The days when paclitaxel was the subject of controversy in connection with peripheral artery disease (PAD) seem to be drawing to a close, thanks in part to a new drug-coated balloon (DCB) by Trireme Medical Inc., of Pleasanton, Calif. Trireme’s Chocolate Touch device, a second-generation DCB with paclitaxel as an antiproliferative, fared well against a legacy paclitaxel device, thus opening a new front in the competition in the PAD space and seemingly relieving any concerns about the safety of paclitaxel.
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.
In a recent study, researchers led by Beth Weaver from the University of Wisconsin, Madison (UW-M) show that paclitaxel treatment in breast cancer patients increased cell division with chromosome missegregation to induce cytotoxicity.
The controversy over the use of paclitaxel in devices for the peripheral vasculature has taken a significant bite out of sales, but a new study serves to help reverse the narrative regarding mortality. According to a study of more than 168,000 Medicare patients, stents and angioplasty balloons coated with paclitaxel (PTX) were non-inferior to non-coated devices for mortality out to nearly three years, a finding that may encourage clinicians to return to normal utilization patterns and thus help to restore sales volumes.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: BD offers little detail in reaction to advisory hearing; FDA invites stakeholders to user fee negotiations; MHRA wary of paclitaxel.
The storm of controversy over the use of paclitaxel in devices for the peripheral vasculature had a dramatic effect on utilization, but a new study coming out of Sweden seems to have helped further ease concerns about purported mortality associated with this antiproliferative. While this unplanned interim analysis lends yet more support to the view that the mortality signal in the so-called Katsanos paper did not reflect a true biological finding, the net effect of the controversy has prompted a call for a registry that might eliminate some statistical noise that had a significant and harmful impact on patients.
Christmas arrived early for Athenex Inc. as the FDA approved Klisyri (tirbanibulin) for treating actinic keratosis on the face or scalp nearly two weeks before the treatment’s PDUFA date.
The drug-eluting balloon (DEB) has not displaced the drug-eluting stent (DES) for treatment of infarcts, but that may be changing with the results of the PICCOLETO II study.
Boston Scientific Corp. has scooped up an approval from the U.S. FDA for the Ranger drug-coated balloon to help those with peripheral artery disease in the superficial femoral artery and proximal popliteal artery.
