'd detailed the then-new $74 billion acquisition of Celgene Corp, Bristol-Myers Squibb Co. CEO Giovanni Caforio told attendees of this year's J.P. Morgan Healthcare Conference he intends to plunge ahead with "the agility and speed of a biotech company."
